Implantation program

Implantation program, Total:496 items.

The international standard classification for "Implantation program" includes: Implants for surgery, prosthetics and orthotics , Aids for disabled or handicapped persons .

The Chinese standard classification for "Implantation program" includes: Medical apparatus and devices in general , Orthopedic devices , Extracorporeal circulation, artificial organ and prosthesis device .

General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China

GB/T 44138-2024 Cardiovascular implants—Cardiovascular absorbable implants
GB/T 12417.1-2008 Non-active surgical implants - Osteosynthesis and joint replacement implants - Part 1: Particular requirements for osteosynthesis implants
GB/T 24629-2009 Implants for surgery—Guidance on care and handling of orthopaedic implants
GBZ 178-2017 Radiological protection requirements for permanent implant therapy of seed source
GB/T 12417.2-2008 Non-active surgical implants - Osteosynthesis and joint replacement implants - Part 2: Particular requirements for joint replacement implants

国家食品药品监督管理局

YY/T 1486-2016 Dentistry-General requirements for instruments and related accessories used in dental implant placement and treatment
YY/T 1457-2016 Non-active surgical implants—Determination method for oligomeric siloxanes in mammary implants
YY/T 1560-2017 Spinal implant—Standard test methods for occipital-cervical and occipital-cervical-thoracic implant constructs in a vertebrectomy model
YY 0989.7-2017 Implants for surgery—Active implantable medical devices—Part 7:Particular requirements for cochlear implant systems
YY 0989.6-2016 Implants for surgery―Active implantable medical devices―Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia(including implantable defibrillators)

Professional Standard - Medicine

YY 0989.3-2023 Implants for surgery - Active implantable medical devices - Part 3: implantable neurostimulators
YY/T 0682-2008 Implants for surgery - Minimum data sets for surgical implants
YY/T 0954-2015 Nonactive surgical implants--Type Ⅰ collagen implants--Specific requirements
YY 0647-2008 Non-active surgical implants - Mammary implants - Particular requirements
YY/T 0919-2014 Non-active surgical implants―Joint replacement implants―Specific requirements for knee-joint replacement implants
YY/T 0920-2014 Non-active surgical implants―Joint replacement implants―Specific requirements for hip-joint replacement implants
YY/T 1860.1-2024
YY 0954-2015 Nonactive surgical implants―Type Ⅰ collagen implants―Specific requirements

国家药监局

YY 0341.2-2020 Non-active surgical implants—Osteosynthesis and spinal implants—Part 2:Particular requirements for spinal implants
YY 0341.1-2020 Non-active surgical implants—Osteosynthesis and spinal implants—Part 1:Particular requirements for osteosynthesis implants
YY/T 0647-2021 Non-active surgical implants-Particular requirements of mammary implants

Group Standards of the People's Republic of China

T/CSBME 003-2018 Implants for surgery -Cleanliness of orthopedic implants-General requirements
T/GDAAV 1011-2024 Implant for surgery–Technical specifications for veterinary hip-joint replacement implants
T/CAMDI 045-2020 Finite Element Analysis Method for 3D Printed Metal Implants

Professional Standard - Civil Administration

MZ/T 210-2024 Electrophysiological detection method for preoperativecochlear implantation

German Institute for Standardization

DIN EN ISO 16054 E:2018-02 Surgical Implants Minimum Data Set for Surgical Implants (Draft)
DIN EN ISO 14607 E:2017-05 Passive Surgical Implants Breast Implant Specific Requirements (Draft)
DIN EN ISO 14801 E:2014-10 Dental Implants Dynamic Fatigue Testing of Bone Dental Implants (Draft)
DIN EN ISO 16672 E:2014-05 Surgical implants for intraocular tamponade (draft)
DIN EN ISO 11979-10 E:2017-02 Ophthalmic Implants Intraocular Lenses Part 10: Phakic Intraocular Lens Implantation (Draft)
DIN EN ISO 16671 E:2014-05 Ophthalmic Implants Ophthalmic Surgery Irrigation Solution (Draft)
DIN EN ISO 19429 E:2016-02 Nomenclature system for dental implants in dentistry (draft)
DIN EN ISO 15798 E:2021-02 Ophthalmic Implants Ophthalmic Viscosurgical Devices (Draft)
DIN EN ISO 15798 E:2012-07 Ophthalmic Implants Ophthalmic Viscosurgical Devices (Draft)
DIN CEN/TS 15277:2006 Non-active surgical implants - Injectable implants; German version CEN/TS 15277:2006
DIN EN ISO 11979-3 E:2011-08 Ophthalmic Implants Intraocular Lenses Part 3: Mechanical Properties and Test Methods (Draft)
DIN EN ISO 5840-2 E:2014-06 Cardiovascular Implants Heart Valve Prostheses Part 2: Surgically Implanted Heart Valve Substitutes (Draft)
DIN EN ISO 11979-1 E:2011-08 Ophthalmic Implants Intraocular Lenses Part 1: Glossary (Draft)
DIN CEN/TS 15277:2006-12 Non-active surgical implants - Injectable implants; German version CEN/TS 15277:2006
DIN EN ISO 11979-2 E:2013-07 Ophthalmic Implants Intraocular Lenses Part 2: Optical Properties and Test Methods (Draft)
DIN EN ISO 21536:2021-08 Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO/DIS 21536:2021); German and English version prEN ISO 21536:2021 / Note: Date of issue 2021-07-16*Intended as replacement for DIN ...
DIN EN ISO 21535:2021-08 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO/DIS 21535:2021); German and English version prEN ISO 21535:2021 / Note: Date of issue 2021-07-16*Intended as replacement for DIN E...
DIN EN ISO 13356 E:2012-10 Surgical implants containing yttria-stabilized tetragonal zirconia ceramic material (Y-TZP) (draft)
DIN EN ISO 11979-2 E:2012-07 Ophthalmic Implants Intraocular Lenses Part 2: Optical Properties and Test Methods (Draft)
DIN EN ISO 21536:2009 Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants
DIN EN ISO 21535:2017-04 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007 + Amd 1:2016); German version EN ISO 21535:2009 + A1:2016 / Note: To be replaced by DIN EN ISO 21535 (2021-08).
DIN EN ISO 21536:2014-07 Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2007 + Amd.1:2014); German version EN ISO 21536:2009 + A1:2014 / Note: To be replaced by DIN EN ISO 21536 (2021-08).
DIN EN ISO 5840-3 E:2011-04 Cardiovascular Implants Heart Valve Prostheses Part 3: Heart Valve Substitutes Implanted by Transcatheter Technology (Draft)
DIN EN ISO 16443 E:2013-06 Glossary of Dental Implant Systems and Related Procedures in Dentistry (Draft)
DIN EN ISO 14607:2018-10 Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2018, Corrected version 2018-08); German version EN ISO 14607:2018
DIN EN ISO 11979-8 E:2016-04 Ophthalmic Implants and Intraocular Lenses Part 8: Basic Requirements (Draft)
DIN EN ISO 13356 E:2014-05 Surgical implants containing yttria-stabilized tetragonal zirconia ceramic material (Y-TZP) (draft)
DIN EN ISO 14607:2007 Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007); German version EN ISO 14607:2007
DIN EN ISO 21535:2007 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007); German version EN ISO 21535:2007
DIN EN ISO 21536:2007 Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2007); German version EN ISO 21536:2007
DIN EN ISO 14602:2012-06 Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010); German version EN ISO 14602:2011
DIN EN ISO 14602:2012 Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010); German version EN ISO 14602:2011
DIN EN ISO 5832-2 E:2017-02 Metallic Materials for Surgical Implants Part 2: Unalloyed Titanium (Draft)
DIN EN ISO 5832-1 E:2023-03 Metallic Materials for Surgical Implants Part 1: Forged Stainless Steel (Draft)
DIN EN ISO 21534:2009-08 Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007); German version EN ISO 21534:2009 / Note: DIN EN ISO 21534 (2007-12) remains valid alongside this standard until 2010-03-21.
DIN EN ISO 7198 E:2014-10 Cardiovascular Implants and Extracorporeal Systems Vascular Prostheses Tubular Vascular Grafts and Vascular Patches (Draft)
DIN EN ISO 16054:2019 Implants for surgery - Minimum data sets for surgical implants (ISO 16054:2019)
DIN EN ISO 16054:2019-10 Implants for surgery - Minimum data sets for surgical implants (ISO 16054:2019); German version EN ISO 16054:2019
DIN EN ISO 21534:2007 Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007); German version EN ISO 21534:2007
DIN EN ISO 25539-2 E:2019-07 Cardiovascular Implants Cardiovascular Devices Part 2: Vascular Stents (Draft)
DIN EN ISO 25539-2 E:2012-03 Cardiovascular Implants Cardiovascular Devices Part 2: Vascular Stents (Draft)
DIN EN ISO 25539-2 E:2007-06 Cardiovascular Implants Cardiovascular Devices Part 2: Vascular Stents (Draft)
DIN EN ISO 5832-1 E:2018-08 Metallic Materials for Surgical Implants Part 1: Forged Stainless Steel (Draft)
DIN EN ISO 14607:2023 Non-active surgical implants - Mammary implants - Specific requirements (ISO/DIS 14607:2023); German and English version prEN ISO 14607:2023
DIN EN ISO 14801:2008 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants (ISO 14801:2007); English version of DIN EN ISO 14801:2008-02

