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Number of results 641
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 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 5832-3:2022 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 50527-1:2016 UNE
Status: Vigente/ 2021-08-25
Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 1: General (Endorsed by Asociación Española de Normalización in January of 2017.)
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 IEC 60601-2-31:2020 UNE
Status: Vigente/ 2020-05-01
Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source (Endorsed by Asociación Española de Normalización in May of 2020.)
UNE-EN IEC 60601-2-66:2020 UNE
Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems (Endorsed by Asociación Española de Normalización in May of 2020.)
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 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 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 45502-1:2015 UNE
Status: Vigente/ 2015-07-01
Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer (Endorsed by AENOR in July of 2015.)
UNE-EN ISO 14630:2013 UNE
Status: Vigente/ 2013-06-19
Non-active surgical implants - General requirements (ISO 14630:2012)
UNE-EN ISO 14602:2012 UNE
Status: Vigente/ 2012-02-22
Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010)
UNE-EN ISO 15001:2012 UNE
Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010)
UNE-EN ISO 21534:2009 UNE
Status: Vigente/ 2009-09-09
Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)
UNE-EN 45502-2-2:2008 UNE
Status: Vigente/ 2008-11-05
Active implantable medical devices -- Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
UNE-EN ISO 22523:2007 UNE
Status: Vigente/ 2007-03-28
External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006)
UNE-EN 45502-2-1:2005 UNE
Status: Vigente/ 2005-07-20
Active implantable medical devices -- Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
UNE 111912:1990 UNE
Status: Vigente/ 1990-07-24
PROTHECTICS AND ORTHOTICS. MEDICAL ASPECTS. DECRIPTION OF LIMB DEFICIENCIES PRESENT AT BIRTH
UNE 111909-1:1990 UNE
Status: Vigente/ 1990-07-05
PROSTHETICS AND ORTHOTICS. VOCABULARY. PART 1: GENERAL TERMS
UNE 111909-2:1990 UNE
PROSTHETICS AND ORTHOTICS. VOCABULARY. PART 1: TERMS RELATING TO PROTHESES AND WEARERS OF PROTHESES
UNE 111909-3:1990 UNE
PROSTHETICS AND ORTHOTICS. VOCABULARY. PART 3: TERMS RELATING TO ORTHOSES
UNE-EN ISO 5840-1:2021/A1:2025 UNE
Status: Vigente/ 2025-05-01
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements - Amendment 1 (ISO 5840-1:2021/Amd 1:2025) (Endorsed by Asociación Española de Normalización in May of 2025.)
UNE-EN ISO 5840-2:2021/A1:2025 UNE
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes - Amendment 1 (ISO 5840-2:2021/Amd 1:2025) (Endorsed by Asociación Española de Normalización in May of 2025.)
UNE-EN ISO 5840-3:2021/A1:2025 UNE
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques - Amendment 1 (ISO 5840-3:2021/Amd 1:2025) (Endorsed by Asociación Española de Normalización in May of 2025.)
UNE-EN ISO 25539-3:2024 UNE
Status: Current/ 2024-12-01
Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2024) (Endorsed by Asociación Española de Normalización in December of 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 7199:2024 UNE
Status: Vigente/ 2024-10-01
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2024) (Endorsed by Asociación Española de Normalización in October of 2024.)
UNE-EN ISO 21917:2023 UNE
Status: Vigente/ 2023-09-20
Anaesthetic and respiratory equipment - Voice prostheses (ISO 21917:2021)
UNE-EN 50527-2-2:2018 UNE
Status: Vigente/ 2023-01-18
Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 2-2: Specific assessment for workers with cardioverter defibrillators (ICDs) (Endorsed by Asociación Española de Normalización in June of 2018.)
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 9713:2022 UNE
Status: Vigente/ 2022-03-01
Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2022) (Endorsed by Asociación Española de Normalización in March of 2022.)
UNE-EN 50527-2-3:2021 UNE
Status: Vigente/ 2021-12-01
Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 2-3: Specific assessment for workers with implantable neurostimulators (Endorsed by Asociación Española de Normalización in December of 2021.)
