EN 868-1:1997

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
• ICS: 11.080 - Sterilization and disinfection
• ICS: 55.040 - Packaging materials and accessories
• 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
• Directive: 90/385/EEC - 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
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
• Ref Project: SIST EN 868-1:2000 - Packaging materials and systems for medical devices which are to be sterilized - Part 1: General requirements and test methods

Relations

• Replaced By: EN ISO 11607-1:2006 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)
• Effective Date: 22-Dec-2008
• Child: EN 868-2:1999 - Packaging materials and systems for medical devices which are to be sterilized - Part 2: Sterilization wrap - Requirements and test methods
• Effective Date: 22-Dec-2008
• Child: EN 868-4:1999 - Packaging materials and systems for medical devices which are to be sterilized - Part 4: Paper bags - Requirements and test methods
• Effective Date: 22-Dec-2008
• Child: EN 868-3:1999 - Packaging materials and systems for medical devices which are to be sterilized - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods
• Effective Date: 22-Dec-2008
• Child: EN 868-5:1999 - Packaging materials and systems for medical devices which are to be sterilized - Part 5: Heat and self-sealable pouches and reels of paper and plastic film construction - Requirements and test methods
• Effective Date: 22-Dec-2008
• Child: EN 868-7:1999 - Packaging materials and systems for medical devices which are to be sterilized - Part 7: Adhesive coated paper for the manufacture of heat sealable packs for medical use for sterilization by ethylene oxide or irradiation - Requirements and test methods
• Effective Date: 22-Dec-2008
• Child: EN 868-6:1999 - Packaging materials and systems for medical devices which are to be sterilized - Part 6: Paper for the manufacture of packs for medical use for sterilization by ethylene oxide or irradiation - Requirements and test methods
• Effective Date: 22-Dec-2008
• Child: EN 868-8:1999 - Packaging materials and systems for medical devices which are to be sterilized - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
• Effective Date: 22-Dec-2008

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
...