AS/NZS 3200.2.39:2001

1 - AS/NZS 3200.2.39:2001 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY-PERITONEAL DIALYSIS EQUIPMENT
4 - PREFACE
5 - CONTENTS
7 - SECTION ONE – GENERAL
7 - 1 Scope and object
7 - 1.1 Scope
7 - 1.2 Object
7 - 1.3 Particular Standards
8 - 2 Terminology and definitions
9 - 3 General requirements
9 - 4 General requirements for tests
9 - 6 Identification, marking and documentation
10 - SECTION TWO – ENVIRONMENTAL CONDITIONS
10 - SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
10 - 19 Continuous LEAKAGE CURRENT and PATIENT AUXILIARY CURRENTS
11 - SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
11 - SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
11 - SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
11 - SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
11 - 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection and compatibility
12 - SECTION EIGHT – ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
12 - 51 Protection against hazardous output
12 - 51.101 DIALYSING SOLUTION temperature
12 - 51.102 Pressures
13 - 51.103 Air infusion
13 - 51.104 DIALYSING SOLUTION overfill
13 - 51.105 PROTECTIVE SYSTEMS
13 - SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS
13 - SECTION TEN – CONSTRUCTION REQUIREMENTS
13 - 59 Construction and layout
13 - 59.101 DIALYSING SOLUTION circuit guides
14 - 59.102 OUTFLOW
15 - ANNEXES

Specifies requirements for the design and manufactrure of electrically safe peritoneal dialysis equipment. This Standard is identical with and reproduced from IEC 60601-2-39:1999.

First published as AS/NZS 3200.2.39:2001.