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Number of results 641
UNE-EN ISO 14630:2025 UNE
Status: Vigente/ 2025-07-30
Non-active surgical implants - General requirements (ISO 14630:2024)
UNE-EN ISO 7197:2025 UNE
Status: Vigente/ 2025-07-09
Neurosurgical implants - Sterile, single-use hydrocephalus shunts (ISO 7197:2024)
UNE-EN ISO 23500-1:2025 UNE
Status: Vigente/ 2025-03-05
Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements (ISO 23500-1:2024)
UNE-EN ISO 23500-2:2025 UNE
Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies (ISO 23500-2:2024)
UNE-EN ISO 21535:2025 UNE
Status: Current/ 2025-01-22
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2023)
UNE-EN ISO 21536:2025 UNE
Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2023)
UNE-EN ISO 23500-3:2024 UNE
Status: Vigente/ 2024-11-27
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO 23500-3:2024)
UNE-EN ISO 12417-1:2024 UNE
Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2024)
UNE-EN ISO 23500-4:2024 UNE
Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO 23500-4:2024)
UNE-EN ISO 23500-5:2024 UNE
Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2024)
UNE-EN ISO 5832-1:2024 UNE
Status: Vigente/ 2024-11-06
Implants for surgery - Metallic materials - Part 1: Wrought stainless steel (ISO 5832-1:2024)
UNE-EN ISO 5832-7:2024 UNE
Implants for surgery - Metallic materials - Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy (ISO 5832-7:2024)
UNE-EN ISO 21917:2023 UNE
Status: Vigente/ 2023-09-20
Anaesthetic and respiratory equipment - Voice prostheses (ISO 21917:2021)
UNE-EN ISO 14708-6:2023 UNE
Status: Vigente/ 2023-05-17
Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) (ISO 14708-6:2019)
UNE-EN ISO 14708-3:2023 UNE
Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators (ISO 14708-3:2017)
UNE-EN ISO 14708-7:2023 UNE
Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear and auditory brainstem implant systems (ISO 14708-7:2019)
UNE-EN ISO 14708-5:2023 UNE
Status: Vigente/ 2023-05-03
Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices (ISO 14708-5:2020)
UNE-EN ISO 14708-4:2023 UNE
Status: Vigente/ 2023-04-26
Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pump systems (ISO 14708-4:2022)
UNE-EN ISO 14708-2:2023 UNE
Status: Vigente/ 2023-04-12
Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers (ISO 14708-2:2019)
UNE-EN ISO 5832-6:2022 UNE
Status: Vigente/ 2022-11-02
Implants for surgery - Metallic materials - Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy (ISO 5832-6:2022)
UNE-EN ISO 5832-3:2022 UNE
Status: Vigente/ 2022-09-21
Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy (ISO 5832-3:2021)
UNE-EN ISO 25539-2:2021 UNE
Status: Vigente/ 2021-04-28
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2020)
UNE-EN ISO 8637-1:2020 UNE
Status: Vigente/ 2020-10-21
Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637-1:2017)
UNE-EN ISO 5832-1:2020 UNE
Status: Anulada/ 2024-11-06
Implants for surgery - Metallic materials - Part 1: Wrought stainless steel (ISO 5832-1:2016)
UNE-EN ISO 5832-6:2020 UNE
Status: Anulada/ 2022-11-02
Implants for surgery - Metallic materials - Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy (ISO 5832-6:1997)
UNE-EN ISO 5832-7:2020 UNE
Implants for surgery - Metallic materials - Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy (ISO 5832-7:2016)
UNE-EN ISO 16054:2020 UNE
Status: Vigente/ 2020-03-25
Implants for surgery - Minimum data sets for surgical implants (ISO 16054:2019)
UNE-EN ISO 23500-4:2019 UNE
Status: Anulada/ 2024-11-27
Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (ISO 23500-4:2019)
UNE-EN ISO 23500-5:2019 UNE
Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (ISO 23500-5:2019)
UNE-EN ISO 23500-2:2019 UNE
Status: Anulada/ 2025-03-05
Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies (ISO 23500-2:2019)
UNE-EN ISO 23500-3:2019 UNE
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (ISO 23500-3:2019)
UNE-EN ISO 23500-1:2019 UNE
Preparation and quality management of fluids for haemodialysis and related therapies - Part 1: General requirements (ISO 23500-1:2019)
UNE-EN ISO 8637-2:2019 UNE
Status: Anulada/ 2024-06-01
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018)
UNE-EN ISO 5832-2:2018 UNE
Status: Vigente/ 2018-12-26
Implants for surgery - Metallic materials - Part 2: Unalloyed titanium (ISO 5832-2:2018)
UNE-EN ISO 7198:2017 UNE
Status: Vigente/ 2017-11-29
Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016)
UNE-EN ISO 5832-3:2017 UNE
Status: Anulada/ 2022-09-21
Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy (ISO 5832-3:2016)
UNE-EN ISO 21535:2009/A1:2017 UNE
Status: Anulada/ 2025-01-22
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants - Amendment 1 (ISO 21535:2007/Amd 1:2016)
UNE-EN ISO 22675:2017 UNE
Status: Vigente/ 2017-02-01
Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2016)
UNE-EN ISO 10328:2017 UNE
Status: Vigente/ 2017-01-25
Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2016)
UNE-EN ISO 26722:2016 UNE
Status: Anulada/ 2019-11-13
Water treatment equipment for haemodialysis applications and related therapies (ISO 26722:2014)
UNE-EN ISO 13959:2016 UNE
Water for haemodialysis and related therapies (ISO 13959:2014)
UNE-EN ISO 13958:2016 UNE
Concentrates for haemodialysis and related therapies (ISO 13958:2014)
UNE-EN ISO 11663:2016 UNE
Quality of dialysis fluid for haemodialysis and related therapies (ISO 11663:2014)
UNE-EN ISO 23500:2016 UNE
Status: Anulada/ 2019-10-30
Guidance for the preparation and quality management of fluids for haemodialysis and related therapies (ISO 23500:2014)
UNE-EN ISO 12417-1:2016 UNE
Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015)
UNE-EN ISO 5840-1:2016 UNE
Status: Anulada/ 2021-03-01
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015)
UNE-EN ISO 5840-2:2016 UNE
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015)
UNE-EN 60601-2-66:2016 UNE
Status: Anulada/ 2023-02-20
Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems
UNE-EN ISO 16061:2015 UNE
Status: Anulada/ 2021-10-13
Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2015)
UNE-EN ISO 7199:2015 UNE
Status: Anulada/ 2017-04-01
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2009 + Amd 1:2012)
