EN 60601-2-52:2010/A1:2015
(Amendment)Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
Medical electrical equipment - Part 2-52: Particular requirements for the 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 de sécurité de base et de 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
- 14-May-2015
- Withdrawal Date
- 21-Apr-2018
- Technical Committee
- CLC/TC 62 - Electrical equipment in medical practice
- Drafting Committee
- IEC/SC 62D - IEC_SC_62D
- Current Stage
- 6060 - Document made available - Publishing
- Start Date
- 15-May-2015
- Completion Date
- 15-May-2015
Relations
- Effective Date
- 28-Jan-2023
Overview
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: 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
EN 60601-2-52:2010/A1:2015 is a amendment published by CLC. Its full title is "Medical electrical equipment - Part 2-52: Particular requirements for the 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.
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.
EN 60601-2-52:2010/A1:2015 has the following relationships with other standards: It is inter standard links to EN 60601-2-52:2010. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
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.
You can purchase EN 60601-2-52:2010/A1:2015 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-september-2015
0HGLFLQVNDHOHNWULþQDRSUHPDGHO 3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLPHGLFLQVNLKSRVWHOM'RSROQLOR$
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
...
표준 SIST EN 60601-2-52:2010/A1:2015는 의료 전기 장비의 기본 안전성과 필수 성능에 대한 구체적인 요구 사항을 규명하고 있으며, 특히 성인을 위한 의료 침대에 적용됩니다. 이 표준은 2009년에 발행된 IEC 60601-2-52의 첫 번째 판으로, 1996년에 발표된 IEC 60601-2-38의 첫 번째 판과 그 개정판(1999)을 대체하며, 기술적으로 수정된 내용입니다. 이 표준의 주요 강점 중 하나는 전 세계적으로 통일된 기준을 제공하여 의료 침대에 대한 신뢰성을 높이는 데 기여하는 점입니다. 또한 IEC 60601-2-38, EN 1970, 그리고 IEC 60601-1의 세 번째 판 사이의 일치를 위해 많은 노력이 기울여졌다는 점에서도 중요한 의의를 지닙니다. 이를 통해 제조업체와 의료 기관 간에 명확한 기대치를 설정함으로써, 환자의 안전성을 보장하고 필수적으로 요구되는 성능을 충족하도록 돕습니다. SIST EN 60601-2-52:2010/A1:2015의 적용 범위는 의료 침대의 설계와 제작 시 반드시 준수해야 하는 기본적인 안전 및 성능 기준을 포함하고 있어, 의사 및 간호사의 작업 환경 개선에도 기여할 수 있습니다. 결과적으로, 이 표준은 의료 침대의 사용 시 발생할 수 있는 잠재적 위험을 최소화하고, 의료 서비스 제공자들에게 필요한 신뢰성을 부여하는 데 핵심적인 역할을 하고 있습니다. 따라서 SIST EN 60601-2-52:2010/A1:2015는 의료 침대의 안전성과 성능을 보장하는 데 필수적인 요소로 자리 잡고 있으며, 이는 환자의 안전성을 제고하고 의료 서비스를 발전시키는 데 매우 중요하다고 할 수 있습니다.
The standard SIST EN 60601-2-52:2010/A1:2015 offers critical guidelines for the basic safety and essential performance of medical beds designed for adult patients. This standard is instrumental in ensuring that medical equipment such as beds complies with safety requirements that protect users and patients alike. The scope of this standard encompasses a detailed technical revision from the previous editions, particularly replacing IEC 60601-2-38, thereby eliminating outdated practices and aligning with current technological advancements. The integration of IEC 60601-2-52:2009 reflects significant progress in standardizing medical devices, ensuring they meet high safety criteria necessary for optimal patient care. One of the key strengths of this standard is its comprehensive nature, which not only details the safety requirements for medical beds but also establishes parameters for essential performance that directly impact patient outcomes. By clarifying these aspects, the standard aids manufacturers in designing and producing safer medical beds that are less prone to malfunction and more user-friendly. Additionally, the alignment efforts with related standards like EN 1970 and the third edition of IEC 60601-1 mark a significant advancement in creating a cohesive framework for medical electrical equipment. This relevance to current industry practices enhances its applicability across various healthcare settings. Furthermore, the standard plays a vital role in promoting compliance among manufacturers, ensuring that their products are rigorously tested against recognized safety benchmarks. In summary, SIST EN 60601-2-52:2010/A1:2015 is an essential directive that strengthens the safety and effectiveness of medical beds for adults, demonstrating its ongoing relevance in the evolution of health technology standards.
標準文書SIST EN 60601-2-52:2010/A1:2015は、医療用電気機器の基本的な安全性と本質的な性能に関連する重要な要素を取り扱っています。この標準は主に成人用医療ベッドに適用され、医療機器の安全基準の向上に寄与することを目的としています。 この標準の範囲はIEC 60601-2-38の初版を取り消し、新たな技術的改訂を提供することに重点を置いています。IEC 60601-2-52は、IEC 60601-2-38、EN 1970及びIEC 60601-1の第三版との整合性を保つために多くの作業が行われた結果として実現されたものであり、最新の医療機器に求められる基準を反映しています。この整合性は、医療ベッドの設計と性能を強化し、患者の安全を確保するための重要な要素です。 この標準の強みは、具体的かつ明確な要求事項を提供している点にあります。医療ベッドの製造者に対し、ユーザーの安全を最優先に考えた設計が求められているため、標準に準拠することで、医療現場において高い信頼性をもたらします。また、この標準は医療機器が直面するさまざまなリスクに対処するための基盤を提供し、医療従事者や患者に対する保護を強化しています。 SIST EN 60601-2-52:2010/A1:2015は、医療用電気機器の分野において、特に医療ベッドの基本的な安全性と本質的な性能を確保する上での重要な指針となります。この標準への準拠は、品質管理及び患者の安全性向上に繋がり、医療機関における信頼性の向上に寄与します。このように、標準は明確な価値を提供し、医療機器の安全性と性能を保証するための重要な枠組みとなっています。
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...