Table of Contents

FOREWORD<br>INTRODUCTION<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 DEGREE OF AUTONOMY (DOA)<br>5 PROCESS STANDARDS supporting DOA<br>6 BASIC SAFETY and ESSENTIAL PERFORMANCE<br>&nbsp;&nbsp;related to DOA<br>Annex A (informative) - Rationale for defining<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;the AUTOMATIC, AUTONOMY and DOA framework<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;and the distinction between a MEDICAL<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ROBOT and other MEE or MES<br>Annex B (informative) - DOA and relevant terms<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;used in MEE standards<br>Annex C (informative) - Exemplar methods for<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;classifying DEGREE OF AUTONOMY<br>Annex D (informative) - Examples of introducing<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;DOA to MEE/MES<br>Annex E (informative) - PATIENT SAFETY<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;characteristics to be taken into account<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;during RISK MANAGEMENT for MEE or MES<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;employing DOA<br>ANNEX F (informative) - PHYSIOLOGIC CLOSED-LOOP<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;CONTROL SYSTEM AND DOA<br>Annex G (informative) - Examples of distributed<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ESSENTIAL PERFORMANCE<br>Bibliography

Abstract

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.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	British Standards Institution
Pages
ISBN
Committee	CH/62/1