UNE-EN ISO 14161:2010

Superseded

Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2009)

Available format(s)

Hardcopy , PDF

Superseded date

12-02-2020

Language(s)

Spanish, Castilian, English

Published date

05-05-2010

Publisher

Asociacion Espanola de Normalizacion

Committee	CTN 111
DocumentType	Standard
Pages	76
PublisherName	Asociacion Espanola de Normalizacion
Status	Superseded
SupersededBy	UNE-EN ISO 11138-7:2020
Supersedes	UNE-EN ISO 14161:2001

Standards	Relationship
SN EN ISO 14161 : 2010	Identical
BS EN ISO 14161:2009	Identical
EN ISO 14161:2009	Identical
I.S. EN ISO 14161:2009	Identical
NF EN ISO 14161 : 2009	Identical
ISO 14161:2009	Identical
NS EN ISO 14161 : 2009	Identical
UNI EN ISO 14161 : 2009	Identical
DIN EN ISO 14161:2010-03	Identical
NBN EN ISO 14161 : 2009	Identical
NEN EN ISO 14161 : 2009	Identical

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