DIN EN ISO 5840-1:2021 Edition

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Cardiovascular implants – Cardiac valve prostheses – Part 1: General requirements

Published By	Publication Date	Number of Pages
DIN	2021-05	88

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Categories: 11.040.40 - Implants for surgery, prosthetics and orthotics, DIN

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Description

This International Standard is applicable to heart valve substitutes intended for human implantation and provides general requirements. Subsequent parts of this International Standard provide specific requirements. This International Standard is applicable to both newly developed and modified heart valve substitutes and to the accessories, packaging, and labelling required for their implantation and for determining the appropriate size of the heart valve substitute to be implanted. This International Standard outlines an approach for qualifying the design and manufacture of a heart valve substitute through risk management. The selection of appropriate qualification tests and methods are 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 may also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished heart valve substitute. This International Standard defines operational conditions for heart valve substitutes. This International Standard excludes homografts.

Additional information

Published Code	DIN
Published By	Deutsches Institut für Normung
Publication Date	2021-05
Pages Count	88
Language	Germany
Descriptors	Accessories, Cardiac valves, Cardiology, Chemical properties, Definitions, Design, Dimensions, Durability, Endurance tests, Evaluations, Fine mechanics, Heart, Implants (surgical), In vitro, In vivo, Inspection, Marking, Material tests, Materials, Measurement, Medical devices, Medical technology, Packages, Physical properties, Production, Properties, Prosthetic devices, Quality assurance, Risk, Risk management, Specification (approval), Sterilization (hygiene), Surgical implants, Testing, User information, Validation, Vascular prostheses, Verification, Medical products, Storage quality
File Size	2.5 MB
ICS Codes	11.040.40 - Implants for surgery, prosthetics and orthotics

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DIN EN ISO 5840-1:2021 Edition

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