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AS/NZS 3200.1.1:1995

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Approval and test specification - Medical electrical equipment General requirements for safety - Collateral Standard: Safety requirements for medical electrical systems
Available format(s)

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

Withdrawn date

03-30-2022

Published date

07-05-1995

Preview

1 - AS/NZS 3200.1.1:1995 APPROVAL AND TEST SPECIFICATION-MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY-COLLATERAL..
4 - PREFACE
6 - CONTENTS
9 - SECTION 1: GENERAL
9 - 1 Scope and object
9 - *1201 Scope
9 - 2 Terminology and definitions
9 - 2.201 COUPLING:
9 - 2.202 INDIRECT CONTACT:
9 - *2.203 MEDICAL ELECTRICAL SYSTEM
9 - *2.204 PATIENT ENVI RONMENT:
9 - 2.205 SEPARATION DEVICE:
10 - *2.206 MULTIPLE PORTABLE SOCKET-OUTLET
10 - 3 General requirements
10 - 3.201 General requirements for the SYSTEM
10 - 4 General requirements for tests
10 - *4.201 General requirements for tests for the SYSTEM
11 - 6 Identification, marking and documents
11 - 6.1.201 Marking
11 - *6.8.201 Accompanying documents
11 - SECTION 2: ENVIRONMENTAL CONDITIONS
11 - SECTION 3: PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
11 - 16 ENCLOSURES and PROTECTIVE COVERS
11 - 16.201 ENCLOSURES
12 - 17 Separation
12 - *17.201 Electrical separation
13 - 19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS
13 - *19.201 LEAKAGE CURRENTS
13 - 19.201.1 ENCLOSURE LEAKAGE CURRENT
13 - 19.201.2 PATIENT LEAKAGE CURRENT
13 - 19.201.3 Connection of SIGNAL INPUT PARTS or SIGNAL OUTPUT PARTS
13 - SECTION 4: PROTECTION AGAINST MECHANICAL HAZARDS
13 - 22 Moving parts
13 - 22.7. 201 Protecti ve means
14 - SECTION 5: PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
14 - SECTION 6: PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
14 - SECTION 7: PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
14 - *43.201 Fire prevent
14 - 44.7. 201 Cleaning, sterilizat ion and disinfection
14 - *49.201 Interruption of the power supply
14 - SECTION 8: ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
14 - SECTION 9: ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS
14 - SECTION 10: CONSTRUCTIONAL REQUIREMENTS
14 - 56.3.201 Connections
15 - 57.2 MAINS CONNECTORS, APPLIANCE INLETS and the like
15 - *57.2.201 MULTIPLE PORTABLE SOCKET-OUTLET
15 - 57.10 CREEPAGE DISTANCES AND AIR CLEARANCES
15 - 57.10.201 SEPARATION DEVICE
15 - *58.201 PROTECTIVE EARTH CONDUCTOR
15 - 59.201 Protection of wiring
17 - Annex AAA - General guidance and rationale
22 - Annex BBB - Examples of combinations of MEDICAL ELECTRICAL EQUIPMENT and non-medical electrical equipment
22 - BBB.1 Introduction
22 - BBB.2 Localities in a medical environment
22 - BBB.3 Basic principles
23 - BBB.4 Assumptions on EQUIPMENT
23 - BBB.5 Equipment codes
23 - BBB.6 Codes assi gned to feasible solutions
25 - BBB.7 Summary of situations
27 - Annex CCC - Normative references
28 - Annex DDD - Bibliography
29 - Annex EEE - Requirements for MULTIPLE PORTABLE SOCKET-OUTLETS
29 - EEE.1 MULTIPLE PORTABLE SOCKET-OUTLETS with separating transformers
29 - EEE.2 MULTIPLE PORTABLE SOCKET-OUTLETS without separating transformers
31 - Annex FFF - Examples of application of MULTIPLE PORTABLE SOCKET-OUTLETS
33 - APPENDIX ZZ - VARIATIONS TO THIS STANDARD APPLICABLE IN AUSTRALIA AND NEW ZEALAND

Applies to the safety of medical electrical systems. It describes the safety requirements for these systems necessary to provide protection to the patient and operator. This Standard is supplementary to AS 3200.1.0-1990, and is identical with and has been reproduced from IEC 60601-1-1:1992.

This standard applies to the safety of MEDICAL ELECTRICAL SYSTEMS, as defined in 2.203. It describes the safety requirements necessary to provide protection for the PATIENT, the OPERATOR and surroundings.NOTE - It is presumed that the party assembling or modifying the MEDICA L ELECTRIC AL SYSTEMS will take the necessary steps to assure compliance with this standard.

Committee
HE-003
DocumentType
Standard
ISBN
0 7262 9762 3
Pages
25
PublisherName
Standards Australia
Status
Withdrawn
Supersedes

Standards Relationship
IEC 60601-1-1:1992 Identical

Amendment 1 to AS/NZS 3200.1.1:1995 see DR 96370 First published as AS/NZS 3200.1.1:1995.

AS/NZS 3260:1993 Approval and test specification - Safety of information technology equipment including electrical business equipment
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AS 1852.826-1983 International electrotechnical vocabulary - Electrical installations of buildings
AS/NZS 3200.2.200:2005 Medical electrical equipment Particular requirements for safety - Oxygen concentrators for individual patient use

AS 3979-2006 Hydrotherapy pools (Reconfirmed 2018)
AS/NZS 2500:1995 Guide to the safe use of electricity in patient care
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AS/NZS 3200.2.2:1999 Medical electrical equipment - Particular requirements for safety - High frequency surgical equipment
AS/NZS 3551:1996 Technical management programs for medical devices
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AS/NZS 3200.1.0-1998 Medical electrical equipment General requirements for safety - Parent Standard
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AS/NZS 3200.2.22:1997 Approval and test specification - Medical electrical equipment Particular requirements for safety - Diagnostic and therapeutic laser equipment
AS/NZS 3200.1.2:2005 Medical electrical equipment General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
AS/NZS 3200.1.8:2005 Medical electrical equipment General requirements for safety - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
AS/NZS 3200.2.40:1999 Medical electrical equipment Particular requirements for safety - Electromyographs and evoked response equipment
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AS/NZS 60598.2.25:2001 Luminaires Particular requirements - Luminaires for use in clinical areas of hospitals and health care buildings (IEC 60598.2.25:1994, MOD) (Reconfirmed 2013)
AS/NZS 3200.1.2:1995 Approval and test specification - Medical electrical equipment General requirements for safety - Collateral Standard: Electromagnetic compatibility - Requirements and tests
AS 4774.2-2002 Work in compressed air and hyperbaric facilities - Hyperbaric oxygen facilities
AS 60118.14-2007 Hearing aids Specification of a digital interface device (Reconfirmed 2019)
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 2500:2004 Guide to the safe use of electricity in patient care

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