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AS/NZS 3200.2.23:2001

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

Medical electrical equipment Particular requirements for safety - Transcutaneous partial pressure monitoring equipment

Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Superseded date

29-07-2024

Superseded by

AS 60601.2.23:2018

Language(s)

English

Published date

12-11-2001

€77.79
Excluding VAT

1 - AS/NZS 3200.2.23:2001 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY-TRANSCUTANEOUS PARTIAL PRESSURE MONIT
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
12 - 3 General requirements
12 - 4 General requirements for tests
12 - 5 Classification
13 - 6 Identification, marking and documents
13 - SECTION TWO – ENVIRONMENTAL CONDITIONS
14 - SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
14 - 14 Requirements related to classification
14 - 17 Separation
14 - 20 Dielectric strength
14 - SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
14 - 21 Mechanical strength
15 - SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
15 - *36 Electromagnetic compatibility
17 - SECTION SIX – PROTECTION AGAINST THE HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
18 - SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
18 - 42 Excessive temperatures
19 - 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection and compatibility
19 - 49 Interruption of the power supply
20 - SECTION EIGHT – ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
20 - 51 Protection against hazardous output
26 - 52 Abnormal operation and fault conditions
26 - SECTION TEN – CONSTRUCTIONAL REQUIREMENTS
26 - 56 Components and general assembly
27 - 57 MAINS PARTS, components and layout
34 - Annex AA - General guidance and rationale

Specifies the particular requirements for the safety, including essential performances, of transcutaneaous partial pressure monitoring equipment, and applies to equipment used with adults, children and neonates, including their use in foetal monitoring during birth. It does not apply to haemoglobin saturation oximeters or to devices applied to surfaces of the body other than the skin. This Standartd is to be read in conjunction with AS/NZS 3200.1.0:1998. It is identical with, and reproduced from, IEC 60601-2-23:1999.

Committee
HE-003
DocumentType
Standard
ISBN
0 7337 4039 1
Pages
30
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.
PublisherName
Standards Australia
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
IEC 60601-2-23:1999 Identical

First published as Joint Standard AS/NZS 3200.2.23:1994.
Second edition 2001.

AS/NZS 3200.1.4:1997 Approval and test specification - Medical electrical equipment General requirements for safety - Collateral Standard: Programmable electrical medical systems
AS/NZS 3200.1.2:2005 Medical electrical equipment General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
AS/NZS 3200.1.0-1998 Medical electrical equipment General requirements for safety - Parent Standard

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