SS IEC 60601-1-6:2018
Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
OVERVIEW
Specifies a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates tobasic safety and essential performance of medical electrical equipment
This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e., normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use.
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 | 34 |
| ICS Classification | 11.040 Medical equipment |
| Committee | Biomedical and Health Standards Committee |
| Available for Purchase | Global |
| Adoption | IEC 60601-1-6 : 2010 IDT |