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

General Information

Status
Published
Current Stage
5060 - Close of voting Proof returned by Secretariat
Start Date
21-Jul-2021
Completion Date
21-Jul-2021
Ref Project

RELATIONS

Buy Standard

Draft
ISO/PRF TS 16775 - 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
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.