CAN/CSA C22.2 No. 60601-2-5:11 (R2021) ✓ Most Recent

Preface

This is the third edition of CAN/CSA-C22.2 No. 60601-2-5, Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment, which is an adoption without modification of the identically titled IEC (International Electrotechnical Commission) Standard 60601-2-5 (third edition, 2009-07). It supersedes the previous edition, published in 2002 as CAN/CSA-C22.2 No. 60601-2-5 (adopted IEC 60601-2-5:2000). It is one in a series of Standards issued by CSA under Part II of the Canadian Electrical Code. This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 60601-1:08, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (adopted IEC 60601-1:2005, with Canadian deviations).

Scope

Replacement:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ULTRASONIC PHYSIOTHERAPY EQUIPMENT as defined in 201.3.216, hereafter referred to as ME EQUIPMENT.

This standard only relates to ULTRASONIC PHYSIOTHERAPY EQUIPMENT employing a single plane unfocused circular transducer per TREATMENT HEAD, producing static beams perpendicular to the face of the TREATMENT HEAD.

This standard can also be applied to ULTRASONIC PHYSIOTHERAPY EQUIPMENT used for compensation or alleviation of disease, injury or disability.

In the case of combined EQUIPMENT (e.g. EQUIPMENT additionally provided with a function or an APPLIED PART for electrical stimulation) such EQUIPMENT shall also comply with any particular standard specifying safety requirements for the additional function.

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.

NOTE 1 See also 4.2 of the general standard.

This particular standard does not apply to: - EQUIPMENT in which a tool is driven by ULTRASOUND (for example EQUIPMENT used in surgery or dentistry);
- EQUIPMENT in which focused ULTRASOUND pulse waves are used to destroy conglomerates such as stones in the kidneys or the bladder (lithotripters) (for information refer to IEC 60601-2-36);
- ULTRASONIC PHYSIOTHERAPY EQUIPMENT in which focused ultrasound pulse waves are used. See more