CSA C22.2 NO. 80601-2-78:19:2019 Edition
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Medical electrical equipment — Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
| Published By | Publication Date | Number of Pages |
| CSA | 2019-09-01 | 185 |
CSA Preface
This is the first edition of CSA C22.2 No. 80601-2-78, Medical electrical equipment — Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation, which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 80601-2-78 (first edition, 2019-07). It is one in a series of Standards issued by CSA Group under Part II of the Canadian Electrical Code.
For brevity, this Standard will be referred to as CSA C22.2 No. 80601-2-78 throughout.
This Standard is intended to be used in conjunction with CAN/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 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 part of IEC 80601 applies to the general requirements for BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ROBOTS that physically interact with a PATIENT with an IMPAIRMENT to support or perform REHABILITATION, ASSESSMENT, COMPENSATION or ALLEVIATION related to the PATIENT’S MOVEMENT FUNCTIONS, as intended by the MANUFACTURER.
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.
NOTE See also 4.2 of the general standard.
This particular standard does not apply to
• external limb prosthetic devices (use ISO 22523)
• electric wheelchairs (use ISO 7176 (all parts))
• diagnostic imaging equipment (e.g. MRI, use IEC 60601-2-33), and • personal care ROBOTS (use ISO 13482).
201.1.2 Object
Replacement:
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for MEDICAL ROBOTS that physically interact with a PATIENT with an IMPAIRMENT, to support or perform REHABILITATION, ASSESSMENT, COMPENSATION or ALLEVIATION related to the PATIENT’S MOVEMENT FUNCTIONS.
