EN ISO 11607-1:2020/A11:2022
(Amendment)Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
This document specifies 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.
It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized.
It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
It does not describe a quality assurance system for control of all stages of manufacture.
It 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.
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 1: Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme (ISO 11607-1:2019/A11:2020)
Dieses Dokument legt Anforderungen an und Prüfverfahren für Materialien, vorgefertigte Sterilbarrieresysteme, Sterilbarrieresysteme und Verpackungssysteme fest, die dazu vorgesehen sind, die Sterilität von in der Endverpackung sterilisierten Medizinprodukten bis zum Anwendungszeitpunkt zu erhalten.
Es gilt für die Industrie, für Einrichtungen des Gesundheitswesens und für alle anderen Einrichtungen, in denen Medizinprodukte in Sterilbarrieresysteme verpackt und sterilisiert werden.
Es erfasst nicht alle Anforderungen an Sterilbarrieresysteme und Verpackungssysteme für aseptisch hergestellte Medizinprodukte. Für Kombinationen von Medikamenten und Medizinprodukten können zusätzliche Anforderungen erforderlich sein.
Es beschreibt kein Qualitätssicherungssystem zur Lenkung aller Herstellungsschritte.
Es gilt nicht für Verpackungsmaterialien und/oder systeme, die dazu verwendet werden, ein verunreinigtes Medizinprodukt während des Transports zur Wiederaufbereitung oder Entsorgung aufzunehmen.
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
Le présent document spécifie les exigences et les méthodes d'essai pour les matériaux, les systèmes de barrière stérile préformés, les systèmes de barrière stérile et les systèmes d'emballage destinés à maintenir l'état de stérilité des dispositifs médicaux stérilisés de façon terminale jusqu'au point d'utilisation.
Il s'applique à l'industrie, aux établissements de santé et à tout lieu où des dispositifs médicaux sont insérés dans des systèmes de barrière stérile et stérilisés.
Il ne couvre pas toutes les exigences relatives aux systèmes de barrière stérile et systèmes d'emballage pour les dispositifs médicaux fabriqués de manière aseptique. Dans ce cas, des exigences supplémentaires peuvent être nécessaires pour garantir les combinaisons médicaments/dispositifs.
Il ne décrit pas de système d'assurance qualité pour le contrôle de toutes les étapes de fabrication.
Il ne s'applique pas aux matériaux d'emballage et/ou systèmes utilisés pour contenir un dispositif médical contaminé pendant le transport du dispositif vers le site de retraitement ou d'élimination.
Embalaža za končno sterilizirane medicinske pripomočke - 1. del: Zahteve za materiale, sterilne pregradne sisteme in sisteme embalaže - Dopolnilo A11 (ISO 11607-1:2019)
Ta dokument določa zahteve in preskusne metode za materiale, izvedene sterilne pregradne sisteme, sterilne pregradne sisteme in sisteme embalaže, ki so namenjeni za vzdrževanje sterilnosti končno steriliziranih medicinskih pripomočkov do njihove uporabe. Uporablja se za industrijo, zdravstvene ustanove in vse medicinske pripomočke, ki so sterilizirani v sterilnih pregradnih sistemih. Ne zajema vseh zahtev za sterilne pregradne sisteme in sisteme embalaže medicinskih pripomočkov, ki so izdelani aseptično. Za kombinacije zdravil/pripomočkov so morda potrebne dodatne zahteve. Ne opisuje sistema zagotavljanja kakovosti za nadzor vseh faz proizvodnje. Ne uporablja se za embalažo in/ali sisteme, ki se uporabljajo za hrambo kontaminiranega medicinskega pripomočka med prevozom elementa na mesto predelave ali odstranjevanja.
General Information
Relations
Overview
EN ISO 11607-1:2020/A11:2022 is an essential European standard developed by CEN, focusing on packaging requirements for terminally sterilized medical devices. This document specifies mandatory requirements and test methods related to materials, sterile barrier systems, and packaging systems designed to maintain the sterility of medical devices from sterilization until the point of use. As an amendment to EN ISO 11607-1:2020, it supports the safe handling and integrity of sterile packaging in healthcare and manufacturing environments.
The standard applies across the medical device industry, healthcare facilities, and any contexts where medical devices are packaged into sterile barrier systems and sterilized. However, it explicitly excludes requirements for aseptically manufactured devices and contaminated device packaging used during transport to reprocessing or disposal facilities.
