Other Applicable Standards (Non-Harmonised)
Beyond harmonised standards, medical device manufacturers commonly apply the following international standards (ISO, IEC, ASTM, etc.) to demonstrate compliance with EU MDR GSPR. While these do not create a presumption of conformity, they represent accepted state-of-the-art practices.
Total: 384 standards across 63 categories
Categories
| Category | Standards | Key Standards |
|---|---|---|
| Active Implants | 4 | ISO 14708-6:2019, ISO 14708-2:2019, ISO 14708-3:2017... |
| Additive Manufacturing (3D Printing) | 5 | ISO/ASTM 52900:2021, ISO/ASTM 52910:2018, ISO/ASTM 52920:2023... |
| AI and Machine Learning | 10 | ISO/TS 24971-2:2026, AAMI/BSI 34971:2023, IEC PAS 63621:2026... |
| Anaesthesia Equipment | 2 | ISO 80601-2-13:2022, ISO 11197:2019 |
| Annex XVI (Non-medical Purpose) | 3 | Regulation (EU) 2017/745 Annex XVI, Regulation (EU) 2022/2346, ISO 14889:2025 |
| Assistive Technology | 6 | ISO 7176-1:2014, ISO 7176-8:2014, ISO/TS 16840-15:2024... |
| Audiology | 5 | IEC 60601-2-66:2019, IEC 60645-1:2017, IEC 60645-7:2025... |
| Biocompatibility | 24 | ISO 10993-1:2025, ISO 10993-2:2022, ISO 10993-6:2026... |
| Biological Materials | 6 | ISO 22442-1:2020, ISO 22442-2:2020, ISO 22442-3:2007... |
| Breathing Gas Pathways | 14 | ISO 80601-2-87:2021, ISO 18562-1:2024, ISO 18562-2:2024... |
| Cardiology | 8 | IEC 60601-2-47:2012, IEC 60601-2-25:2011, IEC 60601-2-31:2020... |
| Clinical Investigation | 2 | ISO 14155:2026, ISO 20916:2019 |
| Cybersecurity | 6 | IEC 81001-5-1:2021, IEC TR 60601-4-5:2021, IEC 80001-1:2021... |
| Dental | 6 | IEC 60601-2-63:2012+AMD1:2017+AMD2:2021, IEC 60601-2-65:2012+AMD1:2017+AMD2:2021, ISO 14801:2016... |
| Diagnostic Imaging | 12 | IEC 60601-2-28:2017, IEC 60601-2-33:2022, IEC 60601-2-43:2022... |
| Dialysis | 6 | IEC 60601-2-39:2024, IEC 60601-2-16:2025, ISO 23500-1:2024... |
| Digital Health & Wearables | 5 | IEC 62304:2006+AMD1:2015, ISO/IEEE 11073-10101:2020, ISO/IEEE 11073-10417:2017... |
| Drug-Device Combination | 3 | ISO 11608-1:2022, ISO 11608-2:2022, ISO 20072:2009 |
| Electrical Safety & EMC | 15 | IEC 60601-1:2005+AMD1:2012+AMD2:2020 CSV, IEC 60601-2-2:2017+AMD1:2023, IEC 60601-2-4:2010+AMD1:2018... |
| Endoscopy | 6 | IEC 60601-2-18:2009, ISO 8600-1:2025, IEC 60601-2-2:2017+AMD1:2023... |
| Environmental Testing | 6 | IEC 60068-2-1:2025, IEC 60068-2-2:2025, IEC 60068-2-30:2025... |
| Home Healthcare | 4 | IEC 60601-1-11:2015+AMD1:2020, IEC 60601-1-12:2014+AMD1:2020, ISO 80601-2-72:2023... |
| Implant Materials | 14 | ISO 5832-2:2025, ISO 5832-4:2024, ISO 5832-5:2022... |
| Implant Testing | 6 | ASTM F2129-25, ASTM F2052-21, ASTM F2213-25... |
| In Vitro Diagnostics | 3 | ISO 15197:2013, ISO 18113-1:2022, ISO 15189:2022 |
| Infusion & Transfusion | 5 | ISO 8536-4:2019, ISO 8536-8:2015, ISO 1135-4:2025... |
| Labelling & Symbols | 3 | ISO 15223-1:2021, ISO 20417:2026, IEC 62366-1:2015+AMD1:2020 |
| Laser Surgery | 3 | IEC 60601-2-22:2019+AMD1:2026, IEC 60825-1:2014, ISO 11810:2015 |
| Lithotripsy | 3 | IEC 60601-2-36:2014, IEC 61846:2025, IEC 61847:2025 |
