CAN/CSA-C22.2 NO. 60601-2-57:11 (R2021):2011 Edition

Preface

This is the first edition of CAN/CSA-C22.2 No. 60601-2-57, Medical electrical equipment – Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use, which is an adoption without modification of the identically titled IEC (International Electrotechnical Commission) Standard 60601-2-57 (first edition, 2011-01). 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 International Standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of equipment incorporating one or more sources of OPTICAL RADIATION in the wavelength range 200 nm to 3 000 nm, with the exception of laser radiation, and intended to create non-visual photobiological effects in humans or animals for therapeutic, diagnostic, monitoring, cosmetic/aesthetic or veterinary applications; hereafter referred to as light source equipment (LS EQUIPMENT).

This particular standard does not apply to equipment for sun tanning, for ophthalmic instruments or for infant phototherapy.

NOTE Safety requirements in this particular standard are intended to address only HAZARDS to the eye and skin; hazards to internal tissues are not included in its scope.

LS EQUIPMENT may consist of a single or multiple sources of OPTICAL RADIATION, with or without power supply, or may be incorporated into a complex system that includes optical, electrical or mechanical systems or sources of other radiation.

NOTE Annexes AA to EE have been included for purposes of general guidance and to illustrate many typical cases. However, the annexes should not be regarded as definitive or exhaustive.None