British Standards Institution (BSI)

BS EN ISO 16671:2015+A1:2017 Ophthalmic implants. Irrigating solutions for ophthalmic surgery
23/30468575 DC Draft BS ISO 16671 Ophthalmic implants. Irrigating solutions for ophthalmic surgery
BS EN ISO 14708-4:2022 Implants for surgery. Active implantable medical devices. - Implantable infusion pump systems
BS ISO 12189:2008 Implants for surgery - Mechanical testing of implantable spinal devices - Fatigue test method for spinal implant assemblies using an anterior support
BS EN ISO 14708-3:2022 Implants for surgery. Active implantable medical devices - Implantable neurostimulators
BS EN 12006-3+A1:1999 Non active surgical implants. Particular requirements for cardiac and vascular implants. Endovascular devices
BS EN ISO 21536:2009+A1:2014 Non-active surgical implants. Joint replacement implants. Specific requirements for knee-joint replacement implants
BS EN 12006-3:1998+A1:2009 Non active surgical implants - Particular requirements for cardiac and vascular implants - Endovascular devices
BS EN ISO 16054:2001 Implants for surgery. Minimum data sets for surgical implants
BS ISO 16054:2001 Implants for surgery - Minimum data sets for surgical implants
BS EN ISO 21535:2009+A1:2016 Non-active surgical implants. Joint replacement implants. Specific requirements for hip-joint replacement implants
BS EN ISO 21536:2009 Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants
BS EN 12180:2000 Non-Active Surgical Implants - Body Contouring Implants - Specific Requirements for Mammary Implants
BS EN 12564:1999 Non-Active Surgical Implants - Joint Replacement Implants - Specific Requirements for Knee Joint Replacement Implants Ratified European Text
BS EN ISO 21535:2024 Non-active surgical implants. Joint replacement implants. Specific requirements for hip-joint replacement implants
BS EN 125:2010+A1:2015 Non-Active Surgical Implants - Joint Replacement Implants - Specific Requirements for Knee Joint Replacement Implants Ratified European Text
BS EN ISO 21535:2009 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants
BS EN ISO 21536:2024 Non-active surgical implants. Joint replacement implants. Specific requirements for knee-joint replacement implants
BS EN ISO 21535:2007 Non-active surgical implants — Joint replacement implants — Specific requirements for hipjoint replacement implants (ISO 21535:2007)
BS EN 12563:1999 Non-active surgical implants - Joint replacement implants - Specific requirements for hip joint replacement implants
BS EN ISO 14607:2018 Non-active surgical implants. Mammary implants. Particular requirements
BS EN ISO 14607:2008 Non-active surgical implants - Mammary implants - Particular requirements
BS EN ISO 21536:2007 Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants
BS EN ISO 14607:2009 Non-active surgical implants - Mammary implants - Particular requirements
BS ISO 17327-1:2018 Non-active surgical implants. Implant coating - General requirements
BS EN ISO 14607:2007 Non-active surgical implants - Mammary implants - Particular requirements
BS ISO 8828:2014 Implants for surgery. Guidance on care and handling of orthopaedic implants
BS EN ISO 14602:1998 Non-active surgical implants - Implants for osteosynthesis - Particular requirements
BS EN ISO 14602:2010 Non-active surgical implants - Implants for osteosynthesis - Particular requirements
BS EN ISO 21534:2009 Non-active surgical implants - Joint replacement implants - Particular requirements
BS EN ISO 14602:2011 Non-active surgical implants. Implants for osteosynthesis. Particular requirements
BS EN 12010:1998 Non-active surgical implants - Joint replacement implants - Particular requirements
BS EN ISO 11979-10:2006 Ophthalmic implants - Intraocular lenses - Phakic intraocular lenses
21/30390836 DC BS EN ISO 21536. Non-active surgical implants. Joint replacement implants. Specific requirements for knee-joint replacement implants
BS ISO 21278-1:2008 Equipment for crop protection - Induction hoppers - Test methods
BS EN ISO 14708-7:2022 Implants for surgery. Active implantable medical devices - Particular requirements for cochlear and auditory brainstem implant systems
BS EN ISO 16054:2019 Implants for surgery. Minimum data sets for surgical implants
21/30390833 DC BS EN ISO 21535. Non-active surgical implants. Joint replacement implants. Specific requirements for hip-joint replacement implants
BS EN ISO 14801:2007 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants
PD ISO/TS 17137:2021 Cardiovascular implants and extracorporeal systems. Cardiovascular absorbable implants
BS ISO 12891-1:2011 Implants for surgery. Retrieval and analysis of surgical implants. Retrieval and handling
BS PD ISO/TS 17137:2014 Cardiovascular implants and extracorporeal systems. Cardiovascular absorbable implants
BS ISO 23317:2009 Implants for surgery. In vitro evaluation for apatite-forming ability of implant materials
15/30316128 DC BS EN ISO 14708-3. Implants for surgery. Active implantable medical devices. Part 3. Implantable neurostimulators
20/30394028 DC BS EN ISO 14708-4. Implants for surgery. Active implantable medical devices. Part 4. Implantable infusion pump systems
BS ISO 19227:2018 Implants for surgery. Cleanliness of orthopedic implants. General requirements
BS 7254-6.2:1990 Orthopaedic implants - Forgings - Method for specifying forgings

