IEC 60601-1-10:2007/Amd 2:2020
Medical electrical equipment — Part 1-10: General requirements for basic safety and essential performance — Collateral standard: Requirements for the development of physiologic closed-loop controllers — Amendment 2
发布时间:2020-09-21 实施时间:


IEC 60601-1-10:2007/Amd 2:2020标准规定了生理闭环控制器的开发要求,以确保医用电气设备的基本安全和基本性能。该标准适用于各种医疗设备,包括呼吸机、心脏起搏器和药物输送系统等。

该标准要求生理闭环控制器必须满足以下要求:

1. 安全性:生理闭环控制器必须满足IEC 60601-1系列标准的安全要求,以确保其安全性。

2. 有效性:生理闭环控制器必须能够准确地监测生理参数,并根据这些参数自动调节医疗设备的控制器,以确保其有效性。

3. 可靠性:生理闭环控制器必须能够在长时间使用中保持稳定和可靠的性能。

此外,该标准还规定了生理闭环控制器的开发过程中需要进行的测试和验证,以确保其符合标准要求。

该标准的修订2主要是对原标准进行了一些技术上的更新和修正,以确保其与最新的技术和法规相符。修订2还增加了一些新的测试和验证要求,以进一步提高生理闭环控制器的安全性、有效性和可靠性。

相关标准
- IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-6:2010 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 60601-1-8:2006 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
- IEC 62304:2006 Medical device software - Software life cycle processes