SS IEC 60601-1-10 (+A1):2018
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
OVERVIEW
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) to control at least one PATIENT VARIABLE (i.e. a PHYSIOLOGIC VARIABLE) in ME EQUIPMENT and ME SYSTEMS. This collateral standard applies to various types of PCLC, e.g. linear and non-linear, adaptive, fuzzy, neural networks.
This collateral standard does not specify:
? additional mechanical requirements; or
? additional electrical requirements.
COMMENTS
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PRODUCT DETAILS
| Status | Current |
|---|---|
| Edition | 2018 |
| No. of Pages | 48 |
| ICS Classification | 11.040 Medical equipment |
| Committee | Biomedical and Health Standards Committee |
| Available for Purchase | Global |
| Adoption | IEC 60601-1-10:2007+AMD2:2020 : 2007 IDT |