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)

ISO/TS 16775:2014 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. It is an informative document, not normative, and 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 to 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.
ISO/TS 16775:2014 provides information for health care facilities and for the medical devices industry. 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.

Verpackungen für in der Endanwendung sterilisierte Medizinprodukte - Leitfaden für die Anwendung von ISO 11607-1 und ISO 11607-2 (ISO/TS 16775:2014)

Diese Technische Spezifikation 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/oder 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/oder ISO 11607-2 besser zu verstehen und um einige der zahlreichen Verfahren und Ansätze, die zur Erfüllung der Anforderun-gen von ISO 11607-1 und/oder ISO 11607-2 zur Verfügung stehen, zu veranschaulichen. Es ist nicht erforderlich, das vorliegende Dokument zum Nachweis der Einhaltung Internationaler Normen anzuwenden.
Dieses Dokument enthält Leitlinien zur Bewertung, Auswahl und Verwendung von Verpackungsmaterialien, vorgefertigten Sterilbarrieresystemen, Sterilbarrieresystemen und Verpackungssystemen. Es enthält außer-dem Hinweise zu den Validierungsanforderungen an Prozesse der Formgebung, Siegelung und der Zusammenstellung.
Dieses Dokument enthält Informationen für Einrichtungen des Gesundheitswesens (siehe Abschnitt 3) und für die Medizinprodukteindustrie (siehe Abschnitt 4).
Dieses Dokument enthält keine Leitlinien für die Verwendung von Verpackungsmaterialien und Verpackungs-systemen 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 Standards 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 16775:2014)

Embalaža za končno sterilizirane medicinske pripomočke - Smernice za uporabo ISO 11607-1 in ISO 11607-2 (ISO/TS 16775:2014)

Standard CEN ISO/TS 16775 podaja smernice za uporabo zahtev standardov ISO 11607-1 in ISO 11607-2. Ne dopolnjuje ali kako drugače spreminja zahtev standarda ISO 11607-1 in/ali ISO 11607-2. To je informativni in ne normativni dokument. Ne vključuje zahtev, ki naj se uporabljajo na osnovi predpisanega pregleda ali aktivnosti ugotavljanja certificiranja. Smernice je mogoče uporabiti za boljše razumevanje zahtev standarda ISO 11607-1 in/ali ISO 11607-2 ter prikazujejo nekatere metode in pristope, ki so na voljo za izpolnjevanje zahtev mednarodnih standardov. Ni zahtevano, da se ta dokument uporablja za dokaz skladnosti z njimi. Smernice so podane za vrednotenje, izbiro in uporabo materialov za embalažo, izvedenih sterilnih pregradnih sistemov, sterilnih pregradnih sistemov in sistemov embalaže. Podane so tudi smernice o zahtevah za validacijo procesov oblikovanja, označevanja in sestavljanja. Ta tehnična specifikacija podaja informacije za zdravstvene ustanove (glejte točko 3) in panogo medicinskih pripomočkov (glejte točko 4). Ne podaja smernic za uporabo materialov za embalažo in sistemov po njihovem odprtju. Za uporabo embalaže v druge namene, kot sta »sterilno polje« ali transport kontaminiranih predmetov, veljajo drugi regulativni standardi.

General Information

• Status: Withdrawn
• Publication Date: 20-May-2014
• Withdrawal Date: 13-Apr-2025
• ICS: 11.080.30 - Sterilized packaging
• Technical Committee: CEN/TC 102 - Sterilizers for medical purposes
• Drafting Committee: CEN/TC 102/WG 4 - Packaging materials
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 24-Nov-2021
• Completion Date: 14-Apr-2025
• Ref Project: 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)

Relations

• Replaced By: 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)
• Effective Date: 08-Aug-2018

Standards Content (Sample)

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

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.

