Table of Contents

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

Abstract

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.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	Standards Australia
ProductNote	Pending Revision indicates that as a result of the Aged Standards review process, the document needs updating. If no project proposal, meeting the quality criteria, is received within the 12 month timeframe, the document shall be withdrawn.
Pages
ISBN
Committee	HE-003
Supersedes	DR 00082