电气安全与EMC
本类别共 19 条标准。
| 标准编号 | 标题 | 适用范围 | GSPR |
|---|---|---|---|
| EN IEC 60601-1:2006+A1:2013+A2:2020 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | Basic safety and essential performance of medical electrical equipment | 14, 14.2, 14.3, 14.4 |
| EN IEC 60601-1-2:2015+A1:2021 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | EMC requirements for medical electrical equipment | 14, 18, 18.5, 18.6 |
| EN IEC 60601-1-6:2010+A1:2015+A2:2020 | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | Usability engineering for medical electrical equipment | 14, 14.1, 14.2, 22 |
| IEC 60601-1:2005+AMD1:2012+AMD2:2020 CSV | Medical electrical equipment — Part 1: General requirements for basic safety and essential performance | Electrical safety requirements for medical electrical equipment | 14, 14.1, 14.2, 14.6 |
| IEC 60601-2-2:2017 | Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories | Particular requirements for the basic safety and essential performance of high f... | 14, 18, 20 |
| IEC 60601-2-4:2010+AMD1:2018 | Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators | Particular requirements for the basic safety and essential performance of cardia... | 14, 18, 19 |
| IEC 60601-2-6:2020 | Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy and hyperthermia equipment | Particular requirements for the basic safety and essential performance of microw... | 14, 16, 18 |
| IEC 60601-2-10:2012+AMD1:2016 | Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators | Particular requirements for the basic safety and essential performance of nerve ... | 14, 18, 19 |
| IEC 60601-2-16:2018 | Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment | Particular requirements for the basic safety and essential performance of haemod... | 14, 18, 21 |
| IEC 60601-2-24:2012 | Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers | Particular requirements for the basic safety and essential performance of infusi... | 14, 18, 21 |
| IEC 60601-2-25:2011+AMD1:2014 | Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs | Particular requirements for the basic safety and essential performance of electr... | 14, 15, 18 |
| IEC 60601-2-27:2011+AMD1:2019 | Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment | Particular requirements for the basic safety and essential performance of electr... | 14, 15, 18 |
| IEC 60601-2-34:2011 | Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment | Particular requirements for the basic safety and essential performance of invasi... | 14, 15, 18 |
| IEC 60601-2-37:2007+AMD1:2015 | Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment | Particular requirements for the basic safety and essential performance of ultras... | 14, 16, 18 |
| IEC 60601-2-49:2018 | Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment | Particular requirements for the basic safety and essential performance of multif... | 14, 15, 18 |
| IEC 60601-2-52:2009+AMD1:2015 | Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds | Particular requirements for the basic safety and essential performance of medica... | 14, 18, 20 |
| IEC 60601-1-8:2006+AMD1:2012+AMD2:2020 | 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 | General requirements for basic safety and essential performance -- Collateral st... | 18 |
| EN IEC 60601-1-8:2006+A1:2012+A2:2020 | 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 | General requirements for basic safety and essential performance -- Collateral st... | 18, 18.4 |
| IEC 62353:2014+AMD1:2020 | Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment | Recurrent and post-repair testing of ME equipment. | 14, 18 |