National foreword

This British Standard is the UK implementation of EN 50637:2017.

The UK participation in its preparation was entrusted to Technical Committee CH/62/4, Electromedical equipment.

A list of organizations represented on this committee can be obtained on request to its secretary.

This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.

Compliance with a British Standard cannot confer immunity from legal obligations.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 November 2017.

European foreword

This document (EN 50637:2017) has been prepared by CLC/TC 62 ”Electrical equipment in medical practice".

The following dates are fixed:

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.

This document has been prepared under a mandate given to CEN and CENELEC by the European Commission.

This European Standard was approved by CENELEC on 2017-08-30. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any otherlanguage made by translation under the responsibility of a CENELEC m ember into its own language and notified to the Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical c ommittees of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.

Introduction

EN 60601‑2‑52 applies to the basic safety and essential performance of medical beds for adults, hence not covering requirement for beds for children and adults with atypical anatomy. This particular standard is based on the Mandate M/467 Medical beds issued by the European Commision with the following background information:

It appears, from a first analysis undertaken by Competent Authorities, that the current set of standards is not adapted to the needs of children or adults with an atypical anatomy. EN 60601‑2‑52 does not foresee a maximum distance for the bars that is small enough to prevent accidents.

According to the Competent Authorities’ representatives, a part of the safety problem is due to the fact that medical beds for adults are not appropriately labelled as being designed only for adults with a normal anatomy. Users are therefore not always aware of the risk of medical beds for young patients or for adults with an atypical anatomy. Hospital administrations do not always see a need to buy medical beds which are appropriate for children or for adults with an atypical anatomy. Therefore, clear labelling of the targeted patient groups for medical beds complying with EN 60601‑2‑52 could reduce the risk of inappropriate use of this kind of medical beds for children or for adults with an atypical anatomy. Labeling is taken care of by Amendment 1 of EN 60601‑2‑52.

Competent Authorities’ representatives also stated that there is a need for the development of requirements for medical beds and cots for children and adults with an atypical anatomy.

In order to prevent EN 60601‑2‑52 from being extraordinary complex to use, CLC/TC 62 decided to develop this particular standard rather than further amending EN 60601‑2‑52 in relation to use for children and adults with an atypical anatomy.

This standard is based on input from the following standards and reports:

EN 60601‑2‑52, Medical electrical equipment — Part 2-52: Particular requirements for basic safety and essential performance of medical beds (IEC 60601‑2‑52)1);
EN 716‑1, Furniture — Children's cots and folding cots for domestic use — Part 1: Safety requirements;
EN 716‑2, Furniture — Children's cots and folding cots for domestic use — Part 2: Test methods;
EN 1130‑2, Furniture — Cribs and cradles for domestic use — Part 2: Test methods;
EN 747‑1, Furniture — Bunk beds and high beds — Part 1: Safety, strength and durability requirements;
EN 747‑2, Furniture — Bunk beds and high beds — Part 2: Test methods;
CEN/TR 13387 (all parts), Child use and care articles — General safety guidelines;
DIN 32623, Hospital children's cots made from metal and plastic — Safety requirements and testing;
Nordic Requirements specification for Adjustable beds for disabled children.

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.

201.2 Normative references

201.3 Terms and definitions

201.4 General requirements

201.4.2 *Risk management process for me equipment and me system

201.5 General requirements for testing of me equipment

201.5.101 * Entrapment test tools

201.5.102 Loading pad

201.5.103 Impactor

201.5.104 Side impactor

201.6 Classification of me equipment and me systems

201.6.2 *Protection against electrical shock

201.7 Me equipment identification, marking and documents

201.7.2.2 Identification

201.7.2.4 Accessories

201.7.4.2 Control devices

201.7.6.3 Symbols for controls and performance

201.7.6.4 Marking of storage location for pendant controls

201.7.9.2 Instructions for use

201.8 Protection against electrical hazards from me equipment

201.8.11.3.2 Types

201.9 Protection against mechanical hazards of me equipment and me systems

201.9.1 *Mechanical hazards of me equipment

201.9.2 Hazards associated with moving parts

201.9.3 hazards associated with surfaces, corners and edges

201.9.8 Hazards associated with support systems

201.9.101 *Protection against inadvertent patient falls

201.10 Protection against unwanted and excessive radiation hazards

201.11 Protection against excessive temperatures and other hazards

201.11.1.1 Maximum temperature during normal use

201.11.2.101 Flammability of textiles, coated textiles and plastics coverings

201.11.6.5 Ingress of water or particulate matter into me equipment and me systems

201.11.6.6 Cleaning and disinfection of me equipment and me systems

201.11.7 Biocompatibility of medical bed

201.11.8 *Interruption of the power supply/supply mains to me equipment

201.12 Accuracy of controls and instruments and protection against hazardous outputs

201.12.2 Usability

201.13 Hazardous situations and fault conditions

201.13.1.4 *Specific mechanical hazards

201.13.2.2 Electrical single fault condition

201.14 Programmable electrical medical systems (pems)

201.15 Construction of me equipment

201.15.3 Mechanical strength

201.15.4 Me equipment components and general assembly

201.16 Me systems

201.17 Electromagnetic compatibility of me equipment and me systems

Bibliography

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