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Found: 27
Overview EN ISO 5840-2:2021 - Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes - is the harmonized CEN/ISO standard for surgical heart valve s…
Overview EN ISO 5840-1:2021 - Cardiovascular implants: Cardiac valve prostheses (Part 1: General requirements) sets out the general requirements for heart valve substitutes intended for implantation.…
Overview - EN ISO 5840-3:2021 (Cardiac valve prostheses, Part 3) EN ISO 5840-3:2021 is the CEN-adopted edition of ISO 5840-3:2021 that addresses heart valve substitutes implanted by transcatheter tec…
Overview EN ISO 5840-2:2021/A1:2025 is a key European amendment to the international standard ISO 5840-2:2021, developed under the collaboration of ISO Technical Committee ISO/TC 150 and CEN Technica…
Overview EN ISO 5840-1:2021/A1:2025 is Amendment 1 to ISO 5840-1:2021, adopted by CEN as a European Standard in March 2025. It updates the general requirements for cardiac valve prostheses (cardiovas…
Overview EN ISO 5840-3:2021/A1:2025 is an important European and international standard that specifies requirements for cardiovascular implants, particularly cardiac valve prostheses designed for imp…
Overview SIST EN ISO 5840-2:2021/A1:2025 is a key European amendment to the international standard ISO 5840-2:2021, developed under the collaboration of ISO Technical Committee ISO/TC 150 and CEN Tec…
Overview SIST EN ISO 5840-3:2021/A1:2025 is an important European and international standard that specifies requirements for cardiovascular implants, particularly cardiac valve prostheses designed fo…
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 5840-1:2021 - "Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements" establishes the general, risk‑based framework for the development, verification and vali…
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…
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 5840-3:2021/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…
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 - Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques - is the international standard that defines engi…
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…
