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

Identifies fundamental considerations to be taken into account in developing Standards to ensure the safety of medical electrical equipment. It also provides a guide to the strategies and methodologies used in developing the IEC 601 and AS/NZS 3200 series of Standards. It is identical with and reproduced from IEC 513:1994.

This report identifies fundamental considerations to be taken into account in developing standards to ensure the safety of medical electrical equipment.NOTE - This report 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.This report is primarily intended to be used by:û those who prepare standards for the design, installation and use of medical electrical equipment;û health care regulatory authorities, test houses and other organizationsresponsible for implementing standards for medical electrical equipment;û manufacturers of medical electrical equipment;û those who assemble systems which include medical electrical equipment.This report may also be of assistance to:û users or operators of medical electrical equipment;û hospital administrators;û non-technical personnel involved in the procurement of medical electrical equipment;û educators and students.û hospital and clinical engineersresponsible for the construction of patient care facilities or for the procurement or maintenance of medical electrical equipment;

First published as Joint Standard AS/NZS 4513:1995.