ISO 5840-3:2013
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques

Standard No.

ISO 5840-3:2013

Release Date

2013

Published By

International Organization for Standardization (ISO)

Status

Be replaced

Replace By

ISO 5840-3:2021

Latest

ISO 5840-3:2021

Scope

This part of ISO 5840 outlines an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management. The selection of appropriate verification/validation tests and methods are to be derived from the risk assessment. The tests may include those to assess the physical, chemical, biological and mechanical properties of heart valve substitutes and of their materials and components. The tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute. This part of ISO 5840 defines operational conditions and performance requirements for transcatheter heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification. This part of ISO 5840 is applicable to all devices intended for implantation in human hearts as a transcatheter heart valve substitute. This part of ISO 5840 is applicable to both newly developed and modified transcatheter heart valve substitutes and to the accessory devices, packaging and labelling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted. This part of ISO 5840 excludes heart valve substitutes designed for implantation in artificial hearts or heart assist devices. This part of ISO 5840 excludes valve-in-valve configurations and homografts. This part of ISO 5840 does not specifically address non-traditional surgically implanted heart valve substitutes (e.g. sutureless). For these devices, the requirements of both this part of ISO 5840 and NOTE A rationale for the provisions of this part of ISO 5840 is given in Annex A.

ISO 5840-3:2013 Referenced Document

• IEC 62366 Medical devices - Application of usability engineering to medical devices*， 2014-01-01 Update
• 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 11135-1 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
• ISO 11137-1 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices AMENDMENT 2: Revision to 4.3.4 and 11.2
• ISO 11137-2 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Amendment 1*， 2022-06-13 Update
• ISO 11137-3 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control*， 2017-06-01 Update
• ISO 11607-1 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1
• ISO 11607-2 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1
• ISO 14155 Clinical investigation of medical devices for human subjects - Good clinical practice*， 2020-09-01 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 14630:2012 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*， 2019-12-01 Update
• ISO 17665-1 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 22442-1 Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management*， 2020-09-15 Update
• ISO 22442-2 Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling*， 2020-09-15 Update
• ISO 22442-3 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/IEC 17025 General requirements for the competence of testing and calibration laboratories [Standard in French]*， 2017-11-01 Update
• ISO/TS 11135-2 Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1; Technical Corrigendum 1

ISO 5840-3:2013 history

• 2021 ISO 5840-3:2021 Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques
• 2013 ISO 5840-3:2013 Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques