AS/NZS 4513:1995

1-AS/NZS 4513:1995 MEDICAL ELECTRICAL EQUIPMENT-FUNDAMENTAL ASPECTS OF SAFETY STANDARDS
4-PREFACE
6-CONTENTS
9-Section 1: General
9-1 Scope
9-2 Concepts
9-2.1 Basic safety
10-2.2 Effectiveness
10-2.3 Efficacy
10-2.4 Essential performance
10-2.5 Essential requirements
11-2.6 Fitness for use
11-2.7 Hazard
11-2.8 Quality assurance
11-2.9 Risk
11-2.10 Risk level
11-2.11 Safety
12-2.12 Safety integrity level
12-2.13 Severity level
12-2.14 User/operator
13-Section 2: Safety and standards
13-3 Hazards
13-3.1 Causes of hazards
14-3.2 Patient related hazards
14-3.3 Operator hazards
15-4 Factors affecting safety
15-5 Measures to achieve safety
15-6 Goal of standards
16-7 Types of standards
16-7.1 Product standards
16-7.2 Process standards
16-7.3 Installation and environmental standards
17-7.4 Application standards
17-8 Acceptable risk levels
19-9 Developing safety and essential performance requirements
19-9.1 Hazard identification
20-9.2 Severity level
21-9.3 Deciding on acceptable risk levels
23-9.4 Fault avoidance and control
25-9.5 Integrity levels
25-9.6 Achieving acceptable risk levels
26-9.7 Surpassing specified requirements
26-9.8 Treatment of risk in the IEC 601 series
27-9.9 Fault conditions
27-9.10 Single fault philosophy
29-9.11 Integrity levels implied in IEC 601-1
30-9.12 Acceptable risk levels according to IEC 601
30-10 Equipment accessories
31-11 Standardization
31-12 Coordination of standards
31-12.1 Overall approach to safety
32-12.2 Overall planning in the development of standards
32-13 Standards and the law
32-14 Role of standards
32-15 Accidents
33-16 Maintenance of standards
33-Section 3: Guide to the development of future product standards
33-17 Identification of problems
33-18 Priority
34-19 Format and structure
34-19.1 Titles
34-19.2 Scope and rationale
34-19.3 Form of specification
34-19.4 Structure
35-20 Specifying safety and essential performance requirements
35-20.1 General
38-20.2 Specific test requirements vs assessment of design process
39-21 Testing requirements
39-21.1 General
39-21.2 Single fault condition and safety hazard
39-21.3 Protective devices
40-21.4 High reliability components
40-21.5 Safety factors
40-21.6 Test methods
41-21.7 Basic safety standards
41-21.8 Marking and labelling
42-21.9 Warning notices
42-21.10 Other information to be provided
42-22 Design verification
43-23 Clinical trials and similar assessment
43-24 Performance requirements
43-24.1 General
43-24.2 Essential performance requirements
44-24.3 Essential disclosure requirements
44-24.4 Non-essential performance requirements
45-Annex A - Classification of applied parts
45-A.1 Introduction
45-A.2 Applied parts
46-A.3 Electric shock protection
49-A.4 Suitability of applied parts for direct cardiac connection
49-A.5 High levels of patient functional current and patient voltage
51-Annex B - The role of standards in the assessment and approval of medical electrical equipment
53-Annex C - Improving overall safety
53-C.1 Overall safety
53-C.2 Improved product standards - Unexpected consequences
55-C.3 Need for users to remain aware of risk
56-C.4 Conclusion
57-Annex D - Safety factors
59-Annex E - History of IEC 513, first edition and IEC 601 series