BS EN 60601-2-2:2007 - Medical electrical equipment. Particular requirements for the safety of high frequency surgical equipment – BSI British Standards

BS EN 60601-2-2:2007

Medical electrical equipment. Particular requirements for the safety of high frequency surgical equipment

Status : Revised, Withdrawn   Published : April 2007 Replaced By : BS EN 60601-2-2:2009+A11:2011

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BS EN 60601-2-2 has been extensively revised and updated to incorporate significant changes. The changes relate mainly to a range of technical changes and the improved safety that they will provide.

This fourth edition specifies the requirements for the safety of HF surgical equipment and HF surgical accessories used in medical practice.

What are the changes to BS EN 60601-2-2?

  • Revision to the requirements and compliance testing for high frequency (HF) surgical accessories to make them independent of specific HF surgical generators.
  • Clause 2 definitions have been revised and expanded.
  • Thermal, electrical and adhesive requirements testing for neutral electrodes have been added.
  • Dielectric strength requirements for HF surgical accessories have been revised.
  • Accommodation of HF surgical generators that don’t require continuous operation of the switch sensor.
  • Information about electromagnetic disturbance (EMD) for HF surgical equipment has been added.

HF surgical equipment having a rated output power not exceeding 50 W (for example for micro-coagulation, or for use in dentistry or ophthalmology) is exempt from certain of the requirements of this standard. These exemptions are indicated in this standard.

Contents include:

  • Terminology and definitions
  • General requirements
  • General requirements for tests
  • Classification
  • Identification, marking and documents
  • Power input
  • Environmental conditions
  • Protection against electrical shock hazards
  • Requirements related to classification
  • Separation
  • Protective earthing, functional earthing and potential equalization
  • Continuous leakage currents and patient auxiliary currents
  • Dielectric strength
  • Protection against mechanical hazards
  • Protection against hazards from unwanted or excessive radiation
  • Electromagnetic compatibility
  • Protection against hazards of ignition flammable anaesthetic mixtures
  • Common requirements for category AP and category APG equipment
  • Protection against excessive temperatures and other safety hazards
  • Excessive temperatures
  • Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization, disinfection and compatibility
  • Human errors
  • Accuracy of operating data and protection against hazardous output
  • Abnormal operation and fault conditions; environmental tests
  • Constructional requirements
  • Components and general assembly
  • Construction and layout
  • Publications mentioned in this standard
  • Guidance and rationale for particular clauses and subclauses
  • Electromagnetic disturbances created by HF surgical equipment
  • Normative references to international publications with their corresponding European publications
  • Coverage of Essential Requirements of EC Directives

BS EN 60601-2-2:2007 replaces BS EN 60601-2-2:2001, which has been withdrawn.

ISBN 978 0 580 50634 5




Standard NumberBS EN 60601-2-2:2007
TitleMedical electrical equipment. Particular requirements for the safety of high frequency surgical equipment
StatusRevised, Withdrawn
Publication Date30 April 2007
Withdrawn Date01 April 2012
Normative References(Required to achieve compliance to this standard)CISPR 11:2003, IEC 60601-1-2:2001, ANSI/AAMI HF18:2001, EN 60601-1-2:2001, IEC 60601-2-34:2000, EN 55011:2007, IEC 60601-2-18:1996/AMD 1:2000, EN 55016-2-1:2004, EN 60601-2-18:1996/AMD 1:2000, EN 60601-2-18:1996, IEC 61000-4-3:2006, IEC 60601-2-4:2005, EN 61000-4-3:2006, EN 61000-4-6, IEC 61000-4-6:2003/AMD 1:2004, EN 60601-2-34:2000, EN 60601-2-2:2000, CISPR 16-2-1:2003, IEC 61000-4-6:2003, IEC 60601-2-18:1996, IEC 60601-2-2:1998
Informative References(Provided for Information)IEC 60601-2-18, IEC 60601-1-2, 93/42/EEC, IEC 60601-2-2, IEC 61000-4-3, IEC 60601-2-34, IEC 61000-4-6
Replaced ByBS EN 60601-2-2:2009+A11:2011
ReplacesBS EN 60601-2-2:2001
International RelationshipsIEC 60601-2-2:2006
Draft Superseded By04/30094882 DC
DescriptorsHigh frequencies, Electrical medical equipment, Protected electrical equipment, Electrical safety, Leakage currents, Surgical equipment, Electrical equipment, Electric current, Safety measures, Signal devices, Earthing, Electronic equipment and components, Electrical testing, Medical equipment
ICS11.040.30
Title in FrenchAppareils électromédicaux. Exigences particulières pour la sécurité des appareils d'électrochirurgie à courant haute fréquence
Title in GermanMedizinische elektrische Geräte. Besondere Festlegungen für die Sicherheit von Hochfrequenz-Chirurgiegeräten
CommitteeCH/62/4
ISBN978 0 580 50634 5
PublisherBSI
FormatA4
DeliveryNo
Pages90
File Size806 KB
Price£274.00


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