AS/NZS IEC 60601.2.2:2016
Medical electrical equipment - Part 2.2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
Establishes particular basic safety and essential performance requirements for medical electrical equipment, including associated accessories intended for the performance of surgical operations, such as, the cutting or coagulation of biological tissues by means of high frequency currents. Identical to and reproduced from IEC 60601-2-2, Ed.5.0 (2009) and its associated Corrigendum 1:2014.
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CONTENTS
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing of ME EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
201.7 ME EQUIPMENT identification, marking and documents
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
201.9 Protection against mechanical hazards of ME EQUIPMENT and ME SYSTEMS
201.10 Protection against unwanted and excessive radiation HAZARDS
201.11 Protection against excessive temperatures and other HAZARDS
201.12 Accuracy of controls and instruments and protection against hazardousoutputs
201.13 HAZARDOUS SITUATIONS and fault conditions
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME SYSTEMs
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
202 * Electromagnetic compatibility – Requirements and tests
208 General requirements, tests and guidance for alarm systems in medicalelectrical equipment and medical electrical systems
Annexes
Annex AA (informative) Particular guidance and rationale
Annex BB (informative) ELECTROMAGNETIC DISTURBANCES created by HF SURGICALEQUIPMENT
Bibliography
Figures
Figure 201.101 – Symbol used with an EARTH REFERENCED PATIENT CIRCUIT
Figure 201.102 – Symbol used with a HF ISOLATED PATIENT CIRCUIT
Figure 201.103 – Circuit suitable for testing compliance to 201.8.4.101
Figure 201.104 – Measurement of HF LEAKAGE CURRENT with NEUTRAL ELECTRODEreferenced to earth and load between electrodes
Figure 201.105 – Measurement of HF LEAKAGE CURRENT with NEUTRAL ELECTRODEreferenced to earth and load from ACTIVE ELECTRODE to earth
Figure 201.106 – Measurement of HF LEAKAGE CURRENT with NEUTRAL ELECTRODEisolated from earth at HIGH FREQUENCY
Figure 201.107 – Measurement of HF LEAKAGE CURRENT from a BIPOLAR ELECTRODE
Figure 201.108 – Test apparatus for anchorages of cords of ACTIVE ACCESSORY
Figure 201.109 – Measurement of output power – MONOPOLAR output
Figure 201.110 – Measurement of output power – BIPOLAR output
Figure 201.111 – Method of testing feedback from one active output to another insimultaneous activation
Figure AA.1 – Example of various parts of an HF surgical system
Figure AA.2 – CREST FACTOR vs. peak voltage
Figure AA.3 – Example of PATIENT circuit with NEUTRAL ELECTRODE referenced to earthat operating frequencies
Figure BB.1 – E-FIELD EMISSIONS test setup
Figure BB.2 – H-FIELD EMISSIONS test setup
Figure BB.3 – Conducted EMISSIONS test setup
Figure BB.4 – Unit ad hoc test
Figure BB.5 – Power cord ad hoc test
Figure BB.6 – ACCESSORY cord ad hoc test
Table
Table 201.101 – Colours of indicator lights and their meaning for HF SURGICALEQUIPMENT
Table 201.102 – Maximum output powers in SINGLE FAULT CONDITIONS
Table 201.103 – Test currents by weight range
Table AA.1 – Summary of measured current and durations for 25 TUR procedures
Table AA.2 – Summary of measured currents and durations for general surgicalprocedures
Table BB.1 – Worst case emissions of spark gap type HF SURGICAL EQUIPMENT
Table BB.2 – Worst case emissions of non-spark gap (modern) HF SURGICAL EQUIPMENT
Previous versions
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Related Information
Similar Standards
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AS/NZS 4512:1999
Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics
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BS 2982:1992
Specification for materials and packaging of surgical scalpels with detachable blades
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BS 5194-2:1989
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CONTENTS
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing of ME EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
201.7 ME EQUIPMENT identification, marking and documents
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
201.9 Protection against mechanical hazards of ME EQUIPMENT and ME SYSTEMS
201.10 Protection against unwanted and excessive radiation HAZARDS
201.11 Protection against excessive temperatures and other HAZARDS
201.12 Accuracy of controls and instruments and protection against hazardousoutputs
201.13 HAZARDOUS SITUATIONS and fault conditions
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME SYSTEMs
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
202 * Electromagnetic compatibility – Requirements and tests
208 General requirements, tests and guidance for alarm systems in medicalelectrical equipment and medical electrical systems
Annexes
Annex AA (informative) Particular guidance and rationale
Annex BB (informative) ELECTROMAGNETIC DISTURBANCES created by HF SURGICALEQUIPMENT
Bibliography
Figures
Figure 201.101 – Symbol used with an EARTH REFERENCED PATIENT CIRCUIT
Figure 201.102 – Symbol used with a HF ISOLATED PATIENT CIRCUIT
Figure 201.103 – Circuit suitable for testing compliance to 201.8.4.101
Figure 201.104 – Measurement of HF LEAKAGE CURRENT with NEUTRAL ELECTRODEreferenced to earth and load between electrodes
Figure 201.105 – Measurement of HF LEAKAGE CURRENT with NEUTRAL ELECTRODEreferenced to earth and load from ACTIVE ELECTRODE to earth
Figure 201.106 – Measurement of HF LEAKAGE CURRENT with NEUTRAL ELECTRODEisolated from earth at HIGH FREQUENCY
Figure 201.107 – Measurement of HF LEAKAGE CURRENT from a BIPOLAR ELECTRODE
Figure 201.108 – Test apparatus for anchorages of cords of ACTIVE ACCESSORY
Figure 201.109 – Measurement of output power – MONOPOLAR output
Figure 201.110 – Measurement of output power – BIPOLAR output
Figure 201.111 – Method of testing feedback from one active output to another insimultaneous activation
Figure AA.1 – Example of various parts of an HF surgical system
Figure AA.2 – CREST FACTOR vs. peak voltage
Figure AA.3 – Example of PATIENT circuit with NEUTRAL ELECTRODE referenced to earthat operating frequencies
Figure BB.1 – E-FIELD EMISSIONS test setup
Figure BB.2 – H-FIELD EMISSIONS test setup
Figure BB.3 – Conducted EMISSIONS test setup
Figure BB.4 – Unit ad hoc test
Figure BB.5 – Power cord ad hoc test
Figure BB.6 – ACCESSORY cord ad hoc test
Table
Table 201.101 – Colours of indicator lights and their meaning for HF SURGICALEQUIPMENT
Table 201.102 – Maximum output powers in SINGLE FAULT CONDITIONS
Table 201.103 – Test currents by weight range
Table AA.1 – Summary of measured current and durations for 25 TUR procedures
Table AA.2 – Summary of measured currents and durations for general surgicalprocedures
Table BB.1 – Worst case emissions of spark gap type HF SURGICAL EQUIPMENT
Table BB.2 – Worst case emissions of non-spark gap (modern) HF SURGICAL EQUIPMENT
Previous versions
AS/NZS IEC 60601.2.2:2016
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.