SIST EN ISO 11607-1:2009/A1:2014
(Amendment)Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2009/Amd 1:2014)
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2009/Amd 1:2014)
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 11607-1:2009/Amd 1:2014)
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 11607-1:2009/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
Relations
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
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, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11607-1:2006/Amd 1:2014 has been approved by CEN as EN ISO 11607-1:2009/A1:2014
without any modification.
3
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SIST EN ISO 11607-1:2009/A1:2014
EN ISO 11607-1:2009/A1:2014 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices
This European 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 Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the 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)/subclause(s) Essential Qualifying remarks/notes
of this International Requirements (ERs)
standard of EU Directive
93/42/EEC
5.1.3, 5.1.4, 5.1.5, 5.5 7.2
5.1.6 e), 5.1.7 a), 5.1.7 d), 7.3, 1st part
5.1.7 f), 5.1.7 g),
5.1.9 a), 5.3.1, 6.1.3,
6.2.3,
5.1.7 a), 5.1.7 g), 5.1.9 a), 7.5, 1st paragraph
5.4 c)
5.1.7 g) 7.5, 2nd paragraph Partly addressed.
Only toxics are dealt with.
5.1.6 a), 5.1.10 b) 7.6 Partly addressed.
5.1.10 c), 5.2, 6.1.1,
To fully address the ER, validation requirements for
6.1.2, 6.1.4 forming, sealing and assembling processes need to be
addressed (ISO 11607-2).
5.1.6 a), 5.1.10 b), 8.1 Partly addressed.
5.1.10 c), 5.2, 6.1.1, To fully address the ER, validation requirements for
6.1.2, 6.1.4, 6.2.2, forming, sealing and assembling processes need to be
addressed (ISO 11607-2).
6.3.5
5.1.10 a), 5.1.10 b), 8.3 Partly addressed.
5.1.10 c), 6.1.1, 6.1.2, To fully address the ER, validation requirements for
forming, sealing and assembling processes need to be
6.1.4, 6.2.2, 6.3.1, 6.3.5,
addressed (ISO 11607-2).
6.4.1, 7.1
5.1.3, 5.1.4, 5.1.5, 8.5
5.1.7 d)
4
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SIST EN ISO 11607-1:2009/A1:2014
EN ISO 11607-1:2009/A1:2014 (E)
5.1.3, 5.1.4, 5.1.5,
8.6
7.1, 5.1.6 e), 5.1.7 f),
5.1.7 g), 5.1.9 a), 5.3,
6.1.3
5.3.6, 7.1 9.1 Partly addressed.
To fully address the ER, validation requirements for
forming, sealing and assembling processes need to be
addressed (ISO 11607-2).
6.2.3 h), 6.2.3 j), 7.1 9.2, 2nd dash Partly addressed.
Standard does not mention or define values and/or limits.
7 13.1 Partly addressed.
Training and knowledge of the potential users is not dealt
with.
7 13.3 a), b), d), e), f), i),
j), m)
5.1.10 d), 5.1.11 b), 13.6 h) Partly addressed.
5.1.12 Standard requires this information only for reusable SBS.
5
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SIST EN ISO 11607-1:2009/A1:2014
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SIST EN ISO 11607-1:2009/A1:2014
INTERNATIONAL ISO
STANDARD 11607-1
First edition
2006-04-15
AMENDMENT 1
2014-07-15
Packaging for terminally sterilized
medical devices —
Part 1:
Requirements for materials, sterile
barrier systems and packaging
systems
AMENDMENT 1
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
Reference number
ISO 11607-1:2006/Amd.1:2014(E)
©
ISO 2014
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SIST EN ISO 11607-1:2009/A1:2014
ISO 11607-1:2006/Amd.1:2014(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2014
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
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Tel. + 41 22 749 01 11
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Published in Switzerland
ii © ISO 2014 – All rights reserved
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SIST EN ISO 11607-1:2009/A1:2014
ISO 11607-1:2006/Amd.1:2014(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (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 WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information.
The committee responsible for this document is ISO/TC 198, Sterilization of health care products.
