EN ISO 11607-2:2020/A11:2022
(Amendment)Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
This document specifies requirements for the 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.
It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized.
It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can 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 2:2019/A11:2020)
Dieses Dokument legt Anforderungen für die Entwicklung und Validierung von Verpackungsprozessen für Medizinprodukte fest, die in der Endverpackung sterilisiert werden. Zu diesen Verfahren gehören die Formung, Siegelung und das Zusammenstellen von vorgefertigten Sterilbarrieresystemen, Steril-barrieresystemen und Verpackungssystemen.
Es gilt für die Industrie, für Einrichtungen des Gesundheitswesens und für alle anderen Einrichtungen, in denen Medizinprodukte verpackt und sterilisiert werden.
Es deckt nicht alle Anforderungen an Verpackungen aseptisch hergestellter Medizinprodukte ab. 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 11607-2:2019)
Le présent document 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.
Il s'applique à l'industrie, aux établissements de santé et à tout lieu où les dispositifs médicaux sont emballés et stérilisés.
Il ne couvre pas toutes les exigences relatives à l'emballage des dispositifs médicaux fabriqués de manière aseptique. Des exigences supplémentaires peuvent être nécessaires pour garantir les combinaisons médicaments/dispositifs.
Embalaža za končno sterilizirane medicinske pripomočke - 2. del: Zahteve za validacijo pri procesih oblikovanja, označevanja in sestavljanja - Dopolnilo A11 (ISO 11607-2:2019)
Ta dokument 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. Uporablja se za industrijo, zdravstvene ustanove in vse medicinske pripomočke, ki so dani v embalažo in sterilizirani. Ne zajema vseh zahtev za embalažo medicinskih pripomočkov, ki so izdelani aseptično. Za kombinacije zdravil/pripomočkov so morda potrebne dodatne zahteve.
General Information
Relations
Overview
EN ISO 11607-2:2020/A11:2022 (Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes) is a CEN-adopted amendment to ISO 11607-2:2019. The standard specifies requirements for the development and validation of packaging processes used to produce packaging and sterile barrier systems for medical devices that are terminally sterilized. It is applicable to industry, health‑care facilities and any location where medical devices are packaged and sterilized.
Key topics and requirements
- Scope of validation: Requirements focus on the forming, sealing and assembly processes for preformed sterile barrier systems (SBS), sterile barrier systems and complete packaging systems.
- Process development and qualification: Guidance on establishing controlled, validated packaging processes and demonstrating reproducible performance (process design, installation/operational/performance qualification - implied by general validation lifecycle).
- Control and change management: Includes management of changes and requirements for revalidation to keep processes in a state of control (document references subclause addressing change management).
- Specific SBS types: The standard addresses specifics for reusable sterile barrier systems and sterile fluid‑path SBS, indicating tailored validation needs for these categories (clauses referenced in the document).
- Regulatory linkage: Annexes ZA, ZB and ZC map the standard to essential requirements of EU medical device directives, supporting presumption of conformity when the standard is cited by the Official Journal.
Note: EN ISO 11607-2:2020/A11:2022 complements EN ISO 11607-1:2020 (requirements for materials, sterile barrier systems and packaging systems). It does not cover aseptically manufactured devices or all requirements for drug/device combinations.
Practical applications and users
Who uses this standard:
- Medical device manufacturers and packaging engineers validating packaging lines
- Quality assurance and regulatory affairs teams preparing technical files and conformity evidence
- Contract packagers, sterilization service providers and third‑party manufacturers
- Hospital sterile supply departments and healthcare facilities that perform final packaging and terminal sterilization
- Notified bodies and auditors assessing compliance to EU requirements
Practical uses:
- Designing and qualifying forming, sealing and assembly equipment and procedures
- Preparing validation protocols, acceptance criteria and revalidation plans
- Demonstrating packaging system performance to support device sterility from sterilization to point of use
Related standards
- EN ISO 11607-1:2020 / ISO 11607-1:2019 - Requirements for materials, sterile barrier systems and packaging systems (normative companion to Part 2)
Keywords: EN ISO 11607-2:2020/A11:2022, packaging for terminally sterilized medical devices, validation requirements, forming sealing assembly processes, sterile barrier systems, packaging systems, ISO 11607-2.
