DIN EN ISO 5840-1:2015-12

Superseded

View Superseded by

Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015)

Available format(s)

Hardcopy , PDF

Superseded date

29-04-2021

Language(s)

German, English

Published date

01-12-2015

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

DocumentType	Standard
Pages	66
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Superseded
SupersededBy	DIN EN ISO 5840-1:2021-05

Standards	Relationship
ISO 5840-1:2015	Identical
EN ISO 5840-1:2015	Identical

DIN EN ISO 5840-2:2016-05	Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015)
DIN EN ISO 25539-1:2015-07 (Draft)	CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)

DIN EN ISO 11135:2014-10	STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014)
ISO/IEC 17025:2005	General requirements for the competence of testing and calibration laboratories
ISO 14160:2011	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 11135:2014	Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
ASTM F 2503 : 2013 : REDLINE	Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
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 14971:2013-04	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
DIN EN ISO 5840-2:2016-05	Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015)
ISO 25539-1:2017	Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses
ISO 22442-1:2015	Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
IEC 62366:2007+AMD1:2014 CSV	Medical devices - Application of usability engineering to medical devices
ISO 14630:2012	Non-active surgical implants General requirements
ASTM F 2052 : 2015 : REDLINE	Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
ISO 16061:2015	Instrumentation for use in association with non-active surgical implants General requirements
DIN EN ISO 14630:2013-03	Non-active surgical implants - General requirements (ISO 14630:2012)
ISO 532:1975	Acoustics Method for calculating loudness level
ISO/TS 11139:2006	Sterilization of health care products Vocabulary
ISO 5840-3:2013	Cardiovascular implants Cardiac valve prostheses Part 3: Heart valve substitutes implanted by transcatheter techniques
ASTM F 2213 : 2017 : REDLINE	Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
ISO/TS 12417:2011	Cardiovascular implants and extracorporeal systems Vascular device-drug combination products
DIN EN ISO 14155:2012-01	CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011 + COR. 1:2011)
ISO 22442-2:2015	Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling
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)
ISO 14155:2011	Clinical investigation of medical devices for human subjects Good clinical practice
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 14160:2011-10	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)
ISO 14971:2007	Medical devices Application of risk management to medical devices
ISO 5840-2:2015	Cardiovascular implants Cardiac valve prostheses Part 2: Surgically implanted heart valve substitutes
IEC 60651:1979+AMD1:1993+AMD2:2000 CSV	Sound level meters