Packaging for terminally sterilized medical devices -- Guidance on the application of ISO 11607-1 and ISO 11607-2

This document provides guidance for the application of the requirements contained in ISO 11607-1 and ISO 11607-2. It does not add to, or otherwise change, the requirements of ISO 11607-1 and ISO 11607-2. This is an informative document, not normative. It does not include requirements to be used as basis of regulatory inspection or certification assessment activities. The guidance can be used to better understand the requirements of ISO 11607-1 and ISO 11607-2 and illustrates the variety of methods and approaches available for meeting the requirements of those International Standards. It is not required that this document be used to demonstrate conformity with them. Guidance is given for evaluation, selection and use of packaging materials, preformed sterile barrier systems, sterile barrier systems and packaging systems. Guidance on validation requirements for forming, sealing and assembly processes is also given. This document provides information for both healthcare facilities and the medical devices industry for terminally sterilized medical devices. This document does not provide guidance for applications of packaging materials and systems after their opening. In the use of packaging for other purposes such as a “sterile field” or transport of contaminated items, other regulatory standards will apply.

Emballages des dispositifs médicaux stérilisés au stade terminal -- Lignes directrices relatives à l'application de l'ISO 11607-1 et l'ISO 11607-2

Le présent document fournit des recommandations pour l’application des exigences énoncées dans l’ISO 11607-1 et dans l’ISO 11607-2. Il ne complète ni ne modifie en aucune manière les exigences de l’ISO 11607-1 et de l’ISO 11607-2. Le présent document est informatif, et non normatif. Il n’inclut pas d’exigence à utiliser comme base pour les activités d’inspection réglementaire ou d’évaluation pour certification. Le présent document d’orientation peut servir à mieux comprendre les exigences de l’ISO 11607-1 et de l’ISO 11607-2, ainsi qu’à illustrer la diversité des méthodes et approches possibles pour satisfaire aux exigences de ces Normes internationales. Il n’est pas nécessaire que le présent document soit utilisé pour démontrer la conformité avec ces dernières. Des recommandations sont fournies pour l’évaluation, la sélection et l’utilisation des matériaux d’emballage, des systèmes de barrière stérile préformés, des systèmes de barrière stérile et des systèmes d’emballage. Des recommandations relatives aux exigences en matière de validation pour les procédés de formage, de scellage et d’assemblage sont également fournies. Le présent document fournit des informations à la fois pour les établissements de santé et l’industrie des dispositifs médicaux concernant les dispositifs médicaux soumis à une stérilisation terminale. Le présent document ne fournit pas de recommandation pour les applications des matériaux et systèmes d’emballage après leur ouverture. D’autres normes réglementaires s’appliquent dans le cadre de l’utilisation d’emballage à d’autres fins, telles que le « champ stérile » ou le transport d’articles contaminés.

General Information

Status
Published
Publication Date
04-Nov-2021
Current Stage
6000 - International Standard under publication
Start Date
05-Nov-2021
Ref Project

RELATIONS

Buy Standard

Technical specification
ISO/TS 16775:2021 - Packaging for terminally sterilized medical devices -- Guidance on the application of ISO 11607-1 and ISO 11607-2
English language
143 pages
sale 15% off
Preview
sale 15% off
Preview
Technical specification
ISO/TS 16775:2021 - Emballages des dispositifs médicaux stérilisés au stade terminal -- Lignes directrices relatives à l'application de l'ISO 11607-1 et l'ISO 11607-2
French language
153 pages
sale 15% off
Preview
sale 15% off
Preview
Draft
ISO/PRF TS 16775:Version 18-apr-2021 - Packaging for terminally sterilized medical devices -- Guidance on the application of ISO 11607-1 and ISO 11607-2
English language
142 pages
sale 15% off
Preview
sale 15% off
Preview

Standards Content (sample)

TECHNICAL ISO/TS
SPECIFICATION 16775
Second edition
2021-11
Packaging for terminally sterilized
medical devices — Guidance on the
application of ISO 11607-1 and ISO
11607-2
Emballages des dispositifs médicaux stérilisés au stade terminal —
Lignes directrices relatives à l'application de l'ISO 11607-1 et l'ISO
11607-2
Reference number
ISO/TS 16775:2021(E)
© ISO 2021
---------------------- Page: 1 ----------------------
ISO/TS 16775:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on

the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below

or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
© ISO 2021 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/TS 16775:2021(E)
Contents Page

Foreword ......................................................................................................................................................................................................................................vii

Introduction ...........................................................................................................................................................................................................................viii

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ..................................................................................................................................................................................... 1

3 Terms and definitions .................................................................................................................................................................................... 1

4 Guidance on Clauses 1-4 of ISO 11607-1:2019 and ISO 11607-2:2019 ..........................................................2

4.1 Scope (ISO 11607-1:2019, Clause 1 and ISO 11607-2:2019, Clause 1)..................................................... 2

4.1.1 Intent ............................................................................................................................................................................................. 2

4.1.2 Guidance .................................................................................................................................................................................... 2

4.2 Normative references (ISO 11607-1:2019, Clause 2 and ISO 11607-2:2019, Clause 2) ............ 3

4.2.1 Intent ............................................................................................................................................................................................. 3

4.2.2 Guidance .................................................................................................................................................................................... 3

4.3 Terms and definitions (ISO 11607-1:2019, Clause 3 and ISO 11607-2:2019, Clause 3) ........... 4

4.3.1 Intent ............................................................................................................................................................................................. 4

4.3.2 Guidance .................................................................................................................................................................................... 4

4.4 Quality and risk management (ISO 11607-1:2019, 4.1, 4.2 and ISO 11607-2:2019,

4.1, 4.2) .......................................................................................................................................................................................................... 4

