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BS EN IEC 60601-2-21:2021

BS EN IEC 60601-2-21:2021

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Medical electrical equipment – Particular requirements for the basic safety and essential performance of infant radiant warmers

Published By Publication Date Number of Pages
BSI 2021 44
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IEC 60601-2-21:2020 is available as IEC 60601-2-21:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-21:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT RADIANT WARMERS as defined in 201.3.204, also referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document, except in 7.2.13 and 8.4.1 of the general standard. IEC 60601-2-21:2020 specifies the safety requirements for INFANT RADIANT WARMERS, but alternate methods of compliance with a specific clause, by demonstrating equivalent safety, will not be judged as non-compliant, if the MANUFACTURER has demonstrated in his RISK MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an acceptable level when weighed against the benefit of treatment from the device. This particular standard does not apply to: – devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information, see IEC 60601-2-35; – INFANT INCUBATORS; for information, see IEC 60601-2-19; – INFANT TRANSPORT INCUBATORS, for information, see IEC 60601-2-20; – INFANT PHOTOTHERAPY EQUIPMENT, for information, see IEC 60601-2-50. SKIN TEMPERATURE SENSORS which are applied to operate a BABY CONTROLLED RADIANT WARMER including the displayed value are not considered to be a CLINICAL THERMOMETER in the sense of the particular standard ISO 80601-2-56. IEC 60601-2-21:2020 cancels and replaces the second edition published in 2009 and Amendment 1:2016. This edition constitutes a technical revision. IEC 60601-2-21:2020 includes the following significant technical change with respect to the previous edition: alignment with IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.

PDF Catalog

PDF Pages PDF Title
2 undefined
5 Annex ZA(normative)Normative references to international publicationswith their corresponding European publications
7 English
CONTENTS
8 FOREWORD
11 INTRODUCTION
12 201.1 Scope, object and related standards
14 201.2 Normative references
201.3 Terms and definitions
15 Figure 201.101 – Layout of test devices
16 201.4 General requirements
Figure 201.102 – Test device
17 201.5 General requirements for testing me equipment
201.6 Classification of me equipment and me systems
201.7 Me equipment identification, marking and documents
Table 201.101 – Additional essential performance requirements
19 201.8 Protection against electrical hazards from me equipment
201.9 Protection against mechanical hazards of me equipment and me systems
21 201.10 Protection against unwanted and excessive radiation hazards
201.11 Protection against excessive temperatures and other hazards
22 201.12 Accuracy of controls and instruments and protection against hazardous outputs
26 201.13 Hazardous situations and fault conditions for me equipment
201.14 Programmable electrical medical systems (PEMS)
201.15 Construction of me equipment
28 201.16 Me systems
201.17 Electromagnetic compatibility of me equipment and me systems
202 Electromagnetic disturbances – Requirements and tests
29 Annexes
30 Annex AA (informative) Particular guidance and rationale
Figure AA.1 – Illustration of the main requirements of this document
39 Bibliography
41 Index of defined terms used in this document

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BS EN IEC 60601-2-21:2021
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