SIST-TS CEN ISO/TS 16775:2014

SLOVENSKI STANDARD
SIST-TS CEN ISO/TS 16775:2014
01-oktober-2014
(PEDODåD]DNRQþQRVWHULOL]LUDQHPHGLFLQVNHSULSRPRþNH6PHUQLFH]DXSRUDER
,62LQ,62,6276
Packaging for terminally sterilized medical devices - Guidance on the application of ISO
11607-1 and ISO 11607-2 (ISO/TS 16775:2014)
Verpackungen für in der Endverpackung sterilisierte Medizinprodukte - Tei 3: Leitfaden
für die Anwendung von ISO 11607-1 und ISO 11607-2 (ISO/TS 16775:2014)
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 16775:2014)
Ta slovenski standard je istoveten z: CEN ISO/TS 16775:2014
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
SIST-TS CEN ISO/TS 16775:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TS CEN ISO/TS 16775:2014

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SIST-TS CEN ISO/TS 16775:2014

TECHNICAL SPECIFICATION
CEN ISO/TS 16775

SPÉCIFICATION TECHNIQUE

TECHNISCHE SPEZIFIKATION
May 2014
ICS 11.080.30
English Version
Packaging for terminally sterilized medical devices - Guidance
on the application of ISO 11607-1 and ISO 11607-2 (ISO
16775:2014)
Emballages des dispositifs médicaux stérilisés au stade Verpackungen für in der Endanwendung sterilisierte
terminal - Lignes directrices relatives à l'application de l'ISO Medizinprodukte - Leitfaden für die Anwendung von ISO
11607-1 et l'ISO 11607-2 (ISO 16775:2014) 11607-1 und ISO 11607-2 (ISO 16775:2014)
This Technical Specification (CEN/TS) was approved by CEN on 18 February 2014 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 16775:2014 E
worldwide for CEN national Members.

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SIST-TS CEN ISO/TS 16775:2014
CEN ISO/TS 16775:2014 (E)
Contents Page
Foreword .3
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SIST-TS CEN ISO/TS 16775:2014
CEN ISO/TS 16775:2014 (E)
Foreword
This document (CEN ISO/TS 16775:2014) has been prepared by Technical Committee ISO/TC 198
"Sterilization of health care products" in collaboration with Technical Committee CEN/TC 102 “Sterilizers for
medical purposes” 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 [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
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, Former Yugoslav Republic of Macedonia, France, Germany,
Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO/TS 16775:2014 has been approved by CEN as CEN ISO/TS 16775:2014 without any
modification.

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SIST-TS CEN ISO/TS 16775:2014

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SIST-TS CEN ISO/TS 16775:2014
TECHNICAL ISO/TS
SPECIFICATION 16775
First edition
2014-05-15
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 16775:2014(E)
©
ISO 2014

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SIST-TS CEN ISO/TS 16775:2014
ISO/TS 16775:2014(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2014
All rights reserved. Unless otherwise specified, 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
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved

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SIST-TS CEN ISO/TS 16775:2014
ISO/TS 16775:2014(E)