4.4.1 Intent ............................................................................................................................................................................................. 4

4.4.2 Guidance .................................................................................................................................................................................... 4

4.5 Sampling (ISO 11607-1:2019, 4.3 and ISO 11607-2:2019, 4.3) ...................................................................... 6

4.5.1 Intent ............................................................................................................................................................................................. 6

4.5.2 Guidance .................................................................................................................................................................................... 6

4.6 Test methods (ISO 11607-1:2019, 4.4 and ISO 11607-2:2019, 4.4) ............................................................ 7

4.6.1 Intent ............................................................................................................................................................................................. 7

4.6.2 Guidance .................................................................................................................................................................................... 7

4.7 Documentation (ISO 11607-1:2019, 4.5 and ISO 11607-2:2019, 4.5) ...................................................... 9

4.7.1 Intent ............................................................................................................................................................................................. 9

4.7.2 Guidance .................................................................................................................................................................................... 9

5 Guidance on Clauses 5-11 of ISO 11607-1:2019 .................................................................................................................10

5.1 General requirements for materials, preformed sterile barrier systems and sterile

barrier systems (ISO 11607-1:2019, 5.1.1 and 5.1.2) ......................................................................................... 10

5.1.1 Intent .......................................................................................................................................................................................... 10

5.1.2 Guidance ................................................................................................................................................................................. 10

5.2 Conditions for production and handling (ISO 11607-1:2019, 5.1.3 and 5.1.4) ............................. 10

5.2.1 Intent .......................................................................................................................................................................................... 10

5.2.2 Guidance ................................................................................................................................................................................. 10

5.3 Source, history and traceability of materials (ISO 11607-1:2019, 5.1.5) ......................................... 11

5.3.1 Intent .......................................................................................................................................................................................... 11

5.3.2 Guidance ................................................................................................................................................................................. 11

5.4 Properties to be evaluated (ISO 11607-1:2019, 5.1.6) ......................................................................................12

5.4.1 Intent .......................................................................................................................................................................................... 12

5.4.2 Guidance .................................................................................................................................................................................12

5.5 General performance requirements for materials (ISO 11607-1:2019, 5.1.7 and

5.1.8) ............................................................................................................................................................................................................. 12

5.5.1 Intent ..........................................................................................................................................................................................12

5.5.2 Guidance .................................................................................................................................................................................13

5.6 Additional requirements for sterile barrier systems and preformed sterile barrier

systems (ISO 11607-1:2019, 5.1.9) ...................................................................................................................................... 16

5.6.1 Intent .......................................................................................................................................................................................... 16

5.6.2 Guidance ................................................................................................................................................................................. 16

5.7 Reusable sterile barrier systems (ISO 11607-1:2019, 5.1.10, 5.1.11 and 5.1.12) ....................... 17

5.7.1 Intent .......................................................................................................................................................................................... 17

iii
© ISO 2021 – All rights reserved
---------------------- Page: 3 ----------------------
ISO/TS 16775:2021(E)

5.7.2 Guidance ................................................................................................................................................................................. 17

5.8 Microbial barrier properties (ISO 11607-1:2019, 5.2) ...................................................................................... 17

5.8.1 Intent .......................................................................................................................................................................................... 17

5.8.2 Guidance ................................................................................................................................................................................. 17

5.9 Compatibility with the sterilization process (ISO 11607-1:2019, 5.3) ............................................... 18

5.9.1 Intent .......................................................................................................................................................................................... 18

5.9.2 Guidance ................................................................................................................................................................................. 18

5.10 Labelling system (ISO 11607-1:2019, 5.4) ................................................................................................................... 19

5.10.1 Intent .......................................................................................................................................................................................... 19

5.10.2 Guidance ................................................................................................................................................................................. 19

5.11 Storage and transport of materials and preformed sterile barrier systems

(ISO 11607-1:2019, 5.5) ................................................................................................................................................................ 21

5.11.1 Intent .......................................................................................................................................................................................... 21

5.11.2 Guidance ................................................................................................................................................................................. 21

5.12 Design and development (ISO 11607-1:2019, 6.1.1) ............................................................................................ 22

5.12.1 Intent .......................................................................................................................................................................................... 22

5.12.2 Guidance .................................................................................................................................................................................22

5.13 Aseptic presentation (ISO 11607-1:2019, 6.1.2) ..................................................................................................... 23

5.13.1 Intent .......................................................................................................................................................................................... 23

5.13.2 Guidance ................................................................................................................................................................................. 23

5.14 Physical protection (ISO 11607-1:2019, 6.1.3 and 6.1.4) ................................................................................ 24

5.14.1 Intent .......................................................................................................................................................................................... 24

5.14.2 Guidance ................................................................................................................................................................................. 24

5.15 Sterilization compatibility (ISO 11607-1:2019, 6.1.5) ....................................................................................... 25

5.15.1 Intent .......................................................................................................................................................................................... 25

5.15.2 Guidance ................................................................................................................................................................................. 25

5.16 Maintenance of Sterility (ISO 11607-1:2019, 6.1.6 and 6.1.7) .................................................................... 25

5.16.1 Intent .......................................................................................................................................................................................... 25

5.16.2 Guidance ................................................................................................................................................................................. 25

5.17 Requirements for multi-layer packaging (ISO 11607-1:2019, 6.1.8) .................................................... 26

5.17.1 Intent .......................................................................................................................................................................................... 26

5.17.2 Guidance ................................................................................................................................................................................. 26

5.18 Packaging families (ISO 11607-1:2019, 6.1.9) .......................................................................................................... 27

