UNE-EN ISO 25424:2011

Superseded

Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009)

Available format(s)

Hardcopy , PDF

Superseded date

10-14-2020

Language(s)

Spanish, Castilian, English

Published date

12-28-2011

Publisher

Asociacion Espanola de Normalizacion

Committee	CTN 111
DevelopmentNote	Supersedes UNE EN 15424. (01/2012)
DocumentType	Standard
Pages	52
PublisherName	Asociacion Espanola de Normalizacion
Status	Superseded
SupersededBy	UNE-EN ISO 25424:2020
Supersedes	UNE-EN 15424:2007

Standards	Relationship
ISO 25424:2009	Identical
EN ISO 25424:2011	Identical

EN 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 11737-2:2009)
IEC 61010-2-040:2015	Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
EN 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 14937:2009)
EN 61010-2-040:2015	Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040 Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
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
EN ISO 10993-17:2009	Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
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
EN ISO 14161:2009	Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2009)
EN 867-5:2001	Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S
EN 14180:2014	Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
EN ISO 11138-1:2017	Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017)
ISO/TS 11139:2006	Sterilization of health care products Vocabulary
AAMI RD47 : 2008	REPROCESSING OF HEMODIALYZERS
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 9000:2015	Quality management systems — Fundamentals and vocabulary
ISO 11138-1:2017	Sterilization of health care products — Biological indicators — Part 1: General requirements
CEN Guide 4:2008	GUIDE FOR ADDRESSING ENVIRONMENTAL ISSUES IN PRODUCT STANDARDS
EN ISO 10012:2003	Measurement management systems - Requirements for measurement processes and measuring equipment (ISO 10012:2003)
ISO 14161:2009	Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
ISO 11138-5:2017	Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
ISO 17664:2017	Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
EN ISO 10993-1:2009/AC:2010	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
EN ISO 11138-5:2017	Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017)
EN ISO 9000:2015	Quality management systems - Fundamentals and vocabulary (ISO 9000:2015)
1997/23/EC : 1997	DIRECTIVE 97/23/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 29 MAY 1997 ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES CONCERNING PRESSURE EQUIPMENT