Tecnología Médica
Mapa TecMedTecnología Médica
ISO 5832-7:2024 - Implants for surgery — Metallic materials — Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy
11/04/2024 -
This document specifies the characteristics of, and corresponding test methods for, forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy for use in the manufacture of surgical...
ISO 15032:2000 - Prostheses — Structural testing of hip units
18/10/2023 -
This standard was last reviewed and confirmed in 2013. Therefore this version remains current.
ISO 7206-10:2018 - Implants for surgery — Partial and total hip-joint prostheses — Part 10: Determination of resistance to static load of modular femoral heads
24/07/2023 -
This document specifies methods of determining the compressive (fracture) or the tension (disassembly) loads required, under specific laboratory conditions, to cause failure of a modular head...
ISO 21535:2023 - Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants
06/07/2023 -
This document specifies requirements for hip-joint replacement implants. With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design...
ISO 21536:2023 - Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants
06/07/2023 -
This document specifies requirements for knee-joint replacement implants. Regarding safety, this document specifies requirements for intended performance, design attributes, materials, design...
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 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/FDIS 21536 - Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants
08/08/2022 -
Status: Under development
ISO/FDIS 21535 - Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants
04/08/2022 -
Status: Under development
ISO/TS 24560-1:2022 - Tissue-engineered medical products — MRI evaluation of cartilage — Part 1: Clinical evaluation of regenerative knee articular cartilage using delayed gadolimium-enhanced MRI of cartilage (dGEMRIC) and T2 mapping
02/08/2022 -
This document provides a principle to determine the parameter settings and operating methods for the evaluation of the composition and structure of articular cartilage by dGEMRIC and T2-mapping...
ISO 19213:2017 - Implants for surgery — Test methods of material for use as a cortical bone model
27/07/2022 -
ISO 19213:2017 specifies mechanical test methods for characterizing cortical bone model materials for use as a standard model for performing mechanical tests for devices or instruments used in...
ISO/CD 5832-11 - Implants for surgery — Metallic materials — Part 11: Wrought titanium 6-aluminium 7-niobium alloy
28/06/2022 -
Status: Under development