5.18.1 Intent .......................................................................................................................................................................................... 27

5.18.2 Guidance ................................................................................................................................................................................. 27

5.19 Design process (ISO 11607-1:2019, 6.2.1) ....................................................................................................................28

5.19.1 Intent ..........................................................................................................................................................................................28

5.19.2 Guidance .................................................................................................................................................................................29

5.20 Design inputs (ISO 11607-1:2019, 6.2.2 and 6.2.3)..............................................................................................29

5.20.1 Intent .......................................................................................................................................................................................... 29

5.20.2 Guidance .................................................................................................................................................................................29

5.21 Sterile fluid path (ISO 11607-1:2019, 6.2.4, 6.2.5) ............................................................................................... 31

5.21.1 Intent .......................................................................................................................................................................................... 31

5.21.2 Guidance ................................................................................................................................................................................. 31

5.22 Usability evaluation for aseptic presentation (ISO 11607-1:2019, 7.1, 7.2 and 7.3) ................ 32

5.22.1 Intent .......................................................................................................................................................................................... 32

5.22.2 Guidance ................................................................................................................................................................................. 32

5.23 Leveraging usability evaluations (ISO 11607-1:2019, 7.4) ............................................................................ 33

5.23.1 Intent .......................................................................................................................................................................................... 33

5.23.2 Guidance ................................................................................................................................................................................. 33

5.24 Usability evaluation failures (ISO 11607-1:2019, 7.5) ....................................................................................... 33

5.24.1 Intent .......................................................................................................................................................................................... 33

5.24.2 Guidance ................................................................................................................................................................................. 33

5.24.3 Guidance on formative and summative studies ..................................................................................34

5.25 Packaging system performance and stability (ISO 11607-1:2019, 8.1) ............................................. 35

5.25.1 Intent .......................................................................................................................................................................................... 35

5.25.2 Guidance ................................................................................................................................................................................. 35

5.26 Packaging system performance testing (ISO 11607-1:2019, 8.2) ........................................................... 37

© ISO 2021 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/TS 16775:2021(E)

5.26.1 Intent .......................................................................................................................................................................................... 37

5.26.2 Guidance ................................................................................................................................................................................. 37

5.27 Stability testing (ISO 11607-1:2019, 8.3) ......................................................................................................................38

5.27.1 Intent ..........................................................................................................................................................................................38

5.27.2 Guidance .................................................................................................................................................................................38

5.28 Packaging system validation and changes (ISO 11607-1:2019, 9.1) .....................................................40

5.28.1 Intent ..........................................................................................................................................................................................40

5.28.2 Guidance .................................................................................................................................................................................40

5.29 Change control (ISO 11607-1:2019, 9.2) ........................................................................................................................40

5.29.1 Intent ..........................................................................................................................................................................................40

5.29.2 Guidance .................................................................................................................................................................................40

5.30 Revalidations (ISO 11607-1:2019, 9.3, 9.4, and 9.5) ............................................................................................40

5.30.1 Intent ..........................................................................................................................................................................................40

5.30.2 Guidance .................................................................................................................................................................................40

5.31 Inspection immediately prior to aseptic presentation (ISO 11607-1:2019, Clause 10) ....... 41

5.31.1 Intent .......................................................................................................................................................................................... 41

5.31.2 Guidance ................................................................................................................................................................................. 41

5.32 Information to be provided (ISO 11607-1:2019, Clause 11) ......................................................................... 41

5.32.1 Intent .......................................................................................................................................................................................... 41

5.32.2 Guidance ................................................................................................................................................................................. 41

6 Guidance on Clauses 5-8 of ISO 11607-2:2019 ...................................................................................................................42

6.1 General Clauses 1-4 of ISO 11607-2:2019 ..................................................................................................................... 42

6.2 Validation of packaging processes – general requirements (ISO 11607-2:2019,

5.1.1 and 5.1.2) ..................................................................................................................................................................................... 42

6.2.1 Intent .......................................................................................................................................................................................... 42

6.2.2 Guidance ................................................................................................................................................................................. 42

6.3 Process specification (ISO 11607-2:2019, 5.1.3) .................................................................................................... 43

6.3.1 Intent .......................................................................................................................................................................................... 43

6.3.2 Guidance ................................................................................................................................................................................. 43

6.4 Process validation of packaging families (ISO 11607-2:2019, 5.1.4) ................................................... 43

6.4.1 Intent .......................................................................................................................................................................................... 43

6.4.2 Guidance ................................................................................................................................................................................. 43

6.5 Installation qualification (ISO 11607-2:2019, 5.2) ...............................................................................................44

6.5.1 Intent ..........................................................................................................................................................................................44

6.5.2 Guidance ................................................................................................................................................................................. 45

6.6 Operational qualification (ISO 11607-2:2019, 5.3) .............................................................................................. 45

6.6.1 Intent .......................................................................................................................................................................................... 45

6.6.2 Guidance .................................................................................................................................................................................46

6.7 Performance qualification (ISO 11607-2:2019, 5.4) ............................................................................................46

6.7.1 Intent ..........................................................................................................................................................................................46

6.7.2 Guidance .................................................................................................................................................................................46

6.8 Formal approval of the process validation (ISO 11607-2:2019, 5.5).................................................... 47

6.8.1 Intent .......................................................................................................................................................................................... 47

6.8.2 Guidance ................................................................................................................................................................................. 47

6.9 Process control and monitoring (ISO 11607-2:2019, 5.6) .............................................................................48

6.9.1 Intent ..........................................................................................................................................................................................48

6.9.2 Guidance .................................................................................................................................................................................48

6.10 Process changes and revalidation (ISO 11607-2:2019, 5.7) .........................................................................48

6.10.1 Intent ..........................................................................................................................................................................................48

6.10.2 Guidance .................................................................................................................................................................................48

6.11 Assembly (ISO
...

SPÉCIFICATION ISO/TS
TECHNIQUE 16775
Deuxième édition
2021-11
Emballages des dispositifs médicaux
stérilisés au stade terminal — Lignes
directrices relatives à l'application de
l'ISO 11607-1 et l'ISO 11607-2
Packaging for terminally sterilized medical devices — Guidance on
the application of ISO 11607-1 and ISO 11607-2
Numéro de référence
ISO/TS 16775:2021(F)
© ISO 2021
---------------------- Page: 1 ----------------------
ISO/TS 16775:2021(F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2021

Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette

publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,

y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut

être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.

ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: +41 22 749 01 11
E-mail: copyright@iso.org
Web: www.iso.org
Publié en Suisse
© ISO 2021 – Tous droits réservés
---------------------- Page: 2 ----------------------
ISO/TS 16775:2021(F)
Sommaire Page

Avant-propos ...........................................................................................................................................................................................................................vii

Introduction ...........................................................................................................................................................................................................................viii

1 Domaine d’application ................................................................................................................................................................................... 1

2 Références normatives ..................................................................................................................................................................................1

3 Termes et définitions ...................................................................................................................................................................................... 1

4 Recommandations relatives aux Articles 1 à 4 de l’ISO 11607-1:2019

et de l’ISO 11607-2:2019 ............................................................................................................................................................................... 2

4.1 Domaine d’application (ISO 11607-1:2019, Article 1 et ISO 11607-2:2019, Article 1).............. 2

4.1.1 Objectif ........................................................................................................................................................................................ 2

4.1.2 Recommandations ............................................................................................................................................................ 2

4.2 Références normatives (ISO 11607-1:2019, Article 2 et ISO 11607-2:2019, Article 2) ............ 3

4.2.1 Objectif ........................................................................................................................................................................................ 3

4.2.2 Recommandations ............................................................................................................................................................ 3

4.3 Termes et définitions (ISO 11607-1:2019, Article 3 et ISO 11607-2:2019, Article 3) ................ 4

4.3.1 Objectif ........................................................................................................................................................................................ 4

4.3.2 Recommandations ............................................................................................................................................................ 4

4.4 Management de la qualité et gestion du risque (ISO 11607-1:2019, 4.1 et 4.2,

et ISO 11607-2:2019, 4.1 et 4.2) ................................................................................................................................................ 4

4.4.1 Objectif ........................................................................................................................................................................................ 4

4.4.2 Recommandations ............................................................................................................................................................ 4

4.5 Échantillonnage (ISO 11607-1:2019, 4.3, et ISO 11607-2:2019, 4.3) ........................................................ 6

4.5.1 Objectif ........................................................................................................................................................................................ 6

4.5.2 Recommandations ............................................................................................................................................................ 6

4.6 Méthodes d’essai (ISO 11607-1:2019, 4.4 et ISO 11607-2:2019, 4.4) ........................................................ 7

4.6.1 Objectif ........................................................................................................................................................................................ 7

4.6.2 Recommandations ............................................................................................................................................................ 7

4.7 Documentation (ISO 11607-1:2019, 4.5, et ISO 11607-2:2019, 4.5) .......................................................... 9

4.7.1 Objectif ........................................................................................................................................................................................ 9

4.7.2 Recommandations ............................................................................................................................................................ 9

5 Recommandations relatives aux Articles 5-11 de l’ISO 11607-1:2019 .....................................................10

5.1 Exigences générales pour les matériaux, les systèmes de barrière stérile

préformés et les systèmes de barrière stérile (ISO 11607-1:2019, 5.1.1 et 5.1.2) .................... 10

5.1.1 Objectif ..................................................................................................................................................................................... 10

5.1.2 Recommandations ......................................................................................................................................................... 10

5.2 Conditions de production et de manipulation (ISO 11607-1:2019, 5.1.3 et 5.1.4) .................... 11

5.2.1 Objectif ..................................................................................................................................................................................... 11

5.2.2 Recommandations ......................................................................................................................................................... 11

5.3 Source, historique et traçabilité des matériaux (ISO 11607-1:2019, 5.1.5) ...................................12

5.3.1 Objectif .....................................................................................................................................................................................12

5.3.2 Recommandations .........................................................................................................................................................12

5.4 Propriétés à évaluer (ISO 11607-1:2019, 5.1.6) ......................................................................................................12

5.4.1 Objectif .....................................................................................................................................................................................12

5.4.2 Recommandations .........................................................................................................................................................12

5.5 Exigences générales de performances des matériaux (ISO 11607-1:2019, 5.1.7

et 5.1.8) ....................................................................................................................................................................................................... 13

5.5.1 Objectif ..................................................................................................................................................................................... 13

5.5.2 Recommandations ......................................................................................................................................................... 13

5.6 Exigences supplémentaires pour les systèmes de barrière stérile préformés et les

systèmes de barrière stérile (ISO 11607-1:2019, 5.1.9) ................................................................................... 17

5.6.1 Objectif ..................................................................................................................................................................................... 17

5.6.2 Recommandations ......................................................................................................................................................... 17

5.7 Systèmes de barrière stérile réutilisables (ISO 11607-1:2019, 5.1.10, 5.1.11 et 5.1.12) ..... 18

iii
© ISO 2021 – Tous droits réservés
---------------------- Page: 3 ----------------------
ISO/TS 16775:2021(F)

5.7.1 Objectif ..................................................................................................................................................................................... 18

