AS/NZS 3200.2.31:1996

1 - AS/NZS 3200.2.31:1996 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY-EXTERNAL CARDIAC PACEMAKERS WITH .....
4 - PREFACE
6 - CONTENTS
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 - 5 Classification
11 - 6 Identification, marking and documents
11 - 6.1 Marking on the outside of the EQUIPMENT or EQUIPMENT parts
12 - 6.3 Marking of Controls and instruments
12 - 6.8 Accompanying documents
12 - 6.8.2 Instructions for use
14 - 7* Power input
14 - SECTION TWO: ENVIRONMENTAL CONDITIONS
15 - SECTION THREE: PROTECTION AGAINST ELECTRICAL SHOCK HAZARDS
15 - 14 Requirements related to classification
15 - 14.1* CLASS I EQUIPMENT
15 - 14.2* CLASS II EQUIPMENT
15 - 14.4* CLASS I and CLASS II EQUIPMENT
15 - 14.5* INTERNALLY POWERED EQUIPMENT
15 - 19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
15 - 19.1 General requirements
15 - 19.3 Allowable values
16 - 19.4 Tests
16 - SECTION FOUR: PROTECTION AGAINST MECHANICAL HAZARDS
16 - SECTION FIVE: PROTECTION AGAINST HAZARDS FROM HAZARDS FROM
16 - 36* Electromagnetic compatibility
16 - 36.202.1* ELECTROSTATIC DISCHARGE
17 - SECTION SIX: PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
17 - SECTION SEVEN: PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
17 - 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection
17 - 44.2* Overflow
17 - 44.3* Spillage
17 - 44.4* Leakage
18 - 44.6* Ingress of liquids
18 - 49 Interruption of the power supply
19 - SECTION EIGHT: ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
19 - 50 Accuracy of operating data
19 - 50.2 Accuracy of controls and instruments
20 - 51 Protection against hazardous output
20 - 51.1* Intentional exceeding of safety limits
20 - 51.101 Protection against electric hazards
20 - 51.102* Protection against accidental change of controls and tampering
21 - 51.103* Protection against a low battery condition
21 - 51.104* Rate limit (runaway protection)
21 - 51.105* Interference reversion
21 - 51.106* MAXIMUM TRACKING RATE
22 - SECTION NINE: ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS
22 - SECTION TEN: CONSTRUCTIONAL REQUIREMENTS
22 - 56 Components and general assembly
22 - 56.3 Connections - General
22 - 56.101* Output indicator
22 - 56.102* Input indicator
24 - Appendix L - References-Publications mentioned in this Standard
25 - Annex AA - General guidance and rationale
35 - Annex BB - Bibliography

Specifies the particular safety requirements for external pacemakers used to pace patients prior to the implanting of an internal pacemaker or for temporary pacing related to other medical procedures. This Standard is to be read in conjunction with AS 3200.1.0-1990. It is identical with and reproduced from IEC 601-2-31:1994.

Addition:This Particular International Standard specifies the particular safety requirements for EXTERNAL PACEMAKERS as defined in 2.1.101, hereinafter referred to as EQUIPMENT, poweredby an INTERNAL ELECTRICAL POWER SOURCE.This Standard applies to PATIENT CABLES as defined in 2.1.104.This Standard does not apply to EQUIPMENT which can be directly or indirectly connected toa SUPPLY MAINS.This Standard does not apply to pacing LEADS, or other equipment for cardiac stimulation which either:1) forms an integral part of equipment with other functions; or2) applies the stimulus across the thorax externally or in the oesophagus; or3) provides antitachycardia therapy beyond high rate burst pacing; or 4) provides pacing system analysis functions.Each of the two channels of DUAL CHAMBER EQUIPMENT is subject to the requirements of this Standard.

First published as Joint Standard AS/NZS 3200.2.31:1996.