SIST EN ISO 11607-2:2006
(Main)Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)
This part of ISO 11607 specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems. This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized. This part of ISO 11607 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements may also be necessary for drug/device combinations.
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 2: Validierungsanforderungen an Prozesse der Formgebung, Siegelung und des Zusammenstellens (ISO 11607-2:2006)
Dieser Teil von ISO 11607 legt die Anforderungen für die Entwicklung und Validierung von Verpackungs-prozessen für Medizinprodukte fest, die in der Endverpackung sterilisiert werden. Zu diesen Verfahren gehören die Formgebung, Siegelung und das Zusammenstellen von vorgefertigten Sterilbarrieresystemen, Sterilbarrieresystemen und Verpackungssystemen.
Dieser Teil von ISO 11607 gilt für die Industrie, für Einrichtungen des Gesundheitswesens und alle anderen Einrichtungen, in denen Medizinprodukte verpackt und sterilisiert werden.
Dieser Teil von ISO 11607 erfasst nicht alle Anforderungen für die Verpackung von aseptisch hergestellten Medizinprodukten. Auch für Kombinationen von Medikamenten und Medizinprodukten können zusätzliche Anforderungen erforderlich sein.
Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2: Exigences de validation pour les procédés de formage, scellage et assemblage (ISO 11607-2:2006)
L'ISO 11607-2:2006 spécifie les exigences pour la mise au point et la validation des procédés d'emballage de dispositifs médicaux qui sont stérilisés au stade terminal. Ces procédés comprennent le formage, le scellage et l'assemblage de systèmes de barrière stérile préformés, de systèmes de barrière stérile et de systèmes d'emballage.
L'ISO 11607-2:2006 s'applique à l'industrie, aux installations de santé et à tout lieu où les dispositifs médicaux sont emballés et stérilisés.
L'ISO 11607-2:2006 ne couvre pas toutes les exigences relatives aux dispositifs médicaux fabriqués de manière aseptique. Des exigences supplémentaires sont nécessaires pour garantir les combinaisons médicaments/dispositifs.
Embalaža za končno sterilizirane medicinske pripomočke - 2. del: Zahteve validacije za proces oblikovanja, označevanja in sestavljanja (ISO 11607-2:2006)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11607-2:2006
01-julij-2006
(PEDODåD]DNRQþQRVWHULOL]LUDQHPHGLFLQVNHSULSRPRþNHGHO =DKWHYH
YDOLGDFLMH]DSURFHVREOLNRYDQMDR]QDþHYDQMDLQVHVWDYOMDQMD ,62
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for
forming, sealing and assembly processes (ISO 11607-2:2006)
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 2:
Validierungsanforderungen an Prozesse der Formgebung, Siegelung und des
Zusammenstellens (ISO 11607-2:2006)
Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2: Exigences de
validation pour les procédés de formage, scellage et assemblage (ISO 11607-2:2006)
Ta slovenski standard je istoveten z: EN ISO 11607-2:2006
ICS:
11.080.30
SIST EN ISO 11607-2:2006 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
EUROPEAN STANDARD
EN ISO 11607-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2006
ICS 11.080.30
English Version
Packaging for terminally sterilized medical devices - Part 2:
Validation requirements for forming, sealing and assembly
processes (ISO 11607-2:2006)
Emballages des dispositifs médicaux stérilisés au stade Verpackungen für in der Endverpackung zu sterilisierende
terminal - Partie 2: Exigences de validation pour les Medizinprodukte - Teil 2: Validierungsanforderungen an
procédés de formage, scellage et assemblage (ISO 11607- Prozesse der Formgebung, Siegelung und des
2:2006) Zusammenstellens (ISO 11607-2:2006)
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 11607-2:2006: E
worldwide for CEN national Members.
---------------------- Page: 2 ----------------------
EN ISO 11607-2:2006 (E)
Foreword
This document (EN ISO 11607-2:2006) 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 October 2006.
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 11607-2:2006 has been approved by CEN as EN ISO 11607-2:2006 without any
modifications.
