SIST EN ISO 11607-1:2020
(Main)Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use. It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized. It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations. It does not describe a quality assurance system for control of all stages of manufacture. It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 1: Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme (ISO 11607-1:2019)
Dieses Dokument legt Anforderungen an und Prüfverfahren für Materialien, vorgefertigte Sterilbarrieresysteme, Sterilbarrieresysteme und Verpackungssysteme fest, die dazu vorgesehen sind, die Sterilität von in der Endverpackung sterilisierten Medizinprodukten bis zum Anwendungszeitpunkt zu erhalten.
Es gilt für die Industrie, für Einrichtungen des Gesundheitswesens und für alle anderen Einrichtungen, in denen Medizinprodukte in Sterilbarrieresysteme verpackt und sterilisiert werden.
Es erfasst nicht alle Anforderungen an Sterilbarrieresysteme und Verpackungssysteme für aseptisch hergestellte Medizinprodukte. Für Kombinationen von Medikamenten und Medizinprodukten können zusätzliche Anforderungen erforderlich sein.
Es beschreibt kein Qualitätssicherungssystem zur Lenkung aller Herstellungsschritte.
Es gilt nicht für Verpackungsmaterialien und/oder systeme, die dazu verwendet werden, ein verunreinigtes Medizinprodukt während des Transports zur Wiederaufbereitung oder Entsorgung aufzunehmen.
Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 1: Exigences relatives aux matériaux, aux systèmes de barrière stérile et aux systèmes d'emballage (ISO 11607-1:2019)
Le présent document spécifie les exigences et les méthodes d'essai pour les matériaux, les systèmes de barrière stérile préformés, les systèmes de barrière stérile et les systèmes d'emballage destinés à maintenir l'état de stérilité des dispositifs médicaux stérilisés de façon terminale jusqu'au point d'utilisation.
Il s'applique à l'industrie, aux établissements de santé et à tout lieu où des dispositifs médicaux sont insérés dans des systèmes de barrière stérile et stérilisés.
Il ne couvre pas toutes les exigences relatives aux systèmes de barrière stérile et systèmes d'emballage pour les dispositifs médicaux fabriqués de manière aseptique. Dans ce cas, des exigences supplémentaires peuvent être nécessaires pour garantir les combinaisons médicaments/dispositifs.
Il ne décrit pas de système d'assurance qualité pour le contrôle de toutes les étapes de fabrication.
Il ne s'applique pas aux matériaux d'emballage et/ou systèmes utilisés pour contenir un dispositif médical contaminé pendant le transport du dispositif vers le site de retraitement ou d'élimination.
Embalaža za končno sterilizirane medicinske pripomočke - 1. del: Zahteve za materiale, sterilne pregradne sisteme in sisteme embalaže (ISO 11607-1:2019)
Ta dokument določa zahteve in preskusne metode za materiale, izvedene sterilne pregradne sisteme, sterilne pregradne sisteme in sisteme embalaže, ki so namenjeni za vzdrževanje sterilnosti končno steriliziranih medicinskih pripomočkov do njihove uporabe. Uporablja se za industrijo, zdravstvene ustanove in vse medicinske pripomočke, ki so sterilizirani v sterilnih pregradnih sistemih. Ne zajema vseh zahtev za sterilne pregradne sisteme in sisteme embalaže medicinskih pripomočkov, ki so izdelani aseptično. Za kombinacije zdravil/pripomočkov so morda potrebne dodatne zahteve. Ne opisuje sistema zagotavljanja kakovosti za nadzor vseh faz proizvodnje. Ne uporablja se za embalažo in/ali sisteme, ki se uporabljajo za hrambo kontaminiranega medicinskega pripomočka med prevozom elementa na mesto predelave ali odstranjevanja.
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SLOVENSKI STANDARD
SIST EN ISO 11607-1:2020
01-marec-2020
Nadomešča:
SIST EN ISO 11607-1:2017
Embalaža za končno sterilizirane medicinske pripomočke - 1. del: Zahteve za
materiale, sterilne pregradne sisteme in sisteme embalaže (ISO 11607-1:2019)
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials,
sterile barrier systems and packaging systems (ISO 11607-1:2019)
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 1:
Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme (ISO
11607-1:2019)
Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 1: Exigences
relatives aux matériaux, aux systèmes de barrière stérile et aux systèmes d'emballage
(ISO 11607-1:2019)
Ta slovenski standard je istoveten z: EN ISO 11607-1:2020
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
SIST EN ISO 11607-1:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11607-1:2020
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SIST EN ISO 11607-1:2020
EN ISO 11607-1
EUROPEAN STANDARD
NORME EUROPÉENNE
January 2020
EUROPÄISCHE NORM
ICS 11.080.30 Supersedes EN ISO 11607-1:2017
English Version
Packaging for terminally sterilized medical devices - Part
1: Requirements for materials, sterile barrier systems and
packaging systems (ISO 11607-1:2019)
Emballages des dispositifs médicaux stérilisés au stade Verpackungen für in der Endverpackung zu
terminal - Partie 1: Exigences relatives aux matériaux, sterilisierende Medizinprodukte - Teil 1:
aux systèmes de barrière stérile et aux systèmes Anforderungen an Materialien, Sterilbarrieresysteme
d'emballage (ISO 11607-1:2019) und Verpackungssysteme (ISO 11607-1:2019)
This European Standard was approved by CEN on 3 November 2018.
This European Standard was corrected and reissued by the CEN-CENELEC Management Centre on 12 February 2020.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
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 NORMALISATIO N
EUROPÄISCHES KOMITEE FÜR NORMUN G
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11607-1:2020 E
worldwide for CEN national Members.
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SIST EN ISO 11607-1:2020
EN ISO 11607-1:2020 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 11607-1:2020
EN ISO 11607-1:2020 (E)
European foreword
This document (EN ISO 11607-1:2020) 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.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by July 2020, and conflicting national standards shall be
withdrawn at the latest by July 2020.
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 EN ISO 11607-1:2017.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: 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 11607-1:2019 has been approved by CEN as EN ISO 11607-1:2020 without any
modification.
