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Number of results 143
UNE-EN ISO 7197:2025 UNE
Status: Vigente/ 2025-07-09
Neurosurgical implants - Sterile, single-use hydrocephalus shunts (ISO 7197:2024)
UNE-EN ISO 11979-2:2025 UNE
Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods (ISO 11979-2:2024)
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 12417-1:2024 UNE
Status: Vigente/ 2024-11-27
Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2024)
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 ISO 16672:2021 UNE
Status: Vigente/ 2021-11-01
Ophthalmic implants - Ocular endotamponades (ISO 16672:2020) (Endorsed by Asociación Española de Normalización in November of 2021.)
UNE-EN ISO 16061:2021 UNE
Status: Vigente/ 2021-10-13
Instruments for use in association with non-active surgical implants - General requirements (ISO 16061:2021)
UNE-EN ISO 11979-5:2021 UNE
Status: Vigente/ 2021-04-28
Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2020)
UNE-EN ISO 25539-2:2021 UNE
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2020)
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 11979-1:2019 UNE
Status: Vigente/ 2019-10-23
Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:2018)
UNE-EN ISO 16671:2016/A1:2018 UNE
Status: Vigente/ 2018-06-20
Ophthalmic implants - Irrigating solutions for ophthalmic surgery - Amendment 1 (ISO 16671:2015/Amd 1:2017)
UNE-EN ISO 11979-10:2018 UNE
Status: Vigente/ 2018-06-01
Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes (ISO 11979-10:2018) (Endorsed by Asociación Española de Normalización in June of 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 11979-8:2017 UNE
Status: Vigente/ 2017-07-26
Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2017)
UNE-EN ISO 16671:2016 UNE
Status: Vigente/ 2016-01-20
Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015)
UNE-EN ISO 11979-6:2015 UNE
Status: Vigente/ 2015-05-13
Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing (ISO 11979-6:2014)
UNE-EN ISO 11979-3:2013 UNE
Status: Vigente/ 2013-07-24
Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods (ISO 11979-3:2012)
UNE-EN ISO 14630:2013 UNE
Status: Vigente/ 2013-06-19
Non-active surgical implants - General requirements (ISO 14630:2012)
UNE-EN ISO 11979-4:2009/A1:2013 UNE
Status: Vigente/ 2013-03-20
Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information - Amendment 1 (ISO 11979-4:2008/Amd 1:2012)
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 21534:2009 UNE
Status: Vigente/ 2009-09-09
Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)
UNE-EN ISO 11979-4:2009 UNE
Status: Vigente/ 2009-05-13
Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information (ISO 11979-4:2008)
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 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 15798:2022 UNE
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2022)
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 ISO 5840-3:2021 UNE
Status: Vigente/ 2021-03-01
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2021) (Endorsed by Asociación Española de Normalización in March of 2021.)
UNE-EN ISO 5840-2:2021 UNE
Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2021) (Endorsed by Asociación Española de Normalización in March of 2021.)
UNE-EN ISO 5840-1:2021 UNE
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2021) (Endorsed by Asociación Española de Normalización in March of 2021.)
UNE-EN ISO 14607:2018 UNE
Status: Vigente/ 2018-12-01
Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2018, Corrected version 2018-08)
UNE-EN ISO 25539-1:2017 UNE
Status: Vigente/ 2017-06-01
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2017) (Endorsed by Asociación Española de Normalización in June of 2017.)
UNE-CEN/TS 15277:2007 EX UNE
Status: Vigente/ 2009-01-25
Non-active surgical implants - Injectable implants
PNE-EN ISO 14630 PROY
Status: Procedure
Non-active surgical implants - General requirements (ISO 14630:2024)
PNE-EN ISO 16671 PROY
Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2025)
PNE-prEN ISO 11979-4 PROY
Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information (ISO/DIS 11979-4:2025)
PNE-prEN ISO 11979-1 PROY
Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO/DIS 11979-1:2025)
PNE-prEN ISO 14607 PROY
Non-active surgical implants - Mammary implants - Specific requirements(ISO/FDIS 14607:2024)
