Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006, including Amd 1:2014)

ISO 11607-1:2006 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.
ISO 11607-1:2006 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized.
ISO 11607-1:2006 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.
ISO 11607-1:2006 does not describe a quality assurance system for control of all stages of manufacture.

Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte — Teil 1: Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme (ISO 11607-1:2006)

Dieser Teil von ISO 11607 legt die Anforderungen und Prüfverfahren für Materialien, vorgefertigte Steril-barrieresysteme, Sterilbarrieresysteme und Verpackungssysteme fest, die dazu vorgesehen sind, die Sterilität der in der Endverpackung zu sterilisierenden Medizinprodukte bis zum Anwendungszeitpunkt aufrecht¬zuerhalten.
Dieser Teil von ISO 11607 gilt für die Industrie, für Gesundheitseinrichtungen und alle anderen Einrichtungen, in denen Medizinprodukte in Sterilbarrieresysteme verpackt und sterilisiert werden.
Dieser Teil von ISO 11607 erfasst nicht alle Anforderungen an Sterilbarrieresysteme und Verpackungs-systeme für aseptisch hergestellte Medizinprodukte. Für Kombinationen von Arzneimitteln und Medizin-produkten können auch zusätzliche Anforderungen erforderlich sein.
Dieser Teil von ISO 11607 beschreibt kein Qualitätssicherungssystem zur Lenkung aller Herstellungsschritte.

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 11607-1:2006, y compris Amd 1:2014)

L'ISO 11607-1:2006 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 au stade terminal jusqu'au point d'utilisation.
L'ISO 11607-1:2006 s'applique à l'industrie, aux installations de santé et à tout lieu où les dispositifs médicaux se trouvent dans des systèmes de barrière stérile et stérilisés.
L'ISO 11607-1:2006 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 sont nécessaires pour garantir les combinaisons médicaments/dispositifs.
L'ISO 11607-1:2006 ne décrit pas de système d'assurance qualité pour le contrôle de toutes les étapes de fabrication.

Embalaža za končno sterilizirane medicinske pripomočke - 1. del: Zahteve za materiale, sterilne pregradne sisteme in sisteme embalaže (ISO 11607-1:2006)

ISO 11607-1:2006 podaja 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.
ISO 11607-1:2006 se uporablja za industrijo, zdravstvene ustanove in vse medicinske pripomočke, ki so sterilizirani v sterilnih pregradnih sistemih.
ISO 11607-1:2006 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.
ISO 11607-1:2006 ne opisuje sistema zagotavljanja kakovosti za nadzor vseh faz proizvodnje.

General Information

Status
Withdrawn
Publication Date
18-Jul-2017
Withdrawal Date
14-Jan-2020
Current Stage
9960 - Withdrawal effective - Withdrawal
Completion Date
15-Jan-2020

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SLOVENSKI STANDARD
SIST EN ISO 11607-1:2017
01-september-2017
1DGRPHãþD
SIST EN ISO 11607-1:2009
SIST EN ISO 11607-1:2009/A1:2014
(PEDODåD]DNRQþQRVWHULOL]LUDQHPHGLFLQVNHSULSRPRþNHGHO=DKWHYH]D
PDWHULDOHVWHULOQHSUHJUDGQHVLVWHPHLQVLVWHPHHPEDODåH ,62

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials,

sterile barrier systems and packaging systems (ISO 11607-1:2006)

Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 1:

Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme (ISO
11607-1:2006)

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 11607-1:2006)
Ta slovenski standard je istoveten z: EN ISO 11607-1:2017
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
SIST EN ISO 11607-1:2017 en

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

---------------------- Page: 1 ----------------------
SIST EN ISO 11607-1:2017
---------------------- Page: 2 ----------------------
SIST EN ISO 11607-1:2017
EN ISO 11607-1
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2017
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 11607-1:2006)

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 11607-1:2006) und Verpackungssysteme (ISO 11607-1:2006)
This European Standard was approved by CEN on 18 July 2017.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, 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: Avenue Marnix 17, B-1000 Brussels

© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11607-1:2017 E

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 11607-1:2017
EN ISO 11607-1:2017 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

Annex ZA (informative) Relationship between this European Standard and the essential

requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered ...................................... 5

Annex ZB (informative) Relationship between this European Standard and the essential

requirements of Directive 90/385/EEC [OJ L 189] aimed to be covered .................................... 7

Annex ZC (informative) Relationship between this European Standard and the essential

requirements of Directive 98/79/EC [OJ L 331] aimed to be covered ......................................... 9

---------------------- Page: 4 ----------------------
SIST EN ISO 11607-1:2017
EN ISO 11607-1:2017 (E)
European foreword

The text of ISO 11607-1:2006 has been prepared by Technical Committee ISO/TC 198 "Sterilization of

health care products” of the International Organization for Standardization (ISO) and has been taken

over as EN ISO 11607-1:2017 by 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 January 2018, and conflicting national standards shall

be withdrawn at the latest by January 2018.

