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EVS-EN 60601-1-10:2008

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

General information
Valid from 09.06.2008
Base Documents
IEC 60601-1-10:2007; EN 60601-1-10:2008
Directives or regulations
93/42/EEC Medical devices (MDD)
Directive 93/42/EEC (Medical devices) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Standard history

Status
Date
Type
Name
17.08.2021
Main + amendment
03.08.2021
Amendment
08.06.2015
Amendment
09.06.2008
Main
This International Standard applies to the  BASIC SAFETY and  ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and  MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS. This collateral standard specifies requirements for the development (analysis, design, VERIFICATION and VALIDATION) of a PHYSIOLOGIC CLOSED-LOOP CONTROLLER  (PCLC) as part of a PHYSIOLOGIC  CLOSED-LOOP CONTROL SYSTEM  (PCLCS) in  ME EQUIPMENT and  ME SYSTEMS to control a PHYSIOLOGIC VARIABLE.
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EVS-EN 60601-1-10:2008/A1:2015

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EVS-EN 60601-1-6:2010

Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability
Valid from 07.06.2010
Amendment

EVS-EN 60601-1-6:2010/A1:2015

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Main

EVS-EN 60601-1-11:2015

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
Valid from 08.06.2015