AS/NZS 3200.2.30:2001

1 - AS/NZS 3200.2.30:2001 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY-AUTOMATIC CYCLING NON-INVASIVE BLOOD
4 - PREFACE
6 - CONTENTS
8 - INTRODUCTION
9 - SECTION ONE – GENERAL
9 - 1 Scope and object
9 - *1. 1 Scope
9 - 1.2 Object
9 - 1.3 Particular Standards
10 - 2 Terminology and definitions
11 - 3 General requirements
12 - 4 General requirements for tests
12 - 5 Classification
12 - 6 Identification, marking and documents
13 - SECTION TWO – ENVIRONMENTAL CONDITIONS
13 - SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
13 - 14 Requirements related to classification
14 - 17 Separation
14 - 19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
14 - 20 Dielectric strength
14 - SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
14 - 21 Mechanical strength
15 - 22 Moving parts
16 - SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
16 - 36 ELECTROMAGNETIC COMPATIBILITY
19 - SECTION SIX – PROTECTION AGAINST THE HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
19 - SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
19 - 42 Excessive temperatures
20 - 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection, and compatibility
20 - 45 Pressure vessels and parts subject to PRESSURE
20 - 49 Interruption of the power supply
21 - SECTION EIGHT – ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
21 - 50 Accuracy of operating data
21 - 51 Protection against hazardous output
27 - SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS
27 - SECTION TEN – CONSTRUCTIONAL REQUIREMENTS
27 - 56 Components and general assembly
28 - 57 MAINS PARTS, components and lay-out
36 - Annex L - References – Publications mentioned in this standard
37 - Annex AA - General guidance and rationale
44 - Annex BB - Alarm diagrams
48 - APPENDIX ZZ - VARIATIONS TO IEC 60601-2-30:1999 FOR APPLICATION IN AUSTRALIA AND NEW ZEALAND
48 - ZZ1 INTRODUCTION
48 - ZZ2 VARIATION

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 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.

First published as AS/NZS 3200.2.30:1996.
Second edition 2001.