Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds (IEC 60601-2-52:2009)

EC 60601-2-52:2009 applies to the basic safety and essential performance of medical beds intended for adults. This first edition cancels and replaces the first edition of IEC 60601-2-38, published in 1996, and its Amendment 1 (1999). This edition constitutes a technical revision. IEC 60601-2-52:2009 is the realization of much work in alignment, and scope adjustment between IEC 60601-2-38, EN 1970, and the third edition of IEC 60601-1.

Medizinische elektrische Geräte - Teil 2-52: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von medizinischen Betten (IEC 60601-2-52:2009)

Appareils électromédicaux - Partie 2-52: Exigences particulières pour la sécurité de base et les performances essentielles des lits médicaux (CEI 60601-2-52:2009)

La CEI 60601-2-52:2009 s'applique à la sécurité de base et aux performances essentielles des lits medicaux destinés aux adultes. Cette première édition annule et remplace la première édition de la CEI 60601-2-38, parue en 1996, et son Amendement (1999). Elle constitue une révision technique. La CEI 60601-2-52:2009 est la réalisation d'un travail important d'alignement et d'ajustement de domaines d'application entre la CEI 60601-2-38, la EN 1970, et la troisième édition de la CEI 60601-1.

Gospodinjski in podobni električni aparati - Varnost - 2-75. del: Posebne zahteve za komercialne dozirne in prodajne avtomate - Dopolnilo A2 (IEC 60335-2-75:2002/A2:2008)

General Information

Status
Published
Publication Date
01-Oct-2008
Drafting Committee
IEC/TC 61 - IEC_TC_61
Parallel Committee
IEC/TC 61 - IEC_TC_61
Current Stage
6060 - Document made available - Publishing
Start Date
02-Oct-2008
Completion Date
02-Oct-2008

Relations

Effective Date
07-Jun-2022

Overview

EN 60601-2-52:2010 (IEC 60601-2-52:2009) is a European particular standard that specifies basic safety and essential performance requirements for medical beds used in healthcare settings. It complements the general medical electrical equipment standard (IEC/EN 60601‑1) by providing additional, device‑specific requirements that address risks unique to beds - for example those related to patient handling, mechanical movement, electrical systems integrated into beds, and usability in clinical environments.

Note: the document extract you provided appears to be from EN 60335‑2‑75 (vending machines). The summary below is based on the EN 60601‑2‑52 title and its typical scope; for authoritative clause‑level requirements please provide the EN 60601‑2‑52 text.

Key topics

  • Scope and definitions specific to medical beds (types of beds covered; terms used for components and functions).
  • Basic safety requirements derived from IEC/EN 60601‑1 applied to bed design, materials and construction.
  • Mechanical safety and stability - safe movement of sections (head/foot), side rails, braked casters, structural strength and prevention of entrapment.
  • Electrical safety and essential performance for powered functions (motors, actuators, controls), protection against electric shock, insulation and fault conditions.
  • Control systems and emergency functions including manual overrides, emergency lowering, and failure modes that could affect patient safety.
  • Alarms, indicators and labeling - adequate alarms and user information to support safe operation and maintenance.
  • Usability and ergonomics to minimize user error during patient transfers, positioning and routine care.
  • Testing and verification methods for demonstrating compliance with the particular requirements (mechanical tests, electrical tests, durability and software checks where applicable).

Applications and who uses it

  • Medical bed manufacturers - to design and certify beds that meet EU safety and performance expectations.
  • Test laboratories and conformity assessors - to perform type testing, CE marking evaluation and conformity assessments.
  • Procurement teams and hospitals - to specify safer equipment and verify supplier claims.
  • Regulators and notified bodies - to assess compliance with medical device directives/regulations and harmonized standards.
  • Maintenance and clinical engineering - to guide safe servicing, testing and risk mitigation during bed lifecycle.

Related standards

  • IEC/EN 60601‑1 - general requirements for basic safety and essential performance of medical electrical equipment.
  • IEC/EN 60601‑1‑2 - electromagnetic compatibility (EMC) requirements.
  • ISO 14971 - risk management for medical devices.
  • IEC/EN 60601‑1‑6 - usability (human factors) considerations.

