UNE-EN ISO 14160:2012

Superseded

Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2011)

Available format(s)

Hardcopy , PDF

Superseded date

09-01-2021

Language(s)

Spanish, Castilian, English

Published date

02-08-2012

Publisher

Asociacion Espanola de Normalizacion

Definisce requisiti per in via di sviluppo, convalidare, comando di processo E monitoraggio della sterilizzazione, utilizzando sostanza chimica liquida sterilants, di singolo uso dispositivi medici consistente (lo : uno) o l'altro Completamente o parzialmente di materiali di origine dell'animale. Non applicabile a materiale di origine umana.

Committee	CTN 111
DocumentType	Standard
Pages	46
PublisherName	Asociacion Espanola de Normalizacion
Status	Superseded
SupersededBy	UNE-EN ISO 14160:2021
Supersedes	UNE-EN ISO 14160:1998

Standards	Relationship
ONORM EN ISO 14160 : 2011	Identical
ISO 14160:2011	Identical
NF EN ISO 14160 : 2011	Identical
NBN EN ISO 14160 : 2011	Identical
NEN EN ISO 14160 : 2011	Identical
NS EN ISO 14160 : 2011	Identical
I.S. EN ISO 14160:2011	Identical
SN EN ISO 14160 : 2011	Identical
UNI EN ISO 14160 : 2011	Identical
BS EN ISO 14160:2011	Identical
EN ISO 14160:2011	Identical
DIN EN ISO 14160:2011-10	Identical

ISO 11137-1:2006	Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
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
ISO 22442-1:2015	Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
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 9004:2009	Managing for the sustained success of an organization A quality management approach
ISO/TS 11139:2006	Sterilization of health care products Vocabulary
ISO 10993-17:2002	Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 10012:2003	Measurement management systems — Requirements for measurement processes and measuring equipment
ISO 22442-2:2015	Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling
ISO 11138-1:2017	Sterilization of health care products — Biological indicators — Part 1: General requirements
ISO 22442-3:2007	Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
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