Table of Contents
SECTION ONE - GENERAL
1. Scope and object
2. Terminology and definitions
3. General requirements
4. General requirements for tests
5. Classification
6. Identification, marking and documents
7. Power input
SECTION TWO - ENVIRONMENTAL CONDITIONS
8. Basic safety categories
9. Removable protective means
10. Environmental conditions
11. Not used
12. Not used
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
20. Dielectric strength
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 ultrasonics)
36. Electromagnetic compatibility
SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION
OF FLAMMABLE ANAESTHETIC MIXTURES
37. Locations and basic requirements
38. Marking and ACCOMPANYING DOCUMENTS
39. Common requirements for CATEGORY AP AND CATEGORY
APG EQUIPMENT
40. Requirements and tests for CATEGORY AP EQUIPMENT,
parts and components thereof
41. Requirements and tests for CATEGORY APG EQUIPMENT,
parts and components thereof
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
42. Excessive temperatures
43. Fire prevention
44. Overflow, spillage, leakage, humidity, ingress of
liquids, cleaning, sterilization, disinfection and
compatibility
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
51. Protection against hazardous 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
55. ENCLOSURES and covers
56. Components and general assembly
57. MAINS PARTS, components and layout
58. Protective earthing - Terminals and connections
59. Construction and layout
APPENDIX A - General guidance and rationale
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 circuits
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 - Variation to IEC 601-1 for application in
Australia and New Zealand
INDEX of defined terms
Abstract
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.
Scope
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 object
Scope
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.
Object
The 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 Standards
A Particular Standard takes priority over this General Standard.
Environmental conditions
See Section Two.
Collateral Standards
In 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.
History
First published in Australia as AS C200-1970.
Revised and redesignated AS 3200-1978.
Second edition 1980.
Third edition 1986.
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.