EN 868-1:1997
(Main)Packaging materials and systems for medical devices which are to be sterilized - Part 1: General requirements and test methods
Packaging materials and systems for medical devices which are to be sterilized - Part 1: General requirements and test methods
1.1 This European Standard specifies the requirements and test methods for packaging materials and systems: - which are used for packaging of medical devices which are to be terminally sterilized; and - which are intended to maintain sterility of the device. NOTE 1: This standard has been developed as a means to show compliance with relevant European Directives. If health care facilities e. g. hospitals do not place medical devices on the market, they are not covered by these Directives. Nevertheless, such health care facilities can fulfil the same requirements as manufacturers but can use alternative means to demonstrate conformity to this standard. NOTE 2: Compliance with other Parts of prEN 868 series can be used to demonstrate compliance with one or more of the requirements of this standard. 1.2 This standard does not apply to packaging materials and systems used for packaging aseptically manufactured products. 1.3 This European Standard does not describe a quality assurance system for control of all stages of manufacture. NOTE: Attention is drawn to the standards for quality systems (see e. g. EN ISO 9001, EN ISO 9002, EN 46001 or EN 46002) which control all stages of manufacture including the sterilization process. It is not a requirement of this standard to have a complete quality system during manufacture but certain elements of such a system can be applied.
Verpackungsmaterialien und -systeme für zu sterilisierende Medizinprodukte - Teil 1: Allgemeine Anforderungen und Prüfverfahren
Diese Europäische Norm legt die allgemeinen Anforderungen und Prüfverfahren für Verpackungsmaterialien und -systeme fest, - die als Verpackung für Medizinprodukte dienen, welche in der Endpackung sterilisiert werden sollen und - die das Produkt steril erhalten sollen. Anmerkung 1: Diese Norm wurde als ein Nachweismittel für die Einhaltung von relevanten Europäischen Richtlinien entwickelt. Wenn Einrichtungen der Gesundheitsfürsorge, z.B. Krankenhäuser, keine Medizinprodukte inverkehrbringen, fallen sie nicht unter diese Richtlinien.
Matériaux et systèmes d'emballages pour les dispositifs médicaux devant être stérilisés - Partie 1: Exigences générales et méthodes d'essai
La présente norme européenne spécifie les exigences ainsi que les méthodes d'essai relatives aux matériaux et systèmes d'emballage: - utilisés pour emballer les dispositifs médicaux stérilisés au stade terminal, et - destinés à maintenir la stérilité du dispositif médical. Note 1: La présente norme européenne a été élaborée à pouvoir être utilisée pour établir la conformité avec les directives européennes concernées. Les établissements de soins médicaux, comme par exemple les hôpitaux, qui ne mettent pas de dispositifs médicaux sur le marché, ne sont pas concernés par ces Directives.
Embalažni materiali in sistemi za medicinske pripomočke, ki jih je treba sterilizirati - 1. del: Splošne zahteve in preskusne metode
General Information
- Status
- Withdrawn
- Publication Date
- 18-Feb-1997
- Withdrawal Date
- 14-Apr-2006
- Technical Committee
- CEN/TC 102 - Sterilizers for medical purposes
- Drafting Committee
- CEN/TC 102/WG 4 - Packaging materials
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 15-Apr-2006
- Completion Date
- 15-Apr-2006
Relations
- Effective Date
- 22-Dec-2008
- Effective Date
- 22-Dec-2008
- Effective Date
- 22-Dec-2008
- Effective Date
- 22-Dec-2008
- Effective Date
- 22-Dec-2008
- Effective Date
- 22-Dec-2008
- Effective Date
- 22-Dec-2008
- Effective Date
- 22-Dec-2008
Frequently Asked Questions
EN 868-1:1997 is a standard published by the European Committee for Standardization (CEN). Its full title is "Packaging materials and systems for medical devices which are to be sterilized - Part 1: General requirements and test methods". This standard covers: 1.1 This European Standard specifies the requirements and test methods for packaging materials and systems: - which are used for packaging of medical devices which are to be terminally sterilized; and - which are intended to maintain sterility of the device. NOTE 1: This standard has been developed as a means to show compliance with relevant European Directives. If health care facilities e. g. hospitals do not place medical devices on the market, they are not covered by these Directives. Nevertheless, such health care facilities can fulfil the same requirements as manufacturers but can use alternative means to demonstrate conformity to this standard. NOTE 2: Compliance with other Parts of prEN 868 series can be used to demonstrate compliance with one or more of the requirements of this standard. 1.2 This standard does not apply to packaging materials and systems used for packaging aseptically manufactured products. 1.3 This European Standard does not describe a quality assurance system for control of all stages of manufacture. NOTE: Attention is drawn to the standards for quality systems (see e. g. EN ISO 9001, EN ISO 9002, EN 46001 or EN 46002) which control all stages of manufacture including the sterilization process. It is not a requirement of this standard to have a complete quality system during manufacture but certain elements of such a system can be applied.
1.1 This European Standard specifies the requirements and test methods for packaging materials and systems: - which are used for packaging of medical devices which are to be terminally sterilized; and - which are intended to maintain sterility of the device. NOTE 1: This standard has been developed as a means to show compliance with relevant European Directives. If health care facilities e. g. hospitals do not place medical devices on the market, they are not covered by these Directives. Nevertheless, such health care facilities can fulfil the same requirements as manufacturers but can use alternative means to demonstrate conformity to this standard. NOTE 2: Compliance with other Parts of prEN 868 series can be used to demonstrate compliance with one or more of the requirements of this standard. 1.2 This standard does not apply to packaging materials and systems used for packaging aseptically manufactured products. 1.3 This European Standard does not describe a quality assurance system for control of all stages of manufacture. NOTE: Attention is drawn to the standards for quality systems (see e. g. EN ISO 9001, EN ISO 9002, EN 46001 or EN 46002) which control all stages of manufacture including the sterilization process. It is not a requirement of this standard to have a complete quality system during manufacture but certain elements of such a system can be applied.
