SS IEC 60601-1-10:2018
Medical electrical equipment – Part 10: General requirements for basic safety and essential performance – Collateral standard: Requirements for the development of physiologic closed-loop controllers
OVERVIEW
Applies to the basic safety and essential performance of medical electrical equipment and systems.
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 medical electrical equipment and systems to control a physiologic variable.
Applies to various types of PCLC, e.g. linear and non-linear, adaptive, fuzzy, neural networks.
Does not specify additional mechanical or electrical requirements.
COMMENTS
The International Electrotechnical Commission (IEC) has issued Amendment No. 1 to this standard. The following are available for purchase at the Singapore Standards e-Shop:
Amendment only (click here).
Standard incorporating the Amendment (click here).
PRODUCT DETAILS
| Status | Current |
|---|---|
| Edition | 2018 |
| No. of Pages | 47 |
| ICS Classification | 11.040 Medical equipment |
| Committee | Biomedical and Health Standards Committee |
| Available for Purchase | Global |
| Adoption | IEC 60601-1-10 : 2007 IDT |