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 standard replaces EN ISO 11607-1:2009.

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 Annex ZA, Annex ZB, and Annex ZC, 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 Equivalent dated standard
listed in Clause 2 of the ISO
EN ISO or IEC
standard
ISO 5636-5 ISO 5636-5:2013
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SIST EN ISO 11607-1:2017
EN ISO 11607-1:2017 (E)

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, Former Yugoslav Republic of Macedonia,

France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,

Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
Endorsement notice

The text of ISO 11607-1:2006 has been approved by CEN as EN ISO 11607-1:2017 without any

modification.
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SIST EN ISO 11607-1:2017
EN ISO 11607-1:2017 (E)
Annex ZA
(informative)
Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered

This European Standard has been prepared under a Commission’s standardization request M/023

concerning the development of European standards relating to medical devices to provide one

voluntary means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June

1993 concerning medical devices [OJ L 169].

Once this standard is cited in the Official Journal of the European Union under that Directive and has

been implemented as a national standard in at least one Member State, compliance with the normative

clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a

presumption of conformity with the corresponding essential requirements of that Directive and

associated EFTA regulations.

NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk

management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This

means that risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’

or ‘removed’, according to the wording of the corresponding essential requirement.

NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential

Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.

NOTE 3 This Annex ZA is based on normative references according to the table of references in the European

foreword, replacing the references in the core text.

NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this

European Standard.

Table ZA.1 — Correspondence between this European Standard and Annex I of Directive

93/42/EEC [OJ L 169]
Essential Requirements of Clause(s)/sub-clause(s) of Remarks/Notes
Directive 93/42/EEC this EN
8.1 6.1.1, 6.1.2, 6.1.4, 6.2.2 E.R. 8.1 is covered only in
respect of the function of the
sterile barrier system(s) to
protect the sterility of the
device from the point of
sterilisation to the point of use
and to allow for aseptic
presentation but only if the
requirements of EN
ISO 11607-2:2006/A1:2014
are met as well (Validation
requirements for forming,
sealing and assembling
processes)
8.3 4.4, 5.2, 6.1.2, 6.1.4, 6.1.6, 6.2.2, E.R. 8.3 is covered only in
---------------------- Page: 7 ----------------------
SIST EN ISO 11607-1:2017
EN ISO 11607-1:2017 (E)
Essential Requirements of Clause(s)/sub-clause(s) of Remarks/Notes
Directive 93/42/EEC this EN
6.3.1, 6.3.4, 6.3.5, 6.4.1, 6.4.2, respect of the function of
6.4.3, 6.4.6, 6.4.7 sterile barrier system(s) to
protect the sterility of the
device from the point of
sterilisation to the point of use
and to allow for aseptic
presentation but only if the
requirements of EN
ISO 11607-2:2006/A1:2014
are met as well (Validation
requirements for forming,
sealing and assembling
processes) In this respect
damage to the “protective
packaging” is taken to mean
damage to or loss of integrity
of the sterile barrier system
only.
8.4 4.4, 5.3.1, 5.3.3, 5.3.5, 6.1.2, E.R. 8.4 is covered only in
6.1.4, 6.1.6, 6.2.2, 6.3.1, 6.3.4, respect of the compatibility
6.3.5, 6.4.1, 6.4.2, 6.4.3, 6.4.6, between the packaging and the
6.4.7 selected sterilisation processes
including packaging system
performance testing and
sterile barrier system stability
testing, but only if the
requirements of EN
ISO 11607-2:2006/A1:2014
are met as well (Validation
requirements for forming,
sealing and assembling
processes)

WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European

Standard is maintained in the list published in the Official Journal of the European Union. Users of this

standard should consult frequently the latest list published in the Official Journal of the European

Union.

WARNING 2 — Other Union legislation may be applicable to the products falling within the scope of

this standard.
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SIST EN ISO 11607-1:2017
EN ISO 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

This European Standard has been prepared under a Commission’s standardization request M/432 to

provide one voluntary means of conforming to essential requirements of Council Directive 90/385/EEC

of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable

medical devices [OJ L 189].