Key Topics
- Materials and Sterile Barrier Systems: Specifies stringent requirements for selecting appropriate materials that form effective sterile barriers essential for preserving sterility throughout the product lifecycle.
- Packaging Systems: Defines packaging design criteria ensuring protection from microbial contamination, physical damage, and environmental factors.
- Test Methods and Validation: Details methods to verify packaging integrity, microbial barrier performance, and sterile barrier system stability. These help validate that packaging meets sterilization and usability requirements.
- Aseptic Presentation: Includes evaluation methods for packaging usability and aseptic presentation to minimize contamination risks during handling at the point of use.
- Compliance with EU Directives: Provides a framework linking packaging requirements to relevant European Directives for medical devices (93/42/EEC, 90/385/EEC, 98/79/EC), facilitating regulatory conformity and market access.
Applications
EN ISO 11607-1:2020/A11:2022 serves numerous vital applications in the medical device and healthcare sectors:
- Medical Device Manufacturing: Ensures that sterile packaging materials and systems meet quality and safety standards to maintain device sterility until use.
- Healthcare Facilities: Supports sterilization and packaging processes implemented at hospitals and clinics, protecting patients by minimizing infection risks.
- Regulatory Compliance: Enables manufacturers and distributors to demonstrate conformity with EU medical device regulations through standardized testing and documentation.
- Packaging Design and Validation: Assists in designing compliant sterile barrier systems and validates packaging processes including forming, sealing, and assembly (in conjunction with ISO 11607-2).
- Risk Management: Integrates with risk management procedures to reduce contamination and handling risks ‘to a minimum’, in accordance with European directives.
Related Standards
- EN ISO 11607-2:2020: Covers validation requirements for packaging process steps such as forming, sealing, and assembly, complementing the material and system requirements of EN ISO 11607-1.
- ISO 5636-5:2013: Referenced for testing of paper and board materials used in sterile packaging.
- Relevant EU Medical Device Directives:
- Directive 93/42/EEC (Medical Devices)
- Directive 90/385/EEC (Active Implantable Medical Devices)
- Directive 98/79/EC (In Vitro Diagnostic Medical Devices)
Compliance with EN ISO 11607-1:2020/A11:2022 ensures that sterile barrier packaging provides a validated microbial barrier and physical protection, meeting international quality and safety requirements vital for effective sterilization and device protection.
Keywords: EN ISO 11607-1:2020/A11:2022, sterile barrier system, medical device packaging, terminal sterilization, sterile packaging materials, packaging validation, aseptic presentation, medical device regulatory compliance, CEN standards, packaging integrity testing.
Frequently Asked Questions
EN ISO 11607-1:2020/A11:2022 is a amendment published by the European Committee for Standardization (CEN). Its full title is "Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)". This standard covers: This document specifies 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. It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized. It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations. It does not describe a quality assurance system for control of all stages of manufacture. It 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.
This document specifies 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. It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized. It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations. It does not describe a quality assurance system for control of all stages of manufacture. It 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.
EN ISO 11607-1:2020/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 11607-1:2020/A11:2022 has the following relationships with other standards: It is inter standard links to EN ISO 11607-1:2020. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 11607-1:2020/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.
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Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2022
Embalaža za končno sterilizirane medicinske pripomočke - 1. del: Zahteve za
materiale, sterilne pregradne sisteme in sisteme embalaže - Dopolnilo A11 (ISO
11607-1:2019)
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials,
sterile barrier systems and packaging systems (ISO 11607-1:2019)
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 1:
Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme (ISO
11607-1:2019/A11:2020)
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials,
sterile barrier systems and packaging systems (ISO 11607-1:2019)
Ta slovenski standard je istoveten z: EN ISO 11607-1:2020/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
1:2020/A11
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2022
ICS 11.080.30
English Version
Packaging for terminally sterilized medical devices - Part
1: Requirements for materials, sterile barrier systems and
packaging systems (ISO 11607-1:2019)
Emballages des dispositifs médicaux stérilisés au stade Verpackungen für in der Endverpackung zu
terminal - Partie 1: Exigences relatives aux matériaux, sterilisierende Medizinprodukte - Teil 1:
aux systèmes de barrière stérile et aux systèmes Anforderungen an Materialien, Sterilbarrieresysteme
d'emballage (ISO 11607-1:2019) und Verpackungssysteme (ISO 11607-1:2019)
This amendment A11 modifies the European Standard EN ISO 11607-1:2020; 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 11607-1:2020/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] (as amended) aimed to be covered . 10
European foreword
This document (EN ISO 11607-1:2020/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 11607-1:2020 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 11607-1:2020 with a revised European Foreword and European Annexes
ZA, ZB and ZC.
