CAN/CSA-C22.2 NO. 601.1-M90 (R2005)
Medical Electrical Equipment - Part 1: General Requirements for Safety
Product Details
CSA Preface
This is the first edition of CSA Standard CAN/CSA-C22.2 No. 601.1, Medical Electrical Equipment, Part 1: General Requirements for Safety. It is based upon the identically titled second edition of IEC (International Eletrotechnical Commission) Standard 601-1 and supplements the existing CSA Standard C22.2 No. 125, Electromedical Equipment, as one of the National Standards of Canada for medical electrical equipment.
The preparation and publication of this Standard mark an important step forward in the harmonization of Canadian medical electrical equipment standards with those developed and used
internationally. This Standard, in contrast to C22.2 No. 125, is more comprehensive and addresses more aspects of device design and specification than the one it supplements. Through the process of international harmonization, guidance for manufacturers is provided on a global scale which allows fairer competition in a larger market, with consequent economic advantage to the user, manufacturer, and diverse national interests. Care has been taken during the preparation of this Standard to avoid the inclusion of requirements which constitute technical non-tariff barriers to trade.
Some compromises have been made in order to integrate special national needs and this has been achieved within a context of concern for patient safety. Overall, the Standard provides an enhanced level of specification where needed but has also simplified manufacture in many areas. Deviations to the original IEC requirements are presented in the pages preceding the bulk of this Standard and constitute what are considered to be the Canadian Deviations. Most of the deviations reflect the requirements of the Canadian Electrical Code, Part I, while others are based on issues relating to improved patient safety. Items of medical electrical equipment used and offered for sale in Canada must meet the requirements of these deviations, insofar as they apply. 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 Canadian Standard with international practice maintains that concern for the welfare of the patient.
This Standard contains its own rationale for many of the requirements. An appendix has been prepared and is included to provide detailed explanations where they are considered necessary.
This Standard was prepared by the CSA Subcommittee on Medical Electrical Equipment under the jurisdiction of
(a) the CSA Standards Steering Committee on the Canadian Electrical Code, Part II, and was formally approved by its Technical Committee on Environmental Products; and
(b) the CSA Standards Steering Committee on Health Care Technology, and was formally approved by its Technical Committee on Medical Electrical Equipment.
This Standard has been approved as a National Standard of Canada by the Standards Council of Canada.
1.1 Scope
This Standard applies to the safety of MEDICAL ELECTRICAL EQUIPMENT (as defined in Sub-Clause 2.2.15) designed to be installed and used in accordance with the rules of the Canadian Electrical Code, Part I.
Although this Standard is primarily concerned with safety, it contains some requirements regarding reliable operation where this is connected with safety.
SAFETY HAZARDS resulting from the intended physiological function of EQUIPMENT covered by this Standard are not considered.
Appendices in this Standard are not mandatory unless made so by an explicit statement in the main text.
Canadian Deviations are included in this Standard.
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