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DIN EN ISO 11135-1:2007-08

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
Available format(s)

Hardcopy , PDF

Superseded date

10-01-2014

Language(s)

English

Published date

01-01-2007

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

Vorwort
Einleitung
1 Anwendungsbereich
2 Normative Verweisungen
3 Begriffe
4 Qualitätsmanagementsysteme
   4.1 Dokumentation
   4.2 Verantwortlichkeit der Leitung
   4.3 Produktrealisierung
   4.4 Messung, Analyse und Verbesserung - Lenkung
       fehlerhafter Produkte
5 Charakterisierung des sterilisierenden Agens
   5.1 Sterilisierendes Agens
   5.2 Keimabtötende Wirkung
   5.3 Auswirkungen auf Materialien
   5.4 Überlegungen zur Umwelt
6 Charakterisierung von Verfahren und Ausrüstung
   6.1 Charakterisierung des Verfahrens
   6.2 Charakterisierung der Ausrüstung
7 Produktdefinition
   7.1 Allgemeines
   7.2 Produktsicherheit und Produktleistung
   7.3 Mikrobiologische Qualität
   7.4 Dokumentation
8 Verfahrensdefinition
9 Validierung
   9.1 Abnahmebeurteilung
   9.2 Funktionsbeurteilung
   9.3 Leistungsbeurteilung
   9.4 Wechselnde Konfigurationen der Beladung
   9.5 Überprüfung und Bestätigung der Validierung
10 Lenkung der Anwendung und Kontrolle
11 Produktfreigabe nach der Sterilisation
12 Aufrechterhaltung der Wirksamkeit des Verfahrens
   12.1 Allgemeines
   12.2 Instandhaltung der Ausrüstung
   12.3 Erneute Beurteilung
   12.4 Beurteilung von Veränderungen
Anhang A (normativ) Bestimmung der keimabtötenden
                       Wirkung des Prozesses - Verfahren mit
                       biologischen Indikatoren und der
                       Keimbelastung
Anhang B (normativ) Konservative Bestimmung der keimabtötenden
                       Wirkung des Prozesses - Keimabtötung
                       über das übliche Mass hinaus ('Overkill')
Anhang C (informativ) Allgemeiner Leitfaden
Literaturhinweise
Anhang ZA (informativ) Zusammenhang zwischen dieser
                       Europäischen Norm und den
                       grundlegenden Anforderungen der
                       EG 93/42/EWG über Medizinprodukte

This standard is included in DIN Handbook 169, 267/2, 268 and 263. Describes requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices.

DevelopmentNote
Supersedes DIN EN ISO 11135 issue 08-2004. (01/2006) Supersedes DIN 58948-6, DIN EN 550. (08/2007)
DocumentType
Standard
Pages
49
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Superseded
SupersededBy
Supersedes

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