Using EN 60601‑2‑52 in product development improves patient safety, supports regulatory compliance and reduces liability risk by ensuring medical beds meet targeted safety and performance expectations.

Amendment

EN 60335-2-75:2004/A2:2009

English language
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Amendment

EN 60335-2-75:2004/A2:2009

English language
5 pages
Preview
Preview
e-Library read for
1 day

Frequently Asked Questions

EN 60601-2-52:2010 is a amendment published by CLC. Its full title is "Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds (IEC 60601-2-52:2009)". This standard covers: EC 60601-2-52:2009 applies to the basic safety and essential performance of medical beds intended for adults. This first edition cancels and replaces the first edition of IEC 60601-2-38, published in 1996, and its Amendment 1 (1999). This edition constitutes a technical revision. IEC 60601-2-52:2009 is the realization of much work in alignment, and scope adjustment between IEC 60601-2-38, EN 1970, and the third edition of IEC 60601-1.

EC 60601-2-52:2009 applies to the basic safety and essential performance of medical beds intended for adults. This first edition cancels and replaces the first edition of IEC 60601-2-38, published in 1996, and its Amendment 1 (1999). This edition constitutes a technical revision. IEC 60601-2-52:2009 is the realization of much work in alignment, and scope adjustment between IEC 60601-2-38, EN 1970, and the third edition of IEC 60601-1.

EN 60601-2-52:2010 is classified under the following ICS (International Classification for Standards) categories: 55.230 - Distribution and vending machines. The ICS classification helps identify the subject area and facilitates finding related standards.

EN 60601-2-52:2010 has the following relationships with other standards: It is inter standard links to EN IEC 60335-2-75:2023. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

EN 60601-2-52:2010 is associated with the following European legislation: EU Directives/Regulations: 2006/95/EC, 2014/35/EU, 2014/53/EU. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.

You can purchase EN 60601-2-52:2010 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CLC standards.

Standards Content (Sample)


SLOVENSKI STANDARD
01-januar-2009
Nadomešča:
SIST EN 62739-1:2014
Gospodinjski in podobni električni aparati - Varnost - 2-75. del: Posebne zahteve
za komercialne dozirne in prodajne avtomate - Dopolnilo A2 (IEC 60335-2-
75:2002/A2:2008)
Household and similar electrical appliances - Safety -- Part 2-75: Particular requirements
for commercial dispensing appliances and vending machines (IEC 60335-2-
75:2002/A2:2008)
Sicherheit elektrischer Geräte für den Hausgebrauch und ähnliche Zwecke -- Teil 2-75:
Besondere Anforderungen für Ausgabegeräte und Warenautomaten für den
gewerblichen Gebrauch (IEC 60335-2-75:2002/A2:2008)
Appareils électrodomestiques et analogues - Sécurité -- Partie 2-75: Règles particulières
pour les distributeurs commerciaux avec ou sans moyen de paiement (IEC 60335-2-
75:2002/A2:2008)
Ta slovenski standard je istoveten z: EN 60601-2-52:2010
ICS:
11.140 Oprema bolnišnic Hospital equipment
55.230 Razdelilni in prodajni Distribution and vending
avtomati machines
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 60335-2-75/A2
NORME EUROPÉENNE
October 2008
EUROPÄISCHE NORM
ICS 55.230
English version
Household and similar electrical appliances -
Safety -
Part 2-75: Particular requirements for commercial dispensing appliances
and vending machines
(IEC 60335-2-75:2002/A2:2008)
Appareils électrodomestiques  Sicherheit elektrischer Geräte
et analogues - für den Hausgebrauch
Sécurité - und ähnliche Zwecke -
Partie 2-75: Règles particulières Teil 2-75: Besondere Anforderungen
pour les distributeurs commerciaux für Ausgabegeräte und Warenautomaten
avec ou sans moyen de paiement für den gewerblichen Gebrauch
(CEI 60335-2-75:2002/A2:2008) (IEC 60335-2-75:2002/A2:2008)

This amendment A2 modifies the European Standard EN 60335-2-75:2004; it was approved by CENELEC on
2008-08-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which
stipulate the conditions for giving this amendment 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 Central Secretariat or to any CENELEC member.

