FOREWORD
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 (PEMS)
15. CONSTRUCTION OF ME EQUIPMENT
16. ME SYSTEMS
17. ELECTROMAGNETIC COMPATIBILITY OF ME EQUIPMENT
AND ME SYSTEMS
202. ELECTROMAGNETIC COMPATIBILITY - REQUIREMENTS AND TESTS
203. RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT
ANNEX
ANNEX C (INFORMATIVE) - GUIDE TO MARKING AND LABELLING
REQUIREMENTS FOR ME EQUIPMENT AND ME SYSTEMS
ANNEX AA (INFORMATIVE) - PARTICULAR GUIDANCE AND RATIONALE
ANNEX BB (INFORMATIVE) - IDENTIFICATION OF PARTS OF DENTAL
X-RAY INTRA-ORAL SYSTEMS IN RELATION TO DEFINED
TERMS IN THIS STANDARD
BIBLIOGRAPHY
INDEX OF DEFINED TERMS
ANNEX ZA (NORMATIVE) - NORMATIVE REFERENCES
TO INTERNATIONAL PUBLICATIONS
WITH THEIR CORRESPONDING
EUROPEAN PUBLICATIONS
ANNEX ZZ (INFORMATIVE) - COVERAGE OF ESSENTIAL
REQUIREMENTS OF EC DIRECTIVES