DIN ISO/TS 11135-2:2010-01
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1
10-01-2014
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Superseded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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