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CENELEC
EN 60601-2-19:2009/A1:2016

EN 60601-2-19:2009/A1:2016

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 (IEC 60601-2-19:2009/A1:2016)

Superseded date

02-01-2022

Published date

01-12-2013

Publisher

European Committee for Standards - Electrical

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.

Committee
TC 62
DevelopmentNote
To be read in conjunction with EN 60601-1:1990 (05/2001)
DocumentType
Standard
PublisherName
European Committee for Standards - Electrical
Status
Superseded
SupersededBy
Supersedes

BS EN 60601-2-20 : 2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-20: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT TRANSPORT INCUBATORS
BS EN 80601-2-35 : 2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS AND MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE
DIN EN 60601-2-35 : 1997 MEDICAL ELECTRICAL EQUIPMENT - PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF BLANKETS, PADS AND MATTRESSES, INTENDED FOR HEATING IN MEDICAL USE
06/30106986 DC : 0 EN 13718-2 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS OF AIR AMBULANCES
UNE-EN 60601-2-20:2010 Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
16/30346835 DC : 0 BS ISO 20789 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - PASSIVE HUMIDIFIERS
I.S. EN 50637:2017 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MEDICAL BEDS FOR CHILDREN
EN 80601-2-35:2009/A1:2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-35: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HEATING DEVICES USING BLANKETS, PADS AND MATTRESSES AND INTENDED FOR HEATING IN MEDICAL USE (IEC 80601-2-35:2009/A1:2016)
BS EN 60601-2-21 : 2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-21: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT RADIANT WARMERS (IEC 60601-2-21:2009)
BS EN 50637:2017 Medical electrical equipment. Particular requirements for the basic safety and essential performance of medical beds for children
UNE-EN 60601-2-21:2010 Medical electrical equipment -- Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
EN 60601-2-21:2009/A1:2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-21: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT RADIANT WARMERS (IEC 60601-2-21:2009/A1:2016)
EN 60601-2-20:2009/A1:2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-20: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT TRANSPORT INCUBATORS (IEC 60601-2-20:2009/A1:2016)
EN 50637:2017 Medical electrical equipment - Particular requirements for the basic safety and essential performance of medical beds for children

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
EN 60601-2-50:2009/A1:2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-50: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT PHOTOTHERAPY EQUIPMENT (IEC 60601-2-50:2009/A1:2016)
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
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
EN 61672-1:2013 Electroacoustics - Sound level meters - Part 1: Specifications
EN 60601-2-21:2009/A1:2016 MEDICAL ELECTRICAL EQUIPMENT - PART 2-21: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT RADIANT WARMERS (IEC 60601-2-21:2009/A1:2016)
EN 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 (ISO 80601-2-56:2017)

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