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  • DIN EN 868-8:2009-09

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 8: RE-USABLE STERILIZATION CONTAINERS FOR STEAM STERILIZERS CONFORMING TO EN 285 - REQUIREMENTS AND TEST METHODS

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  02-03-2019

    Language(s):  English

    Published date:  01-01-2009

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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    Table of Contents - (Show below) - (Hide below)

    Vorwort
    Einleitung
    1 Anwendungsbereich
    2 Normative Verweisungen
    3 Begriffe
    4 Anforderungen
      4.1 Allgemeines
      4.2 Anforderungen an die Konstruktion
          und Ausführung
          4.2.1 Form und Masse
          4.2.2 Deckel und Deckelverriegelungen
          4.2.3 Sicherheits-Anzeigesystem
          4.2.4 Dichtung
          4.2.5 Tragevorrichtung
          4.2.6 Stapelfähigkeit
          4.2.7 Durchlass für das Sterilisiermittel
          4.2.8 Beladung
      4.3 Nutzungsdauer
      4.4 Anforderungen an die Werkstoffe
      4.5 Kennzeichnung
    5 Vom Hersteller bereitzustellende Informationen
    6 Prüfverfahren
    Anhang A (informativ) Angaben über wesentliche
             technische Änderungen zwischen dieser
             Europäischen Norm und der Vorgängerausgabe
    Anhang B (informativ) Leitfaden zu Abmessungen
    Anhang C (normativ) Belastbarkeitsprüfung der
             Tragevorrichtung
    Anhang D (normativ) Stapeldruckprüfung
    Anhang E (normativ) Prüfung der Stapelbarkeit
    Anhang F (normativ) Bestimmung der Sterilisierleistung
    Anhang G (normativ) Prüfung der Trockenheit
             der Beladung
    Anhang H (informativ) Anleitung zur Bestimmung
             der Lebensdauer
    Literaturhinweise

    Abstract - (Show below) - (Hide below)

    This standard is included in DIN Handbook 263 and 265.

    General Product Information - (Show below) - (Hide below)

    Development Note Supersedes DIN 58952-1. (09/1999) DRAFT 2017 issued in August 2017. (08/2017)
    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Withdrawn
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    DIN 58946-6:2002-04 STERILIZATION - STEAM STERILIZERS - PART 6: OPERATING OF LARGE STERILIZERS IN HEALTH CARE FACILITIES
    DIN HDBK 265 : 2ED 2012 STERILISATION VON MEDIZINPRODUKTEN - INDIKATOREN UND VERPACKUNGEN FUER IN DER ENDVERPACKUNG ZU STERILISIERENDE MEDIZINPRODUKTE

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
    ISO 4017:2014 Fasteners Hexagon head screws Product grades A and B
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 4582:2017 Plastics — Determination of changes in colour and variations in properties after exposure to glass-filtered solar radiation, natural weathering or laboratory radiation sources
    EN ISO 4017:2014 Fasteners - Hexagon head screws - Product grades A and B (ISO 4017:2014)
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    EN 10088-1:2014 Stainless steels - Part 1: List of stainless steels
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