Tecnología Médica

Tecnología Médica

IMPRESCINDIBLE

ISO/PAS 7020:2023 - Sizing parameters of surgical valve prostheses: Requirements regarding the application of ISO 5840-2

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/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 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...