AS/NZS 3200.1.2:1995
Approval and test specification - Medical electrical equipment - General requirements for safety - Collateral Standard - Electromagnetic compatibility - Requirements and tests
Applies only to medical electrical equipment, medical electrical systems and information technology equipment used in medical electrical applications which are, or may be, susceptible to electromagnetic interference. This standard is identical to and reproduced from IEC 60601-1-2:1993.
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AS/NZS 3200.1.2:1995 APPROVAL AND TEST SPECIFICATION-MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY-COLLATERAL..
PREFACE
CONTENTS
SECTION 1: GENERAL
1 Scope and object
1.201 Scope
1.202 Object
2 Terminology and definitions
2.201 LIFE SUPPORTING EQUIPMENT and/or SYSTEM
2.202 PATIENT COUPLED EQUIPMENT and/or SYSTEM
2.203 EMC Definitions from IEC 50(161)
2.203.1 ELECTROMAGNETIC ENVIRONMENT
2.203.2 ELECTROMAGNETIC NOISE
*2.203.3 ELECTROMAGNETIC DISTURBANCE
2.203.4 ELECTROMAGNETIC COMPATIBILITY: EMC
2.203.5 (ELECTROMAGNETIC) EMISSION
2.203.6 DEGRADATION (of performance)
2.203.7 IMMUNITY (to a disturbance)
2.203.8 (ELECTROMAGNETIC) SUSCEPTIBILITY
2.203.9 ELECTROSTATIC DISCHARGE: ESD (abbreviation)
2.203.10 TRANSIENT (adjective and noun)
2.203.11 PULSE
2.203.12 BURST (of PULSES or oscillations)
2.203.13 CLICK
*2.203.14 CLICK RATE
2.203.15 INFORMATION TECHNOLOGY EQUIPMENT: ITE (abbreviation)
2.203.16 VOLTAGE CHANGE
*2.203.17 VOLTAGE FLUCTUATION
2.203.18 VOLTAGE DIP
2.203.19 VOLTAGE SURGE
2.204 Definition from IEC 601-1-1: Safety requirements for medical electrical systems
2.204.1 MEDICAL ELECTRICAL SYSTEM (hereinafter referred to as: SYSTEM)
6 Identification, marking and documents
6.1.201 Marking on the outside of EQUIPMENT or EQUIPMENT parts
6.8.201 ACCOMPANYING DOCUMENTS
SECTIONS 2 to 4: Not used
SECTION 5: PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
36 Electromagnetic compatibility
36.201 EMISSIONS
36.201.1 Radio frequency (RF) EMISSIONS
36.201.2 Low frequency EMISSIONS
36.202 IMMUNITY
*36.202.1 ELECTROSTATIC DISCHARGE
36.202.2 Radiated radio-frequency electromagnetic fields
36.202.3 TRANSIENTS
*36.202.4 VOLTAGE DIPS, short interruptions and voltage variations on power supply input lines
*36.202.5 Conducted disturbances, induced by radio-frequency fields above 9 kHz
*36.202.6 Magnetic fields
SECTIONS 6 to 10: Not used
ANNEX AAA - General guidance and rationale
Annex BBB - Normative references
INDEX OF DEFINED TERMS
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AS/NZS 3200.1.2:1995 APPROVAL AND TEST SPECIFICATION-MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY-COLLATERAL..
PREFACE
CONTENTS
SECTION 1: GENERAL
1 Scope and object
1.201 Scope
1.202 Object
2 Terminology and definitions
2.201 LIFE SUPPORTING EQUIPMENT and/or SYSTEM
2.202 PATIENT COUPLED EQUIPMENT and/or SYSTEM
2.203 EMC Definitions from IEC 50(161)
2.203.1 ELECTROMAGNETIC ENVIRONMENT
2.203.2 ELECTROMAGNETIC NOISE
*2.203.3 ELECTROMAGNETIC DISTURBANCE
2.203.4 ELECTROMAGNETIC COMPATIBILITY: EMC
2.203.5 (ELECTROMAGNETIC) EMISSION
2.203.6 DEGRADATION (of performance)
2.203.7 IMMUNITY (to a disturbance)
2.203.8 (ELECTROMAGNETIC) SUSCEPTIBILITY
2.203.9 ELECTROSTATIC DISCHARGE: ESD (abbreviation)
2.203.10 TRANSIENT (adjective and noun)
2.203.11 PULSE
2.203.12 BURST (of PULSES or oscillations)
2.203.13 CLICK
*2.203.14 CLICK RATE
2.203.15 INFORMATION TECHNOLOGY EQUIPMENT: ITE (abbreviation)
2.203.16 VOLTAGE CHANGE
*2.203.17 VOLTAGE FLUCTUATION
2.203.18 VOLTAGE DIP
2.203.19 VOLTAGE SURGE
2.204 Definition from IEC 601-1-1: Safety requirements for medical electrical systems
2.204.1 MEDICAL ELECTRICAL SYSTEM (hereinafter referred to as: SYSTEM)
6 Identification, marking and documents
6.1.201 Marking on the outside of EQUIPMENT or EQUIPMENT parts
6.8.201 ACCOMPANYING DOCUMENTS
SECTIONS 2 to 4: Not used
SECTION 5: PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION
36 Electromagnetic compatibility
36.201 EMISSIONS
36.201.1 Radio frequency (RF) EMISSIONS
36.201.2 Low frequency EMISSIONS
36.202 IMMUNITY
*36.202.1 ELECTROSTATIC DISCHARGE
36.202.2 Radiated radio-frequency electromagnetic fields
36.202.3 TRANSIENTS
*36.202.4 VOLTAGE DIPS, short interruptions and voltage variations on power supply input lines
*36.202.5 Conducted disturbances, induced by radio-frequency fields above 9 kHz
*36.202.6 Magnetic fields
SECTIONS 6 to 10: Not used
ANNEX AAA - General guidance and rationale
Annex BBB - Normative references
INDEX OF DEFINED TERMS
AS/NZS 3200.1.2:1995
Online Library subscription pricing
The cost of your subscription will depend on which standards you want to access, and how many people in your organisation need to be able to access the Online Library subscription at the same time (concurrent users). During your subscription period, we are also able to make any necessary changes and ensure you are aware of any pricing changes that result. For a quote, contact our Online Library team by emailing onlinelibrary@standards.govt.nz.