DIN EN ISO 5840-2:2016-05

Superseded

Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015)

Available format(s)

Hardcopy , PDF

Superseded date

04-29-2021

Language(s)

German, English

Published date

05-01-2016

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

DevelopmentNote	Applies in conjunction with DIN EN ISO 5840-1 issue 12-2015. (12/2015) Supersedes DIN EN ISO 5840. (02/2016)
DocumentType	Standard
Pages	65
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Superseded
SupersededBy	DIN EN ISO 5840-2:2021-05
Supersedes	DIN EN ISO 5840:2009-08 DIN EN ISO 5840-2:2015-12

Standards	Relationship
EN ISO 5840-2:2015	Identical
ISO 5840-2:2015	Identical

DIN EN ISO 5840-1:2015-12	Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015)
DIN EN ISO 5840-1 E : 2015	CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 58401:2015)

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
DIN EN ISO 10993-2:2006-10	Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006)
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)
ISO 10993-2:2006	Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 5840-1:2015	Cardiovascular implants Cardiac valve prostheses Part 1: General requirements
ISO 25539-1:2017	Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses
IEC 62366:2007+AMD1:2014 CSV	Medical devices - Application of usability engineering to medical devices
ISO 14630:2012	Non-active surgical implants General requirements
DIN EN ISO 5840-1:2015-12	Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015)
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 16061:2015-09	Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)
ISO 8601:2004	Data elements and interchange formats Information interchange Representation of dates and times
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
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
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
DIN EN ISO 14155:2012-01	CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011 + COR. 1:2011)
ISO 14155:2011	Clinical investigation of medical devices for human subjects Good clinical practice
ISO 14971:2007	Medical devices Application of risk management to medical devices
IEC 60651:1979+AMD1:1993+AMD2:2000 CSV	Sound level meters
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