CSA Preface
This is the first edition of CAN/CSA-C22.2 No. 80601-2-71, Medical electrical equipment — Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment, which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 80601-2-71 (first edition, 2015-06). It is one in a series of Standards issued by CSA Group under Part II of the Canadian Electrical Code. At the time of publication, IEC 80601-2-71:2015 is available from IEC in English only. CSA Group will publish the French version when it becomes available from IEC.
For brevity, this Standard will be referred to as “CAN/CSA-C22.2 No. 80601-2-71” throughout.
This Standard is intended to be used in conjunction with AN/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, including Amendment 1:2012, with Canadian deviations).
This Standard is considered suitable for use for conformity assessment within the stated scope of the Standard.
This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Consumer and Commercial Products, under the jurisdiction of the CSA 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 Application of Electricity in Health Care, under the jurisdiction of the CSA Strategic Steering Committee on Health Care Technology & Systems.
This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group.
Scope and object
Clause 1 of the general standard1 applies, except as follows:
201.1.1 Scope
Replacement:
This International standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of FUNCTIONAL NIRS EQUIPMENT intended to be used by themselves, or as a part of an ME SYSTEM, for the production of FUNCTIONAL NIRS EQUIPMENT output for adjunctive diagnostic purposes, hereinafter referred to as ME EQUIPMENT.
Not included within the scope of this particular standard are:
a) the part of ME EQUIPMENT, if provided, that measures oxygen saturation of the haemoglobin in the micro vessels (capillaries, arterioles and venules);
b) near-infrared spectroscopy (NIRS) tissue oximeter equipment, which is not intended for obtaining FUNCTIONAL NIRS EQUIPMENT output;
c) pulse oximeter equipment, which is not intended for obtaining FUNCTIONAL NIRS EQUIPMENT output. The requirements for pulse oximeter equipment are found in ISO 80601-2-61.
d) frequency-domain and time-domain equipment for functional near-infrared spectroscopy, which may require different test procedures than defined herein.
e) FUNCTIONAL NEAR-INFRARED SPECTROSCOPY EQUIPMENT which measure changes in the concentration of chromophores other than oxy- and deoxy-haemoglobin, which may require different test procedures than defined herein.
201.1.2 OBJECT
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for FUNCTIONAL NIRS EQUIPMENT as defined in 201.3.205.
