SIST-TS CEN ISO/TS 16775:2022

Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2021)

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

Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Leitfaden für die Anwendung von ISO 11607-1 und ISO 11607-2 (ISO/TS 16775:2021)

Das vorliegende Dokument enthält Leitlinien für die Anwendung der in ISO 11607-1 und ISO 11607-2 enthaltenen Anforderungen. Durch das vorliegende Dokument werden die Anforderungen von ISO 11607-1 und ISO 11607-2 weder ergänzt noch verändert. Dies ist ein informatives, kein normatives Dokument. Das vorliegende Dokument enthält keine Anforderungen, die als Grundlage für regulatorische Überwachungen oder für Abläufe der Zertifizierungsbewertung zu verwenden sind.
Dieser Leitfaden kann verwendet werden, um die Anforderungen von ISO 11607-1 und ISO 11607-2 besser zu verstehen und um die zahlreichen Verfahren und Ansätze, die zur Erfüllung der Anforderungen von ISO 11607-1 und ISO 11607-2 zur Verfügung stehen, zu veranschaulichen. Es ist nicht erforderlich, das vorliegende Dokument zum Nachweis der Übereinstimmung mit diesen Normen anzuwenden.
Dieses Dokument enthält Leitlinien zur Bewertung, Auswahl und Verwendung von Verpackungsmaterialien, vorgefertigten Sterilbarrieresystemen, Sterilbarrieresystemen und Verpackungssystemen. Es enthält außerdem Hinweise zu den Validierungsanforderungen an Prozesse der Formgebung, Siegelung und der Zusammenstellung.
Dieses Dokument enthält Informationen sowohl für Einrichtungen des Gesundheitswesens als auch für die Medizinprodukteindustrie für in der Endverpackung zu sterilisierende Medizinprodukte.
Dieses Dokument enthält keine Leitlinien für die Verwendung von Verpackungsmaterialien und Verpackungssystemen nach dem Öffnen. Für die Verwendung von Verpackungen für andere Zwecke, wie z. B. als „steriles Feld“ oder den Transport kontaminierter Artikel, sind andere regulatorische Normen anwendbar.

Emballages des dispositifs médicaux stérilisés au stade terminal - Lignes directrices relatives à l'application de l'ISO 11607-1 et l'ISO 11607-2 (ISO/TS 16775:2021)

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.

Embalaža za končno sterilizirane medicinske pripomočke - Smernice za uporabo ISO 11607-1 in ISO 11607-2 (ISO/TS 16775:2021)

Ta dokument podaja smernice za uporabo zahtev standardov ISO 11607-1 in ISO 11607-2. Ne dopolnjuje ali kako drugače spreminja zahtev standardov ISO 11607-1 in ISO 11607-2. To je informativni in ne normativni dokument. Ne vključuje zahtev, ki se uporabljajo kot podlaga za predpisani pregled ali dejavnosti ocenjevanja za potrebe certificiranja. Smernice je mogoče uporabiti za boljše razumevanje zahtev standardov ISO 11607-1 in ISO 11607-2 ter prikazujejo nekatere metode in pristope, ki so na voljo za izpolnjevanje zahtev teh mednarodnih standardov. Ni zahtevano, da se ta dokument uporablja za prikaz skladnosti z njimi. Smernice so podane za vrednotenje, izbiro in uporabo materialov za embalažo, izvedenih sterilnih pregradnih sistemov, sterilnih pregradnih sistemov ter sistemov embalaže. Podane so tudi smernice o zahtevah za validacijo procesov oblikovanja, označevanja in sestavljanja. Ta dokument podaja informacije za zdravstvene ustanove in panogo medicinskih pripomočkov za končno sterilizirane medicinske pripomočke. Ne podaja smernic za uporabo materialov za embalažo in sistemov po njihovem odprtju. Za uporabo embalaže v druge namene, kot je »sterilno polje« ali prevoz kontaminiranih predmetov, se uporabljajo drugi regulativni standardi.

General Information

• Status: Published
• Publication Date: 19-Dec-2021
• ICS: 11.080.30 - Sterilized packaging
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 02-Dec-2021
• Due Date: 06-Feb-2022
• Completion Date: 20-Dec-2021
• Ref Project: CEN ISO/TS 16775:2021 - Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2021)

Relations

• Replaces: SIST-TS CEN ISO/TS 16775:2014 - Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2014)
• Effective Date: 01-Jan-2022
• Replaces: SIST-TS CEN ISO/TS 16775:2014 - Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2014)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST-TS CEN ISO/TS 16775:2022
01-januar-2022
Nadomešča:
SIST-TS CEN ISO/TS 16775:2014
Embalaža za končno sterilizirane medicinske pripomočke - Smernice za uporabo
ISO 11607-1 in ISO 11607-2 (ISO/TS 16775:2021)
Packaging for terminally sterilized medical devices - Guidance on the application of ISO
11607-1 and ISO 11607-2 (ISO/TS 16775:2021)
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Leitfaden
für die Anwendung von ISO 11607-1 und ISO 11607-2 (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 (ISO/TS 16775:2021)
Ta slovenski standard je istoveten z: CEN ISO/TS 16775:2021
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
SIST-TS CEN ISO/TS 16775:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TS CEN ISO/TS 16775:2022


CEN ISO/TS 16775
TECHNICAL SPECIFICATION

SPÉCIFICATION TECHNIQUE

November 2021
TECHNISCHE SPEZIFIKATION
ICS 11.080.30 Supersedes CEN ISO/TS 16775:2014
English Version

Packaging for terminally sterilized medical devices -
Guidance on the application of ISO 11607-1 and ISO
11607-2 (ISO/TS 16775:2021)
Emballages des dispositifs médicaux stérilisés au stade Verpackungen für in der Endverpackung zu
terminal - Lignes directrices relatives à l'application sterilisierende Medizinprodukte - Leitfaden für die
de l'ISO 11607-1 et l'ISO 11607-2 (ISO/TS Anwendung von ISO 11607-1 und ISO 11607-2
16775:2021) (ISO/TS 16775:2021)
This Technical Specification (CEN/TS) was approved by CEN on 22 August 2021 for provisional application.

The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to
submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard.

CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS
available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in
parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 16775:2021 E
worldwide for CEN national Members.

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CEN ISO/TS 16775:2021 (E)
Contents Page
European foreword . 3

2

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SIST-TS CEN ISO/TS 16775:2022
CEN ISO/TS 16775:2021 (E)
European foreword
This document (CEN ISO/TS 16775:2021) has been prepared by Technical Committee ISO/TC 198
"Sterilization of health care products" in collaboration with Technical Committee CEN/TC 102
“Sterilizers and associated equipment for processing of medical devices” the secretariat of which is held
by DIN.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes CEN ISO/TS 16775:2014.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
In comparison with the previous edition, the following technical modifications have been made:
─ clause normative references has been added;
─ clause 3 “Terms and definitions” has been updated;
─ structural adaptation of the text to the structure of ISO 11607-1:2019 and ISO 11607-2:2019;
─ updates to reflect current editions of ISO 11607-1:2019 and ISO 11607-2:2019;
─ intent and guidance is provided for each clause of the standard to improve usability of this
document;
─ new annexes have been added;
─ some annexes have been removed.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to announce this Technical Specification: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO/TS 16775:2021 has been approved by CEN as CEN ISO/TS 16775:2021 without any
modification.


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SIST-TS CEN ISO/TS 16775:2022
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

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SIST-TS CEN ISO/TS 16775:2022
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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
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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
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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
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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 .
...