SCC

DANSK DS/EN ISO 16671:2015 Ophthalmic implants - Irrigating solutions for ophthalmic surgery
DANSK DS/EN ISO 16671/A1:2015 Ophthalmic implants - Irrigating solutions for ophthalmic surgery
DIN EN ISO 14602 E:2009 Draft Document - Non-active surgical implants - Implants for Osteosynthesis - Particular requirements; German version prEN ISO 14602:2009
DIN ISO 14708-4 E:2007 Draft Document - Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pumps (ISO/DIS 14708-4:2007)
DIN EN ISO 21536/A1 E:2012 Draft Document - Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants - Amendment 1 (ISO 21536:2007/DAM 1:2012); German version EN ISO 21536:2009/prA1:2012
DIN EN ISO 16054 E:2018 Draft Document - Implants for surgery - Minimum data sets for surgical implants (ISO/DIS 16054:2017); German and English version prEN ISO 16054:2017
DIN ISO 14708-3 E:2007 Draft Document - Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators (ISO/DIS 14708-3:2007)
NS-EN ISO 16671:2015 Ophthalmic implants — Irrigating solutions for ophthalmic surgery (ISO 16671:2015)
DIN EN ISO 14708-3 E:2015 Draft Document - Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators (ISO/DIS 14708-3:2015); German version prEN ISO 14708-3:2015
DIN EN ISO 14607 E:2017 Draft Document - Non-active surgical implants - Mammary implants - Particular requirements (ISO/DIS 14607:2017); German and English version prEN ISO 14607:2017
DIN EN ISO 21536 E:2021 Draft Document – Non-active surgical implants – Joint replacement implants – Specific requirements for knee-joint replacement implants (ISO/DIS 21536:2021); German and English version prEN ISO 21536:2021
DIN EN ISO 21535 E:2021 Draft Document – Non-active surgical implants – Joint replacement implants – Specific requirements for hip-joint replacement implants (ISO/DIS 21535:2021); German and English version prEN ISO 21535:2021
AENOR UNE-EN ISO 21535/A1:2017 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants - Amendment 1 (ISO 21535:2007/Amd 1:2016)
DANSK DS/ISO 16428:2015 Implants for surgery - Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices
DIN EN ISO 14708-6 E:2018 Draft Document - Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators); German and English version prE...
DIN EN 1642 E:2008 Draft Document - Dentistry - Medical devices for dentistry - Dental implants; German version prEN 1642:2008
DIN EN ISO 16672 E:2018 Draft Document - Ophthalmic implants - Ocular endotamponades (ISO/DIS 16672:2018); German and English version prEN ISO 16672:2018
DIN 19412 E:2019 Draft Document - Dentistry - Vocabulary of implantable augmentation materials
DIN EN ISO 14708-2 E:2018 Draft Document - Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers (ISO/DIS 14708-2:2018); German and English version prEN ISO 14708-2:2018
DANSK DS/CEN/TS 15277:2006 Non-active surgical implants - Injectable implants
SN-CEN/TS 15277:2006 Non-active surgical implants — Injectable implants
DIN EN ISO 14630/A1 E:2009 Draft Document - Non-active surgical implants - General requirements (ISO 14630:2008); English version prEN ISO 14630:2008, Amendment 1
DIN EN ISO 14708-4 E:2020 Draft Document - Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pumps (ISO/DIS 14708-4:2020); German and English version prEN ISO 14708-4:2020
DIN EN ISO 14708-5 E:2019 Draft Document - Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices (ISO/DIS 14708-5:2019); German and English version prEN ISO 14708-5:2019
DIN EN 12006-3/A1 E:2009 Draft Document - Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices; English version EN 12006-3:1998/prA1:2008
BS PD 6540:1994 Dental implants. Guidelines for developing dental implants
DANSK DS/ISO 12189:2014 Implants for surgery – Mechanical testing of implantable spinal devices – Fatigue test method for spinal implant assemblies using an anterior support
DANSK DS/ISO 14708-4:2015 Implants for surgery – Active implantable medical devices – Part 4: Implantable infusion pumps
NS-EN 12180:2000 Non-active surgical implants — Body contouring implants — Specific requirements for mammary implants
CEI UNI EN ISO 14708-4:2023 Implants for surgery - Active implantable medical devices Part 4: Implantable infusion pump systems
CEI UNI EN ISO 14708-3:2023 Implants for surgery - Active implantable medical devices Part 3: Implantable neurostimulators
DANSK DS/ISO 14708-3:2015 Implants for surgery – Active implantable medical devices – Part 3: Implantable neurostimulators
AAMI/ISO 14708-3:2017 Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
DANSK DS/EN ISO 21536:2009 Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants
DANSK DS/EN ISO 21535:2009 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants
DANSK DS/EN ISO 14607:2009 Non-active surgical implants – Mammary implants – Particular requirements
DANSK DS/ISO 16054:2019 Implants for surgery – Minimum data sets for surgical implants
DANSK DS/EN ISO 21536/A1:2009 Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants
BS 3531-2:1980 Surgical implants-Specification for materials for metal surgical implants
NS-EN 12563:1998 Non-active surgical implants — Joint replacement implants — Specific requirements for hip joint replacement implants
DANSK DS/EN ISO 21535/A1:2009 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants
DIN EN ISO 5840-2 E:2019 Draft Document - Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO/DIS 5840-2:2019); German and English version prEN ISO 5840-2:2019
DIN EN ISO 14630 E:2022 Draft Document - Non-active surgical implants - General requirements (ISO/DIS 14630:2022); German and English version prEN ISO 14630:2022
NS-EN 12564:1998 Non-active surgical implants — Joint replacement implants — Specific requirements for knee joint replacement implants
