EN 60601-2-37:2008/A11:2011

Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

D139/C149: BT approved the modified Annex ZZ for EN 60601-2-37:2008
2021: CLC legacy converted by DCLab NISOSTS

Medizinische elektrische Geräte - Teil 2-37: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Ultraschallgeräten für die medizinische Diagnose und Überwachung

Appareils électromédicaux - Partie 2-37: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de diagnostic et de surveillance médicaux à ultrasons

Medicinska električna oprema - 2-37. del: Posebne varnostne zahteve za ultrazvočno medicinsko diagnostično in nadzorovalno opremo

Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI ULTRAZVOČNE DIAGNOSTIČNE OPREME, kot je določeno v 201.3.217, v nadaljevanju ME OPREMA. Če bo točka ali podtočka izrecno namenjena samo uporabi za ME OPREMO ali samo za ME SISTEME, bosta naslov in vsebina te točke ali podtočke to tudi navedla. Sicer točka in podtočka veljata za ustrezno ME OPREMO in ME SISTEME. NEVARNOSTI, ki so del fiziološkega delovanja ME OPREME ali ME SISTEMOV v okviru uporabe tega standarda, niso zajete s posebnimi zahtevami tega standarda, razen v točkah 7.2.13 in 8.4.1 tega standarda.

General Information

• Status: Published
• Publication Date: 13-Oct-2011
• Withdrawal Date: 30-Sep-2014
• ICS: 11.040.55 - Diagnostic equipment
• ICS: 17.140.50 - Electroacoustics
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: CLC/TC 62 - Electrical equipment in medical practice
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 14-Oct-2011
• Completion Date: 14-Oct-2011
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: SIST EN 60601-2-37:2008/A11:2012 - Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

Relations

• Replaced By: EN IEC 60601-2-37:2024 - Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
• Effective Date: 23-Aug-2022
• Amends: EN 60601-2-37:2008 - Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
• Effective Date: 28-Jan-2023

Overview

EN 60601-2-37:2008/A11:2011 is a critical European standard developed by CLC (European Committee for Electrotechnical Standardization) focused on the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment. This amendment (A11) updates the original 2008 edition, ensuring alignment with evolving medical device safety requirements and compliance with relevant EC Directives.

This standard forms part 2-37 of the broader EN 60601 series, which governs the safety and performance of electrical medical equipment. It specifically addresses ultrasonic devices used in medical diagnostics and patient monitoring, setting requirements that mitigate risks and ensure devices perform reliably and safely in clinical environments.

Key Topics

• Scope and Applicability
  EN 60601-2-37/A11 applies to all ultrasonic medical diagnostic and monitoring equipment designed for use in patient care. The standard defines safety features and performance criteria to protect patients and operators from electrical, mechanical, and acoustic hazards.

• Safety Requirements
  The standard mandates electrical safety measures, including protection against electric shock, fire, and mechanical hazards. It emphasizes the importance of risk management in design, addressing both basic safety and essential performance parameters.

• Performance Standards
  Essential performance criteria ensure that ultrasonic equipment delivers accurate diagnostic results and consistent monitoring data. The amendment also includes provisions to maintain device reliability throughout its expected lifetime.

• Compliance and Regulatory Context
  EN 60601-2-37:2008/A11 provides conformity with EC Directive 93/42/EEC concerning medical devices, covering most relevant essential requirements except a few specified exceptions. Compliance with this standard helps manufacturers meet European regulatory demands for medical electrical equipment.

Applications

• Medical Ultrasonic Imaging
  This standard is crucial for manufacturers and healthcare providers using ultrasound machines for diagnostic imaging, such as cardiology, obstetrics, and radiology, enabling safer and more precise patient evaluations.

• Patient Monitoring Devices
  It governs the safety and functionality of ultrasonic monitoring equipment used in intensive care units and other medical settings, where real-time patient status assessment is vital.

• Device Design and Manufacturing
  Equipment developers apply EN 60601-2-37/A11 as a framework to incorporate safety features, conduct performance testing, and demonstrate compliance during product development phases.

• Regulatory Approval and Certification
  Medical device manufacturers rely on adherence to this standard to obtain CE marking and other regional certifications, facilitating market access within the European Economic Area.

Related Standards

• EN 60601 Series
  EN 60601-1: General requirements for basic safety and essential performance of medical electrical equipment. The parent standard from which EN 60601-2-37 derives particular requirements for ultrasonic devices.

• EC Directive 93/42/EEC
  The European medical device directive under which EN 60601-2-37/A11 provides compliance pathways, especially concerning essential safety and performance requirements.

• IEC 60601-2-X Series
  Other part 2 standards targeting specific types of medical electrical equipment, such as defibrillators, ventilators, and imaging devices.

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Keywords: EN 60601-2-37, ultrasonic medical diagnostic equipment, medical electrical equipment safety, ultrasonic monitoring devices, medical device standards, CLC medical standards, EU medical device compliance, healthcare ultrasound safety, CE marking ultrasonic devices, medical device performance requirements.

Standards Content (Sample)

SLOVENSKI STANDARD
01-januar-2012
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQHYDUQRVWQH]DKWHYH]D
XOWUD]YRþQRPHGLFLQVNRGLDJQRVWLþQRLQQDG]RURYDOQRRSUHPR
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and
essential performance of ultrasonic medical diagnostic and monitoring equipment
Medizinische elektrische Geräte - Teil 2-37: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Ultraschallgeräten für die
medizinische Diagnose und Überwachung
Appareils électromédicaux - Partie 2-37: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils de diagnostic et de surveillance médicaux
à ultrasons
Ta slovenski standard je istoveten z: EN 60601-2-37:2008/A11:2011
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
17.140.50 Elektroakustika Electroacoustics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN 60601-2-37/A11
NORME EUROPÉENNE
October 2011
EUROPÄISCHE NORM
ICS 11.040.55; 17.140.50
English version
Medical electrical equipment -
Part 2-37: Particular requirements for the basic safety and essential
performance of ultrasonic medical diagnostic and monitoring equipment

Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 2-37: Exigences particulières pour Teil 2-37: Besondere Festlegungen für die
la sécurité de base et les performances Sicherheit einschließlich der wesentlichen
essentielles des appareils de diagnostic et Leistungsmerkmale von
de surveillance médicaux à ultrasons Ultraschallgeräten für die medizinische
Diagnose und Überwachung
This amendment A11 modifies the European Standard EN 60601-2-37:2008; it was approved by CENELEC on
2011-10-01. 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 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 o
...