ISO 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
© ISO 2014 – All rights reserved iii
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SIST EN ISO 11607-1:2009/A1:2014
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SIST EN ISO 11607-1:2009/A1:2014
ISO 11607-1:2006/Amd.1:2014(E)
Packaging for terminally sterilized medical devices —
Part 1:
Requirements for materials, sterile barrier systems and
packaging systems
AMENDMENT 1
Page v, Introduction, 2nd paragraph, 3rd sentence
Replace ‘This part of ISO 11607 is harmonized with EN 868-1’ with ‘This part of ISO 11607 replaces
EN 868-1’.
Page 1, Clause 1, Scope
Add the following new paragraph at the end:
‘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.’
Page 1, Clause 2, Normative references
Delete the date of publication of ISO 5636-5.
Page 2, definition 3.4
Replace the definition of 3.4 with the following definition, and delete the note:
‘characteristics of the closure which ensure that it prevents the ingress of microorganisms,
demonstrated under test conditions which consider sterilization process, handling, distribution,
transport and storage’
Page 2, definition 3.8
Replace the definition of 3.8 with the following definition:
‘property of the sterile barrier system which ensures that it prevents the ingress of microorganisms,
demonstrated under test conditions which consider sterilization process, handling, distribution,
transport and storage’
Page 3, definition 3.12
Replace ‘[ISO 9000:2000]’ with ‘[ISO 9000:2005]’.
Page 4, definition 3.19
Replace the definition of 3.19 with the following definition, and delete the note:
‘characteristic of the seal which ensures that it prevents the ingress of microorganisms, demonstrated
under test conditions which consider sterilization process, handling, distribution, transport and
storage’
Page 6, 4.2.2
Replace ‘It is not necessary’ with ‘It shall not be necessary’.
© ISO 2014 – All rights reserved 1
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SIST EN ISO 11607-1:2009/A1:2014
ISO 11607-1:2006/Amd.1:2014(E)
Page 6, 4.2.3
Replace ‘Health care facilities may use’ with ‘Health care facilities shall consider using’.
Page 10, 5.3.2, Note
Replace the first sentence of the note with the following:
‘For example, see ISO 17665-1, ISO 11135, ISO 11137 (all parts), ISO 14937; EN 285, EN 1422, or
EN 14180.’
Page 11, 6.1.5, Note
Update the date of publication of the reference; read: ‘ANSI/AAMI ST65:2008’.
Page 12, 6.3.2, last sentence
Make a note from the last sentence and update the date of publication of the reference; read:
[36]
‘NOTE For a review of this topic, refer to ANSI/AAMI ST65:2008 and Hansen et al. 1995 .’
Page 13, 7.1
Add the following new dash before the first dash:
‘— the name or trade name and address of the manufacturer or his authorized representative;’
Add, as a new 8th dash, the following:
‘— whether the materials and/or preformed sterile barrier systems are intended for single use or
reuse;’
Add the following new last dash:
‘— if instructions for use are supplied, they shall contain the date of issue or the latest revision.’
Page 13, 7.2
Replace ‘for preformed sterile barrier systems’ with: ‘with the material, preformed sterile barrier
system or sterile barrier system’.
Page 17, B.1, 1st paragraph
Replace the second sentence with the following:
‘When using test methods and procedures listed in Table B.1 it is important to note the date of issue
of these documents.’
Page 17, B.1, 2nd paragraph
Replace the first sentence with the following:
‘The criteria for inclusion of test methods and procedures given in Table B.1 are that they must be
nominated for inclusion and commercially available from a standards development organization,
trade association or national standards body.’
