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DIN ISO/TS 11135-2:2010-01

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1
Superseded date

10-01-2014

Published date

01-12-2013

Vorwort
Einleitung
1 Anwendungsbereich
2 Normative Verweisungen
3 Begriffe
4 Qualitätsmanagementsysteme
5 Charakterisierung des sterilisierenden Agens
6 Charakterisierung von Verfahren und Ausrüstung
7 Produktdefinition
8 Verfahrensdefinition
9 Validierung
10 Routineüberwachung und Kontrolle
11 Produktfreigabe nach der Sterilisation
12 Aufrechterhaltung der Wirksamkeit des Verfahrens
Anhang A (informativ) Leitfaden zu ISO 11135-1:2007,
         Anhang A - Bestimmung der keimabtötenden
         Wirkung des Prozesses - Verfahren mit biologischen
         Indikatoren und der Keimbelastung
Anhang B (informativ) Leitfaden zu ISO 11135-1:2007,
         Anhang B - Konservative Bestimmung der keimabtötenden
         Wirkung des Prozesses - Keimabtötung über das übliche
         Mass hinaus ('Overkill')
Literaturhinweise

This standard is included in DIN HDBK 263.

DocumentType
Standard
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Superseded
SupersededBy

Standards Relationship
ISO/TS 11135-2:2008 Identical

DIN HDBK 263 : 4ED 2014
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DIN EN ISO 15882:2008-12 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
DIN EN ISO 10451:2010-11 Dentistry - Contents of technical file for dental implant systems (ISO 10451:2010)
DIN EN ISO 11737-2:2010-04 STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS

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