DIN EN ISO 14708-7 E:2018 Draft Document - Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear implant systems (ISO/DIS 14708-7:2018); German and English version prEN ISO 14708-7:2018
DIN ISO 14708-5 E:2007 Draft Document - Implants for surgery - Active implantable medical devices - Part 5: Particular requirements for circulatory support systems (ISO/CDV2 14708-5:2006)
DANSK DS/EN ISO 14602:2011 Non-active surgical implants - Implants for osteosynthesis - Particular requirements
NS-EN ISO 14708-4:2022 Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pump systems (ISO 14708-4:2022)
06/30143831 DC ISO 21535. Non-active surgical implants. Joint replacement implants. Specific requirements for hip-joint replacement implants
NS-EN ISO 21535:2009 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007)
06/30143888 DC ISO 21536. Non-active surgical implants. Joint replacement implants. Specific requirements for knee-joint replacement implants
DIN EN ISO 14708-3:2022 Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators (ISO 14708-3:2017); German version EN ISO 14708-3:2022
DIN EN ISO 14708-4:2023 Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pump systems (ISO 14708-4:2022); German version EN ISO 14708-4:2022
DIN EN ISO 16671 E:2014 Draft Document - Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO/DIS 16671:2014); German version prEN ISO 16671:2014
DANSK DS/ISO 19227:2018 Implants for surgery – Cleanliness of orthopedic implants – General requirements
DANSK DS/EN ISO 14708-4:2022 Implants for surgery – Active implantable medical devices – Part 4: Implantable infusion pump systems (ISO 14708-4:2022)
DANSK DS/EN ISO 14708-3:2022 Implants for surgery – Active implantable medical devices – Part 3: Implantable neurostimulators (ISO/FDIS 14708-3:2016)
DIN EN ISO 17509 E:2014 Draft Document - Dentistry - Torque transmitter for handpieces used for implantation (ISO/DIS 17509:2014); German version prEN ISO 17509:2014
NS-EN ISO 14708-3:2022 Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators (ISO 14708-3:2017)
DANSK DS/ISO 8828:2014 Implants for surgery – Guidance on care and handling of orthopaedic implants
DANSK DS/EN ISO 21534:2009 Non-active surgical implants - Joint replacement implants - Particular requirements
AENOR UNE-EN ISO 21535:2009 Non-active surgical implants. Joint replacement implants. Specific requirements for hip joint replacement implants. (ISO 21535:2007)
NS-EN ISO 21535:2007 Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants (ISO 21535:2007)
NS-EN ISO 21536:2009 Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants (ISO 21536:2007)
NS-EN ISO 14607:2007 Non-active surgical implants — Mammary implants — Particular requirements (ISO 14607:2007)
NS-EN ISO 16054:2019 Implants for surgery — Minimum data sets for surgical implants (ISO 16054:2019)
NS-EN ISO 21536:2007 Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants (ISO 21536:2007)
BS EN ISO 21534:2007 Non-active surgical implants. Joint replacement implants. Particular requirements
NS-EN 12010:1998 Non-active surgical implants — Joint replacement implants — Particular requirements
DANSK DS/EN ISO 16054:2019 Implants for surgery – Minimum data sets for surgical implants (ISO 16054:2019)
BS EN ISO 16054:2002 Implants for surgery. Minimum data sets for surgical implants
NS-EN ISO 14607:2009 Non-active surgical implants — Mammary implants — Particular requirements (ISO 14607:2007)
BS 3531-16:1985 Surgical implants-Specification for surgical implants made of heat-vulcanized silicone elastomer
DIN EN ISO 5840-3 E:2019 Draft Document - Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO/DIS 5840-3:2019); German and English version prEN ISO 5840-3:2019
DIN EN ISO 16671/A1 E:2017 Draft Document - Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015/DAM 1:2017); German and English version EN ISO 16671:2015/prA1:2017
NS-EN ISO 14602:2009 Non-active surgical implants - Implants for Osteosynthesis - Particular requirements (ISO 14602:1998)
DIN EN ISO 5840-2/A1 E:2024 Draft Document - Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes - Amendment 1 (ISO 5840-2:2021/DAM 1:2024); German and English version EN ISO 5840-2:2021/prA1:2024
NS-EN ISO 14602:2011 Non-active surgical implants — Implants for osteosynthesis — Particular requirements (ISO 14602:2010)
NS-EN ISO 14602:2010 Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010)
DANSK DS/ISO 17327-1:2018 Non-active surgical implants – Implant coating – Part 1: General requirements
DANSK DS/ISO 14708-6:2022 Implants for surgery – Active implantable medical devices – Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
DANSK DS/ISO/TS 17137:2019 Cardiovascular implants and extracorporeal systems – Cardiovascular absorbable implants
BS 3531-17:1985 Surgical implants-Recommendations for the care and handling of orthopaedic surgical implants
DIN EN ISO 11979-2 E:2013 Draft Document - Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods (ISO/DIS 11979-2:2013); German version prEN ISO 11979-2:2013
BS PD ISO/TS 17137:2019 Cardiovascular implants and extracorporeal systems. Cardiovascular absorbable implants
DIN EN ISO 11979-3 E:2011 Draft Document - Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods (ISO/DIS 11979-3:2011); German version prEN ISO 11979-3:2011
DANSK DS/ISO 14708-7:2022 Implants for surgery – Active implantable medical devices – Part 7: Particular requirements for cochlear and auditory brainstem implant systems
CEI UNI EN ISO 14708-7:2023 Implants for surgery - Active implantable medical devices Part 7: Particular requirements for cochlear and auditory brainstem implant systems
DIN EN ISO 15798/A1 E:2016 Draft Document - Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2013/DAM 1:2016), German and English version EN ISO 15798:2013/prA1:2016

Spanish Association for Standardization (UNE)

