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DIN EN 80601-2-58 VDE 0750-2-58:2015-11

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

(IEC 80601-2-58:2014); German version EN 80601-2-58:2015
Class/Status: Standard, withdrawn
Released: 2015-11
VDE Art. No.: 0700913

This International Standard defines particular requirements for basic safety and esssential performance of lens removal devices and vitrectomy devices, comprising an equipment console, surgical handpieces, and accessories connected to this medical electrical equipment.
In many parts of the world lens removal devices and vitrectomy devices are used in combination by ophthalmic surgeons to perform combined anterior-segment (lens removal) and posterior-segment (vitreoretinal) surgical procedures to maximize surgical outcomes. For this reason both lens removal devices and vitrectomy devices are covered in this international standard.

Standard:

DIN EN 80601-2-58 VDE 0750-2-58:2020-06

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

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