Committee:
ISO/TC 150 Implants for surgery
CEN/CLC/JTC 16 CEN/CENELEC Joint Working Group on Active Implantable Medical Devices
CEN/TC 285 Non-active surgical implants
Standards developed by the committee: CTN 91: 139
Status: VIGENTE / 2013-03-20
Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information - Amendment 1 (ISO 11979-4:2008/Amd 1:2012)
Status: VIGENTE / 2012-02-22
Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010)
Status: VIGENTE / 2009-09-09
Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)
Status: VIGENTE / 2009-05-13
Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information (ISO 11979-4:2008)
Status: VIGENTE / 2009-01-25
Non-active surgical implants - Injectable implants
Status: ANULADA / 2025-07-30
Non-active surgical implants - General requirements (ISO 14630:2012)
Status: ANULADA / 2025-07-09
Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007)
Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods (ISO 11979-2:2014)
Status: ANULADA / 2025-01-22
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007)
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants - Amendment 1 (ISO 21535:2007/Amd 1:2016)
Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2007)
Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants - Amendment 1 (ISO 21536:2007/Amd 1:2014)
Status: ANULADA / 2024-12-01
Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011)
Status: ANULADA / 2024-11-27
Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015)
Status: ANULADA / 2024-11-06
Implants for surgery - Metallic materials - Part 1: Wrought stainless steel (ISO 5832-1:2016)
Implants for surgery - Metallic materials - Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy (ISO 5832-7:2016)
Status: ANULADA / 2024-03-01
Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia (ISO 11979-7:2018) (Endorsed by Asociación Española de Normalización in June of 2018.)
Status: ANULADA / 2022-11-02
Implants for surgery - Metallic materials - Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy (ISO 5832-6:1997)
Status: ANULADA / 2022-09-21
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2013)
Ophthalmic implants - Ophthalmic viscosurgical devices - Amendment 1 (ISO 15798:2013/Amd 1:2017)
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