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.
You can purchase SIST 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 SIST 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
...
SIST EN 60601-2-52:2010/A1:2015는 의료 전기 기기 분야에서 중요한 역할을 하는 표준으로, 특히 의료 침대의 기본 안전성과 필수 성능에 대한 특별 요구사항을 다루고 있습니다. 본 표준은 성인 환자를 위한 의료 침대에 적용되며, IEC 60601-2-38의 첫 번째 판을 대체하는 것으로, 이전에 제정된 표준의 기술적 개정을 포함하고 있습니다. 이 표준의 범위는 의료 침대의 안전성과 성능을 보장하기 위한 필수 요건들을 명확히 정의하고 있어, 의료 분야에서의 신뢰성을 높이는 데 기여하고 있습니다. 특히, IEC 60601-2-52는 다양한 국제 표준인 IEC 60601-2-38, EN 1970 및 IEC 60601-1 제3판 간의 조정과 일치를 통해 진행된 작업을 반영하고 있습니다. 이는 의료 기기 안전성의 글로벌 스탠다드를 향상시킬 뿐만 아니라, 유럽 시장에서의 표준화에도 기여하고 있습니다. 이 표준의 강점 중 하나는 의료 침대를 사용하여 환자의 안전성을 보장하는 데 필요한 다양한 요구 사항을 포괄적으로 포함하고 있다는 점입니다. 따라서 의료기관에서의 침대 사용 시 환자의 안전과 편안함을 동시에 고려할 수 있도록 하고 있습니다. 또한, 이 표준은 기술적 발전에 기초하여 최신 요구 사항을 반영하고 있어, 변화하는 의료 환경에서도 유연하게 대응할 수 있는 편리함을 제공합니다. SIST EN 60601-2-52:2010/A1:2015는 의료 장비의 안전성과 성능을 보장하는 데 필수적인 지침을 제공하며, 의료 침대의 설계 및 사용에 따른 법적 요구사항을 준수하는 데 도움을 줍니다. 의료 현장에서 이해관계자들에게 큰 신뢰를 주며, 환자 치료 품질을 향상시키는 데 중요한 역할을 하고 있습니다. 이러한 이유로 본 표준은 의료 장비의 안전에 있어 필수적이며, 현재의 의료기기 시장에서 그 중요성이 더욱 부각되고 있습니다.
SIST EN 60601-2-52:2010/A1:2015は、医療用電気機器に関する重要な標準であり、成人向けの医療ベッドの基本的安全性と必須性能に特化した規定を提供しています。この標準は、IEC 60601-2-38の初版（1996年版）とその改訂版である改定1（1999年版）を廃止し、技術的な改訂を行った初版です。SIST EN 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図るために多大な作業がなされた結果として実現されました。 この標準のスコープは、医療ベッドの安全性と性能に焦点を当てており、医療現場でのリスクを軽減するための具体的な要件を定めています。特に、患者の安全を確保するための機能や構造に関する詳細が豊富に盛り込まれています。これにより、デザインや製造に関与する専門家が、ベッドが提供すべき安全基準に従って製品を開発できるようになります。 SIST EN 60601-2-52の強みはその包括性と詳細さにあります。この規格は、医療ベッドが様々な使用環境で機能するために必要な安全基準を定めており、医療機器製造者や医療機関にとって非常に有用です。また、医療ベッドに特化した規定があることで、医療現場のニーズに即した製品の開発を促進します。 さらに、この標準の関連性は、医療業界の進化に伴い高まっており、最新の技術や方法論を反映させるための基盤を提供しています。医療ベッドは患者の治療や快適さに直接影響を与えるため、その基本的安全性と性能が確保されていることは、医療提供者や患者にとって重要です。 したがって、SIST EN 60601-2-52:2010/A1:2015は、医療ベッドの安全性と性能に関して不可欠な標準であり、その内容は医療機器の品質向上に寄与するものといえます。
The standard SIST EN 60601-2-52:2010/A1:2015 specifies the particular requirements for the basic safety and essential performance of medical beds intended for adults. Its scope effectively addresses key safety aspects pertinent to medical beds, ensuring that they meet the necessary criteria for use in healthcare settings. One of the significant strengths of this standard is its comprehensive approach to safety, which includes rigorous requirements for construction, performance testing, and electrical safety measures. This focus on basic safety not only mitigates risks to patients but also ensures that healthcare providers can rely on the equipment during critical scenarios. Moreover, the standard highlights essential performance criteria that are crucial for the operational effectiveness of medical beds. These criteria are vital for ensuring that the equipment functions properly under different conditions, therefore enhancing patient care and safety outcomes. The relevance of SIST EN 60601-2-52:2010/A1:2015 is underscored by its alignment with international standards. This standard serves as a crucial reference for manufacturers and healthcare facilities, promoting consistency in safety measures across the medical equipment industry. The transition from IEC 60601-2-38 to this new standard represents a significant advancement in harmonizing efforts with other relevant standards, such as EN 1970 and IEC 60601-1. By focusing on the interaction between safety and performance, this standard not only addresses contemporary challenges in medical technology but also sets a benchmark for future developments in medical beds. The revisions made throughout the standardization process reflect ongoing collaboration and dedication to enhancing the standards within the healthcare sector. In conclusion, SIST EN 60601-2-52:2010/A1:2015 stands out for its diligent approach to basic safety and essential performance, making it indispensable for both manufacturers and healthcare providers in the medical beds domain.
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...