MDR
MEDICINE TECHNICAL PRODUCTS
| SS-EN 60601-1 | Electrical equipment for medical use – Part 1: General requirements for safety and essential performance |
| SS-EN 60601-1-2 | Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance –Collateral standard: Electromagnetic disturbances –Requirements and test |
| IEC 60601-1-1 | Medical electrical equipment – Part 1-1: General requirements for safety – Collateral standard: Safety requirements for medical electrical systems |
| SS-EN 60601-1-6 | Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability |
| SS-EN 60601-1-8 | Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
| SS-EN 60601-1-11 | Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
| SS-EN ISO 14971 | Medical devices – Application of risk management to medical devices (ISO 14971:2019) |