MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MEDICAL BEDS FOR CHILDREN

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2017

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
European 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 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 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
Annex AA (normative) - Particular guidance and rationale
Annex BB (normative) - Design requirements and
         recommendations for MEDICAL BED
Annex CC (informative) - Particular guidance for
         assessing risk of entrapment in v-shaped
         openings
Bibliography
Index of defined terms used in this particular standard

Pertains to MEDICAL BEDS with an internal length of up to 180 cm suitable to a body length of 155 cm.

DocumentType	Standard
Pages	94
PublisherName	National Standards Authority of Ireland
Status	Current

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IEC 60245-1:2003+AMD1:2007 CSV	Rubber insulated cables - Rated voltages up to and including 450/750 V - Part 1: General requirements
DIN 32623:2009-11	Hospital children's cots made from metal and plastic - Safety requirements and testing
EN ISO 9999:2016	Assistive products for persons with disability - Classification and terminology (ISO 9999:2016)
EN 60601-1-3 : 2008 AMD 11 2016	MEDICAL ELECTRICAL EQUIPMENT - PART 1-3: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: RADIATION PROTECTION IN DIAGNOSTIC X-RAY EQUIPMENT (IEC 60601-1-3:2008/A1:2013)
ISO 9614-1:1993	Acoustics — Determination of sound power levels of noise sources using sound intensity — Part 1: Measurement at discrete points
EN 716-2:2017	Furniture - Children's cots and folding cots for domestic use - Part 2: Test methods
EN 1021-1:2014	FURNITURE - ASSESSMENT OF THE IGNITABILITY OF UPHOLSTERED FURNITURE - PART 1: IGNITION SOURCE SMOULDERING CIGARETTE
EN 60601-2-19:2009/A1:2016	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)
EN 71-2:2011+A1:2014	Safety of toys - Part 2: Flammability
IEC 60068-2-31:2008	Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens
IEC 60227-1:2007	Polyvinyl chloride insulated cables of rated voltages up to and including 450/750 V - Part 1: General requirements
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 716-1:2017	Furniture - Children's cots and folding cots for domestic use - Part 1: Safety requirements
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 13451-1:2011+A1:2016	Swimming pool equipment - Part 1: General safety requirements and test methods
IEC 60601-2-52:2009+AMD1:2015 CSV	Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
IEC 60601-1-3:2008+AMD1:2013 CSV	Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
EN 60601-2-52:2010/A1:2015	MEDICAL ELECTRICAL EQUIPMENT - PART 2-52: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MEDICAL BEDS
ISO 9999:2016	Assistive products for persons with disability Classification and terminology
EN ISO 9614-1:2009	Acoustics - Determination of sound power levels of noise sources using sound intensity - Part 1: Measurement at discrete points (ISO 9614-1:1993)
EN 1021-2:2014	Furniture - Assessment of the ignitability of upholstered furniture - Part 2: Ignition source match flame equivalent
EN 60068-2-31:2008	ENVIRONMENTAL TESTING - PART 2-31: TESTS - TEST EC: ROUGH HANDLING SHOCKS, PRIMARILY FOR EQUIPMENT-TYPE SPECIMENS