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Terms and definitions . 1
3 Guidance for health care facilities . 2
3.1 Test methods . 2
3.2 Guidance for conformance to ISO 11607-1 . 2
3.3 Guidance on conformance to ISO 11607-2, Validation requirements for forming,
sealing and assembly processes .10
3.4 Quality system .19
4 Guidance for industry .20
4.1 General guidance .20
4.2 Design inputs .20
4.3 Selection and evaluation of materials .21
4.4 Sterile barrier system and protective packaging design (packaging
system development) .22
4.5 Packaging process feasibility evaluation .24
4.6 Sterile barrier system design feasibility evaluation .25
4.7 Validation of sterile barrier system manufacturing process .26
4.8 Packaging system design validation .28
4.9 Revalidation .29
Annex A (informative) Selection, evaluation and testing of packaging materials and sterile barrier
systems — Guidance for industry and health care facilities .31
Annex B (informative) Sterilization considerations — Guidance for industry and health
care facilities.39
Annex C (informative) Examples of wrapping methods — Guidance for health care facilities .47
Annex D (informative) Validation plan documents — Guidance for health care facilities .54
Annex E (informative) Installation qualification documentation — Guidance for health
care facilities.68
Annex F (informative) Operational qualification documentation — Guidance for health
care facilities.73
Annex G (informative) Performance qualification documentation — Guidance for health
care facilities.77
Annex H (informative) Addressing worst-case requirements — Guidance for industry and health
care facilities.81
Annex I (informative) Generating a final packaging system validation protocol — Guidance
for industry .83
Annex J (informative) Design inputs — Medical device attributes — Guidance for industry .86
Annex K (informative) Risk analysis tools — Guidance for industry and health care facilities .91
Annex L (informative) Considerations for sampling plans — Guidance for health care facilities .93
Annex M (informative) Stability testing (ISO 11607-1:2006, 6.4) — Guidance for industry .95
Annex N (informative) Use of the Internet — Guidance for industry and health care facilities .96
Annex O (informative) Test method validation — Guidance for industry .97
Annex P (informative) Use of contract packagers — Guidance for industry and health
care facilities.98
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Annex Q (informative) Guidance on establishing process parameters — Guidance for industry .99
Annex R (informative) Investigation failure — Guidance for industry and health care facilities .105
Annex S (informative) Packaging manufacturing process and packaging system design feasibility
evaluation — Guidance for industry .108
Bibliography .111
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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. 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. 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 on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 198, Sterilization of health care products.
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Introduction
Sterile barrier systems need to ensure the sterility of their contents until opened for use and ensure
aseptic presentation.
The sterile barrier system, depending on conditions of handling, distribution or storage, may provide
adequate protection for the sterile medical device. In circumstances where the packaged and sterilized
device undergoes repeated handling, additional protective packaging may need to be combined with the
sterile barrier system to create a packaging system.
Each establishment should evaluate the performance of each sterile barrier system or packaging system
before selection and implementation to ensure conditions for sterilization, storage, and handling can be
met. Each establishment that manages sterile items should have a documented plan of education on how
to store, handle and transport sterile items.
Regional differences in quality management systems and other requirements exist and these might
involve different approaches to human resource management. In any case however a sound education
process is a key element and facilities should ensure that its personnel are aware of the relevance and
importance of their packaging and sterilization activities for the safety of the patient.
ISO 11607-1 specifies the requirements for materials, sterile barrier systems, and packaging systems,
including the qualification of the packaging system design and evaluation of that design, ISO 11607-2
specifies the requirements for packaging process validation. Both of these documents provide standards
to ensure medical device protection, the ability to sterilize, maintenance of sterile package integrity and
aseptic presentation. The scope of each of these standards applies to health care facilities and wherever
medical devices are packaged and sterilized. It is recognized that the circumstances of the application
of these standards will be different when they are used in a health care facility from when they are used
by a medical device manufacturer or reprocessor.
The conditions of use of this guidance may vary widely around the world. ISO 11607-1 and ISO 11607-2
and this guidance document provide a guideline for use, subject to interpretation by circumstance and
regulatory environments. In some regions of the world health care facility compliance to the series
ISO 11607 is a national or regional regulatory requirement, in some regions the series ISO 11607 is
considered guidance for health care facilities. For instance, it is recognized that in certain regions or
regulatory applications conformance to ISO 11607-1 may be demonstrated but not conformance to
ISO 11607-2, which requires process validation by the user. In other regions, where compliance to both
ISO 11607-1 and ISO 11607-2 is a national regulatory requirement, this document will also provide
guidance on performing validation. Clause 3 of this guidance document is applicable to health care
facilities and Clause 4 is applicable to industry. Further guidance is given in Annexes A to S that may be
applicable to health care facilities and/or industry, as indicated.
In Europe ISO 11607-1 assists the conformity assessment procedure for manufacturers and is designed
and used as a tool for demonstrating compliance with the relevant essential requirements of the Medical
Device Directive. Compliance with the standard is always voluntary.
At the time of publication of this document, Amendments to ISO 11607-1 and ISO 11607-2 are in the
ballot process. This guidance document already considers the revised versions with the understanding
that specific references to numbering may have changed. Annex B of ISO 11607-1 on test methods has
been extensively revised and should be considered when available.
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SIST-TS CEN ISO/TS 16775:2014
TECHNICAL SPECIFICATION ISO/TS 16775:2014(E)
Packaging for terminally sterilized medical devices —
Guidance on the application of ISO 11607-1 and ISO 11607-
2
1 Scope
This Technical Specification 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/or 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/or ISO 11607-2
and illustrates some of 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 compliance
with them.
Guidelines are 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 Technical Specification provides information for health care facilities (see Clause 3) and for the
medical devices industry (see Clause 4).
It 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.
2 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 11607-1 and ISO 11607-2 and
the following apply.