Frequently Asked Questions
EN ISO 11607-2:2020/A11:2022 is a amendment published by the European Committee for Standardization (CEN). Its full title is "Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)". This standard covers: This document specifies requirements for the 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. It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized. It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
This document specifies requirements for the 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. It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized. It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
EN ISO 11607-2:2020/A11:2022 is classified under the following ICS (International Classification for Standards) categories: 11.080.30 - Sterilized packaging. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 11607-2:2020/A11:2022 has the following relationships with other standards: It is inter standard links to EN ISO 11607-2:2020. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 11607-2:2020/A11:2022 is associated with the following European legislation: EU Directives/Regulations: 2017/745, 2017/746, 90/385/EEC, 93/42/EEC, 98/79/EC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
You can purchase EN ISO 11607-2:2020/A11:2022 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2022
Embalaža za končno sterilizirane medicinske pripomočke - 2. del: Zahteve za
validacijo pri procesih oblikovanja, označevanja in sestavljanja - Dopolnilo A11
(ISO 11607-2:2019)
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for
forming, sealing and assembly processes (ISO 11607-2:2019)
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 2:
Validierungsanforderungen an Prozesse der Formgebung, Siegelung und des
Zusammenstellens (ISO 11607-2:2019)
Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2: Exigences de
validation pour les procédés de formage, scellage et assemblage (ISO 11607-2:2019)
Ta slovenski standard je istoveten z: EN ISO 11607-2:2020/A11:2022
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 11607-
EUROPEAN STANDARD
2:2020/A11
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2022
ICS 11.080.30
English Version
Packaging for terminally sterilized medical devices - Part
2: Validation requirements for forming, sealing and
assembly processes (ISO 11607-2:2019)
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
11607-2:2019) Formgebung, Siegelung und des Zusammenstellens
(ISO 11607-2:2019)
This amendment A11 modifies the European Standard EN ISO 11607-2:2020; it was approved by CEN on 13 April 2022.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, 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: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11607-2:2020/A11:2022 E
worldwide for CEN national Members.
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] (as amended) 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] (as amended) aimed to be covered . 8
Annex ZC (informative) Relationship between this European Standard and the essential
requirements of Directive 98/79/EC [OJ L 331] aimed to be covered . 10
European foreword
This document (EN ISO 11607-2:2020/A11:2022) has been prepared by Technical Committee
CEN/TC 102 “Sterilizers and associated equipment for processing of medical devices”, the secretariat of
which is held by DIN.
This Amendment to the European Standard EN ISO 11607-2:2020 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by December 2022,
and conflicting national standards shall be withdrawn at the latest by December 2022.
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 amends EN ISO 11607-2:2020 with a revised European Foreword and European Annexes
ZA, ZB and ZC.
This Amendment to the European Standard EN ISO 11607-2:2020 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, ZB and ZC, which are an integral part of
this document.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN websites.
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
ISO standard EN ISO or IEC
ISO 11607-1 EN ISO 11607-1:2020 ISO 11607-1:2019
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, Republic of North 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.
Annex ZA
(informative)
Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] (as amended) aimed to be
covered
This European Standard has been prepared under a Commission’s standardization mandate
BC/CEN/CENELEC/09/89 "Standardization mandate jointly to CEN and CENELEC concerning the
preparation of European standards relating to Horizontal aspects in the field of medical devices" referred
to in the mandate 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 requirements of Annex I of
Directive 93/42/EEC [OJ L 169]
Essential Requirements of Clause(s)/sub-clause(s) of Remarks/Notes
Annex I of Directive this EN
93/42/EEC
4.3, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, Partially covered. E.R. 8.1 is
8.1
6.1, 6.2, 6.3, 7, 8 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-
1:2020 (Requirements for
materials, sterile barrier systems
Essential Requirements of Clause(s)/sub-clause(s) of Remarks/Notes
Annex I of Directive this EN
93/42/EEC
and packaging systems) are met
as well.
Clause 5 addresse
...
