Source: https://infostore.saiglobal.com/en-au/standards/as-nzs-3200-1-0-1998-117055_saig_as_as_244853/
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AS/NZS 3200.1.0:1998 | Medical electrical equipment General requirements for safety - Parent Standard | SAI Global
Medical electrical equipment General requirements for safety - Parent Standard
1 - AS/NZS 3200.1.0:1998 MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY-PARENT STANDARD
9 - SECTION ONE-GENERAL
9 - 1. Scope and object
9 - 1.2 Object
9 - 1.3 Particular Standards
9 - 1.4 Environmental conditions
9 - 1.5 Collateral Standards
9 - 2. Terminology and definitions
9 - 2.1 EQUIPMENT parts, auxiliaries and ACCESSORIES
11 - 2.2 EQUIPMENT types (classification)
13 - 2.3 Insulation
14 - 2.4 Voltages
14 - 2.5 Currents
15 - 2.6 Earth terminals and conductors
15 - 2.7 Electrical connection (devices)
16 - 2.8 Transformers
17 - 2.9 Controls and limiting devices
17 - 2.10 Operation of EQUIPMENT
18 - 2.11 Mechanical safety
19 - 2.12 Miscellaneous
20 - 3. General requirements
21 - 4. General requirements for tests
21 - 4.1 Tests
21 - 4.2 Repetition of tests
21 - 4.3 Number of samples
21 - 4.4 Components
22 - 4.5 Ambient temperature, humidity, atmospheric pressure
22 - 4.6 Other conditions
22 - 4.7 Supply and test voltages, type of current, nature of supply, frequency
23 - 4.8 Preconditioning
23 - 4.9 Repairs and modifications
23 - 4.10 Humidity preconditioning treatment
24 - 4.11 Sequence
24 - 5. Classification
25 - 6. Identification, marking and documents
25 - 6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts
29 - 6.2 Marking on the inside of EQUIPMENT or EQUIPMENT parts
30 - 6.3 Marking of controls and instruments
31 - 6.4 Symbols
31 - 6.5 Colours of the insulation of conductors
31 - 6.6 Identification of medical gas cylinders and connections
31 - 6.7 Indicators lights and push-buttons
32 - 6.8 ACCOMPANYING DOCUMENTS
34 - 7. Power input
35 - SECTION TWO-ENVIRONMENTAL CONDITIONS
35 - 8. Basic safety categories
35 - 9. Removable protective means
35 - 10. Environmental conditions
35 - 10.1 Transport and storage
35 - 10.2 Operation
37 - SECTION THREE-PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
37 - 13. General
37 - 14. Requirements related to classification
38 - 15. Limitation of voltage and/or energy
39 - 16. Enclosures and protective covers
42 - 17. Separation
45 - 18. Protective earthing, functional earthing and potential equalization
47 - 19. Continuous leakage currents and patient auxiliary currents
47 - 19.1 General requirements
48 - 19.2 SINGLE FAULT CONDITIONS
49 - 19.3 Allowable values
50 - 19.4 Tests
56 - 20. Dielectric strength
56 - 20.1 General requirements for all types of EQUIPMENT
57 - 20.2 Requirements for EQUIPMENT with an APPLIED PART
58 - 20.3 Values of test voltages
59 - 20.4 Tests
60 - SECTION FOUR-PROTECTION AGAINST MECHANICAL HAZARDS
60 - 21. Mechanical strength
63 - 22. Moving parts
64 - 23. Surfaces, corners and edges
64 - 24. Stability in NORMAL USE
65 - 25. Expelled parts
65 - 26. Vibration and noise
65 - 27. Pneumatic and hydraulic power
66 - 28. Suspended masses
67 - SECTION FIVE-PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
67 - 29. X-Radiation
67 - 30. Alpha, beta, gamma, neutron radiation and other particle radiation
67 - 31. Microwave radiation
67 - 32. Light radiation (including lasers)
67 - 33. Infra-red radiation