3
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SIST EN ISO 11607-1:2020
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SIST EN ISO 11607-1:2020
INTERNATIONAL ISO
STANDARD 11607-1
Second edition
2019-02
Packaging for terminally sterilized
medical devices —
Part 1:
Requirements for materials, sterile
barrier systems and packaging systems
Emballages des dispositifs médicaux stérilisés au stade terminal —
Partie 1: Exigences relatives aux matériaux, aux systèmes de barrière
stérile et aux systèmes d'emballage
Reference number
ISO 11607-1:2019(E)
©
ISO 2019
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SIST EN ISO 11607-1:2020
ISO 11607-1:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019
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
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Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
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SIST EN ISO 11607-1:2020
ISO 11607-1:2019(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 6
4.1 Quality systems . 6
4.2 Risk management . 6
4.3 Sampling . 6
4.4 Test methods . 6
4.5 Documentation . 7
5 Materials, preformed sterile barrier systems and sterile barrier systems .7
5.1 General requirements . 7
5.2 Microbial barrier properties .10
5.3 Compatibility with the sterilization process .11
5.4 Labelling system .11
5.5 Storage and transport of materials and preformed sterile barrier systems .11
6 Design and development for packaging systems .12
6.1 General .12
6.2 Design .12
7 Usability evaluation for aseptic presentation .13
8 Packaging system performance and stability .14
8.1 General .14
8.2 Packaging system performance testing .14
8.3 Stability testing .15
9 Packaging system validation and changes .15
10 Inspection immediately prior to aseptic presentation .16
11 Information to be provided .16
Annex A (informative) Guidance on medical packaging .17
Annex B (informative) Standardized test methods, guides and procedures that can be used
to demonstrate conformity with the requirements of this document .20
Annex C (normative) Test method for resistance of impermeable materials to the passage of air .31
Annex D (informative) Environmental aspects .32
Annex E (informative) Draft guidance on ways to differentiate a sterile barrier system from
protective packaging .33
Bibliography .38
© ISO 2019 – All rights reserved iii
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SIST EN ISO 11607-1:2020
ISO 11607-1:2019(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.
This second edition cancels and replaces the first edition (ISO 11607-1:2006), which has been technically
revised. It also incorporates the amendment ISO 11607-1:2006/Amd.1:2014.
The main changes compared to the previous edition are as follows:
— the definitions have been aligned with the latest version of ISO 11139;
— new requirements for the evaluation of usability for aseptic presentation have been added;
— new requirements for the inspection of sterile barrier system integrity prior to use have been added;
— a new subclause with requirements for revalidation in accordance with ISO 11607-2 has been added;
— Annex B has been updated and various national, international and European test methods have
been added or deleted;
— a new Annex D has been added with environmental considerations;
— a new Annex E has been added with draft guidance on ways to differentiate a sterile barrier system
from protective packaging.
A list of all parts in the ISO 11607 series can be found on the ISO website.
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.
iv © ISO 2019 – All rights reserved
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SIST EN ISO 11607-1:2020
ISO 11607-1:2019(E)
Introduction
The process of designing and developing a packaging system for terminally sterilized medical devices
is a complicated and critical endeavour. The device components and the packaging system should be
combined to create a sterile medical device that performs efficiently, safely and effectively in the hands
of the user.
This document specifies requirements for the design of sterile barrier systems and packaging systems
for terminally sterilized medical devices, the basic attributes required of materials and preformed
sterile barrier systems, and design validation requirements. This document is written as a general
(horizontal) standard considering a wide range of potential materials, medical devices, packaging
system designs and sterilization methods. It can be applied by suppliers of materials or of preformed
sterile barrier systems, by medical device manufacturers or health care facilities. ISO 11607-2 describes
the process development and validation requirements for forming, sealing and assembly processes and
addresses controls during normal operations.
Guidance for ISO 11607 series can be found in ISO/TS 16775.
European standards that provide requirements for particular materials and preformed sterile barrier
systems are available and known as the EN 868 series. Conformity with the EN 868 series can be used
to demonstrate conformity with one or more of the requirements of this document.
The goal of a terminally sterilized medical device packaging system is to allow sterilization, provide
physical protection, maintain sterility up to the point of use and allow aseptic presentation. The
specific nature of the medical device, the intended sterilization methods(s), the intended use, expiry
date, transport and storage all influence the packaging system design and choice of materials.
The term “sterile barrier system” was introduced in ISO 11607-1:2006 to describe the minimum
packaging required to perform the unique functions required of medical packaging: to allow sterilization,
to provide an acceptable microbial barrier, and to allow for aseptic presentation. “Protective packaging”
protects the sterile barrier system, and together they form the packaging system. “Preformed sterile
barrier systems” would include any partially assembled sterile barrier systems such as pouches, header
bags or hospital packaging reels. An overview of sterile barrier systems is given in Annex A.
The sterile barrier system is essential to ensure the safety of terminally sterilized medical devices.
Regulatory authorities recognize the critical nature of sterile barrier systems by considering them as
an accessory or a component of a medical device. Preformed sterile barrier systems sold to health care
facilities for use in internal sterilization are considered medical devices in many parts of the world.
© ISO 2019 – All rights reserved v
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SIST EN ISO 11607-1:2020
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SIST EN ISO 11607-1:2020
INTERNATIONAL STANDARD ISO 11607-1:2019(E)
Packaging for terminally sterilized medical devices —
Part 1:
Requirements for materials, sterile barrier systems and
packaging systems
1 Scope
This document specifies requirements and test methods for materials, preformed sterile barrier
systems, sterile barrier systems and packaging systems that are intended to maintain sterility of
terminally sterilized medical devices until the point of use.
It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile
barrier systems and sterilized.
It does not cover all requirements for sterile barrier systems and packaging systems for medical
devices that are manufactured aseptically. Additional requirements can be necessary for drug/device
combinations.
It does not describe a quality assurance system for control of all stages of manufacture.
It does not apply to packaging materials and/or systems used to contain a contaminated medical device
during transportation of the item to the site of reprocessing or disposal.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 5636-5, Paper and board — Determination of air permeance (medium range) — Part 5: Gurley method
ISO 11607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for
forming, sealing and assembly processes
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
3.1
aseptic presentation
transfer of sterile contents from its sterile barrier system using conditions and procedures that
minimize the risk of microbial contamination
[SOURCE: ISO 11139:2018, 3.13]
© ISO 2019 – All rights reserved 1
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SIST EN ISO 11607-1:2020
ISO 11607-1:2019(E)
3.2
bioburden
population of viable microorganisms on or in product and/or sterile barrier system
[SOURCE: ISO 11139:2018, 3.23]
3.3
closure
means used to complete a sterile barrier system where no seal is formed
EXAMPLE By a reusable container gasket or sequential folding to construct a tortuous path.
