CEI EN 60601-1-10
Medical electrical equipment Part 1: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
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| Organization: | CEI |
| Publication Date: | 1 January 2016 |
| Status: | active |
| Page Count: | 12 |
| ICS Code (Medical equipment): | 11.040 |
scope:
- "the general standard" designates IEC 60601-1 alone (IEC 60601-1:2005+A1:2012
- "this collateral standard" designates IEC 60601-1-10 alone (IEC 60601-1- 10:2007+A1:2013)
Document History
April 1, 2022
Medical electrical equipment Part 1: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
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...
CEI EN 60601-1-10
January 1, 2016
Medical electrical equipment Part 1: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
– "the general standard" designates IEC 60601-1 alone (IEC 60601-1:2005+A1:2012);
– "this collateral standard" designates IEC 60601-1-10 alone (IEC 60601-1- 10:2007+A1:2013)
January 1, 2010
Medical electrical equipment Part 1: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
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....