BS EN ISO 5840-2:2015
Cardiovascular implants. Cardiac valve prostheses. Surgically implanted heart valve substitutes

Standard No.
BS EN ISO 5840-2:2015
Release Date
2015
Published By
British Standards Institution (BSI)
Status
 2021-02
Replace By
BS EN ISO 5840-2:2021
Latest
BS EN ISO 5840-2:2021
Replace
BS EN ISO 5840:2009

BS EN ISO 5840-2:2015 Referenced Document

  • ASTM F2052 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment*2021-10-01 Update
  • ASTM F2119 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants*2023-12-23 Update
  • ASTM F2182 Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging*2019-09-15 Update
  • ASTM F2213 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment*2017-09-01 Update
  • ASTM F2503 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment*2023-04-01 Update
  • IEC 60651 Sound Level Meters (Edition 1.2; Edition 1:1979 Consolidated with Amendments 1:1993 and 2:2000; Replaced by IEC 61672-1:2002 and IEC 61672-2: 2003)
  • IEC 62366 Medical devices - Application of usability engineering to medical devices
  • ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*2018-08-01 Update
  • ISO 10993-2 Biological evaluation of medical devices — Part 2: Animal welfare requirements*2022-11-03 Update
  • ISO 11135 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices — Amendment 1: Revision of Anne*2023-12-23 Update
  • ISO 11137 Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization; Technical Corrigendum 1
  • ISO 11607 Packaging for terminally sterilized medical devices
  • ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes*2016-03-01 Update
  • ISO 14155 Clinical investigation of medical devices for human subjects — Good clinical practice*2020-07-28 Update
  • ISO 14160 Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, developmen*2020-09-21 Update
  • ISO 14630 Non-active surgical implants - General requirements
  • ISO 14937 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 14971 Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements*2019-12-10 Update
  • ISO 16061 Instruments for use in association with non-active surgical implants - General requirements*2021-02-28 Update
  • 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
  • ISO 22442 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 25539-1:2003 Cardiovascular implants — Endovascular devicesPart 1:Endovascular prostheses
  • ISO 532:1975 Acoustics; Method for calculating loudness level
  • ISO 5840-1:2015 Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
  • ISO 8601 Data elements and interchange formats - Information interchange - Representation of dates and times
  • ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
  • ISO/TS 11139:2006 Sterilization of health care products - Vocabulary
  • ISO/TS 12417:2011 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products

BS EN ISO 5840-2:2015 history

  • 2021 BS EN ISO 5840-2:2021 Cardiovascular implants. Cardiac valve prostheses. Surgically implanted heart valve substitutes
  • 2015 BS EN ISO 5840-2:2015 Cardiovascular implants. Cardiac valve prostheses. Surgically implanted heart valve substitutes
  • 2009 BS EN ISO 5840:2009 Cardiovascular implants - Cardiac valve prostheses

BS EN ISO 5840-2:2015 Cardiovascular implants. Cardiac valve prostheses. Surgically implanted heart valve substitutes has been changed from BS EN ISO 5840:2009 Cardiovascular implants - Cardiac valve prostheses.




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