SLOVENSKI STANDARD
01-september-2022
Embalaža za končno sterilizirane medicinske pripomočke - 2. del: Zahteve za
validacijo pri procesih oblikovanja, označevanja in sestavljanja - Dopolnilo A11
(ISO 11607-2:2019)
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for
forming, sealing and assembly processes (ISO 11607-2:2019)
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 2:
Validierungsanforderungen an Prozesse der Formgebung, Siegelung und des
Zusammenstellens (ISO 11607 2:2019/A11:2020)
Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2: Exigences de
validation pour les procédés de formage, scellage et assemblage (ISO 11607-2:2019)
Ta slovenski standard je istoveten z: EN ISO 11607-2:2020/A11:2022
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 11607-
EUROPEAN STANDARD
2:2020/A11
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2022
ICS 11.080.30
English Version
Packaging for terminally sterilized medical devices - Part
2: Validation requirements for forming, sealing and
assembly processes (ISO 11607-2:2019)
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
11607-2:2019) Formgebung, Siegelung und des Zusammenstellens
(ISO 11607-2:2019)
This amendment A11 modifies the European Standard EN ISO 11607-2:2020; it was approved by CEN on 13 April 2022.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, 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: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11607-2:2020/A11:2022 E
worldwide for CEN national Members.
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] (as amended) 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] (as amended) aimed to be covered . 8
Annex ZC (informative) Relationship between this European Standard and the essential
requirements of Directive 98/79/EC [OJ L 331] aimed to be covered . 10
European foreword
This document (EN ISO 11607-2:2020/A11:2022) has been prepared by Technical Committee
CEN/TC 102 “Sterilizers and associated equipment for processing of medical devices”, the secretariat of
which is held by DIN.
This Amendment to the European Standard EN ISO 11607-2:2020 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by December 2022,
and conflicting national standards shall be withdrawn at the latest by December 2022.
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 amends EN ISO 11607-2:2020 with a revised European Foreword and European Annexes
ZA, ZB and ZC.
This Amendment to the European Standard EN ISO 11607-2:2020 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, ZB and ZC, which are an integral part of
this document.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN websites.
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
ISO standard EN ISO or IEC
ISO 11607-1 EN ISO 11607-1:2020 ISO 11607-1:2019
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, Republic of North 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.
Annex ZA
(informative)
Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] (as amended) aimed to be
covered
This European Standard has been prepared under a Commission’s standardization mandate
BC/CEN/CENELEC/09/89 "Standardization mandate jointly to CEN and CENELEC concerning the
preparation of European standards relating to Horizontal aspects in the field of medical devices" referred
to in the mandate 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 requirements of Annex I of
Directive 93/42/EEC [OJ L 169]
Essential Requirements of Clause(s)/sub-clause(s) of Remarks/Notes
Annex I of Directive this EN
93/42/EEC
4.3, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7, Partially covered. E.R. 8.1 is
8.1
6.1, 6.2, 6.3, 7, 8 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-
1:2020 (Requirements for
materials, sterile barrier systems
Essential Requirements of Clause(s)/sub-clause(s) of Remarks/Notes
Annex I of Directive this EN
93/42/EEC
and packaging systems) are met
as well.
Clause 5 add
...
Die Norm EN ISO 11607-2:2020/A11:2022 legt die Anforderungen für die Entwicklung und Validierung von Prozessen zur Verpackung von medizinischen Geräten fest, die terminal sterilisiert werden. Dies umfasst die Prozesse des Formens, Versiegelns und der Montage von vorgeformten sterilen Barrièresystemen, sterilen Barrièresystemen und Verpackungssystemen. Diese Spezifikationen sind von entscheidender Bedeutung für die medizinische Industrie und Einrichtungen des Gesundheitswesens, da sie sicherstellen, dass die gelieferten Produkte nicht nur steril, sondern auch zuverlässig und sicher für den Gebrauch sind. Ein wesentlicher Stärke der Norm liegt in ihrem klaren Fokus auf die Validierungsanforderungen, die für die Endverpackung von medizinischen Geräten erforderlich sind. Die Norm bietet eine detaillierte Anleitung für die Industrie, um sicherzustellen, dass die Verpackungsprozesse den geltenden Vorschriften entsprechen, was zur Gewährleistung der Qualität und Sicherheit der medizinischen Geräte beiträgt. Es ist hervorzuheben, dass die Norm auch für unterschiedliche Verpackungssysteme gilt, was ihre Anwendung in verschiedenen Kontexten und bei unterschiedlichen Produkttypen stärkt. Die Relevanz dieser Norm ist besonders evident in einer Zeit, in der die Anforderungen an die Sicherheit und Sterilität von Medizinprodukten kontinuierlich steigen. Mit der zunehmenden Komplexität der Gesundheitsversorgung und dem Bedarf an effektiven, sicheren Verpackungslösungen spielt die EN ISO 11607-2:2020/A11:2022 eine entscheidende Rolle bei der Gewährleistung, dass Produkte von höchster Qualität in den Markt gelangen. Es ist auch wichtig zu erwähnen, dass die Norm nicht alle Anforderungen für die Verpackung aseptisch hergestellter medizinischer Geräte abdeckt, sondern spezifische Leitlinien für terminal sterilisierten Produkte bietet. So wird sichergestellt, dass die Industrie die einzigartigen Herausforderungen und Vorschriften in diesem Bereich berücksichtigt. Insgesamt bietet die EN ISO 11607-2:2020/A11:2022 klare und umsetzbare Vorgaben, die sowohl für Hersteller als auch für Gesundheitsdienstleister von großer Bedeutung sind. Die Norm unterstützt die Einführung effektiver Maßnahmen zur Validierung und bringt damit einen hohen Stellenwert in der Herstellung und Verpackung von medizinischen Geräten mit sich.
