SIST-TS CEN ISO/TS 16775:2022

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

Contents Page
European foreword . 3

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.
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/TS 16775:2021(E)
© 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
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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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
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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 11607-2:2019, Clause 6) .49
6.11.1 Intent .49
6.11.2 Guidance .49
6.12 Use of reusable sterile barrier systems (ISO 11607-2:2019, Clause 7) . 51
6.12.1 Intent . 51
6.12.2 Guidance . 51
6.13 Sterile fluid path packaging (ISO 11607-2:2019, Clause 8) . 51
6.13.1 Intent . 51
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ISO/TS 16775:2021(E)
6.13.2 Guidance . 51
Annex A (informative) Design and development for packaging systems – guidance for
industry .52
Annex B (informative) Guidance on the application of the ISO 11607 series in healthcare
facilities .60
Annex C (informative) Risk analysis tools — Guidance for industry and healthcare facilities .91
Annex D (informative) Considerations for sampling plans – Guidance for healthcare
facilities .93
Annex E (informative) Guidance on establishing process parameters – guidance for
industry .95
Annex F (informative) Sterilization considerations – Guidance for industry and healthcare
facilities . 101
Annex G (informative) Use of contract packagers – Guidance for industry and healthcare
facilities . 108
Annex H (informative) Example of a handling, distribution and storage checklist – Guidance
for healthcare facilities for selecting a sterile barrier system . 109
Annex I (informative) Investigating failure – Guidance for industry and healthcare facilities . 112
Annex J (informative) Validation summary – Guidance for healthcare facilities .116
Annex K (informative) Validation for wrapping process — Guidance for healthcare facilities . 118
Annex L (informative) Validation for reusable container process – Guidance for healthcare
facilities .124
Annex M (informative) Validation for heat sealing process for preformed sterile barrier
systems (PSBS) – Guidance for healthcare facilities . 130
Annex N (informative) Evaluation of sterile packaging by end users — Guidance for
healthcare facilities . 138
Bibliography . 139
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ISO/TS 16775:2021(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products,
in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/
TC 102, Sterilizers and associated equipment for processing of medical devices, in accordance with the
Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO/TS 16775:2014), which has been
technically revised.
The main changes compared to the previous edition are as follows:
— updates to reflect ISO 11607-1:2019 and ISO 11607-2:2019 editions;
— 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.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
vii
ISO/TS 16775:2021(E)
Introduction
Sterile barrier systems are intended to allow for sterilization, provide physical protection, maintain
the sterility of their contents until the point of use and ensure aseptic presentation. The sterile barrier
system, depending on conditions of handling, distribution or storage, can be combined with additional
protective packaging to create a packaging system.
ISO 11607-1 specifies the requirements for materials, sterile barrier systems, and packaging systems,
including the validation of the packaging system design while ISO 1
...