DIN EN ISO 14160:2011-10

Superseded

View Superseded by

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Superseded date

07-11-2021

Language(s)

German, English

Published date

01-10-2011

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

DocumentType	Standard
Pages	44
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Superseded
SupersededBy	DIN EN ISO 14160:2021-11
Supersedes	DIN EN ISO 14160:1998-06

Standards	Relationship
ONORM EN ISO 14160 : 2011	Identical
BS EN ISO 14160:2011	Identical
NBN EN ISO 14160 : 2011	Identical
I.S. EN ISO 14160:2011	Identical
NS EN ISO 14160 : 2011	Identical
NF EN ISO 14160 : 2011	Identical
UNE-EN ISO 14160:2012	Identical
SN EN ISO 14160 : 2011	Identical
UNI EN ISO 14160 : 2011	Identical
NEN EN ISO 14160 : 2011	Identical
EN ISO 14160:2011	Identical
ISO 14160:2011	Identical

DIN EN ISO 5840-3:2013-06	Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013)
DIN EN ISO 13408-1:2015-12	ASEPTIC PROCESSING OF HEALTH CARE PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 13408-1:2008, INCLUDING AMD 1:2013)
DIN EN ISO 25539-1:2015-07 (Draft)	CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)
VDI 2083 Blatt 13.2:2009-01	Cleanroom technology - Quality, production and distribution of ultrapure water - Microelectronics and other technical applications
VDI 2083 Blatt 13.1:2009-01	Cleanroom technology - Quality, production and distribution of ultrapure water - Fundamentals
DIN EN ISO 5840-1:2015-12	Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015)
DIN EN ISO 7198:2017-07	Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016)
DIN EN ISO 25539-2:2013-05	Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012)
DIN EN ISO 14630:2013-03	Non-active surgical implants - General requirements (ISO 14630:2012)
DIN HDBK 263 : 4ED 2014
DIN EN ISO 11737-1:2009-09	STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS
DIN EN ISO 11737-2:2010-04	STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
DIN EN ISO 5840:2009-08	CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES

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
DIN EN ISO 13485:2016-08	Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
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
DIN EN ISO 11137-1:2015-11	STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11137-1:2006, INCLUDING AMD 1:2013)
DIN EN ISO 14161:2010-03	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
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
DIN EN ISO 17665-1:2006-11	Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
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
DIN EN ISO 11135-1:2007-08	STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
ISO 10993-17:2002	Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
DIN EN ISO 11737-2:2010-04	STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS
DIN EN ISO 22442-2:2016-05	Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2015)
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
DIN EN ISO 11138-1:2015-10 (Draft)	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11138-1:2017)
DIN EN ISO 22442-3:2008-03	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 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
DIN EN ISO 11737-1:2009-09	STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS
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
DIN EN ISO 10993-17:2009-08	Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
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
DIN EN ISO 22442-1:2016-05	Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)