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BS EN ISO 11135-1:2007

Standard Number
BS EN ISO 11135-1:2007
Title
Sterilization of health care products. Ethylene oxideRequirements for development, validation and routine control of a sterilization process for medical devices
Status
Current, Work in hand
Publication Date
29 June 2007
Cross References
ISO 10012, ISO 10993-1, ISO 10993-7, ISO 11138-1:2006, ISO 11138-2:2006, ISO 11140-1, ISO 11737-1, ISO 11737-2, ISO 13485:2003, ISO 14161, ISO 14937:2000, ISO 9000:2005, ISO 9001, ISO/TS 11139:2006, ISO 11607-1, ISO 11607-2, ISO 14001, ISO 14040, ISO 14971, ISO 17664, ISO 22442-1, ISO 22442-2, ISO 22442-3, ISO/IEC 90003, IEC 61010-1, IEC 61010-2-040, ANSI/AAMI ST67, AAMI TIR16, 94/9/EC, EN 556-1, VIM:1993, 90/385/EEC, 93/42/EEC, 98/79/EEC
Replaces
BS EN 550:1994

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Descriptors
Medical equipment, Sterilization (hygiene), Ethylene oxide, Hygiene, Medical instruments, Sterile equipment, Performance, Performance testing, Quality control, Maintenance, Acceptance (approval), Verification, Microbiological analysis, Instructions for use, Personnel, Sterilizers, Management
Title in French
Strilisation des produits de sant. Oxyde dthylne. Exigences de dveloppement, de validation et de contrle de routine dun processus de strilisation pour des dispositifs mdicaux
Title in German
Sterilisation von Produkten fr die Gesundheitsfrsorge. Ethylenoxid. Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens fr Medizinprodukte
Pages
54
File Size
791.3 KB
Price
196.00

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