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UNE-EN ISO 11138-1:2017

Current
Current

The latest, up-to-date edition.

Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017)
Available format(s)

Hardcopy , PDF

Language(s)

Spanish, Castilian, English

Published date

11-08-2017

Committee
CTN 111
DevelopmentNote
Supersedes UNE EN 866-1. (05/2007)
DocumentType
Standard
Pages
56
PublisherName
Asociacion Espanola de Normalizacion
Status
Current
Supersedes

ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
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 11140-1:2014 Sterilization of health care products Chemical indicators Part 1: General requirements
ISO 18472:2006 Sterilization of health care products Biological and chemical indicators Test equipment
ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
ISO/TS 11139:2006 Sterilization of health care products Vocabulary
ISO 14161:2009 Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
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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