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I.S. EN 60601-2-19:2009

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

MEDICAL ELECTRICAL EQUIPMENT - PART 2-19: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT INCUBATORS
Available format(s)

Hardcopy , PDF

Superseded date

08-04-2021

Language(s)

English

Published date

01-01-2009

Publisher

National Standards Authority of Ireland

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

National Foreword
FOREWORD
INTRODUCTION
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 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 hazardous outputs
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
Annexes
Annex AA (informative) - Particular guidance and rationale
Bibliography
Index of defined terms used in this particular standard
Annex ZA (normative) - Normative references to international
         publications with their corresponding European
         publications
Annex ZZ (informative) - Coverage of Essential Requirements
         of EC Directives

Describes safety requirements for INFANT INCUBATORS 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.

DevelopmentNote
For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
DocumentType
Standard
Pages
118
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy

IEC 60601-2-21:2009+AMD1:2016 CSV Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
IEC 60601-2-50:2009+AMD1:2016 CSV Medical electrical equipment - Part 2-50: Particular requirementsfor the basic safety and essential performance of infant phototherapy equipment
ISO 80601-2-56:2017 Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
IEC 60601-2-20:2009+AMD1:2016 CSV Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transportincubators
EN 60601-1-10:2008/A1:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS (IEC 60601-1-10:2007)
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
EN 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

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Hardcopy - English
PDF - English
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