[SOURCE: ISO 11139:2018, 3.51, modified — The example has been added.]
3.4
closure integrity
characteristics of a closure to minimize the risk of ingress of microorganisms
[SOURCE: ISO 11139:2018, 3.52]
3.5
control
regulation of variables within specified limits
[SOURCE: ISO 11139:2018, 3.63]
3.6
expiry date
date by which product should be used
Note 1 to entry: For the purpose of this document and ISO 11607-2, expiry date refers to the medical device in a
sterile barrier system. The term “use by date” (3.29) is used to describe the shelf life of packaging materials and
preformed sterile barrier systems prior to assembly into a sterile barrier system.
[SOURCE: ISO 11139:2018, 3.110, modified — Note 1 to entry has been added.]
3.7
labelling
label, instructions for use and any other information that is related to identification, technical
description, intended purpose and proper use of the health care product, but excluding shipping
documents
[SOURCE: ISO 13485:2016, 3.8, modified — The term “medical device” has been replaced by “health
care product”.]
3.8
medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software,
material or other similar or related article, intended by the manufacturer to be used, alone or in
combination, for human beings, for one or more of the specific medical purpose(s) of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease;
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
— investigation, replacement, modification, or support of the anatomy or of a physiological process;
— supporting or sustaining life;
— control of conception;
— disinfection of medical devices;
2 © ISO 2019 – All rights reserved
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SIST EN ISO 11607-1:2020
ISO 11607-1:2019(E)
— providing information by means of in vitro examination of specimens derived from the human body;
and does not achieve its primary intended action by pharmacological, immunological or metabolic
means, in or on the human body, but which may be assisted in its intended function by such means
Note 1 to entry: Products which may be considered to be medical devices in some jurisdictions but not in others
include:
— items specifically intended for cleaning or sterilization of medical devices;
— pouches, reel goods, sterilization wrap and reusable containers for packaging of medical devices for
sterilization;
— disinfection substances;
— aids for persons with disabilities;
— devices incorporating animal and/or human tissues;
— devices for in vitro fertilization or assisted reproduction technologies.
[SOURCE: ISO 13485:2016, 3.11, modified — The first two list items in Note 1 to entry have been added.]
3.9
microbial barrier
property of a sterile barrier system to minimize the risk of ingress of microorganisms
[SOURCE: ISO 11139:2018, 3.169]
3.10
monitoring
continual checking, supervising, critically observing, or determining the status, in order to identify
change from the performance level required or expected
[SOURCE: ISO Guide 73:2009, 3.8.2.1, modified — The note has been deleted.]
3.11
packaging system
combination of a sterile barrier system and protective packaging
[SOURCE: ISO 11139:2018, 3.192]
3.12
preformed sterile barrier system
sterile barrier system (3.23) that is supplied partially assembled for filling and final closure or sealing
EXAMPLE Pouches, bags and open reusable containers (3.17).
[SOURCE: ISO 11139:2018, 3.201, modified — The example has been added.]
3.13
product
tangible result of a process
EXAMPLE Raw material(s), intermediate(s), sub-assembly(ies), health care product(s).
Note 1 to entry: For the purpose of this document and ISO 11607-2, products include preformed sterile barrier
systems, sterile barrier systems, and contents within them.
[SOURCE: ISO 11139:2018, 3.217, modified — Note 1 to entry has been added.]
© ISO 2019 – All rights reserved 3
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SIST EN ISO 11607-1:2020
ISO 11607-1:2019(E)
3.14
protective packaging
configuration of materials designed to prevent damage to the sterile barrier system and its contents
from the time of their assembly until the point of use
[SOURCE: ISO 11139:2018, 3.219]
3.15
repeatability
condition of measurement, out of a set of conditions that includes the same measurement procedure,
same operators, same measuring system, same operating conditions and same location, and replicate
measurements on the same or similar objects over a short period of time
[SOURCE: ISO/IEC Guide 99:2007, 2.20, modified — The term name has been simplified and the notes
omitted.]
3.16
reproducibility
condition of measurement, out of a set of conditions that includes different locations, processors,
measuring systems, and replicate measurements on the same or similar objects
Note 1 to entry: The different measuring systems may use different measurement procedures.
Note 2 to entry: A specification should give the conditions changed and unchanged to the extent practical.
[SOURCE: ISO/IEC Guide 99:2007, 2.24, modified — The term name has been simplified.]
3.17
reusable container
rigid sterile barrier system (3.23) designed to be used repeatedly
[SOURCE: ISO 11139:2018, 3.235]
3.18
seal
result of joining surfaces together by fusion to form a microbial barrier
Note 1 to entry: Surfaces can be joined together by, for example, adhesives or thermal fusion.
[SOURCE: ISO 11139:2018, 3.244, modified — Note 1 to entry has been added.]
3.19
seal integrity
characteristics of a seal to minimize the ingress of microorganisms
[SOURCE: ISO 11139:2018, 3.245]
3.20
seal strength
mechanical capacity of the seal to withstand force
[SOURCE: ISO 11139:2018, 3.246]
3.21
service life
number of processing cycles and/or lifetime up to which a product is claimed to remain suitable and
safe for its intended use when used according to the labelling
[SOURCE: ISO 11139:2018, 3.251]
4 © ISO 2019 – All rights reserved
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SIST EN ISO 11607-1:2020
ISO 11607-1:2019(E)
3.22
sterile
free from viable microorganisms
[SOURCE: ISO 11139:2018, 3.271]
3.23
sterile barrier system
SBS
minimum package that minimizes the risk of ingress of microorganisms and allows aseptic presentation
of the sterile contents at the point of use
[SOURCE: ISO 11139:2018, 3.272]
3.24
sterile fluid-path packaging
system of protective port covers and/or packaging designed to ensure sterility of the portion of the
medical device intended for contact with fluids
EXAMPLE The interior of the tubing for administration of an intravenous fluid.
