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AS/NZS 3200.2.18:1997

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Approval and test specification - Medical electrical equipment Particular requirements for safety - Endoscopic equipment
Available format(s)

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

Superseded date

10-27-2017

Language(s)

English

Published date

07-05-1997

Preview

1 - AS/NZS 3200.2.18:1997 APPROVAL AND TEST SPECIFICATION - MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR SAFETY.....
4 - PREFACE
6 - CONTENTS
9 - SECTION ONE - GENERAL
9 - 1 Scope and object
10 - 2 Terminology and definitions
12 - 3 General requirements
12 - 4 General requirements for tests
12 - 5 Classification
12 - *6 Identification, marking and documents
14 - SECTION TWO - ENVIRONMENTAL CONDITIONS
15 - SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
15 - 20 Dielectric strength
15 - SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
15 - *21 Mechanical strength
15 - 22 Moving parts
15 - 25 Expelled parts
16 - 26 Vibration and noise
16 - 27 Pneumatic and hydraulic power
16 - 28 Suspended masses
16 - SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
16 - 36 Electromagnetic compatibility
16 - SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
17 - SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS
17 - 42 Excessive temperatures
19 - 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection and compatibility
20 - SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT
20 - SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS
20 - SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
20 - 57 MAINS PARTS, components and layout
22 - Appendix D - Symbols on marking
23 - Appendix L - References – Publications mentioned in this standard
24 - Annex AA - Rationale
24 - 2 Definitions
25 - 3 General requirements
25 - 6 Identification, marking and documents
27 - 20 Dielectric strength
27 - 21 Mechanical strength
27 - 42 Excessive temperatures
28 - 57 MAINS PARTS, components and layout
29 - APPENDIX ZZ - VARIATIONS TO IEC 601-2-18 FOR APPLICATION IN AUSTRALIA ONLY

Specifies requirements for the safety of endoscopic equipment and its interconn ections with endoscopically-used accessories. This Standard is to be read in conjunction wit h AS 3200.1.0-1990. It is based on and reproduced from IEC 601-2-18:1996 and include s the full technical text of that Standard. An Appendix ZZ specifies additional requirements applicable in Australia and New Zealand.

Addition:This Particular Standard specifies requirements for the safety of ENDOSCOPIC EQUIPMENT and itsINTERCONNECTION CONDITIONS with ENDOSCOPICALLY-USED ACCESSORIES.NOTE û As the General Standard does not give requirements for the safety of APPLIED PARTS of different MEDICA L ELECTRIC AL EQUI PMENT when used together, this standard gives requirements for specific INTERCONN ECTION CONDI TIONS commonly encountered during the use of ENDOSCOPES.

Committee
HE-003
DocumentType
Standard
ISBN
0 7337 1244 4
Pages
21
PublisherName
Standards Australia
Status
Superseded
SupersededBy
Supersedes
UnderRevision

First published as AS 3200.2.18-1992.Second edition AS/NZS 3200.2.18:1997. First published as AS 3200.2.18-1992. Second edition AS/NZS 3200.2.18:1997.

AS/NZS 3200.1.1:1995 Approval and test specification - Medical electrical equipment General requirements for safety - Collateral Standard: Safety requirements for medical electrical systems
AS/NZS 3200.2.2:1999 Medical electrical equipment - Particular requirements for safety - High frequency surgical equipment
AS 3200.1.0-1990 Approval and test specification - Medical electrical equipment General requirements for safety - Parent Standard
AS/NZS 3200.1.0-1998 Medical electrical equipment General requirements for safety - Parent Standard
AS/NZS 2064.1:1992 Limits and methods of measurement of electromagnetic disturbance characteristics of industrial, scientific and medical (ISM) radio-frequency equipment General requirements

AS/NZS 3200.2.2:1999 Medical electrical equipment - Particular requirements for safety - High frequency surgical equipment
AS/NZS 60335.2.90:2006 Household and Similar Electrical Appliances - Safety Particular requirements for commercial microwave ovens
AS/NZS 60745.1:2009 Hand-held motor-operated electric tools-Safety General requirements (IEC 60745-1 Ed 4, MOD) (Reconfirmed 2020)
AS/NZS 3200.2.41:2002 Medical electrical equipment Particular requirements for safety - Surgical luminaires and luminaires for diagnosis (IEC 60601-2-41:2000, MOD)
AS 4187-1998 Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities
AS 4774.2-2002 Work in compressed air and hyperbaric facilities - Hyperbaric oxygen facilities

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