NF EN 80601-2-58/A1:2019
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The latest, up-to-date edition.
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
Hardcopy
English, French
01-08-2019
This amendment includes the following major technical changes compared to the approved standard NF EN 80601-2-58, of September 2015: a. integration of the updated definition of ESSENTIAL PERFORMANCE and updating of the analysis of ESSENTIAL PERFORMANCE; b. updating references to the general standard and collateral standards to align them with amendments to the general standard and other collateral standards; c. addition of symbols to the standard; d. updating OF CEM requirements.
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