scope:

CSA Preface

This is the first edition of CSA Standard CAN/CSA-C22.2 No. 601.2.10, Medical Electrical Equipment Part 2: Particular Requirements for the Safety of Nerve and Muscle Stimulators. it is an adoption of the identically titled first edition of IEC (International Electrotechnical Commission) Standard 601-2-10.

This Particular Standard amends and supplements CSA Standard CAN/CSA-C22.2 No. 601.1, Medical Electrical Equipment Part 7: General Requirements for Safety, hereinafter referred to as the General Standard. The requirements of this Particular Standard take precedence over those of the General Standard. For the purposes of testing and approving equipment within the scope of this Standard, the equipment must meet the combined requirements, as applicable, of both this Particular Standard and the General Standard.

Publication of this Particular Standard marks an important step forward in the harmonization of Canadian medical electrical equipment Standards with those used and developed internationally. The Canadian Standards Association has always taken a leadership role in promulgating Standards which provide the very highest level of protection for the end-user of the product. Every effort has been made to ensure that the harmonization of an existing Standard with international practice maintains that concern for the welfare of the patient.

The Canadian adoption of this Particular Standard was prepared by the Technical Committee on Environmental Products and the Technical Committee on Medical Electrical Equipment under the jurisdiction of the CSA Standards Steering Committees of the Canadian Electrical Code, Part II and Health Care Technology, respectively. This Particular Standard has been formally approved by all four committees and has been approved as a National Standard of Canada by the Standards Council of Canada.

August 1992

Notes:

(1) Use of the singular does not exclude the plural (and vice versa) when the sense allows.

(2) Although the intended primary application of this Standard is stated in its Scope, it is important to note that it remains the responsibility of the users of the Standard to judge its suitability for their particular purpose.

(3) CSA Standards are subject to periodic review, and suggestions for their improvement will be referred to the appropriate committee.

(4) All inquiries regarding this Standard, including requests for interpretation, should be addressed to Canadian Standards Association, Standards Division, 178 Rexdale Boulevard, Rexdale, Ontario M9W 1R3.

Requests for interpretation should

(a) define the problem, making reference to the specific clause, and where appropriate, include an illustrative sketch;

(b) provide an explanation of circumstances surrounding the actual field condition; and

(c) be phrased where possible to permit a specific "yes" or "no" answer. Interpretations are published in CSA's periodical Info Update. For subscription details, write to CSA Soles Promotion, Info Update, at the address given above.