CAN/CSA-C22.2 NO. 60601-2-27:11 (R2021):2011 Edition
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Medical electrical equipment – Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
| Published By | Publication Date | Number of Pages |
| CSA | 2011 | 180 |
CSA Preface
This is the third edition of CAN/CSA-C22.2 No. 60601-2-27, Medical electrical equipment – Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment, which is an adoption without modification of the identically titled IEC (International Electrotechnical Commission) Standard 60601-2-27 (third edition, 2011-03). It supersedes the previous edition, published in 2006 as CAN/CSA-C22.2 No. 60601-2-27 (adopted IEC 60601-2-27:2005). 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 is considered suitable for use for conformity assessment within the stated scope of the Standard.
Scope
Replacement:
This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROCARDIOGRAPHIC (ECG) MONITORING EQUIPMENT as defined in 201.3.63 and hereinafter also referred to as ME EQUIPMENT.
This particular standard applies to ME EQUIPMENT used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. This particular standard also applies to ECG telemetry systems used in a hospital environment.
ME EQUIPMENT intended for use under extreme or uncontrolled environmental conditions outside the hospital environment, such as in ambulances and air transport, shall comply with this particular standard. Additional standards may apply to ME EQUIPMENT for those environments of use.
This standard is not applicable to electrocardiographic monitors for home use. However, MANUFACTURERS should consider using relevant clauses of this standard as appropriate for their INTENDED USE.
Ambulatory (Holter) monitors, fetal heart rate monitoring, pulse plethysmographic devices, and other ECG recording equipment are outside the scope of this particular standard.