UNE-EN ISO 16671:2016 Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015)
UNE-EN ISO 16671:2004 Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2003)
UNE-EN ISO 21536:2009/A1:2014 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 21535:2009/A1:2017 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 16671:2016/A1:2018 Ophthalmic implants - Irrigating solutions for ophthalmic surgery - Amendment 1 (ISO 16671:2015/Amd 1:2017)
UNE-CEN/TS 15277:2007 EX Non-active surgical implants - Injectable implants
UNE-EN 12180:2000 Non-active surgical implants. Body contouring implants. Specific requirements for mammary implants.
UNE-EN ISO 14708-4:2023 Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pump systems (ISO 14708-4:2022)
UNE-EN ISO 14708-3:2023 Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators (ISO 14708-3:2017)
UNE-EN ISO 14607:2018 Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2018, Corrected version 2018-08)
UNE-EN ISO 16054:2020 Implants for surgery - Minimum data sets for surgical implants (ISO 16054:2019)
UNE-EN 12563:1999 NON ACTIVE SURGICAL IMPLANTS. JOINT REPLACEMENT IMPLANTS. SPECIFIC REQUIREMENTS FOR HIP JOINT REPLACEMENT IMPLANTS.
UNE-EN 12564:1999 NON ACTIVE SURGICAL IMPLANTS. JOINT REPLACEMENT IMPLANTS. SPECIFIC REQUIREMENTS FOR KNEE JOINT REPLACEMENT IMPLANTS.
UNE-EN ISO 21535:2008 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007)
UNE-EN ISO 21536:2008 Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2007)
UNE-EN ISO 21536:2009 Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2007)
UNE-EN ISO 21535:2009 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007)
UNE-EN ISO 14607:2007 Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007)
UNE-EN ISO 16054:2002 Implants for surgery. Minimum data sets for surgical implants. (ISO 16054:2000)
UNE-EN 12010:1998 NON-ACTIVE SURGICAL IMPLANTS. JOINT REPLACEMENT IMPLANTS. PARTICULAR REQUIREMENTS.
UNE-EN ISO 14602:2010 Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010)
UNE-EN ISO 14602:2009 Non-active surgical implants - Implants for Osteosynthesis - Particular requirements (ISO 14602:1998)
UNE-EN ISO 14708-7:2023 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 14607:2009 Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007)

Association Francaise de Normalisation

NF EN ISO 16671:2015 Ophthalmic Implants - Irrigation Solutions for Ophthalmic Surgery
NF EN ISO 16671/A1:2018 Ophthalmic Implants - Irrigation Solutions for Ophthalmic Surgery - Amendment 1
NF EN ISO 21536/A1:2014 Non-active surgical implants - Joint replacement implants - Specific requirements for knee joint replacement implants - Amendment 1
NF S94-165/A1*NF EN ISO 21535/A1:2017 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants - Amendment 1
NF EN ISO 21535/A1:2017 Non-active surgical implants - Joint replacement implants - Specific requirements for hip joint replacement implants - Amendment 1
NF S94-752/A1*NF EN ISO 16671/A1:2018 Ophthalmic implants - Irrigating solutions for ophthalmic surgery - Amendment 1
XP CEN/TS 15277:2007 Implants chirurgicaux non actifs - Implants injectables
NF S94-751:2013 Ophthalmic implants - Ophthalmic viscosurgical devices
NF EN ISO 14602:2012 Implants chirurgicaux non actifs - Implants pour ostéosynthèse - Exigences particulières
XP S94-092*XP CEN/TS 15277:2007 Non-active surgical implants - Injectable implants
NF EN ISO 14708-3:2022 Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 3 : Neurostimulateurs en implant
NF EN ISO 14708-4:2022 Surgical implants - Active implantable medical devices - Part 4: Implantable infusion pump systems
NF EN ISO 21536:2009 Non-active surgical implants - Joint replacement implants - Specific requirements for knee joint replacement implants
NF EN ISO 14607:2018 Implants chirurgicaux non actifs - Implants mammaires - Exigences particulières
NF S94-174*NF EN ISO 21536:2009 Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants
NF EN ISO 21535:2009 Non-active surgical implants - Joint replacement implants - Specific requirements for hip joint replacement implants
NF S94-103:2002 Implants for surgery - Minimum data sets for surgical implants.
NF S94-103*NF EN ISO 16054:2019 Implants for surgery - Minimum data sets for surgical implants
NF S94-350*NF EN ISO 14607:2018 Non-active surgical implants - Mammary implants - Particular requirements
NF EN ISO 16054:2019 Surgical implants - Minimum data sets for surgical implants
NF S94-350:2009 Non-active surgical implants - Mammary implants - Particular requirements.
NF S94-165*NF EN ISO 21535:2009 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants
NF S94-350:2007 Non-active surgical implants - Mammary implants - Particular requirements.
NF S94-165:2008 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants.
NF S94-174:2008 Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants.
NF S94-101*NF EN ISO 14602:2012 Non-active surgical implants - Implants for osteosynthesis - Particular requirements
NF S94-091*NF ISO 19227:2018 Implants for surgery - Cleanliness of orthopedic implants - General Requirements
NF EN ISO 21534:2009 Non-active surgical implants - Joint replacement implants - Special requirements
NF S94-174/A1*NF EN ISO 21536/A1:2014 Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants - Amendment 1
NF ISO 19227:2018 Implants chirurgicaux - Propreté des implants orthopédiques - Exigences générales
NF S94-164*NF EN ISO 21534:2009 Non-active surgical implants - Joint replacement implants - Particular requirements.
NF S94-164:1998 Non-active surgical implants. Joint replacement implants. Particular requirements.
NF S91-157:2008 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants.
NF S91-157*NF EN ISO 14801:2016 Dentistry - Implants - Dynamic loading test for endosseous dental implants
NF S94-164:2008 Non-active surgical implants - Joint replacement implants - Particular requirements.
NF S90-437:1989 Implants for surgery. Guidance on care and handling of orthopaedic implants.
NF S94-101:1998 Non-active surgical implants. Implants for osteosynthesis. Particular requirements.

Korean Agency for Technology and Standards (KATS)