5.7.2 Recommandations ......................................................................................................................................................... 18

5.8 Propriétés de la barrière microbienne (ISO 11607-1:2019, 5.2) .............................................................. 19

5.8.1 Objectif ..................................................................................................................................................................................... 19

5.8.2 Recommandations ......................................................................................................................................................... 19

5.9 Compatibilité avec le procédé de stérilisation (ISO 11607-1:2019, 5.3) ........................................... 19

5.9.1 Objectif ..................................................................................................................................................................................... 19

5.9.2 Recommandations ......................................................................................................................................................... 19

5.10 Systèmes d’étiquetage (ISO 11607-1:2019, 5.4) ...................................................................................................... 20

5.10.1 Objectif ..................................................................................................................................................................................... 20

5.10.2 Recommandations ......................................................................................................................................................... 20

5.11 Stockage et transport des matériaux et des systèmes de barrière stérile préformés

(ISO 11607-1:2019, 5.5) ................................................................................................................................................................22

5.11.1 Objectif ..................................................................................................................................................................................... 22

5.11.2 Recommandations ......................................................................................................................................................... 22

5.12 Conception et développement (ISO 11607-1:2019, 6.1.1) ............................................................................... 24

5.12.1 Objectif ..................................................................................................................................................................................... 24

5.12.2 Recommandations ......................................................................................................................................................... 24

5.13 Présentation aseptique (ISO 11607-1:2019, 6.1.2) ............................................................................................... 25

5.13.1 Objectif ..................................................................................................................................................................................... 25

5.13.2 Recommandations ......................................................................................................................................................... 25

5.14 Protection physique (voir l’ISO 11607-1:2019, 6.1.3 et 6.1.4) .................................................................... 26

5.14.1 Objectif ..................................................................................................................................................................................... 26

5.14.2 Recommandations ......................................................................................................................................................... 26

5.15 Compatibilité de stérilisation (ISO 11607-1:2019, 6.1.5) ............................................................................... 27

5.15.1 Objectif ..................................................................................................................................................................................... 27

5.15.2 Recommandations ......................................................................................................................................................... 27

5.16 Maintien de la stérilité (voir l’ISO 11607-1:2019, 6.1.6 et 6.1.7) .............................................................. 27

5.16.1 Objectif ..................................................................................................................................................................................... 27

5.16.2 Recommandations ......................................................................................................................................................... 27

5.17 Exigences relatives aux emballages multicouches (ISO 11607-1:2019, 6.1.8) .............................28

5.17.1 Objectif .....................................................................................................................................................................................28

5.17.2 Recommandations .........................................................................................................................................................28

5.18 Familles d’emballage (ISO 11607-1:2019, 6.1.9) .....................................................................................................29

5.18.1 Objectif .....................................................................................................................................................................................29

5.18.2 Recommandations .........................................................................................................................................................29

5.19 Processus de conception (ISO 11607-1:2019, 6.2.1) ........................................................................................... 31

5.19.1 Objectif ..................................................................................................................................................................................... 31

5.19.2 Recommandations ......................................................................................................................................................... 31

5.20 Données de conception (voir l’ISO 11607-1:2019, 6.2.2 et 6.2.3) ............................................................ 32

5.20.1 Objectif ..................................................................................................................................................................................... 32

5.20.2 Recommandations ......................................................................................................................................................... 32

5.21 Dispositif de passage de fluide stérile (ISO 11607-1:2019, 6.2.4, 6.2.5) ...........................................34

5.21.1 Objectif .....................................................................................................................................................................................34

5.21.2 Recommandations .........................................................................................................................................................34

5.22 Évaluation de l’aptitude à l’utilisation pour la présentation aseptique (ISO 11607-

1:2019, 7.1, 7.2 et 7.3) ........................................................................................................................................... ........................... 35

5.22.1 Objectif ..................................................................................................................................................................................... 35

5.22.2 Recommandations ......................................................................................................................................................... 35

5.23 Tirer profit des évaluations de l’aptitude à l’utilisation (ISO 11607-1:2019, 7.4) .....................36

5.23.1 Objectif ..................................................................................................................................................................................... 36

5.23.2 Recommandations ......................................................................................................................................................... 36

5.24 Défaillance de l’évaluation de l’aptitude à l’utilisation (ISO 11607-1:2019, 7.5) ........................ 37

5.24.1 Objectif ..................................................................................................................................................................................... 37

5.24.2 Recommandations ......................................................................................................................................................... 37

5.24.3 Recommandations relatives aux études formatives et sommatives .................................38

5.25 Performance et stabilité du système d’emballage (ISO 11607-1:2019, 8.1) ...................................38

5.25.1 Objectif .....................................................................................................................................................................................38

© ISO 2021 – Tous droits réservés
---------------------- Page: 4 ----------------------
ISO/TS 16775:2021(F)

5.25.2 Recommandations .........................................................................................................................................................39

5.26 Essais de performance du système d’emballage (ISO 11607-1:2019, 8.2) ...................................... 41

5.26.1 Objectif ..................................................................................................................................................................................... 41

5.26.2 Recommandations ......................................................................................................................................................... 41

5.27 Essai de stabilité (ISO 11607-1:2019, 8.3) ................................................................................................................... 42

5.27.1 Objectif ..................................................................................................................................................................................... 42

5.27.2 Recommandations ......................................................................................................................................................... 42

5.28 Validation et modifications du système d’emballage (ISO 11607-1:2019, 9.1) ............................44

5.28.1 Objectif .....................................................................................................................................................................................44

5.28.2 Recommandations .........................................................................................................................................................44

5.29 Contrôles des modifications (ISO 11607-1:2019, 9.2) .......................................................................................44