67 - 34. Ultraviolet radiation
67 - 35. Acoustical energy (including ultra-sonics)
67 - 36. Electromagnetic compatibility
68 - SECTION SIX-PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
68 - 37. Locations and basic requirements
68 - 38. Marking, ACCOMPANYING DOCUMENTS
69 - 39. Common requirements for CATEGORY AP and CATEGORY APG equipment
69 - 39.1 Electrical connections
69 - 39.2 Construction details
70 - 39.3 Prevention of electrostatic charges
70 - 39.4 Corona
70 - 40. Requirements and tests for, parts and components thereof
70 - 40.1 General
71 - 40.2 Temperature limits
71 - 40.3 Low-energy circuits
72 - 40.4 External ventilation with internal overpressure
72 - 40.5 Enclosure with restricted breathing
73 - 41. Requirements and tests for, parts and components thereof
73 - 41.1 General
74 - 41.2 Power supply
74 - 41.3 Temperatures and low-energy circuits
75 - 41.4 Heating elements
75 - 41.5 Humidifiers
76 - SECTION SEVEN-PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
76 - 42. Excessive temperatures
81 - 43. Fire prevention
81 - 43.1 Strength and rigidity
81 - 43.2 Oxygen enriched atmospheres
81 - 44. Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection and compatibility
81 - 44.1 General
81 - 44.2 Overflow
81 - 44.3 Spillage
81 - 44.4 Leakage
82 - 44.5 Humidity
82 - 44.6 Ingress of liquids
82 - 44.7 Cleaning, sterilization and disinfection
82 - 44.8 Compatibility with substances used with the EQUIPMENT
83 - 45. Pressure vessels and parts subject to PRESSURE
84 - 46. Human errors
84 - 47. Electrostatic charges
84 - 48. Biocompatibility
84 - 49. Interruption of the power supply
85 - SECTION EIGHT-ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
85 - 50. Accuracy of operating data
85 - 50.1 Marking of controls and instruments
85 - 50.2 Accuracy of controls and instruments
85 - 51. Protection against hazardous output
85 - 51.1 Intentional exceeding of safety limits
85 - 51.2 Indication of parameters relevant to safety
85 - 51.3 Reliability of components
85 - 51.4 Accidental selection of excessive output values
85 - 51.5 Incorrect output
85 - SECTION NINE-ABNORMAL OPERATION AND FAULT CONDITIONS: ENVIRONMENTAL TESTS
85 - 52. Abnormal operation and fault conditions
91 - 53. ENVIRONMENTAL TESTS
91 - SECTION TEN-CONSTRUCTIONAL REQUIREMENTS
91 - 54. General
91 - 54.1 Arrangements of functions
91 - 54.2 Serviceability
92 - 54.3 Inadvertent changing of settings
92 - 55. ENCLOSURES and covers
92 - 55.1 Materials
92 - 55.2 Mechanical strength
92 - 55.3 ACCESS COVERS
92 - 55.4 Grips and other handling devices
92 - 56. Components and general assembly
92 - 56.1 General
93 - 56.2 Screws and nuts
93 - 56.3 Connections - General
93 - 56.4 Connections of capacitors
93 - 56.5 Protective devices
94 - 56.6 Temperature and overload control devices
94 - 56.7 Batteries
95 - 56.8 Indicators
95 - 56.9 Pre-set controls
95 - 56.10 Actuating parts of controls
96 - 56.11 Cord-connected hand-held and foot-operated control devices
97 - 57. MAINS PARTS, components and layout
97 - 57.1 Isolation from the SUPPLY MAINS
98 - 57.2 MAINS CONNECTORS, APPLIANCE INLETS and the like
98 - 57.3 POWER SUPPLY CORDS
99 - 57.4 Connection of POWER SUPPLY CORDS
101 - 57.5 MAINS TERMINAL DEVICES and wiring of MAINS PART
103 - 57.6 Mains fuses and OVER-CURRENT RELEASES
103 - 57.7 Location of interference suppressors in the MAINS PART
