AS/NZS IEC 60601.2.21:2015
Medical electrical equipment - Part 2.21: Particular requirements for the basic safety and essential performance of infant radiant warmers
Establishes particular basic safety and essential performance requirements for endoscopic equipment. This Standard supplements the general requirements specified in, and is intended to be read in conjunction with, AS/NZS IEC 60601.1:2015. Identical to and reproduced from IEC 60601-2-21, Ed.2.0 (2009) including Cor.1(2013).
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CONTENTS
201
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
210 Requirements for the development of physiologic closed-loop controllers
Annexes
Annex AA (informative) Particular guidance and rationale
Bibliography
Index of defined terms used in this particular standard
Figure 201.101 – Layout of TEST DEVICES
Figure 201.102 – TEST DEVICE
Table 201.101 – Additional ESSENTIAL PERFORMANCE requirements
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CONTENTS
201
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
210 Requirements for the development of physiologic closed-loop controllers
Annexes
Annex AA (informative) Particular guidance and rationale
Bibliography
Index of defined terms used in this particular standard
Figure 201.101 – Layout of TEST DEVICES
Figure 201.102 – TEST DEVICE
Table 201.101 – Additional ESSENTIAL PERFORMANCE requirements
Previous versions
AS/NZS IEC 60601.2.21:2015
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.