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Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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
Hardcopy , PDF
02-03-2019
English
01-01-2009
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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Withdrawn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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