[SOURCE: ISO 11139:2018, 3.273]
3.25
sterilization compatibility
attributes of the packaging material and/or system that allow it both to withstand the
sterilization process and attain the required conditions for sterilization within the packaging system
[SOURCE: ISO 11139:2018, 3.278]
3.26
sterilizing agent
physical or chemical entity, or combination of entities, having sufficient microbiocidal activity to
achieve sterility under specified conditions
[SOURCE: ISO 11139:2018, 3.288]
3.27
terminal steril
...
SLOVENSKI STANDARD
SIST EN ISO 11607-1:2020
01-marec-2020
Nadomešča:
SIST EN ISO 11607-1:2017
Embalaža za končno sterilizirane medicinske pripomočke - 1. del: Zahteve za
materiale, sterilne pregradne sisteme in sisteme embalaže (ISO 11607-1:2019)
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials,
sterile barrier systems and packaging systems (ISO 11607-1:2019)
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 1:
Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme (ISO
11607-1:2019)
Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 1: Exigences
relatives aux matériaux, aux systèmes de barrière stérile et aux systèmes d'emballage
(ISO 11607-1:2019)
Ta slovenski standard je istoveten z: EN ISO 11607-1:2020
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
SIST EN ISO 11607-1:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11607-1:2020
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SIST EN ISO 11607-1:2020
EN ISO 11607-1
EUROPEAN STANDARD
NORME EUROPÉENNE
January 2020
EUROPÄISCHE NORM
ICS 11.080.30 Supersedes EN ISO 11607-1:2009
English Version
Packaging for terminally sterilized medical devices - Part
1: Requirements for materials, sterile barrier systems and
packaging systems (ISO 11607-1:2019)
Emballages des dispositifs médicaux stérilisés au stade Verpackungen für in der Endverpackung zu
terminal - Partie 1: Exigences relatives aux matériaux, sterilisierende Medizinprodukte - Teil 1:
aux systèmes de barrière stérile et aux systèmes Anforderungen an Materialien, Sterilbarrieresysteme
d'emballage (ISO 11607-1:2019) und Verpackungssysteme (ISO 11607-1:2019)
This European Standard was approved by CEN on 3 November 2018.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
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
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11607-1:2020 E
worldwide for CEN national Members.
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SIST EN ISO 11607-1:2020
EN ISO 11607-1:2020 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 11607-1:2020
EN ISO 11607-1:2020 (E)
European foreword
This document (EN ISO 11607-1:2020) 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.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by July 2020, and conflicting national standards shall be
withdrawn at the latest by July 2020.
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 EN ISO 11607-1:2009.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: 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 11607-1:2019 has been approved by CEN as EN ISO 11607-1:2020 without any
modification.
3
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SIST EN ISO 11607-1:2020
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SIST EN ISO 11607-1:2020
INTERNATIONAL ISO
STANDARD 11607-1
Second edition
2019-02
Packaging for terminally sterilized
medical devices —
Part 1:
Requirements for materials, sterile
barrier systems and packaging systems
Emballages des dispositifs médicaux stérilisés au stade terminal —
Partie 1: Exigences relatives aux matériaux, aux systèmes de barrière
stérile et aux systèmes d'emballage
Reference number
ISO 11607-1:2019(E)
©
ISO 2019
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SIST EN ISO 11607-1:2020
ISO 11607-1:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019
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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
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SIST EN ISO 11607-1:2020
ISO 11607-1:2019(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 6
4.1 Quality systems . 6
4.2 Risk management . 6
4.3 Sampling . 6
4.4 Test methods . 6
4.5 Documentation . 7
5 Materials, preformed sterile barrier systems and sterile barrier systems .7
5.1 General requirements . 7
5.2 Microbial barrier properties .10
5.3 Compatibility with the sterilization process .11
5.4 Labelling system .11
5.5 Storage and transport of materials and preformed sterile barrier systems .11
6 Design and development for packaging systems .12
6.1 General .12
6.2 Design .12
7 Usability evaluation for aseptic presentation .13
8 Packaging system performance and stability .14
8.1 General .14
8.2 Packaging system performance testing .14
8.3 Stability testing .15
9 Packaging system validation and changes .15
10 Inspection immediately prior to aseptic presentation .16
11 Information to be provided .16
Annex A (informative) Guidance on medical packaging .17
Annex B (informative) Standardized test methods, guides and procedures that can be used
to demonstrate conformity with the requirements of this document .20
Annex C (normative) Test method for resistance of impermeable materials to the passage of air .31
Annex D (informative) Environmental aspects .32
Annex E (informative) Draft guidance on ways to differentiate a sterile barrier system from
protective packaging .33
Bibliography .38
© ISO 2019 – All rights reserved iii
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SIST EN ISO 11607-1:2020
ISO 11607-1:2019(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.
This second edition cancels and replaces the first edition (ISO 11607-1:2006), which has been technically
revised. It also incorporates the amendment ISO 11607-1:2006/Amd.1:2014.
The main changes compared to the previous edition are as follows:
— the definitions have been aligned with the latest version of ISO 11139;
— new requirements for the evaluation of usability for aseptic presentation have been added;
— new requirements for the inspection of sterile barrier system integrity prior to use have been added;
— a new subclause with requirements for revalidation in accordance with ISO 11607-2 has been added;
— Annex B has been updated and various national, international and European test methods have
been added or deleted;
— a new Annex D has been added with environmental considerations;
— a new Annex E has been added with draft guidance on ways to differentiate a sterile barrier system
from protective packaging.
A list of all parts in the ISO 11607 series can be found on the ISO website.
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.
iv © ISO 2019 – All rights reserved
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SIST EN ISO 11607-1:2020
ISO 11607-1:2019(E)
Introduction
The process of designing and developing a packaging system for terminally sterilized medical devices
is a complicated and critical endeavour. The device components and the packaging system should be
combined to create a sterile medical device that performs efficiently, safely and effectively in the hands
of the user.