Page 17 and the following, B.2
Replace the list of test methods given in B.2 with the following new Table B.1:
2 © ISO 2014 – All rights reserved
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SIST EN ISO 11607-1:2009/A1:2014
ISO 11607-1:2006/Amd.1:2014(E)
Table B.1 — Test methods and their status
Test method has Test method
Attribute/ statement of pre- only has Guidance,
Characteris- Reference Title of reference cision and/or bias, statement Standard
tics repeatability and of precision Practice
reproducibility and/or bias
Accelerated Standard Guide for Accelerated
a
aging ASTM F1980 Aging of Sterile Barrier Systems for NA NA YES
Medical Devices
Packaging for terminally sterilized
medical devices – Part 8: Re-usable
EN 868–8 sterilization containers for steam NA NA YES
sterilizers conforming to EN 285 –
Requirements and test methods
Air permeance Paper and board — Determination
ISO/TS 5636-2 of air permeance (medium range) — NO NO NA
Part 2: Schopper method
Paper and board — Determination
ISO 5636-3 of air permeance (medium range) — NO NO NA
Part 3: Bendtsen method
Paper and board — Determination
of air permeance and air resistance
ISO 5636-5 NO NO NA
(medium range) — Part 5: Gurley
method
Standard test method for air perme-
ASTM D737 YES — NA
ability of textile fabrics
Air Resistance of Paper (Gurley
TAPPI T460 YES — NA
Method)
Resistance of paper to passage of air
TAPPI T536 YES — NA
(high-pressure Gurley method)
Alcohol repel- Aqueous Liquid Repellency: Water/
AATCC-193 NO NO NA
lency Alcohol Solution Resistance Test
Basis weight Paper and board — Determination of
ISO 536 NO NO NA
grammage
Standard test method for package
ASTM D4321 YES — NA
yield of plastic film
Standard test methods for mass per
ASTM D3776–6M YES — NA
unit area (weight) of fabric
Grammage of Paper and Paperboard
TAPPI T410 YES — NA
(We
...
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 approved by CEN as EN ISO 11607-1:2009/prA1:2013
without any modification.
3
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SIST EN ISO 11607-1:2009/oprA1:2013
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SIST EN ISO 11607-1:2009/oprA1:2013
DRAFT AMENDMENT ISO 11607-1:2006/DAM 1
ISO/TC 198 Secretariat: ANSI
Voting begins on Voting terminates on
2013-03-14 2013-08-14
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
Packaging for terminally sterilized medical devices —
Part 1:
Requirements for materials, sterile barrier systems and
packaging systems
AMENDMENT 1
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
ICS 11.080.30
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for Standardization (ISO), and
processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
five-month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments received, will be
submitted to a parallel two-month approval vote in ISO and formal vote in CEN.
To expedite distribution, this document is circulated as received from the committee
secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at
publication stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.
THIS DOCUMENT IS A DRAFT CIRCULATED 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 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 NATIONAL REGULATIONS.
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.
© International Organization for Standardization, 2013
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SIST EN ISO 11607-1:2009/oprA1:2013
ISO 11607-1:2006/DAM 1
Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted
under the applicable laws of the user’s country, neither this ISO draft nor any extract from it may be
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ii © ISO 2013 – All rights reserved
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SIST EN ISO 11607-1:2009/oprA1:2013
ISO 11607-1:2006/DAM 1
Contents Page
Foreword . iv
© ISO 2012 – All rights reserved iii
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SIST EN ISO 11607-1:2009/oprA1:2013
ISO 11607-1:2006/DAM 1
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.
Amendment 1 to ISO 11607-1:2006 was prepared by Technical Committee ISO/TC 198, Sterilization of health
care products.
iv © ISO 2012 – All rights reserved
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SIST EN ISO 11607-1:2009/oprA1:2013
DRAFT AMENDMENT ISO 11607-1:2006/DAM 1
Packaging for terminally sterilized medical devices — Part 1:
Requirements for materials, sterile barrier systems and
packaging systems
nd rd
Introduction 2 paragraph, 3 sentence
Replace 'This part of ISO 11607 is harmonized with EN 868-1' by 'This part of ISO 11607 replaces EN 868-1'
nd
Introduction 2 paragraph, last sentence
After 'European Medical Device Directives' add 'as outlined in Annex ZA of the EN ISO standard.'
Page 1, Scope
Add the following new paragraph at the end:
'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.'
