AS/NZS 3200.1.0:1998
Medical electrical equipment - Part 1.0: General requirements for safety - Parent Standard
Specifies general requirements for safety of electromedical equipment. It is a base specification in the AS/NZS 3200 series; it becomes a complete specification for an individual item of electromedical equipment when combined with a particular specification in the AS/NZS 3200 series. It specifies the degrees of isolation of applied parts from both live parts and earth, sufficient to ensure the safety of the patient from electric shock made under conditions likely to be experienced in services. This revision provides a consolidated version of AS 3200.1.0-1990 (NZS 6150:1990) incorporating its Amendments 1, 2 and 3. Users of AS 3200.1.0-1990 and its Amendments 1, 2 and 3 are informed that changes in this consolidated edition are limited to the designation, title and presentation. This Standard is based on and has been reproduced from IEC 60601-1:1998 and its first and second amendments together with a ZZ appendix added for requirements specific to Australia and New Zealand.
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AS/NZS 3200.1.0:1998 MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY—PARENT STANDARD
PREFACE
CONTENTS
SECTION ONE—GENERAL
1. Scope and object
1.1 Scope
1.2 Object
1.3 Particular Standards
1.4 Environmental conditions
1.5 Collateral Standards
2. Terminology and definitions
2.1 EQUIPMENT parts, auxiliaries and ACCESSORIES
2.2 EQUIPMENT types (classification)
2.3 Insulation
2.4 Voltages
2.5 Currents
2.6 Earth terminals and conductors
2.7 Electrical connection (devices)
2.8 Transformers
2.9 Controls and limiting devices
2.10 Operation of EQUIPMENT
2.11 Mechanical safety
2.12 Miscellaneous
3. General requirements
4. General requirements for tests
4.1 Tests
4.2 Repetition of tests
4.3 Number of samples
4.4 Components
4.5 Ambient temperature, humidity, atmospheric pressure
4.6 Other conditions
4.7 Supply and test voltages, type of current, nature of supply, frequency
4.8 Preconditioning
4.9 Repairs and modifications
4.10 Humidity preconditioning treatment
4.11 Sequence
5. Classification
6. Identification, marking and documents
6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts
6.2 Marking on the inside of EQUIPMENT or EQUIPMENT parts
6.3 Marking of controls and instruments
6.4 Symbols
6.5 Colours of the insulation of conductors
6.6 Identification of medical gas cylinders and connections
6.7 Indicators lights and push-buttons
6.8 ACCOMPANYING DOCUMENTS
7. Power input
SECTION TWO—ENVIRONMENTAL CONDITIONS
8. Basic safety categories
9. Removable protective means
10. Environmental conditions
10.1 Transport and storage
10.2 Operation
SECTION THREE—PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
13. General
14. Requirements related to classification
15. Limitation of voltage and/or energy
16. Enclosures and protective covers
17. Separation
18. Protective earthing, functional earthing and potential equalization
19. Continuous leakage currents and patient auxiliary currents
19.1 General requirements
19.2 SINGLE FAULT CONDITIONS
19.3 Allowable values
19.4 Tests
20. Dielectric strength
20.1 General requirements for all types of EQUIPMENT
20.2 Requirements for EQUIPMENT with an APPLIED PART
20.3 Values of test voltages
20.4 Tests
SECTION FOUR—PROTECTION AGAINST MECHANICAL HAZARDS
21. Mechanical strength
22. Moving parts
23. Surfaces, corners and edges
24. Stability in NORMAL USE
25. Expelled parts
26. Vibration and noise
27. Pneumatic and hydraulic power
28. Suspended masses
SECTION FIVE—PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
29. X-Radiation
30. Alpha, beta, gamma, neutron radiation and other particle radiation
31. Microwave radiation
32. Light radiation (including lasers)