5.29.1 Objectif .....................................................................................................................................................................................44

5.29.2 Recommandations .........................................................................................................................................................44

5.30 Revalidations (ISO 11607-1:2019, 9.3, 9.4, et 9.5) ................................................................................................. 45

5.30.1 Objectif ..................................................................................................................................................................................... 45

5.30.2 Recommandations ......................................................................................................................................................... 45

5.31 Inspection immédiatement avant la présentation aseptique (ISO 11607-1:2019,

Article 10) ................................................................................................................................................................................................ 45

5.31.1 Objectif ..................................................................................................................................................................................... 45

5.31.2 Recommandations ......................................................................................................................................................... 45

5.32 Informations à fournir (ISO 11607-1:2019, Article 11) ....................................................................................46

5.32.1 Objectif .....................................................................................................................................................................................46

5.32.2 Recommandations .........................................................................................................................................................46

6 Recommandations relatives aux Articles 5 à 8 de l’ISO 11607-2:2019 ....................................................46

6.1 Articles généraux 1 à 4 de l’ISO 11607-2:2019 ........................................................................................................46

6.2 Validation des procédés d’emballage — Exigences générales (ISO 11607-2:2019,

5.1.1 et 5.1.2) ......................................................................................................................................................................................... 47

6.2.1 Objectif ..................................................................................................................................................................................... 47

6.2.2 Recommandations ......................................................................................................................................................... 47

6.3 Spécification du procédé (ISO 11607-2:2019, 5.1.3) ........................................................................................... 47

6.3.1 Objectif ..................................................................................................................................................................................... 47

6.3.2 Recommandations ......................................................................................................................................................... 47

6.4 Validation de procédé pour les familles d’emballage (ISO 11607-2:2019, 5.1.4) .......................48

6.4.1 Objectif .....................................................................................................................................................................................48

6.4.2 Recommandations .........................................................................................................................................................48

6.5 Qualification de l’installation (ISO 11607-2:2019, 5.2) ....................................................................................49

6.5.1 Objectif .....................................................................................................................................................................................49

6.5.2 Recommandations .........................................................................................................................................................49

6.6 Qualification opérationnelle (ISO 11607-2:2019, 5.3) ......................................................................................50

6.6.1 Objectif ..................................................................................................................................................................................... 50

6.6.2 Recommandations ......................................................................................................................................................... 50

6.7 Qualification des performances (ISO 11607-2:2019, 5.4) .............................................................................. 51

6.7.1 Objectif ..................................................................................................................................................................................... 51

6.7.2 Recommandations ......................................................................................................................................................... 51

6.8 Approbation formelle de la validation du procédé (ISO 11607-2:2019, 5.5)................................. 52

6.8.1 Objectif ..................................................................................................................................................................................... 52

6.8.2 Recommandations ......................................................................................................................................................... 52

6.9 Contrôle et surveillance du procédé (ISO 11607-2:2019, 5.6) ................................................................... 52

6.9.1 Objectif ..................................................................................................................................................................................... 52

6.9.2 Recommandations ......................................................................................................................................................... 53

6.10 Modifications et revalidation du procédé (ISO 11607-2:2019, 5.7) ......................................................53

6.10.1 Objectif ..................................................................................................................................................................................... 53

6.10.2 Recommandations ......................................................................................................................................................... 53

6.11 Assemblage (ISO 11607-2:2019, Article 6) ..................................................................................................................54

6.11.1 Objectif .....................................................................................................................................................................................54

6.11.2 Recommandations .........................................................................................................................................................54

6.12 Utilisation de systèmes de barrière stérile réutilisables (ISO 11607-2:2019,

Article 7) ................................................................................................................................................................................................... 56

© ISO 2021 – Tous droits réservés
---------------------- Page: 5 ----------------------
ISO/TS 16775:2021(F)
6.12.1 Objectif ................................................
...

TECHNICAL ISO/TS
SPECIFICATION 16775
Second edition
Packaging for terminally sterilized
medical devices — Guidance on the
application of ISO 11607-1 and ISO
11607-2
Emballages des dispositifs médicaux stérilisés au stade terminal —
Lignes directrices relatives à l'application de l'ISO 11607-1 et l'ISO
11607-2
PROOF/ÉPREUVE
Reference number
ISO/TS 16775:2021(E)
ISO 2021
---------------------- Page: 1 ----------------------
ISO/TS 16775:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii PROOF/ÉPREUVE © ISO 2021 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/TS 16775:2021(E)
Contents Page

Foreword ......................................................................................................................................................................................................................................vii

Introduction ............................................................................................................................................................................................................................viii

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Guidance on Clauses 1-4 of ISO 11607-1:2019 and ISO 11607-2:2019 .......................................................2

4.1 Scope (ISO 11607-1:2019, 1 and ISO 11607-2:2019, 1) ..................................................................................... 2

4.1.1 Intent .......................................................................................................................................................................................... 2

4.1.2 Guidance.................................................................................................................................................................................. 2

4.2 Normative references (ISO 11607-1:2019, Clause 2 and ISO 11607-2:2019, Clause 2) ......... 3

4.2.1 Intent .......................................................................................................................................................................................... 3

4.2.2 Guidance.................................................................................................................................................................................. 3

4.3 Terms and definitions (ISO 11607-1:2019, Clause 3 and ISO 11607-2:2019, Clause 3) ........ 3

4.3.1 Intent .......................................................................................................................................................................................... 3

4.3.2 Guidance.................................................................................................................................................................................. 4

4.4 Quality and risk management (ISO 11607-1:2019, 4.1, 4.2 and ISO 11607-2:2019,

4.1, 4.2) .......................................................................................................................................................................................................... 4

