IEC/TR 60601-4-1 Ed. 1.0现行
Medical electrical equipment Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy
出版：International Electrotechnical Committee
专家解读视频
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.
