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DIN EN 868-8:2009-09

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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Withdrawn date

03-02-2019

Language(s)

English

Published date

01-01-2009

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

This standard is included in DIN Handbook 263 and 265.

DevelopmentNote
Supersedes DIN 58952-1. (09/1999) DRAFT 2017 issued in August 2017. (08/2017)
DocumentType
Standard
Pages
21
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Withdrawn
Supersedes

Standards Relationship
I.S. EN 868-8:2009 Identical
UNI EN 868-8 : 2009 Identical
ONORM EN 868-8 : 2009 Identical
SN EN 868-8 : 2009 Identical
BS EN 868-8:2009 Identical
NBN EN 868-8 : 2009 Identical
NF EN 868-8 : 2009 Identical
NS EN 868-8 : 2009 Identical
UNE-EN 868-8:2009 Identical
NEN EN 868-8 : 2009 Identical
EN 868-8:2009 Identical

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

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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