Once this standard is cited in the Official Journal of the European Union under that Directive,

compliance with the normative clauses of this standard given in Table ZB.1 confers, within the limits of

the scope of this standard, a presumption of conformity with the corresponding essential requirements

of that Directive and associated EFTA regulations.

NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk

management process needs to be in compliance with Directive 90/385/EEC as amended by 2007/47/EC. This

means that risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’

or ‘removed’, according to the wording of the corresponding essential requirement.

NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential

Requirements 1, 4, 5, 8, 9 and 10 of the Directive.

NOTE 3 This Annex ZB is based on normative references according to the table of references in the European

foreword, replacing the references in the core text.

NOTE 4 When an Essential Requirement does not appear in Table ZB.1, it means that it is not addressed by this

European Standard.

Table ZB.1 — Correspondence between this European Standard and Annex I of Directive

90/385/EEC [OJ L 189]
Essential Requirements of Clause(s)/sub-clause(s) of Remarks/Notes
Directive 90/385/EEC this EN
7 6.1.4, 6.1.6, 6.2.2, 6.3.1, 6.3.4, E.R. 7 is covered only in
6.3.5, 6.4.1, 6.4.2, 6.4.3, 6.4.6, respect of the function of
6.4.7 sterile barrier system(s) to
protect the sterility of the
device from the point of
sterilisation to the point of use
and to allow for aseptic
presentation but only if the
requirements of EN
ISO 11607-2:2006/A1:2014
are met as well (Validation
requirements for forming,
sealing and assembling
processes)
---------------------- Page: 9 ----------------------
SIST EN ISO 11607-1:2017
EN ISO 11607-1:2017 (E)

WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European

Standard is maintained in the list published in the Official Journal of the European Union. Users of this

standard should consult frequently the latest list published in the Official Journal of the European

Union.

WARNING 2 — Other Union legislation may be applicable to the products falling within the scope of

this standard.
---------------------- Page: 10 ----------------------
SIST EN ISO 11607-1:2017
EN ISO 11607-1:2017 (E)
Annex ZC
(informative)
Relationship between this European Standard and the essential
requirements of Directive 98/79/EC [OJ L 331] aimed to be covered

This European Standard has been prepared under a Commission’s standardization request M/252,

concerning the development of European standards relating to in vitro diagnostic medical devices, to

provide one voluntary means of conforming to essential requirements of Council Directive 98/79/EC of

the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices

[OJ L 331].

Once this standard is cited in the Official Journal of the European Union under that Directive,

compliance with the normative clauses of this standard given in Table ZC.1 confers, within the limits of

the scope of this standard, a presumption of conformity with the corresponding essential requirements

of that Directive and associated EFTA regulations.

NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk

management process needs to be in compliance with Directive 98/79/EC. This means that risks have to be

reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’ or ‘removed’, according to

the wording of the corresponding essential requirement.

NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential

Requirements Part A: 1, 2 and 5; Part B: 1.2, 2, 3, 5, 6 and 7 of the Directive.

NOTE 3 This Annex ZC is based on normative references according to the table of references in the European

foreword, replacing the references in the core text.

NOTE 4 When an Essential Requirement does not appear in Table ZC.1, it means that it is not addressed by this

European Standard.

Table ZC.1 — Correspondence between this European Standard and Annex I of Directive

98/79/EC [OJ L 331]
Essential Requirements of Clause(s)/sub-clause(s) of Remarks/Notes
Directive 98/79/EC this EN
B2.3 4.4, 5.2, 6.1.2, 6.1.4, 6.1.6, 6.2.2, E.R. B2.3 is covered only in
6.3.1, 6.3.4, 6.3.5, 6.4.1, 6.4.2, respect of the function of
6.4.3, 6.4.6, 6.4.7 sterile barrier system(s) to
protect the sterility of the
device from the point of
sterilisation to the point of use
and to allow for aseptic
presentation but only if the
requirements EN
ISO 11607-2:2006/A1:2014
are met as well (Validation
requirements for forming,
sealing and assembling
processes) In this respect
damage to the “protective
packaging” is taken to mean
---------------------- Page: 11 ----------------------
SIST EN ISO 11607-1:2017
EN ISO 11607-1:2017 (E)
Essential Requirements of Clause(s)/sub-clause(s) of Remarks/Notes
Directive 98/79/EC this EN
damage to or loss of integrity
of the sterile barrier system
only.
B2.4 4.4, 5.3.1, 5.3.3, 5.3.5, 6.1.2, E.R. B2.4 is covered only in
6.1.4, 6.1.6, 6.2.2, 6.3.1, 6.3.4, respect of the compatibility
6.3.5, 6.4.1, 6.4.2, 6.4.3, 6.4.6, between the packaging and the
6.4.7 selected sterilisation processes
including packaging system
performance testing and
sterile barrier system stability
testing, but only if the
requirements of EN
ISO 11607-2:2006/A1:2014
are met as well (Validation
requirements for forming,
sealing and assembling
processes)

WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European

Standard is maintained in the list published in the Official Journal of the European Union. Users of this

standard should consult frequently the latest list published in the Official Journal of the European

Union.

