| 标准号 | 名称 | 采信 |
|---|
| EN 21649 | Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006) | UK |
| EN 21969 | High-pressure flexible connections for use with medical gas systems (ISO 21969:2009) | UK |
| EN 21987 | Ophthalmic optics - Mounted spectacle lenses (ISO 21987:2009) | UK |
| EN 22442-1 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk man | UK |
| EN 22442-2 | Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, c | UK |
| EN 22442-3 | Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimi | UK |
| EN 22523 | External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006) | UK |
| EN 22675 | Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO | EU、UK |
| EN 23328-1 | Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to asses | UK |
| EN 23328-2 | Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects (I | UK |
| EN 23747 | Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmon | UK |
| EN 23908 | Sharps injury protection - Sharps protection mechanisms for single-use needles, introducers for | EU |
| EN 25424 | Sterilization of health care products - Low temperature steam and formaldehyde - Requirements fo | EU、UK |
| EN 25539-1 | Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:20 | UK |
| EN 25539-2 | Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539- 2:2008) | UK |
| EN 26782 | Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced | UK |
| EN 27740 | Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985) | UK |
| EN 60118-0 | Electroacoustics - Hearing aids - Part 0: Measurement of the performance characteristics of hear | EU |
| EN 60118-13 | Electroacoustics - Hearing aids - Part 13: Electromagnetic compatibility (EMC) (IEC 60118-13:200 | UK |
| EN 60522 | Determination of the permanent filtration of X- ray tube assemblies (IEC 60522:1999) | UK |
| EN 60580 | Medical electrical equipment - Dose area product meters (IEC 60580:2000) | UK |
| EN 60601-1 | Medical electrical equipment - Part 1: General requirements for basic safety and essential perfo | EU、UK |
| EN 60601-1-1 | Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: | UK |
| EN 60601-1-2 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential per | UK |
| EN 60601-1-3 | Medical electrical equipment - Part 1-3: General requirements for basic safety and essential per | UK |
| EN 60601-1-4 | Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: | UK |
| EN 60601-1-6 | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential per | UK |
| EN 60601-1-8 | Medical electrical equipment - Part 1-8: General requirements for basic safety and essential per | UK |
| EN 60601-2-1 | Medical electrical equipment - Part 2-1: Particular requirements for the safety of electron acce | UK |
| EN 60601-2-2 | Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essent | UK |
| EN 60601-2-3 | Medical electrical equipment - Part 2: Particular requirements for the safety of short-wave ther | UK |
| EN 60601-2-4 | Medical electrical equipment - Part 2-4: Particular requirements for the safety of cardiac defib | UK |
| EN 60601-2-5 | Medical electrical equipment - Part 2-5: Particular requirements for the safety of ultrasonic ph | UK |
| EN 60601-2-8 | Medical electrical equipment - Part 2: Particular requirements for the safety of therapeutic X-r | UK |
| EN 60601-1-10 | Medical electrical equipment - Part 1-10: General requirements for basic safety and essential pe | UK |
| EN 60601-1-11 | Medical electrical equipment - Part 1-11: General requirements for basic safety and essential pe | UK |
| EN 60601-2-10 | Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and mu | UK |
| EN 60601-2-11 | Medical electrical equipment - Part 2-11: Particular requirements for the safety of gamma beam t | UK |
| EN 60601-2-12 | Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventila | UK |
| EN 60601-2-13 | Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential p | UK |
| EN 60601-2-16 | Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysi | UK |
| EN 60601-2-17 | Medical electrical equipment - Part 2-17: Particular requirements for the safety of automaticall | UK |
| EN 60601-2-18 | Medical electrical equipment - Part 2-18: Particular requirements for the safety of endoscopic e | UK |
| EN 60601-2-19 | Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essen | UK |
| EN 60601-2-20 | Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essen | UK |
| EN 60601-2-21 | Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essen | UK |
| EN 60601-2-22 | Medical electrical equipment - Part 2: Particular requirements for the safety of diagnostic and | UK |
