EN 60601-1醫(yī)用電氣設(shè)備. 第1-11部分—標準名稱

EN 60601-1 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

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EN 60601-1醫(yī)用電氣設(shè)備. 第1-11部分: 基本安全和基本性能的通用要求. 副標準: 家庭保健環(huán)境中使用的醫(yī)用電氣設(shè)備和醫(yī)用電氣系統(tǒng)要求

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EN 60601-1醫(yī)用電氣設(shè)備. 第1-11部分—適用范圍

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

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EN 60601-1醫(yī)用電氣設(shè)備. 第1-11部分—引用文件

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

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

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

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IEC 60529:1989, Degrees of protection provided by enclosures (IP Code)

IEC 60529:1989/AMD1 :1 999

IEC 60529:1989/AMD2:2013

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IEC 60601 -1 :2005, Medical electrical equipment – Part 1: General requirements for basic

safety and essential performance

IEC 60601 -1 :2005/AMD1 :2012

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IEC 60601 -1 -2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests

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IEC 60601 -1 -6 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability

IEC 60601 -1 -6:201 0/AMD1 :2013

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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 60601 -1 -8:2006/AMD1 :2012

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