BS EN 60601-1-6:2007:2010 Edition
$215.11
Medical electrical equipment – General requirements for basic safety and essential performance. Collateral Standard. Usability
| Published By | Publication Date | Number of Pages |
| BSI | 2010 | 78 |
Specifies requirements for a process to analyse, design, verify and validate the usability, as it relates to basic safety and essential performance of medical electrical equipment. This collateral standard addresses normal use and use errors but excludes abnormal use. The object of this collateral standard is to specify general requirements that are in addition to those of the general standard IEC 60601-1 and to serve as the basis for particular standards.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 9 | 1 Scope, object and related standards 1.1 Scope 1.2 Object 1.3 Related standards 1.3.1 IEC 60601-1 1.3.2 Particular standards 2 Normative references |
| 10 | 3 Terms and definitions |
| 12 | 4 General requirements 4.1 * Conditions for application to me equipment 4.2 * Risk management process for me equipment 5 Me equipment identification, marking and documents 5.1 * Accompanying documents |
| 13 | 5.2 * Training and materials for training 6 * Use error and usability 6.1 * Safety for the patient, operator and other persons 6.2 * Usability engineering process 6.2.1 General |
| 14 | 6.2.2 Input for the usability engineering process 6.2.2.1 * Me equipment application specification 6.2.2.2 Primary operating functions 6.2.2.3 * Information for safety as a risk control |
| 15 | 6.2.3 * Usability specification 6.2.4 * Usability verification |
| 16 | 6.2.5 Usability validation plan 6.2.6 * Usability validation |