4.4.1 Intent .......................................................................................................................................................................................... 4

4.4.2 Guidance.................................................................................................................................................................................. 4

4.5 Sampling (ISO 11607-1:2019, 4.3 and ISO 11607-2:2019, 4.3) ................................................................... 6

4.5.1 Intent .......................................................................................................................................................................................... 6

4.5.2 Guidance.................................................................................................................................................................................. 6

4.6 Test methods (ISO 11607-1:2019, 4.4 and ISO 11607-2:2019, 4.4) ......................................................... 7

4.6.1 Intent .......................................................................................................................................................................................... 7

4.6.2 Guidance.................................................................................................................................................................................. 7

4.7 Documentation (ISO 11607-1:2019, 4.5 and ISO 11607-2:2019, 4.5) ................................................... 9

4.7.1 Intent .......................................................................................................................................................................................... 9

4.7.2 Guidance.................................................................................................................................................................................. 9

5 Guidance on Clause 5.1.1 of ISO 11607-1:2019 .................................................................................................................... 9

5.1 General requirements for materials, preformed sterile barrier systems and sterile

barrier systems (ISO 11607-1:2019, 5.1.1 and 5.1.2) ........................................................................................... 9

5.1.1 Intent .......................................................................................................................................................................................... 9

5.1.2 Guidance...............................................................................................................................................................................10

5.2 Conditions for production and handling (ISO 11607-1:2019, 5.1.3 and 5.1.4)............................10

5.2.1 Intent .......................................................................................................................................................................................10

5.2.2 Guidance...............................................................................................................................................................................10

5.3 Source, history and traceability of materials (ISO 11607-1:2019, 5.1.5) ..........................................11

5.3.1 Intent .......................................................................................................................................................................................11

5.3.2 Guidance...............................................................................................................................................................................11

5.4 Properties to be evaluated (ISO 11607-1:2019, 5.1.6) ......................................................................................11

5.4.1 Intent .......................................................................................................................................................................................11

5.4.2 Guidance...............................................................................................................................................................................11

5.5 General performance requirements for materials (ISO 11607-1:2019, 5.1.7 and 5.1.8) ....12

5.5.1 Intent .......................................................................................................................................................................................12

5.5.2 Guidance...............................................................................................................................................................................12

5.6 Additional requirements for sterile barrier systems and preformed sterile barrier

systems (ISO 11607-1:2019, 5.1.9) ....................................................................................................................................15

5.6.1 Intent .......................................................................................................................................................................................15

5.6.2 Guidance...............................................................................................................................................................................15

5.7 Reusable sterile barrier systems (ISO 11607-1:2019, 5.1.10, 5.1.11 and 5.1.12) .....................17

5.7.1 Intent .......................................................................................................................................................................................17

5.7.2 Guidance...............................................................................................................................................................................17

© ISO 2021 – All rights reserved PROOF/ÉPREUVE iii
---------------------- Page: 3 ----------------------
ISO/TS 16775:2021(E)

5.8 Microbial barrier properties (ISO 11607-1:2019, 5.2) .....................................................................................17

5.8.1 Intent .......................................................................................................................................................................................17

5.8.2 Guidance...............................................................................................................................................................................17

5.9 Compatibility with the sterilization process (ISO 11607-1:2019, 5.3) ...............................................17

5.9.1 Intent .......................................................................................................................................................................................17

5.9.2 Guidance...............................................................................................................................................................................18

5.10 Labelling system (ISO 11607-1:2019, 5.4) ..................................................................................................................18

5.10.1 Intent .......................................................................................................................................................................................18

5.10.2 Guidance...............................................................................................................................................................................19

5.11 Storage and transport of materials and preformed sterile barrier systems

(ISO 11607-1:2019, 5.5) ..............................................................................................................................................................20

5.11.1 Intent .......................................................................................................................................................................................20

5.11.2 Guidance...............................................................................................................................................................................20

5.12 Design and development (ISO 11607-1:2019, 6.1.1)..........................................................................................21

5.12.1 Intent .......................................................................................................................................................................................21

5.12.2 Guidance...............................................................................................................................................................................21

5.13 Aseptic presentation (ISO 11607-1:2019, 6.1.2) ....................................................................................................22

5.13.1 Intent .......................................................................................................................................................................................22

5.13.2 Guidance...............................................................................................................................................................................22

5.14 Physical protection (ISO 11607-1:2019, 6.1.3 and 6.1.4) ...............................................................................24

5.14.1 Intent .......................................................................................................................................................................................24

5.14.2 Guidance...............................................................................................................................................................................24

5.15 Sterilization compatibility (ISO 11607-1:2019, 6.1.5) ......................................................................................24

5.15.1 Intent .......................................................................................................................................................................................24

5.15.2 Guidance...............................................................................................................................................................................24

5.16 Maintenance of Sterility (ISO 11607-1:2019, 6.1.6 and 6.1.7) ...................................................................25

5.16.1 Intent .......................................................................................................................................................................................25

5.16.2 Guidance...............................................................................................................................................................................25

5.17 Requirements for multi-layer packaging (ISO 11607-1:2019, 6.1.8) ...................................................26

5.17.1 Intent .......................................................................................................................................................................................26

5.17.2 Guidance...............................................................................................................................................................................26

5.18 Packaging families (ISO 11607-1:2019, 6.1.9) .........................................................................................................26

5.18.1 Intent .......................................................................................................................................................................................26

5.18.2 Guidance...............................................................................................................................................................................26

5.19 Design process (ISO 11607-1:2019, 6.2.1) ..................................................................................................................28