WARNING 2 — Other Union legislation may be applicable to the products falling within the scope of

this standard.
---------------------- Page: 12 ----------------------
SIST EN ISO 11607-1:2017
INTERNATIONAL ISO
STANDARD 11607-1
First edition
2006-04-15
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 11607-1:2006(E)
ISO 2006
---------------------- Page: 13 ----------------------
SIST EN ISO 11607-1:2017
ISO 11607-1:2006(E)
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ii © ISO 2006 – All rights reserved
---------------------- Page: 14 ----------------------
SIST EN ISO 11607-1:2017
ISO 11607-1:2006(E)
Contents Page

Foreword............................................................................................................................................................ iv

Introduction ........................................................................................................................................................ v

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................................................................................................................................................ 6

4.4 Test methods......................................................................................................................................... 6

4.5 Documentation...................................................................................................................................... 6

5 Materials and preformed sterile barrier systems .............................................................................. 7

5.1 General requirements........................................................................................................................... 7

5.2 Microbial barrier properties ................................................................................................................. 9

5.3 Compatibility with the sterilization process..................................................................................... 10

5.4 Compatibility with the labelling system ........................................................................................... 10

5.5 Storage and transport ........................................................................................................................ 10

6 Design and development requirements for packaging systems ................................................... 11

6.1 General................................................................................................................................................. 11

6.2 Design .................................................................................................................................................. 11

6.3 Packaging-system performance testing........................................................................................... 12

6.4 Stability testing ................................................................................................................................... 12

7 Information to be provided ................................................................................................................ 13

Annex A (informative) Guidance on medical packaging.............................................................................. 14

Annex B (informative) Standardized test methods and procedures that may be used to

demonstrate compliance with the requirements of this part of ISO 11607 .................................. 17

Annex C (normative) Test method for resistance of impermeable materials to the passage of air........ 21

Bibliography ..................................................................................................................................................... 22

© ISO 2006 – All rights reserved iii
---------------------- Page: 15 ----------------------
SIST EN ISO 11607-1:2017
ISO 11607-1:2006(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.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International Standards

adopted by the technical committees are circulated to the member bodies for voting. Publication as an

International Standard requires approval by at least 75 % of the member bodies casting a vote.

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.

ISO 11607-1 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.

ISO 11607-1 and ISO 11607-2 cancel and replace ISO 11607:2003, which has been technically revised.

ISO 11607 consists of the following parts, under the general title Packaging for terminally sterilized medical

devices:

⎯ Part 1: Requirements for materials, sterile barrier systems and packaging systems

⎯ Part 2: Validation requirements for forming, sealing and assembly processes
iv © ISO 2006 – All rights reserved
---------------------- Page: 16 ----------------------
SIST EN ISO 11607-1:2017
ISO 11607-1:2006(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 product that performs efficiently, safely, and effectively in the hands of the user.

This part of ISO 11607 specifies the basic attributes required of materials and pre-formed systems intended

for use in packaging systems for terminally sterilized medical devices, while considering the wide range of

potential materials, medical devices, packaging system designs, and sterilization methods. ISO 11607-2

describes the validation requirements for forming, sealing and assembly processes. This part of ISO 11607 is

harmonized with EN 868-1 and specifies general requirements for all packaging materials whereas EN 868

Parts 2 to 10 specify particular requirements for a range of commonly used materials. Both parts of ISO 11607

were designed to meet the Essential Requirements of the European Medical Device Directives.

European standards that provide requirements for particular materials and preformed sterile barrier systems

are available and known as the EN 868 series. This part of ISO 11607 has been developed as a means to

show compliance with the relevant Essential Requirements of the European Directives concerning medical

devices. 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.

One significant barrier to harmonization was terminology. The terms “package”, “final package”, “final pack”,

“primary pack”, and “primary package” all have different connotations around the globe, and choosing one of

these terms to be the harmonized basis for this part of ISO 11607 was considered a barrier to successful

completion of this document. As a result, the term “sterile barrier system” was introduced 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. Regulator

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