Contents Page
Foreword .3
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.
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
ISO/TS 16775:2014(E)
© 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 [e-mail]
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved

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
ISO/TS 16775:2014(E)
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
iv © ISO 2014 – All rights reserved

ISO/TS 16775:2014(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. 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.
ISO/TS 16775:2014(E)
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.
vi © ISO 2014 – All rights reserved

TECHNICAL SPECIFICATION ISO/TS 16775:2014(E)
Packaging for terminally sterilized medical devices —
Guidance on the application of ISO 11607-1 and ISO 11607-
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.
ISO/TS 16775:2014(E)
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);
2 © ISO 2014 – All rights reserved

ISO/TS 16775:2014(E)
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.
ISO/TS 16775:2014(E)
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 the health care facility and procedures put in place to
mitigate/control those risks (see Annex K).
To choose the most appropriate material for the sterile barrier system and/or packaging system, the
following should be considered:
a) Duration and conditions of storage may affect the type of sterile barrier system or packaging system
needed. Some items may be stored for some time before use and may require a more durable sterile
barrier system and/or the addition of protective packaging. The more the sterile barrier system
or packaging system is handled the greater the probability that cracks, lid deformation, gasket
damage, tears, holes or material separation may occur.
b) Size, weight and shape of the item to be sterilized should be considered. Some items will require
more durable or more flexible sterile barrier systems than others.
c) If multiple types of packaging components are to be used it is important to verify that components
are compatible with each other as well as the product contained inside and the intended sterilization
process.
d) The means and conditions of transport should be considered. While in some cases routes are
exclusively inside the facility, they can also be between different facilities. Exposure of the packaging
systems to the uncontrolled environment may significantly increase the risk of loss of integrity of
the package, compromise aseptic opening or contaminate the contents.
3.2.2.3 Assembly considerations
The following aspects should be considered:
a) Medical devices should be oriented to facilitate aseptic presentation.
b) Sharp items should be shielded so that the user is protected from injury and the sterile barrier
system and medical device is protected from damage.
c) Associated components can be used inside the sterile barrier system in order to ease or facilitate
the organization, drying or aseptic presentation (e. g. inner wrap, instrument organizer tray, tray
liners or a containment device around the medical device).
d) The protection devices or associated components should:
1) be non-toxic, be intended for use in medical packaging applications, as stated by the
manufacturer;
2) provide protection of the medical device(s) during storage and transportation to the point of
use;
3) allow for and be compatible with the intended sterilization process, and have the ability to
withstand conditions of chosen process;
4 © ISO 2014 – All rights reserved