33. Infra-red radiation
34. Ultraviolet radiation
35. Acoustical energy (including ultra-sonics)
36. Electromagnetic compatibility
SECTION SIX—PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
37. Locations and basic requirements
38. Marking, ACCOMPANYING DOCUMENTS
39. Common requirements for CATEGORY AP and CATEGORY APG equipment
39.1 Electrical connections
39.2 Construction details
39.3 Prevention of electrostatic charges
39.4 Corona
40. Requirements and tests for, parts and components thereof
40.1 General
40.2 Temperature limits
40.3 Low-energy circuits
40.4 External ventilation with internal overpressure
40.5 Enclosure with restricted breathing
41. Requirements and tests for, parts and components thereof
41.1 General
41.2 Power supply
41.3 Temperatures and low-energy circuits
41.4 Heating elements
41.5 Humidifiers
SECTION SEVEN—PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
42. Excessive temperatures
43. Fire prevention
43.1 Strength and rigidity
43.2 Oxygen enriched atmospheres
44. Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection and compatibility
44.1 General
44.2 Overflow
44.3 Spillage
44.4 Leakage
44.5 Humidity
44.6 Ingress of liquids
44.7 Cleaning, sterilization and disinfection
44.8 Compatibility with substances used with the EQUIPMENT
45. Pressure vessels and parts subject to PRESSURE
46. Human errors
47. Electrostatic charges
48. Biocompatibility
49. Interruption of the power supply
SECTION EIGHT—ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
50. Accuracy of operating data
50.1 Marking of controls and instruments
50.2 Accuracy of controls and instruments
51. Protection against hazardous output
51.1 Intentional exceeding of safety limits
51.2 Indication of parameters relevant to safety
51.3 Reliability of components
51.4 Accidental selection of excessive output values
51.5 Incorrect output
SECTION NINE—ABNORMAL OPERATION AND FAULT CONDITIONS: ENVIRONMENTAL TESTS
52. Abnormal operation and fault conditions
53. ENVIRONMENTAL TESTS
SECTION TEN—CONSTRUCTIONAL REQUIREMENTS
54. General
54.1 Arrangements of functions
54.2 Serviceability
54.3 Inadvertent changing of settings
55. ENCLOSURES and covers
55.1 Materials
55.2 Mechanical strength
55.3 ACCESS COVERS
55.4 Grips and other handling devices
56. Components and general assembly
56.1 General
56.2 Screws and nuts
56.3 Connections — General
56.4 Connections of capacitors
56.5 Protective devices
56.6 Temperature and overload control devices
56.7 Batteries
56.8 Indicators
56.9 Pre-set controls
56.10 Actuating parts of controls
56.11 Cord-connected hand-held and foot-operated control devices
57. MAINS PARTS, components and layout
57.1 Isolation from the SUPPLY MAINS
57.2 MAINS CONNECTORS, APPLIANCE INLETS and the like
57.3 POWER SUPPLY CORDS
57.4 Connection of POWER SUPPLY CORDS
57.5 MAINS TERMINAL DEVICES and wiring of MAINS PART
57.6 Mains fuses and OVER-CURRENT RELEASES
57.7 Location of interference suppressors in the MAINS PART
57.8 Wiring of the MAINS PART
57.9 Mains supply transformers
57.10 CREEPAGE DISTANCES and AIR CLEARANCES
58. Protective earthing—Terminals and connections
59. Construction and layout
59.1 Internal wiring
59.2 Insulation
59.3 Excessive current and voltage protection
59.4 Oil containers
APPENDIX A - GENERAL GUIDANCE AND RATIONALE
A1. General Guidance
A2. Rationale to particular clauses and sub-clauses
APPENDIX B - TESTING DURING MANUFACTURE AND/OR INSTALLATION
APPENDIX C - SEQUENCE OF TESTING
APPENDIX D - SYMBOLS ON MARKING
APPENDIX E - SURVEY OF INSULATION PATHS AND TEST
APPENDIX F - TEST APPARATUS FOR FLAMMABLE MIXTURES
APPENDIX G - IMPACT-TEST APPARATUS
APPENDIX H - SCREWED TERMINAL CONNECTIONS
APPENDIX J - MAINS SUPPLY TRANSFORMERS
