EN ISO 11607-1:2009/A1:2014

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

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.

Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 1: Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme (ISO 11607-1:2006 + A1:2014)

N/A

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/Amd 1:2014)

Embalaža za končno sterilizirane medicinske pripomočke - 1. del: Zahteve za materiale, sterilne pregradne sisteme in sisteme embalaže (ISO 11607-1:2009/Amd 1:2014)

Ta del standarda ISO 11607 velja za industrijo, zdravstvene ustanove in vse medicinske pripomočke, ki so sterilizirani v sterilnih pregradnih sistemih.

General Information

• Status: Withdrawn
• Publication Date: 15-Jul-2014
• Withdrawal Date: 18-Jul-2017
• 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
• Completion Date: 19-Jul-2017
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• 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
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic 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 11607-1:2009/A1:2014 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2009/Amd 1:2014)

Relations

• Replaced By: EN ISO 11607-1:2017 - 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)
• Effective Date: 28-Jun-2017
• Amends: 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: 08-Jun-2022

Standards Content (Sample)

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

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials,
sterile barrier systems and packaging systems (ISO 11607-1:2009/Amd 1:2014)
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 1:
Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme (ISO
11607-1:2009/Amd 1:2014)
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 11607-1:2009/Amd 1:2014)
Ta slovenski standard je istoveten z: EN ISO 11607-1:2009/A1:2014
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
SIST EN ISO 11607-1:2009/A1:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11607-1:2009/A1:2014

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SIST EN ISO 11607-1:2009/A1:2014

EUROPEAN STANDARD
EN ISO 11607-1:2009/A1

NORME EUROPÉENNE

EUROPÄISCHE NORM
July 2014
ICS 11.080.30
English Version
Packaging for terminally sterilized medical devices - Part 1:
Requirements for materials, sterile barrier systems and
packaging systems (ISO 11607-1:2009/Amd 1:2014)
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 11607-1:2009/Amd 1:2014) 11607-1:2009/Amd 1:2014)
This amendment A1 modifies the European Standard EN ISO 11607-1:2009; it was approved by CEN on 14 June 2014.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this
amendment into the relevant 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 amendment 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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11607-1:2009/A1:2014 E
worldwide for CEN national Members.

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SIST EN ISO 11607-1:2009/A1:2014
EN ISO 11607-1:2009/A1:2014 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices .4

2

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SIST EN ISO 11607-1:2009/A1:2014
EN ISO 11607-1:2009/A1:2014 (E)
Foreword
This document (EN ISO 11607-1:2009/A1:2014) has been prepared by Technical Committee ISO/TC 198
“Sterilization of health care products” in collaboration with Technical Committee CEN/TC 102 “Sterilizers for
medical purposes” the secretariat of which is held by DIN.
This Amendment to the European Standard EN ISO 11607-1:2009 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by January 2015, and
conflicting national standards shall be withdrawn at the latest by January 2015.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a mandate given to CEN by the European Commission and the
...

SLOVENSKI STANDARD
SIST EN ISO 11607-1:2009/oprA1:2013
01-maj-2013
(PEDODåD]DNRQþQRVWHULOL]LUDQHPHGLFLQVNHSULSRPRþNHGHO=DKWHYH]D
PDWHULDOHVWHULOQHSUHJUDGQHVLVWHPHLQVLVWHPHHPEDODåH'RSROQLOR,62
'$0
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials,
sterile barrier systems and packaging systems - Amendment 1 (ISO 11607-1:2006/DAM
1:2013)
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 1:
Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme -
Änderung 1 (ISO 11607-1:2006/DAM 1:2013)
Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 1: Exigences
relatives aux matériaux, aux systèmes de barrière stérile et aux systèmes d'emballage -
Amendement 1 (ISO 11607-1:2006/DAM 1:2013)
Ta slovenski standard je istoveten z: EN ISO 11607-1:2009/prA1
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
SIST EN ISO 11607-1:2009/oprA1:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11607-1:2009/oprA1:2013

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SIST EN ISO 11607-1:2009/oprA1:2013


EUROPEAN STANDARD
DRAFT
EN ISO 11607-1:2009
NORME EUROPÉENNE

EUROPÄISCHE NORM
prA1
March 2013
ICS 11.080.30
English Version
Packaging for terminally sterilized medical devices - Part 1:
Requirements for materials, sterile barrier systems and
packaging systems - Amendment 1 (ISO 11607-1:2006/DAM
1:2013)
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 -
Amendement 1 (ISO 11607-1:2006/DAM 1:2013) Änderung 1 (ISO 11607-1:2006/DAM 1:2013)
This draft amendment is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee CEN/TC 102.

This draft amendment A1, if approved, will modify the European Standard EN ISO 11607-1:2009. If this draft becomes an amendment,
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this
amendment into the relevant national standard without any alteration.

This draft amendment was established by CEN 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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.

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.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.


EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11607-1:2009/prA1:2013: E
worldwide for CEN national Members.

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SIST EN ISO 11607-1:2009/oprA1:2013
EN ISO 11607-1:2009/prA1:2013 (E)
Contents
Page
Foreword . 3


2

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SIST EN ISO 11607-1:2009/oprA1:2013
EN ISO 11607-1:2009/prA1:2013 (E)
Foreword
This document (EN ISO 11607-1:2009/prA1:2013) 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 document is currently submitted to the parallel Enquiry.
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).
Endorsement notice
The text of ISO 11607-1:2006/DAM 1:2013 has been approve
...