This document specifies requirements for the design of sterile barrier systems and packaging systems
for terminally sterilized medical devices, the basic attributes required of materials and preformed
sterile barrier systems, and design validation requirements. This document is written as a general
(horizontal) standard considering a wide range of potential materials, medical devices, packaging
system designs and sterilization methods. It can be applied by suppliers of materials or of preformed
sterile barrier systems, by medical device manufacturers or health care facilities. ISO 11607-2 describes
the process development and validation requirements for forming, sealing and assembly processes and
addresses controls during normal operations.
Guidance for ISO 11607 series can be found in ISO/TS 16775.
European standards that provide requirements for particular materials and preformed sterile barrier
systems are available and known as the EN 868 series. Conformity with the EN 868 series can be used
to demonstrate conformity with one or more of the requirements of this document.
The goal of a terminally sterilized medical device packaging system is to allow sterilization, provide
physical protection, maintain sterility up to the point of use and allow aseptic presentation. The
specific nature of the medical device, the intended sterilization methods(s), the intended use, expiry
date, transport and storage all influence the packaging system design and choice of materials.
The term “sterile barrier system” was introduced in ISO 11607-1:2006 to describe the minimum
packaging required to perform the unique functions required of medical packaging: to allow sterilization,
to provide an acceptable microbial barrier, and to allow for aseptic presentation. “Protective packaging”
protects the sterile barrier system, and together they form the packaging system. “Preformed sterile
barrier systems” would include any partially assembled sterile barrier systems such as pouches, header
bags or hospital packaging reels. An overview of sterile barrier systems is given in Annex A.
The sterile barrier system is essential to ensure the safety of terminally sterilized medical devices.
Regulatory authorities recognize the critical nature of sterile barrier systems by considering them as
an accessory or a component of a medical device. Preformed sterile barrier systems sold to health care
facilities for use in internal sterilization are considered medical devices in many parts of the world.
© ISO 2019 – All rights reserved v
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SIST EN ISO 11607-1:2020
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SIST EN ISO 11607-1:2020
INTERNATIONAL STANDARD ISO 11607-1:2019(E)
Packaging for terminally sterilized medical devices —
Part 1:
Requirements for materials, sterile barrier systems and
packaging systems
1 Scope
This document specifies requirements and test methods for materials, preformed sterile barrier
systems, sterile barrier systems and packaging systems that are intended to maintain sterility of
terminally sterilized medical devices until the point of use.
It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile
barrier systems and sterilized.
It does not cover all requirements for sterile barrier systems and packaging systems for medical
devices that are manufactured aseptically. Additional requirements can be necessary for drug/device
combinations.
It does not describe a quality assurance system for control of all stages of manufacture.
It does not apply to packaging materials and/or systems used to contain a contaminated medical device
during transportation of the item to the site of reprocessing or disposal.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 5636-5, Paper and board — Determination of air permeance (medium range) — Part 5: Gurley method
ISO 11607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for
forming, sealing and assembly processes
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
3.1
aseptic presentation
transfer of sterile contents from its sterile barrier system using conditions and procedures that
minimize the risk of microbial contamination
[SOURCE: ISO 11139:2018, 3.13]
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SIST EN ISO 11607-1:2020
ISO 11607-1:2019(E)
3.2
bioburden
population of viable microorganisms on or in product and/or sterile barrier system
[SOURCE: ISO 11139:2018, 3.23]
3.3
closure
means used to complete a sterile barrier system where no seal is formed
EXAMPLE By a reusable container gasket or sequential folding to construct a tortuous path.
[SOURCE: ISO 11139:2018, 3.51, modified — The example has been added.]
3.4
closure integrity
characteristics of a closure to minimize the risk of ingress of microorganisms
[SOURCE: ISO 11139:2018, 3.52]
3.5
control
regulation of variables within specified limits
[SOURCE: ISO 11139:2018, 3.63]
3.6
expiry date
date by which product should be used
Note 1 to entry: For the purpose of this document and ISO 11607-2, expiry date refers to the medical device in a
sterile barrier system. The term “use by date” (3.29) is used to describe the shelf life of packaging materials and
preformed sterile barrier systems prior to assembly into a sterile barrier system.
[SOURCE: ISO 11139:2018, 3.110, modified — Note 1 to entry has been added.]
3.7
labelling
label, instructions for use and any other information that is related to identification, technical
description, intended purpose and proper use of the health care product, but excluding shipping
documents
[SOURCE: ISO 13485:2016, 3.8, modified — The term “medical device” has been replaced by “health
care product”.]
3.8
medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software,
material or other similar or related article, intended by the manufacturer to be used, alone or in
combination, for human beings, for one or more of the specific medical purpose(s) of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease;
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
— investigation, replacement, modification, or support of the anatomy or of a physiological process;
— supporting or sustaining life;
— control of conception;
— disinfection of medical devices;
2 © ISO 2019 – All rights reserved
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SIST EN ISO 11607-1:2020
ISO 11607-1:2019(E)
— providing information by means of in vitro examination of specimens derived from the human body;
and does not achieve its primary intended action by pharmacological, immunological or metabolic
means, in or on the human body, but which may be assisted in its intended function by such means
Note 1 to entry: Products which may be considered to be medical devices in some jurisdictions but not in others
include:
— items specifically intended for cleaning or sterilization of medical devices;
— pouches, reel goods, sterilization wrap and reusable containers for packaging of medical devices for
sterilization;
— disinfection substances;
— aids for persons with disabilities;
— devices incorporating animal and/or human tissues;
— devices for in vitro fertilization or assisted reproduction technologies.
[SOURCE: ISO 13485:2016, 3.11, modified — The first two list items in Note 1 to entry have been added.]
3.9
microbial barrier
property of a sterile barrier system to minimize the risk of ingress of microorganisms
[SOURCE: ISO 11139:2018, 3.169]
3.10
monitoring
continual checking, supervising, critically observing, or determining the status, in order to identify
change from the performance level required or expected
[SOURCE: ISO Guide 73:2009, 3.8.2.1, modified — The note has been deleted.]
3.11
packaging system
combination of a sterile barrier system and protective packaging
[SOURCE: ISO 11139:2018, 3.192]
3.12
preformed sterile barrier system
sterile barrier system (3.23) that is supplied partially assembled for filling and final closure or sealing
EXAMPLE Pouches, bags and open reusable containers (3.17).
[SOURCE: ISO 11139:2018, 3.201, modified — The example has been added.]
