Найдено: 11
Overview ISO 5840-2:2021 - "Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes" is an international standard that sets requirements and guidance…
Overview ISO 5840-3:2021 - Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques - is the international standard that defines engi…
Overview ISO 5840-1:2021 - "Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements" establishes the general, risk‑based framework for the development, verification and vali…
1 Scope This part of ISO 5840 is applicable to heart valve substitutes intended for human implantation and provides general requirements. Subsequent parts of the ISO 5840–series provide specific requ…
1 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…
Overview ISO 5840-3:2021/Amd 1:2025 is an important amendment to the ISO 5840-3:2021 international standard, which focuses on cardiovascular implants specifically cardiac valve prostheses delivered b…
Overview ISO 5840-1:2021/Amd 1:2025, titled Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements - Amendment 1, is an important amendment to the internationally recognize…
Overview ISO 5840-2:2021/Amd 1:2025 is an important International Standard amendment that addresses updates to the requirements for cardiovascular implants-specifically, surgically implanted heart va…