EN ISO 11607-1:2006

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

This standard specifies the requirements and test methods for packaging materials and final packages (systems) that are intended to maintain sterility of the terminally sterilized medical devices to the point of use. This standard is applicable to industry, health care facilities, and whererver sterilized medical devices are packed and sterilized.

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 Sterilbarrieresysteme, Sterilbarrieresysteme und Verpackungssysteme fest, die dazu vorgesehen sind, die Sterilität der in der Endverpackung zu sterilisierenden Medizinprodukte bis zum Anwendungszeitpunkt aufrechtzuerhalten.
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 Herstellungs¬schritte.

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)

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

General Information

• Status: Withdrawn
• Publication Date: 14-Apr-2006
• Withdrawal Date: 02-Jun-2009
• ICS: 11.080.30 - Sterilized packaging
• Technical Committee: CEN/TC 102 - Sterilizers for medical purposes
• Drafting Committee: CEN/TC 102/WG 4 - Packaging materials
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 03-Jun-2009
• Completion Date: 03-Jun-2009
• Directive: 90/385/EEC - 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
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Mandate: M/BC/CEN/88/9 - Order for standardization concerning Personal Protective Equipment (P.P.E.) - foot and leg protection
• Ref Project: SIST EN ISO 11607-1:2006 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)

Relations

• Replaces: EN 868-1:1997 - Packaging materials and systems for medical devices which are to be sterilized - Part 1: General requirements and test methods
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 11607-1:2009 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)
• Effective Date: 22-Dec-2008

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2006
1DGRPHãþD
SIST EN 868-1:2000
(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 systemes de barriere stérile et aux systemes d'emballage
(ISO 11607-1:2006)
Ta slovenski standard je istoveten z: EN ISO 11607-1:2006
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 11607-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2006
ICS 11.080.30 Supersedes EN 868-1:1997
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 sterilisierende
terminal - Partie 1: Exigences relatives aux matériaux, aux Medizinprodukte - Teil 1: Anforderungen an Materialien,
systèmes de barrière stérile et aux systèmes d'emballage Sterilbarrieresysteme und Verpackungssysteme (ISO
(ISO 11607-1:2006) 11607-1:2006)
This European Standard was approved by CEN on 13 April 2006.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11607-1:2006: E
worldwide for CEN national Members.

Foreword
This document (EN ISO 11607-1:2006) has been prepared by Technical Committee ISO/TC 198
"Sterilization of health care products" in collaboration with Technical Committee CEN/TC 102
"Sterilizers for medical purposes", the secretariat of which is held by DIN.

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 October 2006, and conflicting national standards
shall be withdrawn at the latest by April 2007.

This document supersedes EN 868-1:1997.

This document has been prepared under a mandate 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, which is an integral part of this
document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Cyprus,
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland,
Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

Endorsement notice
The text of ISO 11607-1:2006 has been approved by CEN as EN ISO 11607-1:2006 without any
modifications.
ANNEX ZA
(informative)
Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices

This International Standard has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association to provide a means of conforming to
Essential Requirements of the New Approach Directive 93/42/EEC on medical devices.

Once this standard is cited in the Official Journal of the European Communities 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.

Table ZA.1 — Correspondence between this International Standard and Directive 93/42/EEC
on medical devices
Clause(s)/Sub-clause(s) of Essential Requirements (ERs) of Qualifying remarks/Notes
this International Standard EU Directive 93/42/EEC
4.1, 4.2 1, 2
4.3, 4.4, 4.5 3, 4, 5, 6
5.1.1 to 5.1.11 (except 5.1.10) 7.1, 7.3, 7.5, 7.6, 8.5

5.1.9 9.1, 9.2
5.2 8.1
5.3 8.3, 8.6
5.4 8.6
5.5 5, 8.3
6.1 1,2, 6
6.2 3, 7.1, 7.3, 7.5, 7.6, 8.3, 8.6, 13.1, 13.5

6.3 8.1, 8.6
6.4 5
7 13
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.

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
ISO 11607-1:2006(E)
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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 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

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 w
...