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.

201.1.2 Object

Replacement:

The object of this particular standard is to establish particular basic safety and essential performance requirements and test methods for medical beds as defined in 201.3.218 intended for children as defined in 201.3.207.

201.1.3 Collateral standards

Addition:

This particular standard refers to those applicable collateral standards that are listed in Clause 2 of EN 60601‑1:2006 standard and its accociated amendments and corrigenda and Clause 2 of this particular standard.

EN 60601‑1‑3 and EN 60601‑1‑10 do not apply. All other published collateral standards in the EN 60601‑1 series apply as published.

201.1.4 Particular standards

Replacement:

In the EN 60601 series, particular standards may modify, replace or delete requirements contained in EN 60601‑1:2006 and collateral standards as appropriate for the particular me equipment under consideration, and may add other basic safety and essential performance requirements.

A requirement of this particular standard takes priority over EN 60601‑1:2006.

The numbering of clauses and subclauses of this particular standard corresponds to that of EN 60601‑1:2006 with the prefix “201” (e.g. 201.1 in this standard addresses the content of Clause 1 of EN 60601‑1:2006) or applicable collateral standard with the prefix “20x” where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular standard addresses the content of Clause 4 of the EN 60601‑1‑2:2015 collateral standard, 203.4 in this particular standard addresses the content of Clause 4 of the EN 60601‑1‑3:2008 collateral standard, etc.). The changes to the text of EN 60601‑1:2006 are specified by the use of the following words:

"Replacement" means that the clause or subclause of EN 60601‑1:2006 or applicable collateral standard is replaced completely by the text of this particular standard.

"Addition" means that the text of this particular standard is additional to the requirements of EN 60601‑1:2006 or applicable collateral standard.

"Amendment" means that the clause or subclause of EN 60601‑1:2006 or applicable collateral standard is amended as indicated by the text of this particular standard.

Subclauses, figures or tables which are additional to those of EN 60601‑1:2006 are numbered starting from 201.101. However, due to the fact that definitions in EN 60601‑1:2006 are numbered 3.1 through 3.147, additional definitions in this standard are numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.

Subclauses, figures or tables which are additional to those of a collateral standard are numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for EN 60601‑1‑2, 203 for EN 60601‑1‑3, etc.

The term "this standard" is used to make reference to EN 60601‑1:2006, any applicable collateral standards and this particular standard taken together.

Where there is no corresponding clause or subclause in this particular standard, the clause or subclause of EN 60601‑1:2006 or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of EN 60601‑1:2006 or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard.

BS EN 50637:2017

Medical electrical equipment. Particular requirements for the basic safety and essential performance of medical beds for children

Current, Under Review

Published:

30 Nov 2017