La norme EN ISO 11607-2:2020/A11:2022 offre un cadre exhaustif pour la validation des processus de conditionnement des dispositifs médicaux stérilisés terminalement. Son champ d'application couvre la formation, le scellement et l'assemblage des systèmes de barrières stériles préformées, des systèmes de barrières stériles ainsi que des systèmes d'emballage. Cette spécification est cruciale tant pour l'industrie que pour les établissements de santé, à une époque où l'importance d'une stérilisation adéquate est primordiale pour la sécurité des patients et l'efficacité des dispositifs médicaux. Parmi ses forces, la norme fournit des directives claires et précises sur les exigences de validation, qui aident les fabricants à établir des processus robustes et fiables. En intégrant des critères rigoureux pour la validation des processus de conditionnement, EN ISO 11607-2 permet de garantir que les dispositifs médicaux atteignent le marché avec un haut niveau de sécurité et de performance. Cela renforce la confiance des professionnels de santé et des patients dans les produits fournis. La pertinence de la norme se manifeste dans sa capacité à s'adapter aux exigences variées de l’industrie, tout en soulignant les aspects spécifiques relatifs au conditionnement des dispositifs médicaux stérilisés. Bien qu'elle ne traite pas entièrement des exigences pour le conditionnement des dispositifs fabriqués aseptiquement, elle constitue néanmoins une fondation solide pour les organisations qui souhaitent se conformer aux meilleures pratiques en matière de validation des processus. La norme est essentielle pour ceux qui cherchent à assurer un emballage fiable et efficace des dispositifs médicaux, contribuant ainsi à la sécurité et à la qualité des soins de santé.
EN ISO 11607-2:2020/A11:2022は、終末滅菌された医療機器のパッケージングに関する標準であり、特に形成、シール、および組立プロセスの検証要件を定めています。この文書は、医療機器のパッケージングにおけるプロセスの開発と検証に必要な要件を具体的に規定しており、そのスコープは非常に広範です。 この標準の強みは、滅菌された医療機器のパッケージングプロセスに対する明確なガイドラインを提供する点です。これにより、医療機関や業界が遵守すべき具体的なプロセスを理解しやすくなり、安全で効果的な製品の供給に寄与します。形成、シール、および組立の各プロセスにおいて、厳格な検証が求められるため、パッケージシステムの信頼性が大いに向上します。 さらに、この標準は、滅菌されたバリアシステムやパッケージングシステムにおける要件を詳細に説明することにより、様々な医療機関において適用可能です。プロセスのバリエーションを考慮しつつ、一貫した品質管理を実現できる点が、業界全体における重要性を増しています。 ただし、この文書は無菌製造された医療機器のパッケージングにおける全ての要件をカバーしているわけではなく、特に薬剤/デバイスの組み合わせに対しては追加の要件が必要な場合があります。この点は、医療機器の種類や用途を考慮する際に留意すべき重要なポイントです。 したがって、EN ISO 11607-2:2020/A11:2022は、終末滅菌された医療機器のパッケージングにおける基準を遵守し、安全で効果的な製品を提供するための不可欠なガイドラインであり、その重要性は今後も増していくことでしょう。