103 - 57.8 Wiring of the MAINS PART
104 - 57.9 Mains supply transformers
108 - 57.10 CREEPAGE DISTANCES and AIR CLEARANCES
110 - 58. Protective earthing-Terminals and connections
111 - 59. Construction and layout
111 - 59.1 Internal wiring
112 - 59.2 Insulation
113 - 59.3 Excessive current and voltage protection
114 - 59.4 Oil containers
154 - APPENDIX A - GENERAL GUIDANCE AND RATIONALE
154 - A1. General Guidance
161 - A2. Rationale to particular clauses and sub-clauses
186 - APPENDIX B - TESTING DURING MANUFACTURE AND/OR INSTALLATION
187 - APPENDIX C - SEQUENCE OF TESTING
190 - APPENDIX D - SYMBOLS ON MARKING
194 - APPENDIX E - SURVEY OF INSULATION PATHS AND TEST
198 - APPENDIX F - TEST APPARATUS FOR FLAMMABLE MIXTURES
199 - APPENDIX G - IMPACT-TEST APPARATUS
200 - APPENDIX H - SCREWED TERMINAL CONNECTIONS
200 - APPENDIX J - MAINS SUPPLY TRANSFORMERS
201 - APPENDIX K - EXAMPLES OF THE CONNECTION OF THE APPLIED PART FOR MEASUREMENT OF THE PATIENT LEAKAGE CURRENT
203 - APPENDIX L - REFERENCES-PUBLICATIONS MENTIONED IN THIS STANDARD
207 - APPENDIX ZZ - VARIATIONS TO IEC 601-1 FOR APPLICATION IN AUSTRALIA AND NEW ZEALAND
209 - INDEX OF DEFINED TERMS
210 - CORRIGENDUM
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. 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 60601-1:1988 and its first and second amendments together with a ZZ appendix added for requirements specific to Australia and New Zealand.
This Standard applies to the safety of MEDICAL ELECTRICAL EQUIPMENT (as defined in Sub-clause 2.2.15).Although this Standard is primarily concerned with safety, it contains some requirements regarding reliable operation where this is connected with safety.SAFETY HAZARDS resulting from the intended physiological function of EQUIPMENT covered by this Standard are not considered.Appendices in this Standard are not mandatory unless made so by an explicit statement in the main text.* 1. Scope and objectScopeThis Standard applies to the safety of MEDICAL ELECTRICAL EQUIPMENT (as defined in Sub-clause 2.2.15).Although this Standard is primarily concerned with safety, it contains some requirements regarding reliable operation where this is connected with safety.SAFETY HAZARDS resulting from the intended physiological function of EQUIPMENT covered by this Standard are not considered.Appendices in this Standard are not mandatory unless made so by an explicit statement in the main text.ObjectThe object of this Standard is to specify general requirements for the safety of MEDICAL ELECTRICAL EQUIPMENT and to serve as the basis for the safety requirements of Particular Standards.Particular StandardsA Particular Standard takes priority over this General Standard.Environmental conditionsSee Section Two.Collateral StandardsIn the IEC 601 series, Collateral Standards specify general requirements for safety applicable to:- a group of MEDICAL ELECTRICAL EQUIPMENT (e.g. radiological equipment);- a specific characteristic of all MEDICAL ELECTRICAL EQUIPMENT not fully addressed in the General Standard (e.g. electromagnetic compatibility).If a Collateral Standard applies to a Particular Standard, then the Particular Standard takes priority over the Collateral Standard.
ProductNote See also AS 3200-1986
DR AS/NZS 60601.1:2015
AS 3200.1.0-1990
AS/NZS IEC 60601.1:2015
First published in Australia as AS C200-1970.
Revised and redesignated AS 3200-1978.
