AS/NZS 3200.2.30:2001
Approval and test specification - Medical electrical equipment - Particular requirements for safety - Automatic cycling non-invasive blood pressure monitoring equipment
Specifies the particular requirements for the safety, including essential performances, of automatic cycling non-invasive blood pressure monitoring equipment, which may be attended or unattended. It does not apply to blood pressure measuring equipment, which may be attended or unattended. It does not apply to blood pressure measuring equipment which uses finger transducers or to semi-automatic blood pressure measuring equipment, typically in which each determination needs to be initiated manually. This Standard is to be read in conjunction with AS/NZS 3200.1.0:1998. It modifies and has been reproduced from IEC 60601-2-30:1999 with variations for Australia and New Zealand included in Appendix ZZ.
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AS/NZS 3200.2.30:2001 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY-AUTOMATIC CYCLING NON-INVASIVE BLOOD
PREFACE
CONTENTS
INTRODUCTION
SECTION ONE – GENERAL
1 Scope and object
*1. 1 Scope
1.2 Object
1.3 Particular Standards
2 Terminology and definitions
3 General requirements
4 General requirements for tests
5 Classification
6 Identification, marking and documents
SECTION TWO – ENVIRONMENTAL CONDITIONS
SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
14 Requirements related to classification
17 Separation
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
20 Dielectric strength
SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength
22 Moving parts
SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
36 ELECTROMAGNETIC COMPATIBILITY
SECTION SIX – PROTECTION AGAINST THE HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
42 Excessive temperatures
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection, and compatibility
45 Pressure vessels and parts subject to PRESSURE
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
SECTION TEN – CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly
57 MAINS PARTS, components and lay-out
Annex L - References – Publications mentioned in this standard
Annex AA - General guidance and rationale
Annex BB - Alarm diagrams
APPENDIX ZZ - VARIATIONS TO IEC 60601-2-30:1999 FOR APPLICATION IN AUSTRALIA AND NEW ZEALAND
ZZ1 INTRODUCTION
ZZ2 VARIATION
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AS/NZS 3200.2.30:2001 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY-AUTOMATIC CYCLING NON-INVASIVE BLOOD
PREFACE
CONTENTS
INTRODUCTION
SECTION ONE – GENERAL
1 Scope and object
*1. 1 Scope
1.2 Object
1.3 Particular Standards
2 Terminology and definitions
3 General requirements
4 General requirements for tests
5 Classification
6 Identification, marking and documents
SECTION TWO – ENVIRONMENTAL CONDITIONS
SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
14 Requirements related to classification
17 Separation
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
20 Dielectric strength
SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength
22 Moving parts
SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
36 ELECTROMAGNETIC COMPATIBILITY
SECTION SIX – PROTECTION AGAINST THE HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
42 Excessive temperatures
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection, and compatibility
45 Pressure vessels and parts subject to PRESSURE
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
SECTION TEN – CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly
57 MAINS PARTS, components and lay-out
Annex L - References – Publications mentioned in this standard
Annex AA - General guidance and rationale
Annex BB - Alarm diagrams
APPENDIX ZZ - VARIATIONS TO IEC 60601-2-30:1999 FOR APPLICATION IN AUSTRALIA AND NEW ZEALAND
ZZ1 INTRODUCTION
ZZ2 VARIATION
Previous versions
AS/NZS 3200.2.30:2001
Online Library subscription information
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