Tecnología Médica
Mapa TecMedTecnología Médica
ISO/FDIS 7199 - Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators)
04/03/2024 -
Status: Under development
ISO/FDIS 25539-3 - Cardiovascular implants — Endovascular devices — Part 3: Vena cava filters
14/02/2024 -
Status : Under development
ISO 12417-1:2024 - Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirements
08/02/2024 -
This document specifies requirements for vascular device-drug combination products (VDDCPs).
With regard to safety, this document outlines requirements for intended performance, design...
ISO/CD TR 18965 - Cardiac valve manufacturing risk management
01/02/2024 -
Status: Under development
ISO/FDIS 5910 - Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices
28/11/2023 -
Status: Under development
ISO 5840-2:2021/DAmd 1 - Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes — Amendment 1
23/11/2023 -
Status : Under development
ISO 5840-1:2021/DAmd 1 - Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements — Amendment 1
23/11/2023 -
Status : Under development
ISO 11318:2002 - Cardiac defibrillators — Connector assembly DF-1 for implantable defibrillators — Dimensions and test requirements
17/10/2023 -
This standard was last reviewed and confirmed in 2018. Therefore this version remains current.
ISO 5841-3:2013 - Implants for surgery — Cardiac pacemakers — Part 3: Low-profile connectors (IS-1) for implantable pacemakers
17/10/2023 -
This standard was last reviewed and confirmed in 2018. Therefore this version remains current.
ISO 12417-1 - Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirements
12/09/2023 -
Status: Under development
ISO 18242:2016/Amd 1 - Cardiovascular implants and extracorporeal systems — Centrifugal blood pumps — Amendment 1: Worst-case conditions for testing
25/07/2023 -
Status: Under development
ISO/DIS 7199 - Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators)
29/05/2023 -
Status: Under development
ISO 18242:2016/FDAmd 1 - Cardiovascular implants and extracorporeal systems — Centrifugal blood pumps — Amendment 1: Worst-case conditions for testing
04/05/2023 -
Status: Under development
ISO 20696:2018 - Sterile urethral catheters for single use
18/04/2023 -
This document specifies requirements and test methods for sterile urethral catheters for single use, with or without a balloon.
This document does not include drainage catheters covered...
ISO/PAS 7020 - Size designation of surgical valve prostheses: Requirements regarding the application of ISO 5840-2
13/04/2023 -
Status: Under development
ISO/DIS 5910 - Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices
06/03/2023 -
Status: Under development
ISO/CD 8417 - Risk management of particulate contamination for devices with intravascular access
13/12/2022 -
Status: Under development
