SIST EN ISO 11607-2:2017
(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)
ISO 11607-2:2006 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.
ISO 11607-2:2006 is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized.
ISO 11607-2:2006 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 za validacijo pri procesih oblikovanja, označevanja in sestavljanja (ISO 11607-2:2006)
ISO 11607-2:2006 podaja zahteve za razvoj in validacijo procesov za embalažo medicinskih pripomočkov, ki so končno sterilizirani. Ti procesi vključujejo oblikovanje, označevanje in sestavljanje izvedenih sterilnih pregradnih sistemov, sterilnih pregradnih sistemov in sistemov embalaže.
ISO 11607-2:2006 se uporablja za industrijo, zdravstvene ustanove in vse medicinske pripomočke, ki so dani v embalažo in sterilizirani.
ISO 11607-2:2006 ne zajema vseh zahtev za embalažo medicinskih pripomočkov, ki so izdelani aseptično. Za kombinacije zdravil/pripomočkov so morda potrebne dodatne zahteve.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11607-2:2017
01-september-2017
1DGRPHãþD
SIST EN ISO 11607-2:2006
SIST EN ISO 11607-2:2006/A1:2014
(PEDODåD]DNRQþQRVWHULOL]LUDQHPHGLFLQVNHSULSRPRþNHGHO =DKWHYH]D
YDOLGDFLMRSULSURFHVLKREOLNRYDQMDR]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 11607-2:2017
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
SIST EN ISO 11607-2:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11607-2:2017
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SIST EN ISO 11607-2:2017
EN ISO 11607-2
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2017
EUROPÄISCHE NORM
ICS 11.080.30 Supersedes EN ISO 11607-2:2006
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
terminal - Partie 2: Exigences de validation pour les sterilisierende Medizinprodukte - Teil 2:
procédés de formage, scellage et assemblage (ISO Validierungsanforderungen an Prozesse der
11607-2:2006) Formgebung, Siegelung und des Zusammenstellens
(ISO 11607-2:2006)
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 11607-2:2017 E
worldwide for CEN national Members.
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SIST EN ISO 11607-2:2017
EN ISO 11607-2:2017 (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
2
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SIST EN ISO 11607-2:2017
EN ISO 11607-2:2017 (E)
European foreword
The text of ISO 11607-2:2006 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 11607-2:2017 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 11607-2:2006.
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 Equivalent dated standard
as listed in Clause 2 of the
EN ISO or IEC
ISO standard
ISO 11607-1 EN ISO 11607-1:2009/A1: 2014
3
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SIST EN ISO 11607-2:2017
EN ISO 11607-2:2017 (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 11607-2:2006 has been approved by CEN as EN ISO 11607-2:2017 without any
modification.
4
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SIST EN ISO 11607-2:2017
EN ISO 11607-2:2017 (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 related 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 4.3, 5, 6, 7, 8 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 and only if the
requirements of EN
ISO 11607-1:2009/A1:2014
(Requirements for materials,
sterile barrier systems and
packaging systems) are met as
well.
8.3 4.3, 5, 6, 8 E.R. 8.3 is covered only in
5
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SIST EN ISO 11607-2:2017
EN ISO 11607-2:2017 (E)
Essential Requirements of Clause(s)/sub-clause(s) of Remarks/Notes
Directive 93/42/EEC this EN
respect of the function of
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 11607-1:2009/A1:2014
are met as well (Requirements
for materials, sterile barrier
systems and packaging
systems). 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 5, 6, 8 E.R. 8.4 is covered only in
respect of the compatibility
between the packaging and the
selected sterilisation processes
including packaging system
performance testing and
sterile barrier system stability
testing, but only if the
requirements of EN
ISO 11607-1:2009/A1:2014
are met as well (Requirements
for materials, sterile barrier
systems and packaging
systems).
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.
6
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SIST EN ISO 11607-2:2017
EN ISO 11607-2:2017 (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 4.3, 5, 6, 8 E.R. 7 is covered only in
respect of the function of
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 11607-1:2009/A1:2014
are met as well (Requirements
for materials, sterile barrier
systems and packaging
systems).
7
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SIST EN ISO 11607-2:2017
EN ISO 11607-2:2017 (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.
8
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SIST EN ISO 11607-2:2017
EN ISO 11607-2:2017 (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 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 4.3, 5, 6, 8 E.R. B2.3 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 11607-1:2009/A1:2014
are met as well (Requirements
for materials, sterile barrier
systems and packaging
systems). In this respect
damage to the “protective
packaging” is taken to mean
9
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SIST EN ISO 11607-2:2017
EN ISO 11607-2:2017 (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 5, 6, 8 E.R. B2.4 is covered only in
respect of the compatibility
between the packaging and the
selected sterilisation processes
including packaging system
performance testing and
sterile barrier system stability
testing, but only if the
requirements of EN
ISO 11607-1:2009/A1:2014
are met as well (Requirements
for materials, sterile barrier
systems and packaging
systems).
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.
10
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SIST EN ISO 11607-2:2017
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
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SIST EN ISO 11607-2:2017
ISO 11607-2:2006(E)
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ii © ISO 2006 – All rights reserved
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SIST EN ISO 11607-2:2017
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
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SIST EN ISO 11607-2:2017
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
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SIST EN ISO 11607-2:2017
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
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SIST EN ISO 11607-2:2017
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SIST EN ISO 11607-2:2017
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 amend
...
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