This Amendment to the European Standard EN ISO 11607-1:2020 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 Annexes 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, ZB or ZC', 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 as Equivalent dated standard
listed in Clause 2 of the ISO
standard EN ISO or IEC
ISO 5636-5 ISO 5636-5:2013
ISO 11607-2 EN ISO 11607-2:2020 ISO 11607-2:2019
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 relating 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
8.1 6.1.1, 6.1.2, 6.1.3, 6.1.6, 6.1.8, 7 Partially covered. E.R. 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. The
standard includes a way to
evaluate the packaging design in
terms of usability to provide
supportive evidence for easy
Essential Requirements of Clause(s)/sub-clause(s) of Remarks/Notes
Annex I of Directive this EN
93/42/EEC
handling covering the aspect of
...
記事のタイトル: EN ISO 11607-1:2020/A11:2022 - 端末滅菌医療機器の包装 - 第1部: 材料、無菌バリアシステムおよび包装システムの要件 (ISO 11607-1:2019) 記事の内容: この文書では、終末滅菌された医療機器の滅菌状態を使用時まで維持するための材料、予め形成された無菌バリアシステム、無菌バリアシステムおよび包装システムの要件と試験方法を規定しています。 これは産業や医療施設だけでなく、医療機器が無菌バリアシステムに配置されたり滅菌される場所など、あらゆる場所に適用されます。ただし、無菌的に製造される医療機器のための無菌バリアシステムおよび包装システムのすべての要件を網羅しているわけではなく、医薬品/医療機器の組み合わせには追加の要件が必要な場合があります。 また、製造のすべての段階を制御するための品質保証システムについては説明されていません。また、汚染された医療機器を再処理または廃棄場所まで輸送するために使用される包装材料やシステムには適用されません。
The article discusses EN ISO 11607-1:2020/A11:2022, which is a standard that outlines requirements for materials, sterile barrier systems, and packaging systems used for terminally sterilized medical devices. The purpose of this standard is to maintain the sterility of these devices until they are used. The standard is applicable to various industries, healthcare facilities, and any other place where medical devices are stored in sterile barrier systems and sterilized. However, it does not cover all requirements for sterile barrier systems and packaging systems for medical devices manufactured aseptically, and additional requirements may be necessary for drug/device combinations. It also does not describe a quality assurance system for controlling all stages of manufacture, nor does it apply to packaging materials and systems used for transporting contaminated medical devices for reprocessing or disposal.
기사 제목: EN ISO 11607-1:2020/A11:2022 - 의료용 단말 살균 지원 재료에 대한 포장 - 제 1부: 재료, 살균 장벽 시스템 및 포장 시스템에 대한 요구 사항 (ISO 11607-1:2019) 기사 내용: 본 문서는 단말 살균 지원 재료, 사전 형성된 살균 장벽 시스템, 살균 장벽 시스템 및 포장 시스템의 요구 사항과 시험 방법을 규정합니다. 이러한 요구 사항은 단말 살균 지원 의료 기기의 사용 시점까지 살균 상태를 유지하기 위한 것입니다. 이 표준은 산업과 의료 시설뿐만 아니라 의료기기가 살균 장벽 시스템에 넣어지고 살균된 곳과 같은 모든 장소에 적용될 수 있습니다. 그러나 이 표준은 무균적으로 제조되는 의료 기기의 살균 장벽 시스템 및 포장 시스템에 대한 모든 요구 사항을 다루지 않으며, 약/기기 조합에 대해서는 추가 요구 사항이 필요할 수 있습니다. 또한, 이 표준은 생산의 모든 단계를 통제하기 위한 품질 보증 시스템을 설명하지 않습니다. 또한, 오염된 의료 기기를 재처리하거나 폐기처리 장소로 운반하기 위해 사용되는 포장 재료나 시스템에는 적용되지 않습니다.
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