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Number of results 143
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 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 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 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 15798:2022 UNE
Status: Vigente/ 2022-09-21
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2022)
UNE-EN ISO 5832-3:2022 UNE
Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy (ISO 5832-3:2021)
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 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 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 15798:2014/A1:2018 UNE
Status: Anulada/ 2022-09-21
Ophthalmic implants - Ophthalmic viscosurgical devices - Amendment 1 (ISO 15798:2013/Amd 1:2017)
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 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 12417-1:2016 UNE
Status: Anulada/ 2024-11-27
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 ISO 16671:2016 UNE
Status: Vigente/ 2016-01-20
Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015)
UNE-EN ISO 16672:2016 UNE
Status: Anulada/ 2021-11-01
Ophthalmic implants - Ocular endotamponades (ISO 16672:2015)
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 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 11979-7:2015 UNE
Status: Anulada/ 2018-06-01
Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations (ISO 11979-7:2014)
UNE-EN ISO 11979-2:2015 UNE
Status: Anulada/ 2025-07-09
Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods (ISO 11979-2:2014)
UNE-EN ISO 11979-8:2015 UNE
Status: Anulada/ 2017-07-26
Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006 + Amd 1:2011)
UNE-EN ISO 11979-10:2007/A1:2014 UNE
Ophthalmic implants - Intraocular lenses - Part 10: Phakic intraocular lenses (ISO 11979-10:2006/Amd 1:2014)
UNE-EN ISO 11979-9:2007/A1:2014 UNE
Ophthalmic implants - Intraocular lenses - Part 9: Multifocal intraocular lenses (ISO 11979-9:2006/Amd 1:2014)
UNE-EN ISO 21536:2009/A1:2014 UNE
Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants - Amendment 1 (ISO 21536:2007/Amd 1:2014)
UNE-EN ISO 15798:2014 UNE
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2013)
UNE-EN ISO 5840-3:2013 UNE
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013)
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 25539-2:2013 UNE
Status: Anulada/ 2021-04-28
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012)
UNE-EN ISO 14630:2013 UNE
Status: Anulada/ 2025-07-30
Non-active surgical implants - General requirements (ISO 14630:2012)
UNE-EN ISO 11979-1:2013 UNE
Status: Anulada/ 2019-10-23
Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:2012)
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)
