Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

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Hardcopy , PDF

Language(s)

Spanish, Castilian, English

Published date

28-12-2011

Publisher

Asociación Española de Normalización

€82.80

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Committee	CTN 111
DevelopmentNote	Supersedes UNE EN 13824. (01/2012)
DocumentType	Standard
Pages	26
PublisherName	Asociación Española de Normalización
Status	Current

ISO 13408-4:2005	Aseptic processing of health care products — Part 4: Clean-in-place technologies
ISO 14937:2009	Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 13408-1:2008	Aseptic processing of health care products — Part 1: General requirements
ISO/TS 11139:2006	Sterilization of health care products — Vocabulary
CFR 21(PTS1-99) : 0	FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 1-99
ISO 9000:2015	Quality management systems — Fundamentals and vocabulary
ISO/IEC 90003:2014	Software engineering — Guidelines for the application of ISO 9001:2008 to computer software
ISO 14161:2009	Sterilization of health care products — Biological indicators — Guidance for the selection, use and interpretation of results
ISO 17665-1:2006	Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

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UNE-EN ISO 13408-5:2011