Page 1, Terms and definitions
Delete date of publication of ISO 5636-5
Page 2, definition 3.4
Replace definition 3.4 by the following definition and delete the note:
'characteristics of the closure which ensure that it prevents the ingress of microorganisms, demonstrated
under test conditions which consider sterilization process, handling, distribution, transport and storage'
Page 2, definition 3.8
Replace definition 3.8 by the following definition:
'property of the sterile barrier system which ensures that it prevents the ingress of microorganisms,
demonstrated under test conditions which consider sterilization process, handling, distribution, transport and
storage'
Page 4, definition 3.12
Replace '[ISO 9000:2000]' by '[ISO 9000:2005]'
Page 4, definition 3.19
Replace definition 3.19 by the following definition and delete the note:
© ISO 2012 – All rights reserved 1
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SIST EN ISO 11607-1:2009/oprA1:2013
ISO 11607-1:2006/DAM 1
'characteristics of the seal which ensures that it prevents the ingress of microorganisms, demonstrated under
test conditions which consider sterilization process, handling, distribution, transport and storage'
Page 6, 4.2.2
Replace 'It is not necessary' by 'It shall not be necessary'
Page 6, 4.2.3
Replace 'Health care facilities may use' by 'Health care facilities shall consider using'
Page 10, 5.3.2, Note
Replace the first sentence of the note by the following
'For Example see ISO 17665-1, ISO 11135-1, ISO 11137 (all parts), ISO 14937; EN 285, EN 1422, or
EN 14180.'
Page 12, 6.1.5, Note
Update date of publication of reference, read: ANSI/AAMI ST65:2008
Page 12, 6.3.2 last sentence
Make a note from the last sentence and update date of publication of reference, read: ANSI/AAMI ST65:2008
Page 13, 7.1
Add the following new dash before the first dash:
the name or trade name and address of the manufacturer or his authorized representative;
Add as a new 8 dash the following:
whether the materials and/or preformed sterile barrier systems are intended for single use or reuse;
Add the following new last dash:
if instructions for use are supplied, they shall contain the date of issue or the latest revision.
Page 13, 7.2
replace 'for preformed sterile barrier systems" by: "with the material, preformed sterile barrier system or sterile
barrier system'
st
Page 17, B.1, 1 paragraph
Replace the second sentence with the following:
'When using test methods and procedures listed in Table B.1 it is important to note the date of issue of these
documents.'
2 © ISO 2012 – All rights reserved
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SIST EN ISO 11607-1:2009/oprA1:2013
ISO 11607-1:2006/DAM 1
nd
Page 17, B.1, 2 paragraph
Replace the first sentence with the following:
'The criteria for inclusion of test methods and procedures given in table B.1 are that they must be nominated
for inclusion and commercially available from a standards development organization, trade association or
national standards body.'
Page 17 and following
Replace the list of test methods given in B.2 by the following new table
Table B.1 ― Test methods and their status
Test
Test method
method
has statement
only has
Attribute/ of precision Guidance,
statement
Character-Reference Title of reference and/or bias, Standard
of
istics repeatability Practice
precision
and
and/or
reproducibility
bias
Accelerated ASTM Standard Guide for Accelerated
a
NA NA YES
aging F1980 Aging of Sterile Barrier Systems
for Medical Devices
EN 868-8 Packaging materials and
systems for medical devices
which are to be sterilized —
NA NA YES
Part 8: Re-usable sterilization
containers for steam sterilizers
conforming to EN 285 —
Requirements and test methods
Air ISO/TS 56 Paper and board —
permeance 36-2 Determination of air permeance NO NO NA
(medium range) — Part 2:
Schopper method
ISO 5636- Paper and board —
3 Determination of air permeance NO NO NA
(medium range) — Part 3:
Bendtsen method
ISO 5636- Paper and board —