EN 868-1:1997 is classified under the following ICS (International Classification for Standards) categories: 11.080 - Sterilization and disinfection; 55.040 - Packaging materials and accessories. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 868-1:1997 has the following relationships with other standards: It is inter standard links to EN ISO 11607-1:2006; is excused to EN 868-7:1999, EN 868-2:1999, EN 868-6:1999, EN 868-8:1999, EN 868-5:1999, EN 868-4:1999, EN 868-3:1999. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 868-1:1997 is associated with the following European legislation: EU Directives/Regulations: 90/385/EEC, 93/42/EEC; Standardization Mandates: M/BC/CEN/89/9. 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)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Verpackungsmaterialien und -systeme für zu sterilisierende Medizinprodukte - Teil 1: Allgemeine Anforderungen und PrüfverfahrenMatériaux et systemes d'emballages pour les dispositifs médicaux devant etre stérilisés - Partie 1: Exigences générales et méthodes d'essaiPackaging materials and systems for medical devices which are to be sterilized - Part 1: General requirements and test methods11.080.30Sterilizirana embalažaSterilized packagingICS:Ta slovenski standard je
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기사 제목: EN 868-1:1997 - 의료기기를 살균하기 위한 포장 재료 및 시스템에 대한 일반 요구사항 및 시험 방법 기사 내용: 이 유럽표준은 의료기기를 종결적으로 살균하기 위해 사용되는 포장 재료와 시스템에 대한 요구사항과 시험 방법을 명시합니다. 이는 의료기기의 멸균 상태를 유지하는 데에 목적을 두고 있습니다. 참고 1: 이 표준은 관련 유럽 지침을 준수하기 위한 수단으로 개발되었습니다. 의료 시설(병원 등)이 의료기기를 시장에 출시하지 않는 경우, 해당 지침의 적용 대상이 아닙니다. 그러나 이러한 의료 시설은 제조업체와 동일한 요구사항을 충족시킬 수 있으며, 이 표준과 일치성을 검증하기 위해 대체 수단을 사용할 수 있습니다. 참고 2: prEN 868 시리즈의 다른 부분을 준수하는 경우, 이 표준의 하나 이상의 요구사항을 충족시킬 수 있습니다. 본 유럽표준은 무균으로 제조된 제품의 포장 재료와 시스템에는 적용되지 않습니다. 또한, 이 유럽표준은 제조 과정의 모든 단계를 통제하기 위한 품질 보증 시스템에 대해 기술하지 않습니다. 그러나 제조과정을 포함하여 살균 과정을 포함한 모든 단계의 품질 보증 시스템에 대한 표준(예: EN ISO 9001, EN ISO 9002, EN 46001 또는 EN 46002)에 주의를 기울여야 합니다. 이 표준은 제조 중 완전한 품질 시스템을 요구하지 않지만, 일부 요소들은 적용될 수 있습니다.
記事のタイトル：EN 868-1:1997 - 医療機器の滅菌を目的とした包装材料およびシステムに関する一般的要件と試験方法 記事の内容：このヨーロッパ標準は、滅菌が必要な医療機器の包装材料およびシステムに関する要件と試験方法を規定しています。この標準は、医療機器の滅菌効果を維持することを目的としています。 注1：この標準は、関連するヨーロッパ指令の適合性を示す手段として開発されました。医療施設（例：病院）が医療機器を市場に提供しない場合、この指令の対象外となりますが、同様の要件を満たすことができ、この標準への適合性を示す代替手段を使用することができます。 注2：prEN 868シリーズの他の部分を適合することで、この標準の1つまたは複数の要件に適合したことを示すことができます。 このヨーロッパ標準は、無菌に製造された製品の包装材料およびシステムには適用されません。 さらに、このヨーロッパ標準では、製造全般の品質保証システムについては記述されていません。ただし、製造過程全体、滅菌プロセスを含む品質保証システムのための標準（例：EN ISO 9001、EN ISO 9002、EN 46001またはEN 46002）に注意を払う必要があります。この標準では製造過程全体の完全な品質保証システムを要求していませんが、一部の要素を適用することができます。
EN 868-1:1997 is a European Standard that provides requirements and test methods for packaging materials and systems used for medical devices that need to be sterilized. The standard aims to maintain the sterility of the device. It is important to note that this standard is applicable only for medical devices that are intended to be placed on the market. Health care facilities that do not place medical devices on the market can still meet the same requirements as manufacturers but may use alternative means to demonstrate conformity to the standard. It is also mentioned that compliance with other Parts of the prEN 868 series can be used to demonstrate compliance with this standard. It is stated that this standard does not apply to packaging materials and systems used for aseptically manufactured products. Additionally, this European Standard does not describe a quality assurance system for controlling all stages of manufacture. However, reference is made to other standards for quality systems such as EN ISO 9001, EN ISO 9002, EN 46001, or EN 46002, which control all stages of manufacture including the sterilization process. Although not required, certain elements of a quality system can be applied during manufacture.
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