Table of Contents

Introduction
1 Scope, object and related standards
2 Normative references
3 Terms and definitions
4 General requirements
5 General requirements for testing ME EQUIPMENT
6 Classification of ME EQUIPMENT and ME SYSTEMS
7 ME EQUIPMENT identification, marking and documents
8 Protection against electrical HAZARDS from ME EQUIPMENT
9 Protection against MECHANICAL HAZARDS OF ME EQUIPMENT
and ME SYSTEMS
10 Protection against unwanted and excessive radiation HAZARDS
11 Protection against excessive temperatures and other HAZARDS
12 Accuracy of controls and instruments and protection against
hazardous outputs
13 HAZARDOUS SITUATIONS and fault conditions
14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
15 Construction of ME EQUIPMENT
16 ME SYSTEMS
17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
Annex A (informative) - General guidance and rationale
Annex B (informative) - Sequence of testing
Annex C (informative) - Guide to marking and labelling requirements
for ME EQUIPMENT and ME SYSTEMS
ANNEX D (informative) - Symbols on marking
Annex E (informative) - Examples of the connection of the measuring
device (MD) for measurement of the PATIENT LEKAGE CURRENT
and PATIENT AUXILIARY CURRENT
Annex F (informative) - Suitable measuring supply circuits
Annex G (normative) - Protection against HAZARDS of ignition
of flammable anaesthetic mixtures
Annex H (informative) - PEMS structure, PEMS DEVELOPMENT
LIFE-CYCLE and documentation
Annex I (informative) - ME SYSTEMS aspects
Annex J (informative) - Survey of insulation paths
Annex K (informative) - Simplified PATIENT LEAKAGE CURRENT
diagrams
Annex L (normative) - Insulated winding wires for use without
interleaved
Bibliography
Annex JA (informative) - Index of defined terms
Annex JB (informative) - Index of abbreviations and acronyms
Annex JC (informative) - Comparison table between JIS and
corresponding International Standard

Abstract

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	Japanese Standards Association
ProductNote	Supersedes JIS T1001, JIS T1002, JIS T1005 and JIS T1309. (01/2007)
Pages
ISBN
Supersedes	JIS T 1005:1983 JIS T 1002:1992 JIS T 1001:1992 JIS T 0601-1:1999 JIS T 1309:1986