3.13
product
tangible result of a process
EXAMPLE Raw material(s), intermediate(s), sub-assembly(ies), health care product(s).
Note 1 to entry: For the purpose of this document and ISO 11607-2, products include preformed sterile barrier
systems, sterile barrier systems, and contents within them.
[SOURCE: ISO 11139:2018, 3.217, modified — Note 1 to entry has been added.]
© ISO 2019 – All rights reserved 3
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SIST EN ISO 11607-1:2020
ISO 11607-1:2019(E)
3.14
protective packaging
configuration of materials designed to prevent damage to the sterile barrier system and its contents
from the time of their assembly until the point of use
[SOURCE: ISO 11139:2018, 3.219]
3.15
repeatability
condition of measurement, out of a set of conditions that includes the same measurement procedure,
same operators, same measuring system, same operating conditions and same location, and replicate
measurements on the same or similar objects over a short period of time
[SOURCE: ISO/IEC Guide 99:2007, 2.20, modified — The term name has been simplified and the notes
omitted.]
3.16
reproducibility
condition of measurement, out of a set of conditions that includes different locations, processors,
measuring systems, and replicate measurements on the same or similar objects
Note 1 to entry: The different measuring systems may use different measurement procedures.
Note 2 to entry: A specification should give the conditions changed and unchanged to the extent practical.
[SOURCE: ISO/IEC Guide 99:2007, 2.24, modified — The term name has been simplified.]
3.17
reusable container
rigid sterile barrier system (3.23) designed to be used repeatedly
[SOURCE: ISO 11139:2018, 3.235]
3.18
seal
result of joining surfaces together by fusion to form a microbial barrier
Note 1 to entry: Surfaces can be joined together by, for example, adhesives or thermal fusion.
[SOURCE: ISO 11139:2018, 3.244, modified — Note 1 to entry has been added.]
3.19
seal integrity
characteristics of a seal to minimize the ingress of microorganisms
[SOURCE: ISO 11139:2018, 3.245]
3.20
seal strength
mechanical capacity of the seal to withstand force
[SOURCE: ISO 11139:2018, 3.246]
3.21
service life
number of processing cycles and/or lifetime up to which a product is claimed to remain suitable and
safe for its intended use when used according to the labelling
[SOURCE: ISO 11139:2018, 3.251]
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SIST EN ISO 11607-1:2020
ISO 11607-1:2019(E)
3.22
sterile
free from viable microorganisms
[SOURCE: ISO 11139:2018, 3.271]
3.23
sterile barrier system
SBS
minimum package that minimizes the risk of ingress of microorganisms and allows aseptic presentation
of the sterile contents at the point of use
[SOURCE: ISO 11139:2018, 3.272]
3.24
sterile fluid-path packaging
system of protective port covers and/or packaging designed to ensure sterility of the portion of the
medical device intended for contact with fluids
EXAMPLE The interior of the tubing for administration of an intravenous fluid.
[SOURCE: ISO 11139:2018, 3.273]
3.25
sterilization compatibility
attributes of the packaging material and/or system that allow it both to withstand the
sterilization process and attain the required conditions for sterilization within the packaging system
[SOURCE: ISO 11139:2018, 3.278]
3.26
sterilizing agent
physical or chemical entity, or combination of entities, having sufficient microbiocidal activity to
achieve sterility under specified conditions
[SOURCE: ISO 11139:2018, 3.288]
3.27
terminal sterilization
process whereby a product is sterilized within its sterile barrier system
[SOURCE: ISO 11139:2018, 3.295]
3.28
termina
...
SLOVENSKI STANDARD
oSIST prEN ISO 11607-1:2018
01-januar-2018
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Packaging for terminally sterilized medical devices - Part 1: Requirements for materials,
sterile barrier systems and packaging systems (ISO/DIS 11607-1:2017)
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 1:
Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme (ISO/DIS
11607-1:2017)
Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 1: Exigences
relatives aux matériaux, aux systèmes de barrière stérile et aux systèmes d'emballage
(ISO/DIS 11607-1:2017)
Ta slovenski standard je istoveten z: prEN ISO 11607-1
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
oSIST prEN ISO 11607-1:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 11607-1:2018
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oSIST prEN ISO 11607-1:2018
DRAFT INTERNATIONAL STANDARD
ISO/DIS 11607-1
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
2017-09-18 2017-12-11
Packaging for terminally sterilized medical devices —
Part 1:
Requirements for materials, sterile barrier systems and
packaging systems
Emballages des dispositifs médicaux stérilisés au stade terminal —
Partie 1: Exigences relatives aux matériaux, aux systèmes de barrière stérile et aux systèmes d’emballage
ICS: 11.080.30
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 11607-1:2017(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2017
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oSIST prEN ISO 11607-1:2018
ISO/DIS 11607-1:2017(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland
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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved
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oSIST prEN ISO 11607-1:2018
ISO/DIS 11607-1:2017(E)
Contents Page
Foreword .v
Introduction .vii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 5
4.1 General . 5
4.2 Quality systems . 5
4.3 Sampling . 5
4.4 Test methods . 5
4.5 Documentation . 6
5 Materials, preformed sterile barrier systems and sterile barrier systems .6
5.1 General requirements . 6
5.2 Microbial barrier properties . 9
5.3 Compatibility with the sterilization process .10
5.4 Labelling system .10
5.5 Storage and transport of materials and preformed sterile barrier systems .10
6 Design and development for packaging systems .11
6.1 General .11
6.2 Design .11
7 Usability evaluation for aseptic presentation .12
8 Packaging system performance and stability .13
8.1 General .13
8.2 Packaging system performance testing .13
8.3 Stability testing .13
9 Design changes and revalidation .14
10 Inspection of sterile medical devices packages immediately prior to
aseptic presentation .14
11 Information to be provided .15
Annex A (informative) Guidance on medical packaging .16
Annex B (informative) Standardized test methods, guides and procedures that may be used
to demonstrate compliance with the requirementsof this part of ISO 11607 .19
Annex C (normative) Test method for defining impermeable materials to the passage of air .30
Annex D (informative) Environmental aspects .31
Annex E (informative) Draft guidance on the relationship between this standard and the
general safety and performance requirements of Regulation (EU) 2017/745 of
the European Parliament and of the Council of 5 April 2017 on medical devices,
amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation
(EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC .33
Annex F (informative) Draft guidance on the relationship between this standard and
general safety and performance requirements of Regulation (EU) 2017/746 of
the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic
medical devices and repealing Directive 98/79/EC and Commission Decision
2010/227/EU .36
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered .38
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oSIST prEN ISO 11607-1:2018
ISO/DIS 11607-1:2017(E)
Annex ZB (informative) Relationship between this European Standard and the essential
requirements of Directive 90/385/EEC [OJ L 189] aimed to be covered .40
Annex ZC (informative) Relationship between this European Standard and the essential
requirements of Directive 98/79/EC [OJ L 331] aimed to be covered .41
Bibliography .43
iv © ISO 2017 – All rights reserved
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oSIST prEN ISO 11607-1:2018
ISO/DIS 11607-1:2017(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 on 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 the following URL: www . i so .org/ iso/ foreword .html.