APPENDIX K - EXAMPLES OF THE CONNECTION OF THE APPLIED PART FOR MEASUREMENT OF THE PATIENT LEAKAGE CURRENT
APPENDIX L - REFERENCES—PUBLICATIONS MENTIONED IN THIS STANDARD
APPENDIX ZZ - VARIATIONS TO IEC 601-1 FOR APPLICATION IN AUSTRALIA AND NEW ZEALAND
INDEX OF DEFINED TERMS
CORRIGENDUM
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AS/NZS 3200.1.0:1998 MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY—PARENT STANDARD
PREFACE
CONTENTS
SECTION ONE—GENERAL
1. Scope and object
1.1 Scope
1.2 Object
1.3 Particular Standards
1.4 Environmental conditions
1.5 Collateral Standards
2. Terminology and definitions
2.1 EQUIPMENT parts, auxiliaries and ACCESSORIES
2.2 EQUIPMENT types (classification)
2.3 Insulation
2.4 Voltages
2.5 Currents
2.6 Earth terminals and conductors
2.7 Electrical connection (devices)
2.8 Transformers
2.9 Controls and limiting devices
2.10 Operation of EQUIPMENT
2.11 Mechanical safety
2.12 Miscellaneous
3. General requirements
4. General requirements for tests
4.1 Tests
4.2 Repetition of tests
4.3 Number of samples
4.4 Components
4.5 Ambient temperature, humidity, atmospheric pressure
4.6 Other conditions
4.7 Supply and test voltages, type of current, nature of supply, frequency
4.8 Preconditioning
4.9 Repairs and modifications
4.10 Humidity preconditioning treatment
4.11 Sequence
5. Classification
6. Identification, marking and documents
6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts
6.2 Marking on the inside of EQUIPMENT or EQUIPMENT parts
6.3 Marking of controls and instruments
6.4 Symbols
6.5 Colours of the insulation of conductors
6.6 Identification of medical gas cylinders and connections
6.7 Indicators lights and push-buttons
6.8 ACCOMPANYING DOCUMENTS
7. Power input
SECTION TWO—ENVIRONMENTAL CONDITIONS
8. Basic safety categories
9. Removable protective means
10. Environmental conditions
10.1 Transport and storage
10.2 Operation
SECTION THREE—PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
13. General
14. Requirements related to classification
15. Limitation of voltage and/or energy
16. Enclosures and protective covers
17. Separation
18. Protective earthing, functional earthing and potential equalization
19. Continuous leakage currents and patient auxiliary currents
19.1 General requirements
19.2 SINGLE FAULT CONDITIONS
19.3 Allowable values
19.4 Tests
20. Dielectric strength
20.1 General requirements for all types of EQUIPMENT
20.2 Requirements for EQUIPMENT with an APPLIED PART
20.3 Values of test voltages
20.4 Tests
SECTION FOUR—PROTECTION AGAINST MECHANICAL HAZARDS
21. Mechanical strength
22. Moving parts
23. Surfaces, corners and edges
24. Stability in NORMAL USE
25. Expelled parts
26. Vibration and noise
27. Pneumatic and hydraulic power
28. Suspended masses
SECTION FIVE—PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
29. X-Radiation
30. Alpha, beta, gamma, neutron radiation and other particle radiation
31. Microwave radiation
32. Light radiation (including lasers)
33. Infra-red radiation
34. Ultraviolet radiation
35. Acoustical energy (including ultra-sonics)
36. Electromagnetic compatibility
SECTION SIX—PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
37. Locations and basic requirements
38. Marking, ACCOMPANYING DOCUMENTS
39. Common requirements for CATEGORY AP and CATEGORY APG equipment
39.1 Electrical connections
39.2 Construction details
39.3 Prevention of electrostatic charges
39.4 Corona
40. Requirements and tests for, parts and components thereof
40.1 General
40.2 Temperature limits
40.3 Low-energy circuits
40.4 External ventilation with internal overpressure
40.5 Enclosure with restricted breathing
41. Requirements and tests for, parts and components thereof
41.1 General
41.2 Power supply
41.3 Temperatures and low-energy circuits
41.4 Heating elements
41.5 Humidifiers