2.1
packaging system
combination of the sterile barrier system and protective packaging
[SOURCE: ISO/TS 11139:2006, 2.28]
Note 1 to entry: The packaging system includes the sterile barrier system and the protective packaging. However,
if the sterile barrier system protects the medical device, facilitates aseptic presentation, and is resilient enough
not to require additional protective packaging, the sterile barrier system would also fulfil the requirements of a
packaging system. Protective packaging is not always necessary however aseptic opening/presentation has to be
ensured in all cases.
2.2
protective packaging
configuration of materials designed to prevent damage to the sterile barrier system and its contents
assembly until the point of use
[SOURCE: ISO/TS 11139:2006, 2.37]
Note 1 to entry: National or regional regulations may require that protective packaging is used to avoid the
potential contamination of the surgical environment. These regulations may also require that the protective
packaging is removed prior to introduction of the sterile barrier system into the surgical environment.
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Note 2 to entry: Protective packaging protects the sterile barrier and the contents. Examples would include a dust
cover, a box, transport tray.
2.3
sterile barrier system
SBS
minimum package that prevents ingress of microorganisms and allows aseptic presentation of product
at the point of use
[SOURCE: ISO/TS 11139:2006, 2.44]
2.4
preformed sterile barrier system
sterile barrier system that is supplied partially assembled for filling and final closure or sealing
EXAMPLE Pouches, bags, and open reusable container.
[SOURCE: ISO/TS 11139:2006, 2.31]
Note 1 to entry: Preformed sterile barrier systems exist in a wide range of forms. The examples listed above are
not intended to be all inclusive.
3 Guidance for health care facilities
IMPORTANT — Written instructions for use should be obtained from the packaging material
and/or medical device manufacturer concerning their recommendations for sterilization and
the subsequent maintenance of sterility of a sterile barrier system.
3.1 Test methods
For guidance on the requirements for test methods contained in ISO 11607-1 and ISO 11607-2, see the
health care annexes of this document.
3.2 Guidance for conformance to ISO 11607-1
3.2.1 General guidance for materials, preformed sterile barrier systems and sterile barrier
systems
3.2.1.1 Preformed sterile barrier systems should be evaluated before purchase and use. Therefore, the
supplier should consider providing a statement of compliance to the applicable sections of ISO 11607-1
for the materials and/or preformed sterile barrier systems to be purchased. Before introducing associated
components (e. g. labels, tapes, tray liners) into production, users should confirm that they will be suitable
for use in their specific applications and conditions of use.
3.2.1.2 The key concepts that apply to all packaging materials and components are as follows:
a) they should be made of known and traceable materials with processes capable of meeting the
requirements of ISO 11607-1 (see requirements in ISO 11607-1:2006, 5.1.3, 5.1.4 and 5.1.5);
b) they should be non-toxic, for guidance see A.3.3 (see requirement in ISO 11607-1:2006, 5.1.6);
NOTE 1 If the sterile barrier system or associated components contain natural rubber latex, the sterile
barrier system should be labelled indicating natural rubber latex is present.
c) there should be documented evidence that the ingress of microorganisms can be prevented when
demonstrated under test conditions which consider sterilization process, handling, distribution,
transport and storage (see requirement in ISO 11607-1:2006, 5.1.6 and 5.2);
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d) they should have a demonstrated ability to meet the required physical properties for materials
and closures (such as weight or grade, seal width and seal strength), resist tearing or puncture,
be capable of opening or peeling in a continuous and homogenous manner, without delamination
tearing (see requirements in ISO 11607-1:2006, 5.1.7 and 5.1.9);
e) they should be compatible with the intended sterilization process and parameters capable of
producing a sterile medical device (see requirement in ISO 11607-1:2006, 5.3);
f) they should be compatible with the labelling system; if present, have colour fast printing inks that
do not degrade, fade or become illegible after exposure to the intended sterilization process (see
requirement in ISO 11607-1:2006, 5.4);
g) they should be protected from the effects of environmental conditions (e.g. relative humidity, direct
sunlight or fluorescent light, temperature) during storage (see requirement in ISO 11607-1:2006,
5.5 and Clause 7);
NOTE 2 Suggested storage conditions and shelf life should be provided by the material or preformed sterile
barrier system manufacturer. If anticipated or actual storage is outside these conditions the manufacturer
should be consulted.
h) they should allow aseptic presentation.
NOTE 3 Instructions for aseptic presentation should be provided by the manufacturer of the medical
device and/or packaging system.
NOTE 4 The internet is a useful tool for finding information on materials, see Annex N.
3.2.2 Design and development guidance for packaging systems (ISO 11607-1:2006, 6.1 and 6.2)
3.2.2.1 Selection criteria
When a health care facility determines which packaging system to use, the design and development
guidance for those packaging systems should be considered (see requirements in ISO 11607-1:2006, 6.1
and 6.2). When a health care facility uses a contract packager or sterilizer additional considerations are
necessary (see Annex P).
The materials and systems chosen should:
a) be intended for use in medical packaging applications, as stated by the manufacturer;
b) be supported by technical information from the manufacturer confirming that it meets the
requirements of ISO 11607-1 that relate to materials;
c) provide adequate protection for the medical device(s) during specified intended storage and
transportation conditions to the point of use;
d) allow for and be compatible with the intended sterilization process, and have the ability to withstand
conditions of the chosen process;
NOTE Not all materials are appropriate for all sterilization processes. Information on compatibility
with a given sterilization process is typically provided by the manufacturer of the medical device and/or
packaging system. For further explanation of challenges of common sterilization processes see Annex B.
e) maintain sterile barrier integrity until its time of use;
f) ensure aseptic presentation at the point of use;
g) allow a method of closure that is tamper evident;
h) allow for ease of identification of contents.
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The user of the packaging materials should ensure that the sterile barrier system or packaging system
complies with ISO 11607-1, that requirements concerning product compatibility are met and that
processes for packaging, sterilization, storage and distribution are validated and controlled.
3.2.2.2 Selection considerations
The selection process at the health care facility should include an evaluation of the ability of both the
sterile barrier system and protective packaging (if required) utilized to maintain the integrity of that
sterile barrier system until its time of use and permit aseptic presentation at the point of use.
The choice of packaging components will be dependent on the risk associated with the medical device,
its conditions of use, the storage and transport requirements and health care procedures practiced at
the facility. These risks should be analysed by
...