ISO/TS 16775:2014(E)
NOTE 1 Not all materials are appropriate for all sterilization processes. Information on compatibility with
a given sterilization process is typically provided by the manufacturer. For further explanation of challenges
of common sterilization processes see Annex B.
4) not undergo chemical or physical change to such an extent that the performance or safety is
impaired or the medical device that they contact is adversely affected;
5) not compromise aseptic presentation;
6) allow for easy identification of contents;
7) be stored in a controlled environment to maintain cleanliness and fitness for use.
e) The weight of the packaging system and its contents should not exceed national regulations for
manual handling.
NOTE 2 Current national regulations range from about 5 kg to 11,4 kg.
3.2.2.4 Labelling considerations
Part of the selection process should include consideration of how labelling is to be accomplished. The
facility’s labelling procedure for the sterile barrier system or packaging system should include the
following:
a) When identification is performed in a health care facility:
— for pouches and reels the label should be placed on the film if applied before sterilization or on
either side if after, the label should not conceal the device;
— for pouches and reels printing or writing should be placed outside the area enclosed by the
outside dimensions of the seals;
— care should be taken when applying labels to filled sterile barrier systems so as not to damage
packaging materials or contents.
b) Writing on wrapped packages should be on the closure tape, not directly on wrappers.
c) Special labels intended for a specific sterilization process may be written on. If these labels are used
they should not impede the sterilization process (i.e. should not block the breathable area of the
package).
d) Labelling should remain securely adhered to the sterile barrier system through the sterilization
process and storage until the point of use.
e) Labels or closure tapes used as labels, and their adhesive systems should be non-toxic.
f) Only non-toxic ink that is suitable for use with the chosen sterilization process should be used.
g) Ballpoint pens or any writing instrument with the potential for creating a hole or puncture in the
sterile barrier system should not be used.
3.2.2.5 Regulatory considerations
Specific national or regional regulatory requirements may apply. These requirements should be
considered during the selection process for a sterile barrier system and/or for a packaging system.
ISO/TS 16775:2014(E)
3.2.2.6 Common choices for sterile barrier systems
3.2.2.6.1 General
Sterile barrier systems can be manufactured using mainly, but not limited to, the following concepts:
— sealable pouches and reels; and/or
— sterilization wrap; and/or
— reusable container.
Aspects to be considered in using these systems follow.
3.2.2.6.2 Sealable pouches and reels (preformed sterile barrier systems)
Sealable pouches and reels are typically purchased in two forms:
— The continuous roll or reel type is sealed along both edges. The roll is unwound and cut to the
desired length. The medical device is placed between the two layers and both ends are sealed.
— The pouch is pre-cut to a specific size and sealed on three sides. The medical device is placed inside
the pouch and the fourth side is sealed.
The following aspects should be considered:
a) The size of the pouch and the strength of the packaging materials should be based on the medical
device which is going to be packaged. Items either too large for a package or with sharp edges will
put extra pressure on the seals and the materials. This may cause rupture. There should be enough
space to make seal closure possible. Too many small items in the sterile barrier system may cause
the items to move around, rupture the seal, penetrate or abrade the package materials. Thin or
fragile materials can be damaged during handling, transport, and distribution.
b) If not specified otherwise by the manufacturer the preformed sterile barrier system should be filled
up to a maximum of 75 % of the inner surface area of the porous side. Care should also be taken to
ensure that the distance from the seals is increased for products of greater height.
c) When two pouches are used, the inner pouch should be able to move within the outer pouch. This
allows penetration of the sterilant and prevents the pouches from sticking together during the
sterilization process. Folding of the inner pouch in order to fit into the outer pouch or folding of
the outer pouches should be avoided in order to prevent stressing or damage to the sterile barrier
system. For combining two pouches made from film and porous material it is important that film
meets film and porous material meets porous material for identification of content and permeation
of sterilant.
d) All pouch seals, including closure seal, should be smooth, i.e. without folds, bubbles, or wrinkles.
e) Self-seal pouches and those closed with tape may provide less security than heat sealed pouches.
Sealing procedure should dictate that folds and closures should not be skewed, and care should be
taken to ensure that both corners are well sealed, in order to ensure a complete closure across the
entire end. Correct tape placement is critical to provide complete closure and thus sterile barrier
system integrity. Special attention should be paid to proper method of closure to ensure package
integrity.
f) Sealing devices should be able to control and monitor critical process parameters (e.g. temperature,
pressure, sealing time/speed) in accordance with their validation criteria (e.g. alarms, warning
system or machine stop in the event of any critical process parameter deviation). Operators should
not modify critical process parameters unless they have been suitably trained, fully comply with
appropriate operating procedures and stay within the validation process. The sealer should be
capable of attaining the sealing conditions suggested by the preformed sterile barrier system
6 © ISO 2014 – All rights reserved

