MEDICAL ELECTRICAL EQUIPMENT - PART 4-1: GUIDANCE AND INTERPRETATION - MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS EMPLOYING A DEGREE OF AUTONOMY
International Electrotechnical Committee
FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 DEGREE OF AUTONOMY (DOA)
5 PROCESS STANDARDS supporting DOA
6 BASIC SAFETY and ESSENTIAL PERFORMANCE
related to DOA
Annex A (informative) - Rationale for defining
the AUTOMATIC, AUTONOMY and DOA framework
and the distinction between a MEDICAL
ROBOT and other MEE or MES
Annex B (informative) - DOA and relevant terms
used in MEE standards
Annex C (informative) - Exemplar methods for
classifying DEGREE OF AUTONOMY
Annex D (informative) - Examples of introducing
DOA to MEE/MES
Annex E (informative) - PATIENT SAFETY
characteristics to be taken into account
during RISK MANAGEMENT for MEE or MES
employing DOA
ANNEX F (informative) - PHYSIOLOGIC CLOSED-LOOP
CONTROL SYSTEM AND DOA
Annex G (informative) - Examples of distributed
ESSENTIAL PERFORMANCE
Bibliography
Gives a definition of DOA of MEE or MES and a MEDICAL ROBOT, and also provides guidance on: - methodologies to perform the RISK MANAGEMENT PROCESS and USABILITY ENGINEERING for an MEE or MES with a DOA; - considerations of BASIC SAFETY and ESSENTIAL PERFORMANCE for an MEE and MES with a DOA; and - identifying the use of DOA, and similar concepts in existing ISO/IEC standards dealing with MEE or MES with the goal to facilitate alignment of standards by consistent use of the concept of DOA; and - distinguishing between MEDICAL ROBOTS, and other MEE and MES.
| Document Type | Standard |
| Status | Current |
| Publisher | International Electrotechnical Committee |
| Committee | TC 62 |
