Tecnología Médica
Mapa TecMedTecnología Médica
ISO/PRF 19211 - Anaesthetic and respiratory equipment — Fire-activated oxygen shut-off devices for use during oxygen therapy
03/04/2024 -
Status: Under development
ISO 18562-2:2024 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter
12/03/2024 -
This document specifies tests for the emissions of particulate matter from the gas pathways of a medical device, its parts or accessories, which are intended to...
ISO 18562-1:2024 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process
12/03/2024 -
This document specifies:
the general principles governing the biological evaluation within a risk management process of the gas pathways of a medical...
ISO 18562-4:2024 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate
12/03/2024 -
This document specifies tests for substances leached by liquid water condensing in gas pathways of a medical device, its parts or accessories, which are intended to...
ISO/FDIS 7199 - Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators)
04/03/2024 -
Status: Under development
ISO 18562-3 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 3: Tests for emissions of volatile organic substances
19/02/2024 -
Status: Under development
ISO/CD TS 22175 - Connectors for respiratory devices
13/11/2023 -
Status: Under development
ISO 15002 - Flow control devices for connection to a medical gas supply system
31/07/2023 -
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/CD 7396-3 - Medical gas pipeline systems — Part 3: Part 3: Proportioning units for the production of synthetic medical air
12/06/2023 -
Status: Under development
ISO/CD 18777-1.2 - Transportable liquid oxygen systems for medical use — Part 1: Common requirements and particular requirements for base units
08/06/2023 -
Status: Under development
ISO/CD 18777-2.2 - Transportable liquid oxygen systems for medical use — Part 2: Particular requirements for portable units
08/06/2023 -
Status: Under development
ISO 24072 - Aerosol bacterial retention test method for air-inlet filter on administration devices
15/05/2023 -
Status: Under development
ISO 10524-4:2008 - Pressure regulators for use with medical gases — Part 4: Low-pressure regulators
17/04/2023 -
This standard was last reviewed and confirmed in 2018. Therefore this version remains current.
ISO/DIS 8637-3 - Extracorporeal systems for blood purification — Part 3: Plasmafilters
20/03/2023 -
Status: Under development
ISO 10524-1:2018 - Pressure regulators for use with medical gases — Part 1: Pressure regulators and pressure regulators with flow-metering devices
25/01/2023 -
ISO 10524-1:2018 specifies the design, construction, type testing, and marking requirements for pressure regulators (as defined in 3.18) intended for the administration of medical gases and their...
ISO 10524-2:2018 - Pressure regulators for use with medical gases — Part 2: Manifold and line pressure regulators
24/01/2023 -
ISO 10524-2:2018 specifies design, construction, type testing, and marking requirements for manifold pressure regulators (as defined in 3.7) and line pressure regulators (as defined in 3.5)...
ISO 11195:2018 - Gas mixers for medical use — Stand-alone gas mixers
24/01/2023 -
ISO 11195:2018 specifies requirements for the performance and safety of stand-alone gas mixers intended for mixing oxygen with another gas for medical use.
ISO 11195:2018 does not apply...