KS P ISO 16428-2022 Implants for surgery－Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices
KS P ISO 12189-2009(2019) Implants for surgery－Mechanical testing of implantable spinal devices－Fatigue test method for spinal implant assemblies using an anterior support
KS P ISO 14708-4:2021 Implants for surgery — Active implantable medical devices —Part 4: Implantable infusion pumps
KS P ISO 14708-4:2010 Implants for surgery-N implantable medical devices-Part 4:Implantable infusion pumps
KS P ISO 12189-2019 Implants for surgery－Mechanical testing of implantable spinal devices－Fatigue test method for spinal implant assemblies using an anterior support
KS P ISO 14708-4-2010(2016) Implants for surgery－Active implantable medical devices－Part 4：Implantable infusion pumps
KS P ISO TR 11175:2010 Dental implants－Guidelines for developing dental implants
KS P ISO TR 11175-2010(2016) Dental implants－Guidelines for developing dental implants
KS P ISO 12189:2009 Implants for surgery－Mechanical testing of implantable spinal devices－Fatigue test method for spinal implant assemblies using an anterior support
KS P ISO 14708-3:2010 Implants for surgery-N implantable medical devices-Part 3:Implantable neurostimulators
KS P ISO 14708-3:2021 Implants for surgery — Active implantable medical devices —Part 3: Implantable neurostimulators
KS P ISO 14708-3-2010(2016) Implants for surgery－Active implantable medical devices－Part 3：Implantable neurostimulators
KS P ISO 16054-2019 Implants for surgery－Minimum data sets for surgical implants
KS P ISO 16054-2009(2019) Implants for surgery－Minimum data sets for surgical implants
KS P ISO 16054:2009 Implants for surgery－Minimum data sets for surgical implants
KS P ISO 21535:2010 Non-active surgical implants－Joint replacement implants－Specific requirements for hip-joint replacement implants
KS P ISO 21536:2020 Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants
KS P ISO 14602:2017 Non-active surgical implants－Implants for osteosynthesis－Particular requirements
KS P ISO 8828:2019 Implants for surgery — Guidance on care and handling of orthopaedic implants
KS P ISO 14602-2022 Non-active surgical implants－Implants for osteosynthesis－Particular requirements
KS P ISO 14607:2020 Non-active surgical implants — Mammary implants — Particular requirements
KS P ISO 21535:2017 Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants
KS P ISO 14607:2009 Implants for surgery-Specific requirements for mammary implants
KS P ISO 14801:2019 Dentistry — Implants — Dynamic loading test for endosseous dental implants
KS P ISO 14602:2010 Non-N surgical implants-Implants for osteosynthesis-Particular requirements
KS P ISO 21536:2009 Non-active surgical implants－Joint replacement implants－Specific requirements for knee-joint replacement implants
KS P ISO 21534-2019 Non－active surgical implants－Joint replacement implants－Particular requirements
KS P ISO 13782:2009 Implants for surgery－Metallic materials－Unalloyed tantalum for surgical implant applications
KS P ISO 8828-2023 Implants for surgery — Guidance on care and handling of orthopaedic implants
KS P ISO TR 18130:2019 Dentistry — Screw loosening test using cyclic torsional loading for implant body/implant abutment connection of endosseous dental implants
KS P ISO 13782:2021 Implants for surgery — Metallic materials — Unalloyed tantalum for surgical implant applications
KS P ISO 13782-2009(2019) Implants for surgery－Metallic materials－Unalloyed tantalum for surgical implant applications
KS P ISO 21534:2009 Non－active surgical implants－Joint replacement implants－Particular requirements
KS P ISO 21534-2009(2019) Non－active surgical implants－Joint replacement implants－Particular requirements
KS P ISO 8828:2008 Implants for surgery-Guidance on care and handling of orthopaedic implants
KS P ISO 14801:2013 Dentistry－Implants－Dynamic fatigue test for endosseous dental implants
KS P ISO 5841-1:2007 Implants for surgery－Cardiac pacemakers－Part 1：Implantable pacemakers
KS P ISO 5841-1-2007 Implants for surgery－Cardiac pacemakers－Part 1：Implantable pacemakers
KS P ISO 5841-1:2002 Implants for surgery－Cardiac pacemakers－Part 1：Implantable pacemakers
KS P ISO 10310:2010 Neurosurgical implants-Marking and packaging of implantable neural stimulators

European Committee for Standardization (CEN)

prEN ISO 16671 Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO/DIS 16671:2023)
EN 12180:2000 Non-Active Surgical Implants - Body Contouring Implants - Specific Requirements for Mammary Implants
EN ISO 14708-4:2022 Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pump systems (ISO 14708-4:2022)
EN ISO 14708-3:2022 Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators (ISO 14708-3:2017)
EN 12564:1998 Non-Active Surgical Implants - Joint Replacement Implants - Specific Requirements for Knee Joint Replacement Implants Ratified European Text
EN ISO 16054:2019 Implants for surgery - Minimum data sets for surgical implants (ISO 16054:2019)
EN ISO 21535:2009 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (Incorporates Amendment A1: 2016)
EN ISO 14708-7:2022 Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear and auditory brainstem implant systems (ISO 14708-7:2019)
EN ISO 14607:2018 Non-active surgical implants - Mammary implants - Particular requirements
EN ISO 21536:2009 Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2007)
EN ISO 14607:2009 Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007)
EN ISO 14602:2010 Non-active surgical implants - Implants for osteosynthesis - Particular requirements
EN ISO 14602:2009 Non-active surgical implants - Implants for Osteosynthesis - Particular requirements
EN ISO 21536:2007 Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants
EN ISO 14602:2011 Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010)
prEN ISO 21535:2021 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO/DIS 21535:2021)
EN ISO 16054:2002 Implants for surgery - Minimum data sets for surgical implants ISO 16054: 2000
FprEN ISO 21536 Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO/FDIS 21536:2023)
FprEN ISO 21535 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO/FDIS 21535:2023)
EN ISO 21534:2009 Non-active surgical implants - Joint replacement implants - Particular requirements
prEN ISO 21536:2021 Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO/DIS 21536:2021)
EN ISO 14801:2007 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants
EN ISO 14801:2003 Dentistry - Fatigue test for endosseous dental implants ISO 14801:2003
EN ISO 21535:2007 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants [Superseded: CEN EN 12563]
EN ISO 21535:2009/A1:2016 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants - Amendment 1 (ISO 21535:2007/Amd 1:2016)
prEN ISO 14607 Non-active surgical implants - Mammary implants - Particular requirements (ISO/DIS 14607:2023)

