Tecnología Médica
Mapa TecMedTecnología Médica
IMPRESCINDIBLE
18/05/2023 -
This document describes in vitro methods of measurement of the sizing parameters for surgical valves (referring to mechanical and stented bioprosthetic valves only here and hereafter). It represents a consensus reached among manufacturers, independent bioengineers and clinicians, and is underpinned by interlaboratory studies.
ISO 6028:2023 - Healthcare organization management — Pandemic response — Functional requirements for self-symptom checker app
05/06/2023 -
This document specifies functional requirements for a self-initiated disease symptom checker app to be used for early screening and control of pandemics such as COVID-19.
There are four...
ISO/FDIS 9584 - Implants for surgery — Non-destructive testing — Radiographic examination of cast metallic surgical implants
29/05/2023 -
Status: Under development
ISO/FDIS 14630 - Non-active surgical implants — General requirements
29/05/2023 -
Status: Under development
ISO/DIS 7199 - Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators)
29/05/2023 -
Status: Under development
ISO/TS 4549 - Orthotics — Method for testing the reliability of microprocessor-controlled ankle moment units of ankle-foot orthoses
15/05/2023 -
Status: Under development
ISO/FDIS 18562-4 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate
15/05/2023 -
Status: Under development
ISO/FDIS 18562-2 - Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter
15/05/2023 -
Status: Under development
ISO 24072 - Aerosol bacterial retention test method for air-inlet filter on administration devices
15/05/2023 -
Status: Under development
ISO 21536 - Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants
08/05/2023 -
Status: Under development
ISO 21535 - Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants
08/05/2023 -
Status: Under development
ISO/TS 10974:2018 - Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
08/05/2023 -
This standard was last reviewed and confirmed in 2023. Therefore this version remains current.
ISO/TS 10974:2018 is applicable to implantable parts of active implantable medical...
ISO/CD 8549-4 - Prosthetics and orthotics — Vocabulary — Part 4: Terms relating to limb amputation
04/05/2023 -
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 14242-4:2018 - Implants for surgery — Wear of total hip-joint prostheses — Part 4: Testing hip prostheses under variations in component positioning which results in direct edge loading
18/04/2023 -
This document specifies the test conditions to simulate edge loading in hip prostheses due to steep acetabular cup inclination angle and dynamic separation conditions.
This document is...
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 20697:2018 - Sterile drainage catheters and accessory devices for single use
18/04/2023 -
This document specifies requirements for sterile, single use drainage catheters, wound and fluid accumulation drainage systems, surgical drainage catheters and their components, where the catheter...
