Surgical Implants - Related International Standards
The following non-harmonised international standards are related to Surgical Implants for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| ISO 5832-1:2024 | Implants for surgery - Metallic materials - Part 1: Wrought stainless steel | active | 10, 14 | Link |
| ISO 5832-3:2021 | Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy | active | 10, 14 | Link |
| ISO 5840-1:2021 | Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements | active | 10, 14, 19 | Link |
| ISO 14708-1:2014 | Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer | active | 14, 18, 19, 23 | Link |
| ASTM F2083-21 | Standard Specification for Knee Replacement Prosthesis | withdrawn | 10, 14 | Link |
| ASTM F2033-25 | Standard Specification for Hip Joint Replacement Bearing Surfaces | active | 10, 14 | Link |
| IEC 60601-2-41:2021 | Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis | active | 14, 14.1 | Link |
| IEC 60601-2-46:2023 | Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables | active | 14, 14.1 | Link |
| IEC 60601-2-76:2018+AMD1:2023 | Medical electrical equipment - Part 2-76: Particular requirements for the basic safety and essential performance of low energy ionized gas haemostasis equipment | active | 14, 14.1 | Link |
| ISO 14630:2024 | Non-active surgical implants - General requirements (ISO 14630:2024) | active | 19 | Link |
| ISO 21535:2023 | Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2023) | active | 10, 10.1, 10.3, 11, 19 | Link |
| ISO 21536:2024 | Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2023) | active | 10, 10.1, 10.3, 11, 19 | Link |
| ISO 14607:2024 | Non-active surgical implants - Mammary implants - Specific requirements (ISO 14607:2024) | active | 10, 10.1, 10.3, 10.4, 11, 19 | Link |