GSO

BH GSO ISO 16428:2017 Implants for surgery -- Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices
GSO ISO 16428:2016 Implants for surgery -- Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices
OS GSO ISO 16428:2016 Implants for surgery -- Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices
GSO ISO 14708-4:2015 Implants for surgery -- Active implantable medical devices -- Part 4: Implantable infusion pumps
OS GSO ISO 14708-4:2015 Implants for surgery -- Active implantable medical devices -- Part 4: Implantable infusion pumps
OS GSO ISO 12189:2015 Implants for surgery -- Mechanical testing of implantable spinal devices -- Fatigue test method for spinal implant assemblies using an anterior support
OS GSO ISO 14708-3:2015 Implants for surgery -- Active implantable medical devices -- Part 3: Implantable neurostimulators
GSO ISO 14708-3:2015 Implants for surgery -- Active implantable medical devices -- Part 3: Implantable neurostimulators
GSO ISO 14708-3:2024 Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators
GSO ISO 14708-4:2024 Implants for surgery — Active implantable medical devices — Part 4: Implantable infusion pump systems
GSO ISO 21535:2015 Non-active surgical implants -- Joint replacement implants -- Specific requirements for hip-joint replacement implants
OS GSO ISO 21536:2015 Non-active surgical implants -- Joint replacement implants -- Specific requirements for knee-joint replacement implants
BH GSO ISO 21536:2017 Non-active surgical implants -- Joint replacement implants -- Specific requirements for knee-joint replacement implants
BH GSO ISO 21535:2017 Non-active surgical implants -- Joint replacement implants -- Specific requirements for hip-joint replacement implants
GSO ISO 21536:2015 Non-active surgical implants -- Joint replacement implants -- Specific requirements for knee-joint replacement implants
GSO ISO 14607:2015 Non-active surgical implants -- Mammary implants -- Particular requirements
OS GSO ISO 21535:2015 Non-active surgical implants -- Joint replacement implants -- Specific requirements for hip-joint replacement implants
BH GSO ISO 16054:2017 Implants for surgery -- Minimum data sets for surgical implants
OS GSO ISO 14607:2015 Non-active surgical implants -- Mammary implants -- Particular requirements
OS GSO ISO 16054:2015 Implants for surgery -- Minimum data sets for surgical implants
BH GSO ISO 14602:2017 Non-active surgical implants -- Implants for osteosynthesis -- Particular requirements
GSO ISO 14602:2015 Non-active surgical implants -- Implants for osteosynthesis -- Particular requirements
GSO ISO 21534:2015 Non-active surgical implants -- Joint replacement implants -- Particular requirements
BH GSO ISO 21534:2017 Non-active surgical implants -- Joint replacement implants -- Particular requirements
BH GSO ISO 8828:2017 Implants for surgery -- Guidance on care and handling of orthopaedic implants
OS GSO ISO 21534:2015 Non-active surgical implants -- Joint replacement implants -- Particular requirements
OS GSO ISO 8828:2016 Implants for surgery -- Guidance on care and handling of orthopaedic implants
GSO ISO 8828:2016 Implants for surgery -- Guidance on care and handling of orthopaedic implants
OS GSO ISO/TS 17137:2015 Cardiovascular implants and extracorporeal systems -- Cardiovascular absorbable implants

International Organization for Standardization (ISO)

ISO 14117:2019 Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization device
ISO 12189:2008 Implants for surgery - Mechanical testing of implantable spinal devices - Fatigue test method for spinal implant assemblies using an anterior support
ISO 14708-4:2008 Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pumps
ISO 15798:2013 Ophthalmic implants.Ophthalmic viscosurgical devices
ISO/TR 11175:1993 Dental implants; guidelines for developing dental implants
ISO 14708-4:2022 Implants for surgery — Active implantable medical devices — Part 4: Implantable infusion pump systems
ISO 14708-3:2008 Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
ISO 14708-3:2017 Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
ISO 14607:2002 Implants for surgery - Specific requirements for mammary implants
ISO 16054:2000 Implants for surgery - Minimum data sets for surgical implants
ISO/DIS 14607:2023 Non-active surgical implants — Mammary implants — Specific requirements
ISO/FDIS 14607:2024 Non-active surgical implants — Mammary implants — Specific requirements
ISO 21535:2007 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants
ISO 21536:2007 Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants
ISO 16054:2019 Implants for surgery — Minimum data sets for surgical implants
ISO 21535:2023 Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants
ISO/PRF 5832-7:2024 Implants for surgery
ISO/CD 14607 Non-active surgical implants — Mammary implants — Specific requirements
ISO/FDIS 21535 Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants
ISO/FDIS 21536 Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants
ISO 14708-7:2013 Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear implant systems
ISO 11979-7:2024 Ophthalmic implants
ISO/CD 5834-2:2024 Implants for surgery
ISO/DIS 16436-1:2024 Implants for surgery
ISO 14607:2007 Non-active surgical implants - Mammary implants - Particular requirements
ISO 14607:2018 Non-active surgical implants - Mammary implants - Particular requirements
ISO 5840:1984 Implants for surgery — Cardiovascular implants — Cardiac valve prostheses
ISO 21536:2023 Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants
ISO/CD 5834-3:2024 Implants for surgery
ISO/CD 5834-1:2024 Implants for surgery
ISO/CD 5834-4:2024 Implants for surgery
ISO 5832-4:2024 Implants for surgery
ISO/CD 11979-4:2024 Ophthalmic implants
ISO/CD 5834-5:2024 Implants for surgery
ISO 5832-11:2024 Implants for surgery
ISO/PRF 5832-1:2024 Implants for surgery
ISO 5832-7:2024 Implants for surgery
ISO/PRF 5832-11:2024 Implants for surgery
ISO 21535:2002 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants
ISO/DIS 16671:2023 Ophthalmic implants
ISO/PRF 5832-4:2024 Implants for surgery
ISO 21536:2002 Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants
ISO 14801:2016 Dentistry - Implants - Dynamic loading test for endosseous dental implants
ISO 8828:1988 Implants for surgery; guidance on care and handling of orthopaedic implants
ISO 8828:2014 Implants for surgery - Guidance on care and handling of orthopaedic implants
ISO 15798:2013/Amd 1:2017 Ophthalmic implants - Ophthalmic viscosurgical devices; Amendment 1
ISO 14602:2010 Non-active surgical implants - Implants for osteosynthesis - Particular requirements
ISO 13782:1996 Implants for surgery - Metallic materials - Unalloyed tantalum for surgical implant applications
ISO 14602:1998 Non-active surgical implants - Implants for Osteosynthesis - Particular requirements
ISO 5840-3:2021/CD Amd 1:2023 Cardiovascular implants
ISO/FDIS 25539-3:2024 Cardiovascular implants
ISO 21535:2007/Amd 1:2016 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants; Amendment 1
ISO 5840-3:2021/DAmd 1:2024 Cardiovascular implants
ISO 5840-1:2021/DAmd 1:2023 Cardiovascular implants
ISO 5840-2:2021/CD Amd 1:2023 Cardiovascular implants
ISO 5840-2:2021/DAmd 1:2023 Cardiovascular implants
ISO 5840-1:2021/CD Amd 1:2023 Cardiovascular implants
ISO 21536:2007/Amd 1:2014 Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants; Amendment 1
ISO 21534:2007 Non-active surgical implants - Joint replacement implants - Particular requirements
ISO 14801:2007 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants
ISO 14708-7:2019 Implants for surgery — Active implantable medical devices — Part 7: Particular requirements for cochlear and auditory brainstem implant systems
ISO 21534:2002 Non-active surgical implants - Joint replacement implants - Particular requirements
ISO/TS 20721:2020 Implants for surgery — General guidelines and requirements for assessment of absorbable metallic implants
ISO/TS 17137:2019 Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants
ISO 19227:2018 Implants for surgery - Cleanliness of orthopedic implants - General requirements
ISO 23317:2014 Implants for surgery - In vitro evaluation for apatite-forming ability of implant materials