SIST EN ISO 11607-2:2020/A11:2022는 최종적으로 멸균된 의료 기기를 포장하기 위한 표준으로서, 포장의 개발 및 검증 과정에 대한 명확한 요구사항을 제공합니다. 이 문서는 의료 기기의 포장 과정에서의 성형, 밀봉 및 조립 과정을 포괄적으로 다루고 있어, 의료 기기 제조업체와 의료 기관 등이 이해하고 준수해야 할 중요 요소를 제시합니다. 이 표준의 강점은 명확하게 정의된 검증 요구사항이 있다는 점입니다. 최종 멸균의 목적을 위해 사용되는 미세한 변수가 포장 과정에 어떤 영향을 미칠 수 있는지를 명확히 인식할 수 있도록 돕습니다. 이는 포장 공정의 개선과 위험 관리 측면에서 매우 중요하며, 제조업체가 안전하고 효과적인 제품을 시장에 공급할 수 있도록 지원합니다. 또한, SIST EN ISO 11607-2:2020/A11:2022는 의료 기기 포장 및 멸균과 관련된 모든 분야에서 실질적인 적용이 가능하다는 점에서 유의미합니다. 이는 의료 기기가 포장되고 멸균되는 모든 환경, 즉 산업 현장 및 의료 시설과 같은 장소에서 유용하게 쓰일 수 있으며, 각기 다른 환경과 요구사항에 부응하는 유연성을 제공합니다. 그러나 이 표준은 무균적으로 제조된 의료 기기에 대한 모든 요구 사항을 포함하지 않으며, 약물/기기 조합에 대해서는 별도의 추가 요구 사항이 필요할 수 있다는 점에 유의해야 합니다. 이는 특정 제품군에 대한 품질과 안전성을 높이기 위한 추가적인 검증 과정이 필요함을 시사합니다. 결론적으로, SIST EN ISO 11607-2:2020/A11:2022는 최종 멸균된 의료 기기 포장 과정에서 필수적으로 필요한 기준을 제공하며, 의료 기기 포장 산업의 안전성과 효율성을 높이는 데 기여하는 표준입니다.
Die Norm EN ISO 11607-2:2020/A11:2022 behandelt die Anforderungen an die Entwicklung und Validierung von Prozessen zur Verpackung von terminal sterilisierten Medizinprodukten. Diese Norm ist von zentraler Bedeutung für die Branche, da sie spezifische Kriterien für das Formen, Verschließen und Montieren von vorkonfektionierten sterilen Barrieresystemen sowie Verpackungssystemen definiert. Ein wesentlicher Stärke dieser Norm liegt in ihrem umfassenden Anwendungsbereich. Sie ist nicht nur für die Industrie relevant, sondern auch für Gesundheitseinrichtungen und überall dort, wo medizinische Geräte verpackt und sterilisiert werden. Dadurch gewährleistet sie, dass die Qualität und Sicherheit von Sterilverpackungen in verschiedenen Umgebungen gewährleistet sind. Die Norm legt auch klar fest, dass sie nicht alle Anforderungen für die Verpackung von aseptisch hergestellten Medizinprodukten abdeckt. Diese Präzisierung ist wichtig, da sie aufzeigt, dass zusätzliche Anforderungen für Kombinationen von Arzneimitteln und Geräten erforderlich sein können. Dies erleichtert es den Unternehmen, die Norm gezielt anzuwenden und entsprechende Ergänzungen vorzunehmen. Insgesamt trägt die EN ISO 11607-2:2020/A11:2022 dazu bei, die Effizienz und Zuverlässigkeit von Verpackungsprozessen für medizinische Geräte zu steigern. Durch die klare Definition der Validierungsanforderungen wird sichergestellt, dass die Integrität der sterilen Barrieresysteme zuverlässig geschützt ist, was letztendlich einen entscheidenden Einfluss auf die Patientensicherheit und die Qualität der medizinischen Produkte hat.
