Publication details
| Publication CODE |
Title |
| NBN EN 50637:2017 (2017-11) |
MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MEDICAL BEDS FOR CHILDREN |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
98.00 €
|
89. |
Description
201.1 Scope, object and related standards
Clause 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 * Scope
Replacement:
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 1 The 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 2 See also 4.2 of EN 60601-1:2006.
NOTE 3 Body length is measured from crown to sole.
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| Class |
C
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Available files
ATTENTION: Belgian registered standards (NBN EN or NBN HD) are generally
only available in English or French. Only the cover page is translated
and the document itself is in English or in French.
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Status
| Status |
Registered trilingual Belgian standard EN or FR or DE |
| Situation |
Currently active
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Origin
| Committee |
CLC TC 62
ELECTRICAL EQUIPMENTS IN MEDICAL PRACTICE
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| Responsible |
De heer VAN HECKE Luk
|
Approval
| BEC Approval |
2017-08-30 |
| NBN Approval |
2017-12-21 |
| Registration |
177365 |
| Numbers identifying the european directives |
93/42/EEC
(Medical devices)
|
| ICS-Code (International Standards Classification) |
11.140
|
| NBN Status |
New |
|
| Date of ratification (d.o.r.) |
2017-08-30 |
| Date of availability (d.a.v.) |
2017-11-17 |
| Date of announcement (d.o.a.) |
2018-02-28 |
| Date of publication (d.o.p.) |
2018-08-30 |
| Date of withdrawal former edition (d.o.w.) |
2020-08-30 |
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Correspondences with international standards
| Relation |
International standard |
Date |
| is identical to |
EN 50637:2017
|
2017-11-17 |
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