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

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: rue de Stassart 35, B - 1050 Brussels

© 2008 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60335-2-75:2004/A2:2008 E

EN 60335-2-75:2004/A2:2008 - 2 -
Foreword
The text of document 61/3643/FDIS, future amendment 2 to IEC 60335-2-75:2002, prepared by
IEC TC 61, Safety of household and similar electrical appliances, was submitted to the IEC-CENELEC
parallel vote and was approved by CENELEC as amendment A2 to EN 60335-2-75:2004 on 2008-08-01.
The following dates are applicable:
- latest date by which the amendment has to be
implemented at national level by publication of
an identical national standard or by endorsement (dop) 2009-05-01
- date on which national standards conflicting
with the amendment have to be withdrawn (dow) 2011-08-01
This amendment supplements or modifies the corresponding clauses of EN 60335-2-75:2004.
There are no special national conditions causing a deviation from this amendment.
There are no national deviations from this ame
...


SLOVENSKI STANDARD
01-januar-2009
*RVSRGLQMVNLLQSRGREQLHOHNWULþQLDSDUDWL9DUQRVWGHO3RVHEQH]DKWHYH
]DNRPHUFLDOQHDSDUDWH]DSURGDMRKUDQHLQSLMDþHLQSURGDMQHDYWRPDWH ,(&
$
Household and similar electrical appliances - Safety -- Part 2-75: Particular requirements
for commercial dispensing appliances and vending machines
Sicherheit elektrischer Geräte für den Hausgebrauch und ähnliche Zwecke -- Teil 2-75:
Besondere Anforderungen für Ausgabegeräte und Warenautomaten für den
gewerblichen Gebrauch
Appareils électrodomestiques et analogues - Sécurité -- Partie 2-75: Règles particulières
pour les distributeurs commerciaux avec ou sans moyen de paiement
Ta slovenski standard je istoveten z: EN 60335-2-75:2004/A2:2008
ICS:
55.230 Razdelilni in prodajni Distribution and vending
avtomati machines
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 60335-2-75/A2
NORME EUROPÉENNE
October 2008
EUROPÄISCHE NORM
ICS 55.230
English version
Household and similar electrical appliances -
Safety -
Part 2-75: Particular requirements for commercial dispensing appliances
and vending machines
(IEC 60335-2-75:2002/A2:2008)
Appareils électrodomestiques  Sicherheit elektrischer Geräte
et analogues - für den Hausgebrauch
Sécurité - und ähnliche Zwecke -
Partie 2-75: Règles particulières Teil 2-75: Besondere Anforderungen
pour les distributeurs commerciaux für Ausgabegeräte und Warenautomaten
avec ou sans moyen de paiement für den gewerblichen Gebrauch
(CEI 60335-2-75:2002/A2:2008) (IEC 60335-2-75:2002/A2:2008)

This amendment A2 modifies the European Standard EN 60335-2-75:2004; it was approved by CENELEC on
2008-08-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which
stipulate the conditions for giving this amendment 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 Central Secretariat or to any CENELEC member.

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

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus, the
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: rue de Stassart 35, B - 1050 Brussels

© 2008 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60335-2-75:2004/A2:2008 E

EN 60335-2-75:2004/A2:2008 - 2 -
Foreword
The text of document 61/3643/FDIS, future amendment 2 to IEC 60335-2-75:2002, prepared by
IEC TC 61, Safety of household and similar electrical appliances, was submitted to the IEC-CENELEC
parallel vote and was approved by CENELEC as amendment A2 to EN 60335-2-75:2004 on 2008-08-01.
The following dates are applicable:
- latest date by which the amendment has to be
implemented at national level by publication of
an identical national standard or by endorsement (dop) 2009-05-01
- date on which national standards conflicting
with the amendment have to be withdrawn (dow) 2011-08-01
This amendment supplements or modifies the corresponding clauses of EN 60335-2-75:2004.
There are no special national conditions causing a deviation from this amendment.
There are no national deviations from this amendment.
p NOTE  In this document, p is used in the margin to indicate ins
...

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