RU-GOST R

GOST 31619-2012 Implantable mammary prostheses. General technical requirements. Test methods
GOST R ISO 16428-2014 Implants for surgery. Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices
GOST R ISO 14708-4-2016 Implants for surgery. Active implantable medical devices. Part 4. Implantable infusion pumps
GOST R ISO 12189-2017 Implants for surgery. Mechanical testing of implantable spinal devices. Fatigue test method for spinal implant assemblies using an anterior support
GOST R ISO 14708-3-2016 Implants for surgery. Active Implantable medical devices. Part 3. Implantable neurostimulators
GOST R 57390-2017 Implants for surgery. Specification standard test methods for spinal implant constructs in a vertebrectomy model
GOST R ISO 21535-2013 Non-active surgical implants. Joint replacement implants. Specific requirements for hip-joint replacement implants
GOST R ISO 16054-2013 Implants for surgery. Minimum data sets for surgical implants
GOST R ISO 21536-2013 Non-active surgical implants. Joint replacement implants. Specific requirements for knee-joint replacement implants
GOST R ISO 14708-7-2016 Implants for surgery. Active Implantable medical devices. Part 7. Particular requirements for cochlear implant systems
GOST 30399-1995 Implants for surgery. Metal bone screws with asymmetrical thrend and spherical under-surface. Mechanical requirements and test methods
GOST R ISO 14607-2017 Non-active surgical implants. Mammary implants. Particular requirements
GOST R ISO 14602-1999 Non-active surgical implants. Implants for osteosynthesis. Particular requirements
GOST R ISO 21534-2013 Non-active surgical implants. Joint replacement implants. Particular requirements
GOST R ISO 14801-2012 Dentistry. Implants. Dynamic fatigue tests for endosseous dental implants
GOST R ISO 13782-2017 Implants for surgery. Metallic materials. Unalloyed tantalum for surgical implant applications
GOST ISO 14602-2012 Non-active surgical implants. Implants for osteosynthesis. Particular requirements
GOST R 53078-2008 Ophthalmic implants. Ophthalmic viscosurgical devices. General safety requirements

YU-JUS

JUS N.S5.710-1990 Implants for surgerjr. Implantable cardlac pacemakers

American National Standards Institute （ANSI)

ANSI/AAMI/ISO 14708-4:2008(2011) Implants for surgery—Active implantable medical devices—Part 4: Implantable infusion pumps
ANSI/AAMI/ISO 14708-4:2008 Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pumps
ANSI/AAMI/ISO 14708-3:2017 Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators
ANSI/AAMI/ISO 14708-3:2008 Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators

Danish Standards Foundation

DS/CEN/TS 15277:2007 Non-active surgical implants - Injectable implants
DS/EN ISO 21535:2009 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants
DS/EN ISO 14607:2009 Non-active surgical implants - Mammary implants - Particular requirements
DS/EN ISO 21536:2009 Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants
DS/EN ISO 21534:2009 Non-active surgical implants - Joint replacement implants - Particular requirements
DS/EN ISO 14602:2012 Non-active surgical implants - Implants for osteosynthesis - Particular requirements
DS/EN ISO 16054:2002 Implants for surgery - Minimum data sets for surgical implants (ISO 16054:2000)
DS/EN ISO 14801:2008 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants
DS/ISO/TS 17137:2021 Cardiovascular implants and extracorporeal systems – Cardiovascular absorbable implants

KR-KS

KS P ISO 14708-4-2021 Implants for surgery — Active implantable medical devices —Part 4: Implantable infusion pumps
KS P ISO 14708-3-2021 Implants for surgery — Active implantable medical devices —Part 3: Implantable neurostimulators
KS P ISO 21536-2020 Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint replacement implants
KS P ISO 14801-2019 Dentistry — Implants — Dynamic loading test for endosseous dental implants
KS P ISO 21535-2017 Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants
KS P ISO 21535-2022 Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants
KS P ISO 14607-2020 Non-active surgical implants — Mammary implants — Particular requirements
KS P ISO 8828-2019 Implants for surgery — Guidance on care and handling of orthopaedic implants
KS P ISO 14602-2017 Non-active surgical implants－Implants for osteosynthesis－Particular requirements
KS P ISO TR 18130-2019 Dentistry — Screw loosening test using cyclic torsional loading for implant body/implant abutment connection of endosseous dental implants
KS P ISO 14602-2017(2022) Non-active surgical implants－Implants for osteosynthesis－Particular requirements
KS P ISO 13782-2021 Implants for surgery — Metallic materials — Unalloyed tantalum for surgical implant applications
KS P ISO 5841-1-2002 Implants for surgery－Cardiac pacemakers－Part 1：Implantable pacemakers

Standard Association of Australia （SAA）

AS ISO 8828:2015 Implants for surgery - Care and handling of orthopaedic implants
AS ISO 14602:2015 Non-active surgical implants — Implants for osteosynthesis — Particular requirements

BR-ABNT

ABNT NBR ISO 14607:2013 Non-active surgical implants - Mammary implants - Particular requirements

BSI

DANSK DS/ISO 21535:2024 Non-active surgical implants – Joint replacement implants – Specific requirements for hip-joint replacement implants
DANSK DS/ISO 21536:2024 Non-active surgical implants – Joint replacement implants – Specific requirements for knee-joint replacement implants

GOSTR

GOST R ISO 21535-2020 Non-active surgical implants. Joint replacement implants. Specific requirements for hip-joint replacement implants

Australian/New Zealand Standard (AU-AS/NZS)

AS/NZS 2817:1997 Implants for surgery - Care and handling of orthopaedic implants

CEN - European Committee for Standardization

EN 12010:1998 Non-Active Surgical Implants - Joint Replacement Implants - Particular Requirements

Indonesia Standards

SNI ISO 21534:2011 Non-active surgical implants - Joint replacement implants - Particular requirements

TH-TISI

TIS 1684-1998 Implants for surgery.guidance on care and handling of orthopaedic implants

Lithuanian Standards Office

LST EN ISO 21535:2009 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007)
LST EN ISO 21536:2009 Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2007)
LST EN ISO 16054:2003 Implants for surgery - Minimum data sets for surgical implants (ISO 16054:2000)
LST EN ISO 14607:2009 Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007)

VN-TCVN

TCVN 6796-2001 Implants for surgery.Guidance on care and handling of orthopaedic implants

American Society for Testing and Materials (ASTM)

ASTM F703-96 Standard Specification for Implantable Breast Prostheses
ASTM F703-96(2002)e1 Standard Specification for Implantable Breast Prostheses
ASTM F703-96(2002) Standard Specification for Implantable Breast Prostheses
ASTM F703-18(2022) Standard Specification for Implantable Breast Prostheses

AT-ON

OENORM EN ISO 21536:2021 Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO/DIS 21536:2021)
OENORM EN ISO 21535:2021 Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO/DIS 21535:2021)

PT-IPQ

NP EN 12010-2000 Non-active surgical implants Joint replacement implants Particular requirements

DIN

DIN EN ISO 14602:1998 Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:1998)