CSA C22.2 NO. 60601-2-62:15 (R2020)

Preface:

This is the first edition of CAN/CSA-C22.2 No. 60601-2-62, Medical electrical equipment — Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment, which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 60601-2-62 (first edition, 2013-07). It is one in a series of Standards issued by CSA Group under Part II of the Canadian Electrical Code.

For brevity, this Standard will be referred to as "CAN/CSA-C22.2 No. 60601-2-62" throughout.

This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 60601-1:14, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance (adopted IEC 60601-1:2005+A1:2012, with Canadian deviations).

201.1.1 Scope:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HIGH INTENSITY THERAPEUTIC ULTRASOUND EQUIPMENT as defined in 201.3.218, hereafter referred to as ME EQUIPMENT.

This International Standard adds or replaces clauses listed in the IEC 60601-1 that are specific for HIGH INTENSITY THERAPEUTIC ULTRASOUND EQUIPMENT.

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.

NOTE 2 As, in HITU fields, the acoustic waveform is expected to be extremely distorted due to non-linear propagation effects, the ultrasonic measurements are to be made under quasi linear conditions and then extrapolated following procedures given in IEC/TS 62556. See also IEC/TS 61949

This standard can also be applied to:

• therapeutic equipment for thrombolysis through exposure to high-intensity therapeutic ultrasound;
• therapeutic equipment for the treatment of occluding feeding vessels through exposure to high-intensity focused ultrasound;
• equipment intended to be used for relieving cancer pain due to bone metastases.

This particular standard does not apply to:

• ULTRASOUND EQUIPMENT intended to be used for physiotherapy (use: IEC 60601-2-5 [1]2) and IEC 61689);
• ULTRASOUND EQUIPMENT intended to be used for lithotripsy (use: IEC 60601-2-36 [2]);
• ULTRASOUND EQUIPMENT intended to be used for dedicated hyperthermia devices;
• ULTRASOUND EQUIPMENT intended to be used for phacoemulsification.

201.1.2 Object:

The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for HIGH INTENSITY THERAPEUTIC ULTRASOUND (HITU) EQUIPMENT [as defined in 201.3.218.]