| EN 60601-2-23 | Medical electrical equipment - Part 2-23: Particular requirements for the safety, including esse | UK |
| EN 60601-2-24 | Medical electrical equipment - Part 2-24: Particular requirements for the safety of infusion pum | UK |
| EN 60601-2-25 | Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardi | UK |
| EN 60601-2-26 | Medical electrical equipment - Part 2-26: Particular requirements for the safety of electroencep | UK |
| EN 60601-2-27 | Medical electrical equipment - Part 2-27: Particular requirements for the safety, including esse | UK |
| EN 60601-2-28 | Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essen | UK |
| EN 60601-2-29 | Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essen | UK |
| EN 60601-2-30 | Medical electrical equipment - Part 2-30: Particular requirements for the safety, including esse | UK |
| EN 60601-2-33 | Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essen | UK |
| EN 60601-2-34 | Medical electrical equipment - Part 2-34: Particular requirements for the safety, including esse | UK |
| EN 60601-2-36 | Medical electrical equipment - Part 2: Particular requirements for the safety of equipment for e | UK |
| EN 60601-2-37 | Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essen | UK |
| EN 60601-2-39 | Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential | UK |
| EN 60601-2-40 | Medical electrical equipment - Part 2-40: Particular requirements for the safety of electromyogr | UK |
| EN 60601-2-41 | Medical electrical equipment - Part 2-41: Particular requirements for basic safety and essential | UK |
| EN 60601-2-43 | Medical electrical equipment - Part 2-43: Particular requirements for basic safety and essential | UK |
| EN 60601-2-44 | Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essen | UK |
| EN 60601-2-45 | Medical electrical equipment - Part 2-45: Particular requirements for the safety of mammographic | UK |
| EN 60601-2-46 | Medical electrical equipment - Part 2-46: Particular requirements for the safety of operating ta | UK |
| EN 60601-2-47 | Medical electrical equipment - Part 2-47: Particular requirements for the safety, including esse | UK |
| EN 60601-2-49 | Medical electrical equipment - Part 2-49: Particular requirements for the safety of multifunctio | UK |
| EN 60601-2-50 | Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essen | UK |
| EN 60601-2-51 | Medical electrical equipment - Part 2-51: Particular requirements for safety, including essentia | UK |
| EN 60601-2-52 | Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential | UK |
| EN 60601-2-54 | Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essen | UK |
| EN 60601-2-83 | Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essen | EU |
| EN 60627 | Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-sc | UK |
| EN 60645-1 | Electroacoustics - Audiological equipment - Part 1: Pure-tone audiometers (IEC 60645-1:2001) | UK |
| EN 60645-2 | Audiometers - Part 2: Equipment for speech audiometry (IEC 60645-2:1993) | UK |
| EN 60645-3 | Electroacoustics - Audiometric equipment - Part 3: Test signals of short duration (IEC 60645-3:2 | UK |
| EN 60645-4 | Audiometers - Part 4: Equipment for extended high-frequency audiometry (IEC 60645-4:1994) | UK |
| EN 61217 | Radiotherapy equipment - Coordinates, movements and scales (IEC 61217:2011) | UK |
| EN 61676 | Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray | UK |
| EN 62083 | Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning sy | UK |
| EN 62220-1 | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determ | UK |
| EN 62220-1-2 | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Dete | UK |
| EN 62220-1-3 | Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Dete | UK |
| EN 62304 | Medical device software - Software life-cycle processes (IEC 62304:2006) | UK |
| EN 62366 | Medical devices - Application of usability engineering to medical devices (IEC 62366:2007) | UK |
| EN 62366-1 | Medical devices - Part 1: Application of usability engineering to medical devices | UK |
| EN 80369-2 | Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for | EU |
| EN 80601-2-35 | Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essen | UK |
| EN 80601-2-58 | Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essen | UK |
| EN 80601-2-59 | Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essen | UK |
| EN 81060-1 | Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measure | UK |
| EN 81060-2 | Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measur | UK |