DIN EN ISO 5840-2:2016
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015); German version EN ISO 5840-2:2015

Standard No.

DIN EN ISO 5840-2:2016

Release Date

2016

Published By

German Institute for Standardization

Status

Be replaced 2019-04

Replace By

DIN EN ISO 5840-2:2019

Latest

DIN EN ISO 5840-2:2016

DIN EN ISO 5840-2:2019

DIN EN ISO 5840-2:2021-05

Replace

DIN EN ISO 5840-2:2015

DIN EN ISO 5840-2:2016 Referenced Document

• ASTM F2052-15 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment*， 2023-12-24 Update
• ASTM F2119-07 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants*， 2023-12-24 Update
• ASTM F2182-11 Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging*， 2023-12-24 Update
• ASTM F2213-06 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment*， 2023-12-24 Update
• DIN EN ISO 10993-1:2010 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009); German version EN ISO 10993-1:2009
• DIN EN ISO 10993-2:2006 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006); English version of DIN EN ISO 10993-2:2006-10
• DIN EN ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011 + Cor. 1:2011); German version EN ISO 14155:2011 + AC:2011
• DIN EN ISO 14630:2013 Non-active surgical implants - General requirements (ISO 14630:2012); German version EN ISO 14630:2012
• DIN EN ISO 14971:2013 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); German version EN ISO 14971:2012
• DIN EN ISO 16061:2015 Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015); German version EN ISO 16061:2015
• DIN EN ISO 5840-1:2015 Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015); German version EN ISO 5840-1:2015
• DIN EN ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2005); German and English version EN ISO/IEC 17025:2005

DIN EN ISO 5840-2:2016 history

• 2021 DIN EN ISO 5840-2:2021 Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2021); German version EN ISO 5840-2:2021
• 2019 DIN EN ISO 5840-2:2019 Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO/DIS 5840-2:2019); German and English version prEN ISO 5840-2:2019
• 2016 DIN EN ISO 5840-2:2016 Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015); German version EN ISO 5840-2:2015
• 0000 DIN EN ISO 5840-2:2015
• 1970 DIN EN ISO 5840-2 E:2014-06