CSA C22.2 NO. 60601-2-39:09 (R2019):2009 Edition
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Medical electrical equipment – Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
| Published By | Publication Date | Number of Pages |
| CSA | 2009 | 57 |
CSA Preface
This is the second edition of CAN/CSA-C22.2 No. 60601-2-39, Medical electrical equipment – Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment, which is an adoption without modification of the identically titled IEC (International Electrotechnical Commission) Standard 60601-2-39 (second edition, 2007-11). It supersedes the previous edition, published in 2002 as CAN/CSA-C22.2 No. 60601-2-39, Medical electrical equipment – Part 2-39: Particular requirements for the safety of peritoneal dialysis equipment (adopted CEI/IEC 60601-2-39:2003). 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).
This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Consumer and Commercial Products, under the jurisdiction of the Strategic Steering Committee on Requirements for Electrical Safety, and has been formally approved by the Technical Committee. Due to the medical content of this Standard, it was also approved by the CSA Technical Committee on Applications of Electricity in Health Care under the jurisdiction of the Strategic Steering Committee on Health Care Technology. This Standard has been approved as a National Standard of Canada by the Standards Council of Canada.
201.1 Scope, object and related standards
Clause 1 of the general standard applies, except as follows:
201.1.1 Scope
Replacement:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PERITONEAL DIALYSIS ME EQUIPMENT as defined in 201.3.208, hereafter referred to as PD EQUIPMENT. It applies to PD EQUIPMENT intended for use either by medical staff or under the supervision of medical experts, including PD EQUIPMENT operated by the PATIENT, regardless of whether the PD EQUIPMENT is used in a hospital or domestic environment.
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 See also 4.2 of the general standard.
This standard can also be applied to PD EQUIPMENT used for compensation or alleviation of disease, injury or disability.
These particular requirements do not apply to the DIALYSING SOLUTION, or the DIALYSING SOLUTION CIRCUIT.
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for PD EQUIPMENT as defined in 201.3.208.
201.1.3 Collateral standards
Addition:
This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 2 of this particular standard.
The requirements of IEC 60601-1-3 and IEC 60601-1-8 do not apply to this standard.
