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: 249 standards across 50 categories
Categories
| Category | Standards | Key Standards |
|---|---|---|
| Active Implants | 6 | EN 45502-1:2015, EN 45502-2-1:2003+A1:2020, EN 45502-2-2:2008+A1:2020... |
| Anaesthesia | 1 | IEC 60601-2-13:2022 |
| Audiology | 1 | IEC 60601-2-66:2019 |
| Biocompatibility | 23 | EN ISO 10993-1:2020, EN ISO 10993-3:2014, EN ISO 10993-5:2009... |
| Biological Materials | 3 | ISO 22442-1:2020, ISO 22442-2:2020, ISO 22442-3:2007+AMD1:2015 |
| Breathing Gas Pathways | 10 | ISO 7396-1:2016, ISO 80601-2-12:2020, ISO 80601-2-70:2020... |
| Cardiology | 3 | IEC 60601-2-47:2012+AMD1:2019, IEC 60601-2-51:2003+AMD1:2015, IEC 60601-2-31:2020 |
| Clinical Investigation | 3 | ISO 14155:2020, ISO 14155:2020+AMD1:2024, ISO 20916:2019 |
| Connectors | 3 | ISO 80369-1:2018+AMD1:2021, ISO 80369-7:2021, EN ISO 80369-1:2018+A1:2021 |
| Cybersecurity | 1 | IEC 80001-1:2021 |
| Dental | 4 | ISO 7405:2018, IEC 60601-2-63:2023, IEC 60601-2-65:2012+AMD1:2016... |
| Diagnostic Imaging | 13 | IEC 60601-2-7:1998, IEC 60601-2-28:2017, IEC 60601-2-33:2022... |
| Dialysis | 1 | IEC 60601-2-39:2018 |
| Drug Device Combination | 2 | ISO 11608-1:2022, ISO 11608-2:2022 |
| Electrical Safety | 19 | EN IEC 60601-1:2006+A1:2013+A2:2020, EN IEC 60601-1-2:2015+A1:2021, EN IEC 60601-1-6:2010+A1:2015+A2:2020... |
| Endoscopy | 1 | IEC 60601-2-18:2009+AMD1:2016 |
| Environmental Testing | 7 | IEC 60068-2-1:2007, IEC 60068-2-2:2007, IEC 60068-2-30:2005... |
| Home Healthcare | 1 | IEC 60601-1-11:2015+AMD1:2020 |
| Implant Materials | 14 | ISO 5832-2:2018, ISO 5832-4:2014, ISO 5832-5:2005... |
| Implant Testing | 6 | ASTM F2129-23, ASTM F2052-22, ASTM F2213-17... |
| Ivd | 4 | ISO 15197:2013, ISO 18113-1:2022, ISO 15197:2013+AMD1:2024... |
| Labelling | 1 | EN ISO 20417:2021 |
| Laser Surgery | 1 | IEC 60601-2-22:2019 |
| Lithotripsy | 1 | IEC 60601-2-36:2023 |
| Mechanical Testing | 2 | ASTM F2477:2019, ASTM F2346:2018 |
| Medical Gloves | 2 | EN 455-1:2020, EN 455-3:2015 |
| Mri Safety | 4 | ASTM F2052:2015, ASTM F2213:2017, ASTM F2182:2019... |
| Needles Syringes | 2 | ISO 7864:2016, ISO 7886-1:2017 |
| Neonatal | 4 | IEC 60601-2-19:2009+AMD1:2016, IEC 60601-2-20:2020, IEC 60601-2-21:2020... |
| Neurology | 4 | IEC 60601-2-26:2019, IEC 60601-2-40:2016, IEC 60601-2-14:2024... |
| Nuclear Medicine | 2 | IEC 61675-1:2022, IEC 61675-2:2015 |
| Ophthalmic | 2 | ISO 11979-1:2018, IEC 80601-2-58:2014+AMD1:2016 |
| Packaging | 7 | ASTM F1980:2021, ASTM D4169:2022, ASTM F2825:2010(R2020)... |
| Patient Monitoring | 9 | IEC 60601-2-23:2011+AMD1:2019, IEC 60601-2-85:2021, IEC 60601-2-30:2018... |
| Patient Warming | 1 | IEC 60601-2-35:2020 |
| Phototherapy | 3 | IEC 60601-2-57:2011+AMD1:2021, IEC 60601-2-75:2017, IEC 60601-2-83:2019 |
| Physiotherapy | 2 | IEC 60601-2-3:2012+AMD1:2016, IEC 60601-2-5:2009+AMD1:2015 |
| Pms | 1 | ISO/TR 20416:2020 |
| Ppe Barrier | 1 | EN 14683:2019+AC:2019 |
| Quality Management | 1 | ISO 13485:2016 |
| Radiation Protection | 11 | IEC 60601-2-1:2020, IEC 60601-1-3:2008+AMD1:2013+AMD2:2021, EN IEC 60601-1-3:2008+A1:2013+A2:2021... |
| Regulatory References | 17 | Directive 2011/65/EU (RoHS 2), Regulation (EC) No 1907/2006 (REACH), Regulation (EC) No 1272/2008 (CLP)... |
| Reprocessing | 2 | ISO 17664-1:2021, ISO 17664-2:2021 |
| Risk Management | 2 | ISO 14971:2019, ISO/TR 24971:2020 |
| Software | 14 | EN IEC 62304:2006+A1:2015, EN IEC 82304-1:2017, IEC 62304:2006+AMD1:2015... |
| Sterilization | 11 | EN 556-1:2001, ISO 11737-1:2018, ISO 11135:2014... |
| Surgical Implants | 9 | ISO 5832-1:2016, ISO 5832-3:2016, ISO 5840-1:2021... |
| Therapeutic Ultrasound | 1 | IEC 60601-2-62:2013+AMD1:2023 |
| Usability | 5 | IEC/TR 62366-2:2016, EN IEC 62366-1:2015+A1:2020, IEC 62366-1:2015+AMD1:2020... |
| Wound Care | 1 | EN 13795-1:2019 |
Navigation
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