ISO/TS 16775:2014(E)
manufacturer. Sealing devices manufactured and intended for preformed sterile barrier systems
should be used.
g) Closing accessories that compress the package or medical device should not be used (e.g. ropes,
string, elastic bands, paperclips, staples or similar items).
h) The pouch should be loaded so that the enclosed medical device will be presented aseptically. For
instance, the grip of the medical device should be placed toward the opening end. It should be noted
[108]
that the seal areas are considered non-sterile when opened.
i) The pouch should be opened according to the manufacturer instructions, if there is a specific
orientation needed to prevent fibres delamination when opening that orientation should be followed.
The formed package should show by design which direction the packaging has to be opened (e.g.
arrow sign, shape of seal).
j) Reels (rolls) are used for the packaging of medical devices of diverse dimensions that do not easily
fit standard preformed pouch sizes. Due to the fact that the packaging is sealed on two sides the
pointed seal (chevron) is missing. In the absence of the chevron, the peel direction for reels should
be provided by the manufacturer. Additionally, it is advisable to have more space above the seal that
is intended to be opened according to the manufacturer’s information.
NOTE In most areas of the world, certain sterile barrier systems, which are not peelable and require cutting
to gain access to the product inside, are used in lieu of peelable preformed sterile barrier systems. For example,
some of the sterile barrier systems formed using either sterilization bags, header bags, or pouches produced using
reel material constructed from one layer of porous material and one layer of plastics film, sealed together along
the parallel sides. In these applications, there is a greater risk of the product coming into contact with the non-
sterile outer surface of the sterile barrier system and extra care should be taken to ensure aseptic presentation.
This is achieved by cutting the top off and then inverting to allow the medical device to drop out onto a suitable
surface without touching the outsides.
3.2.2.6.3 Sterilization wrap
Sterilization wrap comes in many sizes and grades to accommodate a wide range of applications. It is
also available in single use or reusable fabric forms. Careful consideration should be given to the item
to be wrapped and the technique to be used. Sterilization wrap can be used for wrapping of individual
medical devices or medical devices in instrument cases, cassettes or instrument organizing trays.
The following aspects should be considered:
a) The grade of the sterilization wrap should be chosen according to the size, shape and weight of
the medical devices to be wrapped or based on guidelines within the health care facility and wrap
manufacturer’s recommendations for use.
b) The size of the sterilization wrap should be selected to achieve adequate coverage of the item being
packaged. It is essential to wrap the item securely to prevent gaps, billowing and air pockets from
forming. The item should not be wrapped too tightly as this could create holes or tears in the wrap.
It is also necessary that the sterilization wrap be large enough to accommodate movement of the
wrap during the sterilization cycle without ripping or tearing. When choosing sheets of sterilization
wrap the wrapper should be large enough to cover the medical device, but it should not be so big
that it has to be wrapped several times around the medical device, as this may impede sterilant
penetration.
c) Proper wrapping technique is essential to provide a tortuous pathway to impede microbial
migration into the sterile barrier system. A wrapping technique can be used if the manufacturer
has demonstrated the efficacy of this technique and recommends it for this application (see 3.2.2.1).
The wrapping method chosen should allow aseptic presentation of the medical device. The health
care facility should verify or validate the application in its own facilities per national or regional
regulations. National standards or professional guidelines for wrapping techniques may be available.
Examples are given in Annex C.
ISO/TS 16775:2014(E)
d) The sterilization wrapping technique should be designed in a manner that the opened wrapper
should drape away from the sterile field.
e) The assembly surface area for wrapping should be flat, smooth, of adequate size, well lit and clean.
f) The wrapped package should be designed in a manner so that all edges are secured and do not
interfere with aseptic presentation into the sterile field.
g) Closure systems should provide evidence of tampering.
h) Indicator tape is the most common closure for wrapped packages and there are different kinds of
tape based on the method of sterilization. There are different tapes designed for use on woven or
nonwoven wrappers. Closures that compress the package or medical device should not be used (e.g.
ropes, strings, elastic bands, paperclips, staples or similar items).
i) When reusable fabrics are used as sterilization wrap there are additional requirements to ensure
the suitability of the wrap prior to each use (see requirements in ISO 11607-1:2006, 5.1.11 and
5.1.12).
3.2.2.6.4 Reusable containers
A rigid reusable container is designed to hold medical devices and accessories and is sterilized without
exterior wrapping. This container typically consists of a bottom or base with carrying handles and a
lid that is secured to the base by a latching mechanism. It may contain a basket or tray to hold medical
devices. The container incorporates a means for air evacuation and sterilant penetration. In regional or
other standards it may be referred to as a “rigid container” or a “reusable container”.
Instrument cases, cassettes or organizing trays are containment devices but not sterile barrier systems.
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