SS IEC 60601-1-11:2018
Medical electrical equipment – Part 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
OVERVIEW
Applies to the basic safety and essential performance of medical electrical equipment and systems for use in the home healthcare environment. Applies regardless of whether the medical electrical equipment or system is intended for use by a lay operator or by trained healthcare personnel.
Does not apply to medical electrical equipment and systems intended solely for use in the emergency medical services environment covered by SS IEC 60601-1-12 or solely for use in professional healthcare facilities covered by IEC 60601-1 without the additions of IEC 60601-1-12 or this collateral standard.
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 | 65 |
| ICS Classification | 11.040 Medical equipment |
| Committee | Biomedical and Health Standards Committee |
| Available for Purchase | Global |
| Adoption | IEC 60601-1-11 : 2015 IDT |