This document was prepared by Technical committee ISO/TC 198, Sterilization of health care products.
This second edition cancels and replaces the first edition (ISO 11607-1:2006+Amd1: 2014), which has
been technically revised.
The main changes compared to the previous edition are as follows:
— Alignments of definitions following ISO 11139 to ensure harmonization throughout the standards
under ISO TC198.
— Editorial changes, paragraph restructuring and rewrites for better flow of the document.
— New requirements for evaluation of usability for aseptic presentation.
— New requirements for inspection of sterile barrier system integrity prior to use.
— A new section with requirements for revalidation in line with ISO 11607-2.
— Annex B has been updated and various international test methods have been added or deleted.
— A new informative Annex D has been added with environmental considerations.
— A new informative Annex E has been added with guidance on the relationship of this standard with
the general safety and performance requirements of the European MDR and IVDR.
A list of all parts in the ISO 11607 series can be found on the ISO website.
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European foreword
This document (prEN ISO 11607-1:2017) has been prepared by Technical Committee CEN/TC 102
“Sterilizers and associated equipment for processing of medical devices”, the secretariat of which is
held by DIN.
This document is currently submitted to the CEN Enquiry.
This document will supersede EN ISO 11607-1:2009+A1: 2014.
This document has been prepared under a standardization request given to CEN by the European
Commission and the European Free Trade Association, and supports essential requirements of
EU Directive(s).
For relationship with EU Directive(s), see informative Annexes ZA, B and C, which are an integral part
of this document.
The following referenced documents are indispensable for the application of this document. For undated
references, the latest edition of the referenced document (including any amendments) applies. For dated
references, only the edition cited applies. However, for any use of this standard ‘within the meaning of
Annex ZA’, the user should always check that any referenced document has not been superseded and
that its relevant contents can still be considered the generally acknowledged state-of-art.
When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard, as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table — Correlation between normative references and dated EN and ISO standards
Normative references as listed in Equivalent dated standard
Clause 2 of the ISO standard
EN ISO or IEC
ISO 5636-5 ISO 5636-5:2013
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Introduction
The process of designing and developing a packaging system for terminally sterilized medical devices
is a complicated and critical endeavour. The device components and the packaging system should be
combined to create a sterile medical device that performs efficiently, safely, and effectively in the hands
of the user.
This part of ISO 11607 specifies requirements for design of sterile barrier systems and packaging
systems for terminally sterilized medical devices, the basic attributes required of materials and pre-
formed sterile barrier systems as well as design validation requirements. This International Standard
is written as a general (horizontal) standard considering a wide range of potential materials, medical
devices, packaging system designs, and sterilization methods and can be applied by suppliers of
material, of preformed sterile barrier system, by medical device manufacturers or health care facilities.
ISO 11607-2 describes the process development and validation requirements for forming, sealing and
assembly processes and addresses controls during normal operations. Both parts of ISO 11607 were
designed to meet the selected Essential Requirements of the European Medical Device Directives.
During the revision of ISO 11607-1 and -2, the European Commission published the drafts and final
versions of the European Medical Device Regulations (MDR) and the In Vitro Diagnostics Regulation
(IVDR). The committee responsible for ISO 11607-1 and -2 incorporated changes in this revision to
meet the specific requirements of the MDR and IVDR.
European standards that provide requirements for particular materials and preformed sterile barrier
systems are available and known as the EN 868 series. Compliance with EN 868 Parts 2 to 10 can be
used to demonstrate compliance with one or more of the requirements of this part of ISO 11607.
The goal of a terminally sterilized medical device packaging system is to allow sterilization, provide
physical protection, maintain sterility up to the point of use and allow aseptic presentation. The
specific nature of the medical device, the intended sterilization methods(s), the intended use, expiry
date, transport and storage all influence the packaging system design and choice of materials.
The term “sterile barrier system” was introduced by this standard in 2006 to describe the minimum
packaging required to perform the unique functions required of medical packaging: to allow sterilization,
to provide an acceptable microbial barrier, and to allow for aseptic presentation. “Protective packaging”
protects the sterile barrier system, and together they form the packaging system. “Preformed sterile
barrier systems” would include any partially assembled sterile barrier systems such as pouches, header
bags or hospital packaging reels. An overview of sterile barrier systems can be found in Annex A.
The sterile barrier system is essential to ensure the safety of terminally sterilized medical devices.
Regulatory authorities recognize the critical nature of sterile barrier systems by considering them as
an accessory or a component of a medical device. Preformed sterile barrier systems sold to healthcare
facilities for use in internal sterilization are considered as medical devices in many parts of the world.
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DRAFT INTERNATIONAL STANDARD ISO/DIS 11607-1:2017(E)
Packaging for terminally sterilized medical devices —
Part 1:
Requirements for materials, sterile barrier systems and
packaging systems
1 Scope
This part of ISO 11607 specifies the requirements and test methods for materials, preformed sterile
barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility
of terminally sterilized medical devices until the point of use.
This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices
are placed in sterile barrier systems and sterilized.
This part of ISO 11607 does not cover all requirements for sterile barrier systems and packaging
systems for medical devices that are manufactured aseptically. Additional requirements might also be
necessary for drug/device combinations.
This part of ISO 11607 does not describe a quality assurance system for control of all stages of
manufacture.
