BS EN 60601-1-11医疗电气设备.基本安全性和必要性能的一般要求.附属标准.

标准名称

BS EN 60601-1-11 Medical electrical equipment. 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

BS EN 60601-1-11医疗电气设备.基本安全性和必要性能的一般要求.附属标准.家庭保健环境中使用的医疗电气设备和医疗电气系统要求

适用范围

Scope:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS for use in the HOME HEALTHCARE ENVIRONMENT , as defined in 3.1 , and specified by the MANUFACTURER in the instructions for use. This International Standard applies regardless of whether the ME EQUIPMENT or ME SYSTEM is intended for use by a LAY OPERATOR or by trained healthcare personnel

引用文件

IEC 60068-2-27 Environmental testing – Part 2-27: Tests – Test Ea and guidance: Shock

IEC 60068-2-31 Environmental testing – Part 2-31: Tests – Test Ec: Rough handling shocks, primarily for equipment-type specimens

IEC 60068-2-64 Environmental testing Part 2-64: Tests – Test Fh: Vibration, broadband random and guidance

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出自GF2022