| Mechanical Testing | 2 | ASTM F2477-24, ASTM F2346-18(2026) |
| Medical Gloves | 2 | EN 455-1:2020+A2:2024, EN 455-3:2023 |
| MRI Safety | 5 | ASTM F2052-21, ASTM F2119-24, ASTM F2182-19e2... |
| Needles & Syringes | 8 | ISO 7864:2016, ISO 7886-1:2017, ISO 8536-16:2025... |
| Neonatal | 4 | IEC 60601-2-19:2020+AMD1:2023, IEC 60601-2-20:2020, IEC 60601-2-21:2020+AMD1:2023... |
| Neurology | 4 | IEC 80601-2-26:2019+AMD1:2024, IEC 60601-2-40:2024, IEC 80601-2-71:2025... |
| Nuclear Medicine | 2 | IEC 61675-1:2022, IEC 61675-2:2015 |
| Ophthalmic | 7 | IEC 80601-2-58:2024, ISO 11979-1:2026, ISO 11979-2:2024... |
| Packaging | 7 | ASTM F1980-21, ASTM D4169-23e1, ASTM F2825-18(2026)... |
| Patient Monitoring | 7 | IEC 60601-2-23:2011, ISO 80601-2-85:2021, IEC 80601-2-30:2018... |
| Patient Warming | 1 | IEC 60601-2-35:2020+AMD1:2023 |
| Phototherapy | 3 | IEC 60601-2-57:2023, IEC 60601-2-75:2017+AMD1:2023, IEC 60601-2-83:2019 |
| Physiotherapy | 5 | IEC 60601-2-10:2012+AMD1:2016+AMD2:2023, IEC 60601-2-3:2012+AMD1:2016+AMD2:2022, IEC 60601-2-5:2009... |
| Point-of-Care Testing (POCT) | 5 | ISO 15197:2013, ISO 15189:2022, ISO 18113-1:2022... |
| Post-market Surveillance | 3 | ISO/TR 20416:2020, ISO 20916:2019, AAMI TIR73:2019 |
| PPE & Barrier | 6 | EN 14683:2025, EN 455-1:2020+A2:2024, EN 455-2:2024... |
| Quality Management | 3 | ISO 13485:2016, ISO 19011:2026, AAMI TIR75:2019 |
| Radiation Protection | 9 | IEC 60601-2-1:2020, IEC 60601-1-3:2008+AMD1:2013+AMD2:2021, IEC 60601-2-8:2010+AMD1:2015... |
| Regulatory References | 17 | Directive 2011/65/EU (RoHS 2), Regulation (EC) No 1907/2006 (REACH), Regulation (EC) No 1272/2008 (CLP)... |
| Reprocessing | 5 | ISO 17664-1:2021, ISO 17664-2:2021, ISO 15883-1:2024... |
| Respiratory & Anaesthesia | 5 | ISO 4135:2022, ISO 80601-2-55:2018+AMD1:2023, ISO 80601-2-12:2023... |
| Risk Management | 4 | ISO 14971:2019, ISO/TR 24971:2020, IEC 80001-1:2021... |
| Robotic Surgery | 5 | IEC 80601-2-77:2019+AMD1:2023, IEC 80601-2-78:2019, ISO 13482:2014... |
| Small-bore Connectors | 3 | ISO 80369-1:2025, ISO 80369-7:2021, ISO 80369-2:2024 |
| Software & Usability | 11 | IEC 62304:2006+AMD1:2015, IEC 82304-1:2016, AAMI TIR57:2016/(R)2022... |
| Sterilization | 13 | ISO 11737-1:2018/Amd 1:2021, ISO 11135:2014+AMD1:2018, ISO 11138-1:2017... |
| Surgical Implants | 12 | ISO 5832-1:2024, ISO 5832-3:2021, ISO 5840-1:2021... |
| Surgical Instruments | 7 | ISO 7151:2024, ISO 13402:2025, ISO 7153-1:2016... |
| Therapeutic Ultrasound | 3 | IEC 60601-2-62:2013, IEC 61161:2013, IEC 61689:2022 |
| Tissue Engineering | 4 | ISO/TS 21560:2020, ISO 13022:2012, ASTM F2150-19... |
| Urogenital | 5 | ISO 7439:2023, IEC 60601-2-41:2021, ISO 8009:2014... |
| Usability Engineering | 2 | IEC 62366-1:2015+AMD1:2020, IEC/TR 62366-2:2016 |
| Vascular Devices | 5 | ISO 25539-1:2017, ISO 25539-3:2024, ISO 7198:2016... |
| Wound Care | 5 | EN 13795-1:2025, EN 13726:2023, ISO/TS 20721:2025... |
Navigation
Click on a category above to see all standards in that category with their scope, applicable GSPRs, and official source links.