The standard EN ISO 11607-2:2020/A11:2022 provides comprehensive guidelines regarding the validation requirements for the forming, sealing, and assembly processes in the packaging of terminally sterilized medical devices. This document is essential for ensuring that the packaging processes meet the necessary criteria for patient safety and product efficacy. One of the key strengths of this standard is its clarity in outlining the requirements needed to develop and validate packaging processes. It effectively addresses the complexities involved in forming, sealing, and assembling preformed sterile barrier systems and packaging systems. By specifying these requirements, the standard helps industry professionals establish consistent and reliable packaging processes that are crucial for maintaining the sterility of medical devices for their entire shelf life. Moreover, the relevance of EN ISO 11607-2:2020/A11:2022 extends beyond just the manufacturing environment. Its applicability to health care facilities and varying contexts where medical devices are packaged ensures that a wide range of stakeholders can utilize the standard to improve their practices. This inclusivity enhances compliance with global best practices and reinforces the importance of robust packaging processes in the health care sector. While the document outlines essential requirements, it is important to note that it does not encompass all conditions related to aseptic manufacturing of medical devices. Consequently, users may need to consult additional guidelines, particularly when dealing with drug/device combinations, ensuring the complete applicability of safety standards in these contexts. Overall, EN ISO 11607-2:2020/A11:2022 is a pivotal standard that provides a strong foundation for the validation of packaging processes for terminally sterilized medical devices, making it a vital resource for industry stakeholders aiming to enhance device safety and compliance in the medical packaging landscape.
The EN ISO 11607-2:2020/A11:2022 standard presents a comprehensive framework for the development and validation of processes integral to the packaging of terminally sterilized medical devices. With its clear focus on forming, sealing, and assembly processes, this standard ensures that medical devices are packaged in a manner that maintains their sterility throughout their shelf life. One of the notable strengths of this standard is its thorough delineation of requirements that guide manufacturers, healthcare facilities, and related entities in validating their packaging processes. By specifying validation requirements, the standard emphasizes the importance of consistent and reliable sterilization, thus enhancing patient safety and device effectiveness. The detailed guidelines provided aid in minimizing risks associated with sterile barrier systems, ensuring that medical devices remain protected from contamination until they are ready for use. The relevance of EN ISO 11607-2:2020/A11:2022 cannot be overstated, especially in an industry where compliance with stringent packaging standards is essential for regulatory approval. This standard not only supports manufacturers in achieving compliance but also fosters a culture of quality assurance and continuous improvement in medical device packaging processes. Furthermore, the standard acknowledges the varied contexts in which medical devices are packaged and sterilized, making it applicable to a diverse range of environments. This adaptability reinforces its utility in the industry, as it addresses the specific needs of entities involved in the packaging of terminally sterilized devices. It is essential to note that while the EN ISO 11607-2:2020/A11:2022 standard provides a robust framework, it does not encompass all requirements for aseptically manufactured medical devices. The mention of additional necessary requirements for drug/device combinations highlights the complexity and dynamic nature of medical device packaging, requiring continued vigilance and adherence to various regulatory considerations. In summary, the EN ISO 11607-2:2020/A11:2022 standard stands out as a vital reference for professionals in the medical device packaging sector, emphasizing the importance of validation in the processes of forming, sealing, and assembling sterile barrier systems. Its comprehensive guidelines and focus on safety make it an indispensable tool for ensuring that terminally sterilized medical devices are effectively packaged and ready for safe use.
SIST EN ISO 11607-2:2020/A11:2022 문서는 최종 멸균된 의료기기를 위한 포장에 관한 표준으로, 의료기기 포장 과정의 개발 및 검증에 대한 요구사항을 명확히 규정하고 있습니다. 이 표준의 범위는 사전 형성된 멸균 장벽 시스템, 멸균 장벽 시스템 및 포장 시스템의 형성, 봉인 및 조립과 같은 프로세스를 포함합니다. 이 표준의 강점 중 하나는 포장 과정의 각 단계에 대한 상세한 검증 요구사항을 명시하고 있어, 의료기기 산업과 의료 기관에서 활용할 수 있는 실용적인 지침을 제공한다는 점입니다. 특히, 멸균 장벽 시스템이 가진 안전성과 신뢰성을 보장하기 위해 필요한 검증 절차를 포괄적으로 포함하고 있어, 제조 및 포장 공정에서의 일관성과 품질 유지를 지원합니다. 또한, SIST EN ISO 11607-2:2020/A11:2022는 의료기기를 포장하고 멸균하는 모든 분야에 적용 가능하다는 점에서 매우 중요합니다. 이는 건강 관리 시설이나 산업 전반에서 포장 및 멸균 프로세스의 일관성을 보장하며, 환자 안전과 제품 품질을 높이는 데 기여합니다. 하지만 이 표준은 무균적으로 제조된 의료기기에 대한 모든 요구사항을 포괄하지 않기 때문에, 약물-장치 조합과 같은 특정 경우에는 추가 요구사항이 필요할 수 있음을 염두에 두어야 합니다. 결론적으로, EN ISO 11607-2:2020/A11:2022는 의료기기의 포장 및 멸균 과정에 대한 체계적이고 포괄적인 요구사항을 제공함으로써, 산업 표준으로서의 큰 의의와 실용성을 갖추고 있습니다. 이러한 표준이 의료기기 포장 산업의 품질 관리 및 안전성 증진에 기여할 것으로 기대됩니다.