2
---------------------- Page: 3 ----------------------
EN ISO 11607-2:2006 (E)
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 1, 2
4.2, 4.3, 4.4 3, 4, 5, 6
5.1 to 5.7 7.1, 7.5, 7.6, 8.1, 8.5
6.1 8.5
6.3 8.6
7 1,2, 6, 8.5, 8.6
8.1, 8.2 7.1, 7.5, 7.6, 8.1
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
3
---------------------- Page: 4 ----------------------
INTERNATIONAL ISO
STANDARD 11607-2
First edition
2006-04-15
Packaging for terminally sterilized
medical devices —
Part 2:
Validation requirements for forming,
sealing and assembly processes
Emballages des dispositifs médicaux stérilisés au stade terminal —
Partie 2: Exigences de validation pour les procédés de formage,
scellage et assemblage
Reference number
ISO 11607-2:2006(E)
©
ISO 2006
---------------------- Page: 5 ----------------------
ISO 11607-2:2006(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
© ISO 2006
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2006 – All rights reserved
---------------------- Page: 6 ----------------------
ISO 11607-2:2006(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references. 1
3 Terms and definitions. 1
4 General requirements. 4
4.1 Quality systems. 4
4.2 Sampling. 4
4.3 Test methods. 4
4.4 Documentation. 5
5 Validation of packaging processes. 5
5.1 General. 5
5.2 Installation qualification (IQ) . 6
5.3 Operational qualification (OQ). 6
5.4 Performance qualification (PQ) . 7
5.5 Formal approval of the process validation . 8
5.6 Process control and monitoring . 8
5.7 Process changes and revalidation. 8
6 Packaging system assembly. 8
7 Use of reusable sterile barrier systems. 9
8 Sterile fluid-path packaging. 9
Annex A (informative) Process development. 10
Bibliography . 11
© ISO 2006 – All rights reserved iii
---------------------- Page: 7 ----------------------
ISO 11607-2:2006(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 11607-2 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: 8 ----------------------
ISO 11607-2:2006(E)
Introduction
Medical devices delivered in a sterile state should be designed, manufactured and packed to ensure that they
are sterile when placed on the market and remain sterile, under documented storage and transport conditions,
until the sterile barrier system is damaged or opened. Additionally, medical devices delivered in a sterile state
should have been manufactured and sterilized by an appropriate, validated method.
One of the most critical characteristics of a sterile barrier system and packaging system for sterile medical
devices is the assurance of sterility maintenance. The development and validation of packaging processes are
crucial to ensure that sterile barrier system integrity is attained and will remain so until opened by the users of
sterile medical devices.
There should be a documented process validation program demonstrating the efficacy and reproducibility of
all sterilization and packaging processes. Along with the sterilization process, some of the packaging
operations that can affect sterile barrier system integrity are forming, sealing, capping or other closure
systems, cutting and process handling. This part of ISO 11607 provides the framework of activities and
requirements to develop and validate the process used to make and assemble the packaging system.
ISO 11607-1 and ISO 11607-2 are designed to meet the Essential Requirements of the European Medical
Device Directives.
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.
The sterile barrier system is essential to ensure the safety of terminally sterilized medical devices. Regulatory
authorities recognize the critical nature of sterile barrier systems by considering them as an accessory or a
component of a medical device. Preformed sterile barrier systems sold to healthcare facilities for use in
internal sterilization are considered as medical devices in many parts of the world.
© ISO 2006 – All rights reserved v
---------------------- Page: 9 ----------------------
INTERNATIONAL STANDARD ISO 11607-2:2006(E)
Packaging for terminally sterilized medical devices —
Part 2:
Validation requirements for forming, sealing and assembly
processes
1 Scope
This part of ISO 11607 specifies the requirements for development and validation of processes for packaging
medical devices that are terminally sterilized. These processes include forming, sealing, and assembly of
preformed sterile barrier systems, sterile barrier systems and packaging systems.
This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are
packaged and sterilized.
This part of ISO 11607 does not cover all requirements for packaging medical devices that are manufactured
aseptically. Additional requirements may also be necessary for drug/device combinations.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile
barrier systems and packaging systems
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
expiry date
indication of the date, by which the product should be used, expressed at least as the year and month
3.2
installation qualification
IQ
process of obtaining and documenting evidence that equipment has been provided and installed in
accordance with its specification
[ISO/TS 11139:2006]
© ISO 2006 – All rights reserved 1
---------------------- Page: 10 ----------------------
ISO 11607-2:2006(E)
3.3
labelling
written, printed, electronic or graphic matter affixed to a medical device or its packaging system; or
accompanying a medical device
NOTE Labelling is related to identification, technical description and use of the medical device but excludes shipping
documents.
3.4
operational qualification
OQ
process of obtaining and documenting evidence that installed equipment operates within predetermined limits
when used in accordance with its operational procedures
[ISO/TS 11139:2006]
3.5
packaging system
combination of the sterile barrier system and protective packaging
[ISO/TS 11139:2006]
3.6
performance qualification
PQ
process of obtaining and documenting evidence that the equipment, as installed and operated in accordance
with operational procedures, consistently performs in accordance with predetermined criteria and thereby
yields product meeting its specification
[ISO/TS 11139:2006]
3.7
preformed sterile barrier system
sterile barrier system that is supplied partially assembled for filling and final closure or sealing
EXAMPLE Pouches, bags and open reusable containers
[ISO/TS 11139:2006]
3.8
process development
establishing the nominal values and limit(s) for critical process parameters
3.9
product
result of a process
[ISO 9000:2000]
NOTE For the purpose of sterilization standards, product is tangible and can be raw material(s), intermediate(s), sub-
assembly(ies) and health care product(
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.