BS EN ISO 11137-1:2006+A1:2013

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BS EN ISO 11137-1:2006+A1:2013

Standard Number
BS EN ISO 11137-1:2006+A1:2013
Title
Sterilization of health care products. RadiationRequirements for development, validation and routine control of a sterilization process for medical devices
Status
Current
Publication Date
31 August 2006
Cross References
ISO 10012-1, ISO 11137-2, ISO 11737-1, ISO 11737-2, ISO 13485:2003, ISO 9000:2005, ISO 9001:2000, ISO 10993-1:2003, ISO 11137:1995, ISO 11137-3:2006, ISO/TS 11139:2006, ISO 11607-1, ISO 11607-2, ISO 14001:2004, ISO 14040:1997, VIM:1993, ISO 22442-1, ISO 22442-2, ISO 22442-3, EN 556-1:2001, AAMI TIR17:1997, ANSI/AAMI ST67:2003, ANSI/HGB N43.10-2001
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Descriptors
Medical equipment, Sterilization (hygiene), Radiation, Ionizing radiation, Gamma-radiation, Electron beams, X-rays, Radiation measurement, Verification, Quality control, Quality assurance, Medical technology, Process specification, Documents, Records (documents), Calibration, Maintenance, Medical instruments
Title in French
Sterilisation des produits de sante. Irradiation. Exigences relatives a la mise au point, a la validation et au controle de routine dun procede de sterilisation pour les dispositifs medicaux
Title in German
Sterilisation von Produkten fuer die Gesundheitsfuersorge. Strahlen. Anforderungen an die Entwicklung, Validierung und Lenkung der Anwendung eines Sterilisationsverfahrens fuer Medizinprodukte
Pages
50
File Size
1.128 MB
Price
184.00