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UNE-EN ISO 14161:2010

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2009)

Available format(s)

Hardcopy , PDF

Language(s)

Spanish, Castilian, English

Published date

05-05-2010

Superseded date

12-02-2020

£110.97
Excluding VAT

Committee
CTN 111
DocumentType
Standard
Pages
76
PublisherName
Asociación Española de Normalización
Status
Superseded

ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
ISO 19011:2011 Guidelines for auditing management systems
ISO 11138-3:2017 Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes
EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
ISO 11737-2:2009 Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
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
AAMI TIR31 : 2008 PROCESS CHALLENGE DEVICES/TEST PACKS FOR USE IN HEALTH CARE FACILITIES
ISO 11138-2:2017 Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
ISO/IEC 17011:2004 Conformity assessment — General requirements for accreditation bodies accrediting conformity assessment bodies
ISO 11135-1:2007 Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 18472:2006 Sterilization of health care products — Biological and chemical indicators — Test equipment
ISO 20857:2010 Sterilization of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO/TS 11139:2006 Sterilization of health care products — Vocabulary
ISO 9001:2015 Quality management systems — Requirements
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
ISO/IEC Guide 2:2004 Standardization and related activities — General vocabulary
ISO 11138-1:2017 Sterilization of health care products — Biological indicators — Part 1: General requirements
ISO 11138-4:2017 Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes
ISO 11138-5:2017 Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
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

£110.97
Excluding VAT