標準SIST EN ISO 11607-2:2020/A11:2022は、終末滅菌された医療機器の包装に関する重要なガイドラインを提供しています。このドキュメントは、医療機器の包装に関するプロセスの開発および検証の要件を明確に示しており、特に形成、シーリング、アセンブリプロセスに焦点を当てています。 この標準の強みは、滅菌された医療機器のパッケージングに関連する製造工程の各段階が適切に管理されることを保証する点にあります。特に、事前に形成された滅菌バリアシステムや包装システムに対する要求事項が詳細に述べられており、業界および医療施設において高い適用性を示しています。医療機器が安全に包装および滅菌されることを意識した設計が求められるため、多くのビジネスにとって不可欠な標準となっています。 また、SIST EN ISO 11607-2は、滅菌プロセスと直接関連する工程のバリデーション要件を明確にしているため、医療機器の品質管理に寄与します。この標準は医療機器の包装に携わる全ての関係者にとって実用的であり、業界全体の基準を引き上げる役割を果たすでしょう。 ただし、この標準は無菌製造された医療機器の包装に関する全ての要件を網羅しているわけではなく、薬物とデバイスの組み合わせに対しては追加の要件が必要となる場合があります。この点を考慮することで、医療機器業界全体におけるパッケージングプロセスの向上への取り組みが進むことでしょう。 総じて、SIST EN ISO 11607-2:2020/A11:2022は、終末滅菌された医療機器の包装におけるプロセスの標準化を促進するための重要なリソースであり、関連する利害関係者にとって非常に重要です。
La norme EN ISO 11607-2:2020/A11:2022 établit des exigences claires pour le développement et la validation des processus de conditionnement des dispositifs médicaux destinés à être stérilisés terminalement. Son champ d'application couvre l'ensemble des méthodes de formage, de scellement et d'assemblage des systèmes de barrières stériles préformées, des systèmes de barrières stériles et des systèmes d'emballage, ce qui en fait un document essentiel pour l'industrie ainsi que pour les établissements de santé. Une des forces majeures de cette norme réside dans son approche structurée et détaillée, qui permet de garantir que les processus de conditionnement respectent des critères de qualité élevés. Cela assure non seulement la sécurité et l'efficacité des dispositifs médicaux, mais renforce également la confiance des utilisateurs et des professionnels de santé dans les produits emballés. De plus, elle est pertinente non seulement pour les dispositifs médicaux individuels, mais aussi pour l'ensemble des installations où ces produits sont emballés et stérilisés, établissant ainsi une cohérence au niveau des pratiques de conditionnement en milieu clinique et industriel. Il convient également de noter que cette norme ne couvre pas tous les aspects liés à l'emballage des dispositifs médicaux fabriqués en mode aseptique, ce qui peut nécessiter l'application de réglementations et de recommandations supplémentaires pour les combinaisons médicament/dispositif. Cette spécificité souligne l'importance d'une compréhension approfondie des exigences annexes qui pourraient s'appliquer en fonction des types de dispositifs médicaux et des méthodes de fabrication utilisées. Dans l'ensemble, la norme EN ISO 11607-2:2020/A11:2022 est une référence essentielle pour toutes les parties prenantes impliquées dans le conditionnement de dispositifs médicaux stérilisés terminalement, fournissant un cadre robuste pour la validation des processus essentiels à la sécurité et à l'efficacité des soins de santé modernes.
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