Tecnología Médica

ISO 25539-3 - Cardiovascular implants — Endovascular devices — Part 3: Vena cava filters

25/07/2024 - Status: Under development

ISO 7199 - Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators)

11/07/2024 - ISO 7199:2016 specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for supply of oxygen to, and removal of carbon dioxide from, the blood of...

ISO 5910:2024 - Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices

08/07/2024

ISO/DIS 11979-1 - Ophthalmic implants — Intraocular lenses — Part 1: Vocabulary

04/07/2024 - Status: Under development

ISO/DIS 16671.2 - Ophthalmic implants — Irrigating solutions for ophthalmic surgery

01/07/2024

ISO 14630 - Non-active surgical implants — General requirements

01/07/2024

ISO/DIS 11979-4 - Ophthalmic implants — Intraocular lenses — Part 4: Labelling and information

01/07/2024

ISO/FDIS 11979-2 - Ophthalmic implants — Intraocular lenses — Part 2: Optical properties and test methods

01/07/2024

ISO 7197 - Neurosurgical implants — Sterile, single-use hydrocephalus shunts

01/07/2024

ISO 5910 - Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices

13/06/2024 - Status: Under development

ISO/CD TR 18965 - Medical devices — Examples of the application of the risk management process to cardiac valve replacement and repair systems

10/06/2024

ISO/DIS 23317 - Implants for surgery — Materials — Simulated body fluid (SBF) preparation procedure and test method to detect apatite formation in SBF for initial screening of bone-contacting implant materials

09/05/2024 - Status: Under development

IEC/DIS 80601-2-31 - Medical electrical equipment — Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

09/05/2024 - Status: Under development

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 5832-4:2024 - Implants for surgery — Metallic materials — Part 4: Cobalt-chromium-molybdenum casting alloy

04/04/2024 - This document specifies the characteristics of, and corresponding test methods for, cobalt-chromium-molybdenum casting alloy for use in the manufacture of surgical implants. NOTE: The...

ISO 5832-1:2024 - Implants for surgery — Metallic materials — Part 1: Wrought stainless steel

04/04/2024 - This document specifies the characteristics of, and corresponding test methods for, wrought stainless steel for use in the manufacture of surgical implants. NOTE 1: The mechanical...

ISO 5832-11:2024 - Implants for surgery — Metallic materials — Part 11: Wrought titanium 6-aluminium 7-niobium alloy

21/03/2024 - This document specifies the characteristics of, and corresponding test methods for, the wrought titanium alloy known as titanium 6-aluminium 7-niobium alloy (Ti-6Al-7Nb) for use in the manufacture...

ISO/DTS 6838 - Ophthalmic optics — Contact lenses — Tolerances and methods for measurement of multifocal contact lens addition power

12/03/2024 - Status: Under development

ISO/FDIS 14607 - Non-active surgical implants — Mammary implants — Specific requirements

04/03/2024 - Status: Under development

ISO/DIS 16436-1 - Implants for surgery — Wear of total shoulder-joint prostheses — Part 1: Force and displacement parameters for wear-testing machines and corresponding environmental conditions for test of anatomic total shoulder-joint prostheses

29/02/2024 - Status : Under development

ISO 5832-11 - Implants for surgery — Metallic materials — Part 11: Wrought titanium 6-aluminium 7-niobium alloy

22/02/2024 - Status: Under development

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