SIST EN 60601-2-52:2010/A1:2015
(Amendment)Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds
Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds
IEC 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
Appareils électromédicaux - Partie 2-52: Exigences particulières pour la sécurité de base et les performances essentielles des lits médicaux
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.
Medicinska električna oprema - 2-52. del: Posebne zahteve za osnovno varnost in bistvene lastnosti medicinskih postelj - Dopolnilo A1
General Information
- Status
- Published
- Publication Date
- 13-Aug-2015
- Technical Committee
- IEMO - Electrical equipment in medical practice
- Current Stage
- 6060 - National Implementation/Publication (Adopted Project)
- Start Date
- 15-Jun-2015
- Due Date
- 20-Aug-2015
- Completion Date
- 14-Aug-2015
Relations
- Effective Date
- 01-Sep-2015
Overview
SIST EN 60601-2-52:2010/A1:2015 is a European standard specifying particular requirements for the basic safety and essential performance of medical beds designed for adult patients. Aligned with the international IEC 60601-2-52:2009/A1:2015 standard by the International Electrotechnical Commission (IEC), this document supersedes earlier versions, incorporating updated risk management processes and safety measures. It applies specifically to adult medical beds-defined for patients equal to or taller than 146 cm, weighing more than 40 kg, and with a Body Mass Index (BMI) of 17 or more-to ensure patient safety and equipment efficacy in clinical environments.
Key Topics
- Scope and Application: Defines the standard for safety and performance of medical electrical beds intended for adults in healthcare settings.
- Risk Management: Mandates manufacturers to incorporate risk assessments for hazards including entrapment, falls, and patient size variations (e.g., patients taller than 185 cm).
- Mechanical Safety Measures:
- Protection against mechanical hazards such as patient entrapment in gaps within side rails or bed extensions.
- Use of specific testing tools (e.g., cone and cylinder tools) to evaluate potential entrapment zones.
- Static force requirements to ensure bed components withstand expected loading conditions.
- Identification and Marking:
- Medical beds must bear clear markings indicating suitability for adult patients.
- Includes symbolic representation of the adult patient size for quick reference.
- Instructions for Use:
- Must specify intended patient group(s) and any limitations.
- Provides warnings on risks such as incompatibility between side rails and mattresses that may cause entrapment hazards.
- Patient Parameters Defined:
- Adult patients characterized by physical size and BMI to prevent misclassification and related safety risks.
Applications
- Hospitals and Clinical Facilities: Ensures medical beds meet stringent safety requirements critical to patient care.
- Medical Equipment Manufacturers: Provides design and testing criteria to meet regulatory compliance and improve product safety.
- Healthcare Providers: Enables informed selection of beds tailored to adult patients, ensuring safer patient handling and reducing injury risks.
- Regulatory Bodies: Supports harmonized evaluation and certification of medical electrical beds within the EU and countries recognizing CENELEC standards.
Related Standards
- IEC 60601-1: General requirements for basic safety and essential performance of medical electrical equipment.
- IEC 60601-2-38: Previous edition addressing medical beds; now replaced by IEC 60601-2-52.
- EN 1970: European standard for hospital beds-related to safety and performance requirements.
- EU Medical Device Directive: EN 60601-2-52 supports compliance with essential requirements of EU directives regarding medical devices.
Keywords: SIST EN 60601-2-52:2010/A1:2015, medical electrical equipment, medical beds, adult patients, basic safety, essential performance, risk management, patient entrapment, medical bed safety, CENELEC, IEC 60601-2-52, medical device standards, hospital equipment, patient fall prevention
Frequently Asked Questions
SIST EN 60601-2-52:2010/A1:2015 is a amendment published by the Slovenian Institute for Standardization (SIST). Its full title is "Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds". This standard covers: IEC 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.
IEC 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.
SIST EN 60601-2-52:2010/A1:2015 is classified under the following ICS (International Classification for Standards) categories: 11.140 - Hospital equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN 60601-2-52:2010/A1:2015 has the following relationships with other standards: It is inter standard links to SIST EN 60601-2-52:2010. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN 60601-2-52:2010/A1:2015 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/467. 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.
SIST EN 60601-2-52:2010/A1:2015 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2015
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Medical electrical equipment - Part 2-52: Particular requirements for basic safety and
essential performance of medical beds
Medizinische elektrische Geräte - Teil 2-52: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von medizinischen Betten
Appareils électromédicaux - Partie 2-52: Exigences particulières pour la sécurité de base
et les performances essentielles des lits médicaux
Ta slovenski standard je istoveten z: EN 60601-2-52:2010/A1:2015
ICS:
11.140 Oprema bolnišnic Hospital equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN 60601-2-52:2010/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2015
ICS 11.140
English Version
Medical electrical equipment -
Part 2-52: Particular requirements for the basic safety and
essential performance of medical beds
(IEC 60601-2-52:2009/A1:2015)
Appareils électromédicaux - Medizinische elektrische Geräte -
Partie 2-52: Exigences particulières de sécurité de base et Teil 2-52: Besondere Festlegungen für die Sicherheit
de performances essentielles des lits médicaux einschließlich der wesentlichen Leistungsmerkmale von
(IEC 60601-2-52:2009/A1:2015) medizinischen Betten
(IEC 60601-2-52:2009/A1:2015)
This amendment A1 modifies the European Standard EN 60601-2-52:2010; it was approved by CENELEC on 2015-04-22. 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 CEN-CENELEC
Management Centre 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 CEN-CENELEC Management Centre has the same status as
the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-2-52:2010/A1:2015 E
Foreword
The text of document 62D/1186/FDIS, future IEC 60601-2-52:2009/A1, prepared by
SC 62D "Electromedical equipment" of IEC/TC 62 "Electrical equipment in medical practice" was
submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
The following dates are fixed:
• latest date by which the document has to be (dop) 2016-01-22
implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2018-04-22
• latest date by which the national
standards conflicting with the
document have to be withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive.
For the relationship with EU Directive see informative Annex ZZ, included in EN 60601-2-52:2010.
Endorsement notice
The text of the International Standard IEC 60601-2-52:2009/A1:2015 was approved by CENELEC as
a European Standard without any modification.
IEC 60601-2-52
Edition 1.0 2015-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
Medical electrical equipment –
Part 2-52: Particular requirements for the basic safety and essential performance
of medical beds
Appareils électromédicaux –
Partie 2-52: Exigences particulières de sécurité de base et de performances
essentielles des lits médicaux
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.140 ISBN 978-2-8322-2390-1
– 2 – IEC 60601-2-52:2009/AMD1:2015
© IEC 2015
FOREWORD
This amendment has been prepared by subcommittee 62D: Electromedical equipment, of IEC
technical committee 62: Electrical equipment in medical practice.
The text of this amendment is based on the following documents:
FDIS Report on voting
62D/1186/FDIS 62D/1232/RVD
Full information on the voting for the approval of this amendment can be found in the report
on voting indicated in the above table.
The committee has decided that the contents of this amendment and the base publication will
remain unchanged until the stability date indicated on the IEC web site under
"http://webstore.iec.ch" in the data related to the specific publication. At this date, the
publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
_____________
201.1.1 * Scope
Replace the existing te
...
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