5 Determination of air permeance NO NO NA
and air resistance (medium
range) — Part 5: Gurley method
ASTM Standard test method for air YES — NA
D737 permeability of textile fabrics
YES — NA
TAPPI Air Resistance of Paper (Gurley
T460 Method)
TAPPI Resistance of paper to passage
YES — NA
T536 of air (high-pressure Gurley
method)
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SIST EN ISO 11607-1:2009/oprA1:2013
ISO 11607-1:2006/DAM 1
Table B.1 (continued)
Test method Test
has statement method
Attribute/ of precision only has Guidance,
Character-Reference Title of reference and/or bias, statement Standard
istics repeatability of Practice
and precision
reproducibility and/or bias
Alcohol AAT CC- Aqueous Liquid Repellency:
repellency
193 Water/Alcohol Solution NO NO NA
Resistance Test
Basis ISO 536 Paper and board —
NO NO NA
weight Determination of grammage
ASTM Standard test method for
YES — NA
D4321 package yield of plastic film
ASTM Standard test methods for mass
YES — NA
D3776-6M per unit area (weight) of woven
fabric
TAPPI Grammage of Paper and
YES — NA
T410 Paperboard (Weight per Unit
Area)
Biocompa- ISO 10993 Biological evaluation of medical
NA NA YES
tibility -1 devices — Part 1: Evaluation and
testing
ASTM
Standard Guide for
F2475
Biocompatibility Evaluation of NA NA YES
Medical Device Packaging
Materials
Burst ISO 2758 Paper — Determination of YES — NA
bursting strength
TAPPI Bursting Strength of Paper YES — NA
T403
Standard Test Methods for
ASTM
Internal Pressurization Failure YES — NA
F1140
Resistance of Unrestrained
Packages
ASTM
Standard Test Method for Burst
F2054
Testing of Flexible Package
YES — NA
Seals Using Internal Air
Pressurization Within Restraining
Plates
Chlorides ISO 9197 Paper, board and pulps —
— YES NA
Determination of water-soluble
chlorides
— YES NA
TAPPI T Water-soluble chlorides in pulp
256 and paper
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SIST EN ISO 11607-1:2009/oprA1:2013
ISO 11607-1:2006/DAM 1
Table B.1 (continued)
Test
Test method
method
has statement
only has
Attribute/ of precision Guidance,
statement
Character-Reference Title of reference and/or bias, Standard
of
istics repeatability Practice
precision
and
and/or
reproducibility
bias
EN 868-4 Packaging for terminally sterilized
medical devices — Part 4: Paper
b
bags - Requirements and test NO NO NA
methods (Annex D: Method for
hot extraction of sulphates)
Cleanliness TAPPI T Dirt in paper and paperboard
YES — NA
437
TAPPI T Transparent chart for the
NO NO NA
564 estimation of defect size
Coat weight ASTM Standard practice for
NA NA YES
F2217-02 coating/adhesive weight
determination
Condition-
ISO 187 Paper, board and pulps —
ing
Standard atmosphere for
conditioning and testing and NA NA YES
procedure for monitoring the
atmosphere and conditioning of
samples
ASTM Standard practice conditioning
D4332-01 containers, packages or NA NA YES
packaging components for
testing
ISO 2233 Complete, filled transport
NA NA YES
packages and unit loads —
Conditioning for testing
Dimensions ASTM Standard test method for linear
YES — NA
F2203-02 measurement using precision
steel rule
Drapability ISO 9073 Textiles — Test methods for
NO NO NA
-9 nonwovens — Part 9:
Determination of drape
coefficient
ISO 2493 Paper and board —
-1 Determination of bending YES — NA
resistance — Part 1: Constant
rate of deflection
ISO 2493 Paper and board —
-2 Determination of bending YES — NA
resistance — Part 2: Taber-type
tester
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SIST EN ISO 11607-1:2009/oprA1:2013
ISO 11607-1:2006/DAM 1
Table B.1 (continued)
Test method
Test
has statement
method
Attribute/ of precision Guidance,
only has
Character-Reference Title of reference and/or bias, Standard
statement
istics repeatability Practice
of precision
and
and/or bias
reproducibility
DIN 53121 Testing of paper and board —
Determination of the bending NO NO NA
stiffness by the beam method
TAPPI Bending Resistance (Sti
...
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