Revised and redesignated AS 3200.1-1990.
Redesignated AS 3200.1.0-1990.
First published in New Zealand as NZS 6150-1990.
AS 3200.1.0-1990 and NZS 6150-1990 revised, amalgamated and designated AS/NZS 3200.1.0:1998.
AS/NZS 3200.1.3:1996 Approval and test specification - Medical electrical equipment General requirements for safety - Collateral Standard: Requirements for radiation protection in diagnostic X-ray equipment
AS 3108-1990 Approval and test specification - Particular requirements for isolating transformers and safety isolating transformers
AS/NZS 4513:1995 Medical electrical equipment - Fundamental aspects of safety Standards
AS 2684-1984 Medical equipment - Humidifiers, for medical use
AS 2472-1985 Valves for medical gas cylinders
AS/NZS 4274:1995 X-ray tube assemblies for medical diagnosis - Characteristics of focal spots
AS/NZS 3200.1.1:1995 Approval and test specification - Medical electrical equipment General requirements for safety - Collateral Standard: Safety requirements for medical electrical systems
AS 1683.20-1980 Methods of test for rubber Standard temperatures, humidities and times for conditioning and testing test pieces
AS 4484-1997 Industrial, medical and refrigerant compressed gas cylinder identification
AS 3200.2.20-1992 Approval and test specification - Medical electrical equipment Particular requirements for safety - Baby incubators (transport)
AS/NZS 3200.2.1:1999 Medical electrical equipment Particular requirements for safety - Electron accelerators in the range of 1 MeV to 50 MeV
AS/NZS ISO 10535:2011 Hoists for the transfer of disabled persons - Requirements and test methods
AS/NZS 3200.2.23:2001 Medical electrical equipment Particular requirements for safety - Transcutaneous partial pressure monitoring equipment
AS/NZS 3200.2.41:2002 Medical electrical equipment Particular requirements for safety - Surgical luminaires and luminaires for diagnosis
AS/NZS 3200.2.38:2007 Medical electrical equipment Particular requirements for safety - Electrically and manually operated medical beds for adult use (IEC 60601-2-38, Ed.1.0(1996) MOD)
AS/NZS 3200.2.24:1999 Medical electrical equipment Particular requirements for safety - Infusion pumps and controllers
AS/NZS 3551:2012 Management programs for medical equipment
AS/NZS 3200.2.8:1994 Medical electrical equipment Particular requirements for safety - Therapeutic X-ray generators
AS/NZS 4434.2:1996 Medical electrical equipment - Medical electron accelerators Periodic function performance testing
AS/NZS 4173:1994 Guide to the safe use of lasers in health care
AS/NZS 3695.2:2013 Wheelchairs Requirements and test methods for electrically powered wheelchairs (including mobility scooters)
AS/NZS 3200.2.30:2001 Medical electrical equipment Particular requirements for safety - Automatic cycling non-invasive blood pressure monitoring equipment
AS/NZS 2394:1994 Conditioning equipment for the treatment of nocturnal enuresis (bedwetting)
AS/NZS 3200.2.45:1999 Medical electrical equipment Particular requirements for safety - Mammographic X-ray equipment and mammographic stereotactic devices
AS/NZS 4184.3.3:1998 Evaluation and routine testing in medical imaging departments Acceptance tests - Imaging performance of X-ray equipment for digital subtraction angiography (DSA)
AS 3200.2.19-1992 Approval and test specification - Medical electrical equipment Particular requirements for safety - Baby incubators (nursing)
AS/NZS 4537:1999 Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy
AS/NZS 3200.2.26:2005 Medical electrical equipment Particular requirements for safety - Electroencephalographs
AS/NZS 3200.2.201:2000 Medical electrical equipment Particular requirements for safety - Dento-maxillofacial X-ray equipment
AS/NZS 4434.1:1996 Medical electrical equipment - Medical electron accelerators Functional performance characteristics