EN 50637:2017

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

201.1Scope, object and related standardsClause 1 of EN 60601-1:2006, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, applies, except as follows:201.1.1* ScopeReplacement:This Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL BEDS, hereafter referred to as MEDICAL BEDS as defined in 201.3.218, intended for CHILDREN as defined in 201.3.207, and ADULTS with atypical anatomy (ADULTS ranging outside the definition for ADULTS in 201.3.201).This standard applies to medical beds with nonadjustable and electrical / mechanical adjustable functions.This Standard applies to MEDICAL BEDS with an internal length of up to 180 cm suitable to a body length of 155 cm.NOTE 1The limitation of 180 cm is in order to minimize the foreseeable misuse, of a parent sharing the bed with the child or that the bed will be used by an ADULT.If a manufacturer wishes to make a bed that can be used by both a child and an ADULT, e.g. length of 180 cm or more, then it will fulfil both EN 60601-2-52 and this particular standard.This Standard does not apply to MEDICAL BEDS intended for ADULTS as defined in 201.3.201 (covered by EN 60601-2-52). This Standard does not apply to :-incubators covered by EN 60601-2-19 ;-beds for children, covered by EN 716-1 and EN 716-2 ;-cribs and cradles covered by EN 1130 (all parts) ;-bunk beds and high beds, covered by EN 747-1 and 747-2.If a clause or subclause is specifically intended to be applicable to a MEDICAL BED 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 MEDICAL BEDS and to ME SYSTEMS, as relevant.HAZARDS inherent in the intended physiological function of MEDICAL BED or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of EN 60601-1:2006.NOTE 2See also 4.2 of EN 60601-1:2006.NOTE 3Body length is measured from crown to sole.