IEC TR 60513:1994

Foreword
Section 1. General
1 Scope
2 Concepts
Section 2. Safety and standards
3 Hazards
4 Factors affecting safety
5 Measures to achieve safety
6 Goal of standards
7 Types of standards
8 Acceptable risk levels
9 Developing safety and essential performance
     requirements
10 Equipment accessories
11 Standardization
12 Coordination of standards
13 Standards and the law
14 Role of standards
15 Accidents
16 Maintenance of standards
Section 3. Guide to the development of future product
            standards
17 Identification of problems
18 Priority
19 Format and structure
20 Specifying safety and essential performance
     requirements
21 Testing requirements
22 Design verification
23 Clinical trials and similar assessment
24 Performance requirements
Annexes
A Classification of applied parts
B The role of standards in the assessment and
     approval of medical electrical equipment
C Improving overall safety
D Safety factors
E History of IEC 513, 1st edition and IEC 601 series
Figures
1 Flow diagram for risk management
2 Structure of IEC 601 series under the third edition
     of IEC 601-1
C.1 Overall safety
Tables
1 Risk classification of accidents
2 Interpretation of risk level
3 Third edition of IEC 601-1 and its collateral
     standards
B.1 Hazards and causes
B.2 Role of standards in overall safety

This report identifies fundamental considerations to be taken into account in developing standards to ensure the safety of medical electrical equipment. It follows closely recommendations of ISO/IEC Guide 51 and expands on matters which are unique to, or critical in, the application of medical electrical equipment.