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