5.19.1 Intent .......................................................................................................................................................................................28

5.19.2 Guidance...............................................................................................................................................................................28

5.20 Design inputs (ISO 11607-1:2019, 6.2.2 and 6.2.3) .............................................................................................29

5.20.1 Intent .......................................................................................................................................................................................29

5.20.2 Guidance...............................................................................................................................................................................29

5.21 Sterile fluid path (ISO 11607-1:2019, 6.2.4, 6.2.5) ...............................................................................................31

5.21.1 Intent .......................................................................................................................................................................................31

5.21.2 Guidance...............................................................................................................................................................................31

5.22 Usability evaluation for aseptic presentation (ISO 11607-1:2019, 7.1, 7.2 and 7.3) ..............32

5.22.1 Intent .......................................................................................................................................................................................32

5.22.2 Guidance...............................................................................................................................................................................32

5.23 Leveraging usability evaluations (ISO 11607-1:2019, 7.4) ...........................................................................33

5.23.1 Intent .......................................................................................................................................................................................33

5.23.2 Guidance...............................................................................................................................................................................33

5.24 Usability evaluation failures (ISO 11607-1:2019, 7.5) ......................................................................................33

5.24.1 Intent .......................................................................................................................................................................................33

5.24.2 Guidance...............................................................................................................................................................................33

5.24.3 Guidance on formative and summative studies .................................................................................34

5.25 Packaging system performance and stability (ISO 11607-1:2019, 8.1) .............................................35

5.25.1 Intent .......................................................................................................................................................................................35

5.25.2 Guidance...............................................................................................................................................................................35

5.26 Packaging system performance testing (ISO 11607-1:2019, 8.2) ...........................................................36

5.26.1 Intent .......................................................................................................................................................................................36

iv PROOF/ÉPREUVE © ISO 2021 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/TS 16775:2021(E)

5.26.2 Guidance...............................................................................................................................................................................37

5.27 Stability testing (ISO 11607-1:2019, 8.3) .....................................................................................................................38

5.27.1 Intent .......................................................................................................................................................................................38

5.27.2 Guidance...............................................................................................................................................................................38

5.28 Packaging system validation and changes (ISO 11607-1:2019, 9.1).....................................................39

5.28.1 Intent .......................................................................................................................................................................................39

5.28.2 Guidance...............................................................................................................................................................................39

5.29 Change control (ISO 11607-1:2019, 9.2) ......................................................................................................................40

5.29.1 Intent .......................................................................................................................................................................................40

5.29.2 Guidance...............................................................................................................................................................................40

5.30 Revalidations (ISO 11607-1:2019, 9.3, 9.4, and 9.5) ...........................................................................................40

5.30.1 Intent .......................................................................................................................................................................................40

5.30.2 Guidance...............................................................................................................................................................................40

5.31 Inspection immediately prior to aseptic presentation (ISO 11607-1:2019, Clause 10) ......40

5.31.1 Intent .......................................................................................................................................................................................40

5.31.2 Guidance...............................................................................................................................................................................41

5.32 Information to be provided (ISO 11607-1:2019, Clause 11) .......................................................................41

5.32.1 Intent .......................................................................................................................................................................................41

5.32.2 Guidance...............................................................................................................................................................................41

6 Guidance on Clauses 5-8 of ISO 11607-2:2019 ..................................................................................................................42

6.1 General Clauses 1-4 of ISO 11607-2:2019 ...................................................................................................................42

6.2 Validation of packaging processes – general requirements (ISO 11607-2:2019,

5.1.1 and 5.1.2) .................. ...................................................................................................................................................................42

6.2.1 Intent .......................................................................................................................................................................................42

6.2.2 Guidance...............................................................................................................................................................................42

6.3 Process specification (ISO 11607-2:2019, 5.1.3) ...................................................................................................42

6.3.1 Intent .......................................................................................................................................................................................42

6.3.2 Guidance...............................................................................................................................................................................42

6.4 Process validation of packaging families (ISO 11607-2:2019, 5.1.4) ...................................................43

6.4.1 Intent .......................................................................................................................................................................................43

6.4.2 Guidance...............................................................................................................................................................................43

6.5 Installation qualification (ISO 11607-2:2019, 5.2) ...............................................................................................44

6.5.1 Intent .......................................................................................................................................................................................44

6.5.2 Guidance...............................................................................................................................................................................44

6.6 Operational qualification (ISO 11607-2:2019, 5.3)..............................................................................................45

6.6.1 Intent .......................................................................................................................................................................................45

6.6.2 Guidance...............................................................................................................................................................................45

6.7 Performance qualification (ISO 11607-2:2019, 5.4) ...........................................................................................46

6.7.1 Intent .......................................................................................................................................................................................46

6.7.2 Guidance...............................................................................................................................................................................46

6.8 Formal approval of the process validation (ISO 11607-2:2019, 5.5) ....................................................47

6.8.1 Intent .......................................................................................................................................................................................47

6.8.2 Guidance...............................................................................................................................................................................47

6.9 Process control and monitoring (ISO 11607-2:2019, 5.6) .............................................................................47

6.9.1 Intent .......................................................................................................................................................................................47

6.9.2 Guidance...............................................................................................................................................................................47

6.10 Process changes and revalidation (ISO 11607-2:2019, 5.7).........................................................................48

6.10.1 Intent .......................................................................................................................................................................................48

6.10.2 Guidance...............................................................................................................................................................................48

6.11 Assembly (ISO 11607-2:2019, Clause 6) .......................................................................................................................49

6.11.1 Intent .......................................................................................................................................................................................49

6.11.2 Guidance...............................................................................................................................................................................49

6.12 Use of reusabl
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.