BS EN 60601-2-2:2007 - Page 2

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.

• 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.

• 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

ISBN 978 0 580 50634 5