BS EN IEC 60601-2-21:2021+A1:2023:2024 Edition

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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	2024	46

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Categories: 11.040.10 - Anaesthetic, respiratory and reanimation equipment, BSI

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PDF Pages	PDF Title
2	undefined
6	Annex ZA(normative)Normative references to international publicationswith their corresponding European publications
8	English CONTENTS
9	FOREWORD
12	INTRODUCTION
13	201.1 Scope, object and related standards
15	201.2 Normative references 201.3 Terms and definitions
16	Figure 201.101 – Layout of test devices
17	201.4 General requirements Figure 201.102 – Test device
18	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
20	201.8 Protection against electrical hazards from me equipment 201.9 Protection against mechanical hazards of me equipment and me systems
22	201.10 Protection against unwanted and excessive radiation hazards 201.11 Protection against excessive temperatures and other hazards
23	201.12 Accuracy of controls and instruments and protection against hazardous outputs
27	201.13 Hazardous situations and fault conditions for me equipment 201.14 Programmable electrical medical systems (PEMS) 201.15 Construction of me equipment
29	201.16 Me systems 201.17 Electromagnetic compatibility of me equipment and me systems 202 Electromagnetic disturbances – Requirements and tests
30	Annexes
31	Annex AA (informative) Particular guidance and rationale Figure AA.1 – Illustration of the main requirements of this document
33	Blank Page
41	Bibliography
43	Index of defined terms used in this document

Additional information

Status	Definitive
Title	Medical electrical equipment – Particular requirements for the basic safety and essential performance of infant radiant warmers
Replaces	BS EN 60601-2-21:2009+A1:2016
Publisher	BSI
Committee	CH/62/4
Pages	46
Publication Date	2024-01-10
ISBN	978 0 539 16772 6
Standard Number	BS EN IEC 60601-2-21:2021+A1:2023
Identical National Standard Of	EN 60601-2-21 Amd.1 Ed.3.0, IEC 60601-2-21 Amd.1 Ed.3.0
Descriptors	Infrared radiation, Mechanical testing, Electrical equipment, Marking, Paediatrics, Instructions for use, Infants, Electrical insulation, Radiant heaters, Thermal testing, Baby equipment, Automatic control systems, Strength of materials, Incubators, Testing conditions, Electrical medical equipment, Hazards, Temperature, Hospital equipment, Performance testing, Accuracy, Electronic equipment and components, Electrical safety, Alarm systems, Equipment safety, Safety devices, Environmental testing, Sound intensity, Incubators (infant), Medical equipment, Safety measures
Amends	BS EN IEC 60601-2-21:2021
ICS Codes	11.040.10 - Anaesthetic, respiratory and reanimation equipment

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BS EN IEC 60601-2-21:2021+A1:2023:2024 Edition

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