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Committee

Committee:

CTN 91 - Implants for surgery

Secretary:
FENIN - FEDERACIÓN ESPAÑOLA DE EMPRESAS DE TECNOLOGÍA SANITARIA
Field of Activity:
Standardization of:

Specific materials both basic and composite for implants for surgery and standardization of the required instrumentation for its implantation, covering terminology, specifications and test methods.

Excluding:

Materials and surgical instruments which are within the scope of other committees.

Note: Implants for surgery are meant objects or devices which are surgically implanted in the body either temporarily or permanently for diagnostic or therapeutic purposes.
International Relations:

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: 138

UNE-EN ISO 7197:2025

Status: VIGENTE / 2025-07-09

Neurosurgical implants - Sterile, single-use hydrocephalus shunts (ISO 7197:2024)

UNE-EN ISO 11979-2:2025

Status: VIGENTE / 2025-07-09

Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods (ISO 11979-2:2024)

UNE-EN ISO 5840-1:2021/A1:2025 (Ratificada)

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 (Ratificada)

Status: VIGENTE / 2025-05-01

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 (Ratificada)

Status: VIGENTE / 2025-05-01

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 21535:2025

Status: VIGENTE / 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

Status: VIGENTE / 2025-01-22

Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2023)

UNE-EN ISO 25539-3:2024 (Ratificada)

Status: VIGENTE / 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 12417-1:2024

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

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

Status: VIGENTE / 2024-11-06

Implants for surgery - Metallic materials - Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy (ISO 5832-7:2024)

UNE-EN ISO 14708-3:2023

Status: VIGENTE / 2023-05-17

Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators (ISO 14708-3:2017)

UNE-EN ISO 14708-6:2023

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 14708-7:2023

Status: VIGENTE / 2023-05-17

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

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

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

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

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

Status: VIGENTE / 2022-09-21

Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2022)

UNE-EN ISO 5832-3:2022

Status: VIGENTE / 2022-09-21

Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy (ISO 5832-3:2021)

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