SECTION SEVEN—PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
42. Excessive temperatures
43. Fire prevention
43.1 Strength and rigidity
43.2 Oxygen enriched atmospheres
44. Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection and compatibility
44.1 General
44.2 Overflow
44.3 Spillage
44.4 Leakage
44.5 Humidity
44.6 Ingress of liquids
44.7 Cleaning, sterilization and disinfection
44.8 Compatibility with substances used with the EQUIPMENT
45. Pressure vessels and parts subject to PRESSURE
46. Human errors
47. Electrostatic charges
48. Biocompatibility
49. Interruption of the power supply
SECTION EIGHT—ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
50. Accuracy of operating data
50.1 Marking of controls and instruments
50.2 Accuracy of controls and instruments
51. Protection against hazardous output
51.1 Intentional exceeding of safety limits
51.2 Indication of parameters relevant to safety
51.3 Reliability of components
51.4 Accidental selection of excessive output values
51.5 Incorrect output
SECTION NINE—ABNORMAL OPERATION AND FAULT CONDITIONS: ENVIRONMENTAL TESTS
52. Abnormal operation and fault conditions
53. ENVIRONMENTAL TESTS
SECTION TEN—CONSTRUCTIONAL REQUIREMENTS
54. General
54.1 Arrangements of functions
54.2 Serviceability
54.3 Inadvertent changing of settings
55. ENCLOSURES and covers
55.1 Materials
55.2 Mechanical strength
55.3 ACCESS COVERS
55.4 Grips and other handling devices
56. Components and general assembly
56.1 General
56.2 Screws and nuts
56.3 Connections — General
56.4 Connections of capacitors
56.5 Protective devices
56.6 Temperature and overload control devices
56.7 Batteries
56.8 Indicators
56.9 Pre-set controls
56.10 Actuating parts of controls
56.11 Cord-connected hand-held and foot-operated control devices
57. MAINS PARTS, components and layout
57.1 Isolation from the SUPPLY MAINS
57.2 MAINS CONNECTORS, APPLIANCE INLETS and the like
57.3 POWER SUPPLY CORDS
57.4 Connection of POWER SUPPLY CORDS
57.5 MAINS TERMINAL DEVICES and wiring of MAINS PART
57.6 Mains fuses and OVER-CURRENT RELEASES
57.7 Location of interference suppressors in the MAINS PART
57.8 Wiring of the MAINS PART
57.9 Mains supply transformers
57.10 CREEPAGE DISTANCES and AIR CLEARANCES
58. Protective earthing—Terminals and connections
59. Construction and layout
59.1 Internal wiring
59.2 Insulation
59.3 Excessive current and voltage protection
59.4 Oil containers
APPENDIX A - GENERAL GUIDANCE AND RATIONALE
A1. General Guidance
A2. Rationale to particular clauses and sub-clauses
APPENDIX B - TESTING DURING MANUFACTURE AND/OR INSTALLATION
APPENDIX C - SEQUENCE OF TESTING
APPENDIX D - SYMBOLS ON MARKING
APPENDIX E - SURVEY OF INSULATION PATHS AND TEST
APPENDIX F - TEST APPARATUS FOR FLAMMABLE MIXTURES
APPENDIX G - IMPACT-TEST APPARATUS
APPENDIX H - SCREWED TERMINAL CONNECTIONS
APPENDIX J - MAINS SUPPLY TRANSFORMERS
APPENDIX K - EXAMPLES OF THE CONNECTION OF THE APPLIED PART FOR MEASUREMENT OF THE PATIENT LEAKAGE CURRENT
APPENDIX L - REFERENCES—PUBLICATIONS MENTIONED IN THIS STANDARD
APPENDIX ZZ - VARIATIONS TO IEC 601-1 FOR APPLICATION IN AUSTRALIA AND NEW ZEALAND
INDEX OF DEFINED TERMS
CORRIGENDUM
Previous versions
AS/NZS 3200.1.0:1998
Online Library subscription information
Online library subscriptions provide a cost-effective solution for organisations of any size to access the latest standards, offering 24/7 access to a personalised catalogue. The service ensures subscribers have have the most up-to-date version of selected standards, incluing automatic updates for any amendments or versions. Pricing is dependent on the chosen standards and the number of concurrent users, with discounts applied from the standards PDF price. For customised subscriptions or further inquiries, contact the Online Library team.