This part of ISO 11607 does not apply to packaging materials and/or systems used to contain a
contaminated medical device during transportation of the item to the site of reprocessing or disposal.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 5636-5, Paper and board — Determination of air permeance (medium range) — Part 5: Gurley method
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at http:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
aseptic presentation
transfer of the sterile contents from its sterile barrier system using conditions and procedures that
minimize the risk of microbial contamination
3.2
bioburden
population of viable microorganisms on or in product and/or sterile barrier system
[SOURCE: ISO/DIS 11139:2017]
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3.3
closure
means used to close a sterile barrier system where no seal is formed
Note 1 to entry: For example, a sterile barrier system can be closed by a reusable container gasket or sequential
folding to construct a tortuous path.
3.4
closure integrity
a characteristic of the closure which minimizes the risk of ingress of microorganisms demonstrated
under test conditions which consider sterilization process, handling, distribution, transport and storage
3.5
expiry date
the date by which product should be used
3.6
labelling
label, instructions for use, and any other information that is related to identification, technical
description, intended purpose and proper use of the medical device but excluding shipping documents
[SOURCE: ISO/DIS 11139:2017]
3.7
medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use or calibrator,
software, material or other similar related article, intended by the manufacturer to be used, alone or in
combination, for human beings for one or more of the specific medical purpose(s) of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease;
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
— investigation, replacement, modification or support of the anatomy or of a physiological process;
— supporting or sustaining life;
— control of conception;
— disinfection of medical devices;
— providing information by means of in vitro examination of specimens derived from the human body;
— and does not achieve its primary intended action by pharmacological, immunological or metabolic
means, but which may be assisted in its intended function by such means
Note 1 to entry: Products which may be considered to be medical devices in some jurisdictions but not in others
include:
— items specifically intended for cleaning or sterilization of medical devices
— pouches, reel goods, sterilization wrap and reusable containers for packaging of medical devices for
sterilization
— disinfection substances;
— aids for persons with disabilities;
— devices incorporating animal and/or human tissues;
— devices for in vitro fertilization or assisted reproduction technologies.
[SOURCE: Modified from ISO/DIS 11139:2017]
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3.8
microbial barrier
property of the sterile barrier system which minimizes the risk of ingress of microorganisms
demonstrated under test conditions which consider sterilization process, handling, distribution,
transport and storage
3.9
monitoring
continual checking, supervising, critically observing or determining the status in order to identify
change from the performance level required or expected
[SOURCE: ISO/DIS 11139:2017]
3.10
packaging system
combination of the sterile barrier system and protective packaging
[SOURCE: ISO/DIS 11139:2017]
3.11
preformed sterile barrier system
sterile barrier system (3.21) that is supplied partially assembled for filling and final closure or sealing
EXAMPLE Pouches, bags, and open reusable containers
[SOURCE: ISO/ DIS 11139: 2017]
3.12
product
tangible result of a process
EXAMPLE Raw material(s), intermediate(s), sub-assembly(ies), healthcare product(s)
Note 1 to entry: For the purpose of ISO 11607-1 and ISO 11607-2, product includes preformed sterile barrier
systems, sterile barrier systems, and contents within them.
[SOURCE: Modified from ISO/DIS 11139:2017]
3.13
protective packaging
configuration of materials designed to prevent damage to the sterile barrier system and its contents
from the time of their assembly until the point of use
3.14
repeatability
closeness of the agreement between the results of successive measurements of the same particular
quantity subject to measurement (measurand) carried out under the same conditions of measurement
[SOURCE: ISO/DIS 11139:2017]
3.15
reproducibility
condition of measurement, out of a set of conditions that includes different locations, operators,
measuring systems, and replicate measurements on the same or similar objects
[SOURCE: ISO/DIS 11139:2017]
3.16
reusable container
rigid sterile barrier system designed to be repeatedly used
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3.17
seal
result of joining surfaces together
Note 1 to entry: For example, surfaces can be jointed together by use of adhesives or thermal fusion.
3.18
seal integrity
a characteristic of the seal which minimizes the risk of ingress of microorganisms demonstrated under
test conditions which consider sterilization process, handling, distribution, transport and storage
3.19
seal strength
mechanical capacity of the seal to withstand force
[SOURCE: ISO/DIS 11139:2017]
3.20
sterile
free from viable microorganisms
[SOURCE: ISO/DIS 11139:2017]
3.21
sterile barrier system
minimum package that minimizes the risk of ingress of microorganisms and allows aseptic presentation
of the sterile contents at the point of use
[SOURCE: ISO/DIS 11139:2017]
3.22
sterile fluid-path packaging
system of protective port covers and/or packaging designed to ensure sterility of the portion of the
medical device intended for contact with fluids
Note 1 to entry: An example of sterile fluid-path packaging would be the interior of the tubing for administration
of an intravenous fluid.
3.23
sterilization compatibility
attributes of the packaging material and/or system that allow it to both withstand the sterilization
process and attain the required conditions for sterilization within the packaging system
3.24
sterilizing agent
physical or chemical entity, or combination of entities having sufficient microbicidal activity to achieve
sterility under defined conditions
[SOURCE: ISO/DIS 11139:2017]
3.25
terminal sterilization
process whereby product is sterilized within its sterile barrier system
3.26
useful life
period during which all the performance requirements are met
[SOURCE: ISO/DIS 11139:2017]
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3.27
validation
confirmation process, through the provision of objective evidence that the requirements for a specific
intended use or application have been fulfilled
Note 1 to entry: The objective evidence needed for a validation is the result of a test or other form
of determination such as performing alternative calculations or reviewing documents.
Note 2 to entry: The word “validated” is used to designate the corresponding status.
Note 3 to entry: The use conditions for validation can be real or simulated.
4 General requirements
4.1 General
Practices in 4.2, 4.3, 4.4 and 4.5 are a fundamental prerequisite of demonstrating compliance to
ISO 11607-1.
4.2 Quality systems
4.2.1 The activities described within this part of ISO 11607 shall be carried out within a formal
quality system.
NOTE ISO 9001 and ISO 13485 contain requirements for suitable quality systems. Additional requirements
might be specified by a country or region.
4.2.2 It shall not be necessary to obtain third-party certification of the quality system to fulfil the
...
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