CSA - CAN/CSA-C22.2 NO. 80601-2-58-10
Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
| Organization: | CSA |
| Publication Date: | 1 January 2010 |
| Status: | inactive |
| Page Count: | 78 |
| ICS Code (Ophthalmic equipment): | 11.040.70 |
scope:
CSA Preface
This is the first edition of CAN/CSA-C22.2 No. 80601-2-58, Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery, which is an adoption without modification of the identically titled IEC (International Electrotechnical Commission) Standard 80601-2-58 (first edition, 2008-10). 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 Standard 60601-1:2005, 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 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.
Interpretations: The Strategic Steering Committee on Requirements for Electrical Safety has provided the following direction for the interpretation of standards under its jurisdiction: "The literal text shall be used in judging compliance of products with the safety requirements of this Standard. When the literal text cannot be applied to the product, such as for new materials or construction, and when a relevant committee interpretation has not already been published, CSA's procedures for interpretation shall be followed to determine the intended safety principle."
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