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AAMI ANSI/AAMI/IEC 80601-2-58:2024

Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal and vitrectomy devices for ophthalmic surgery
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The purpose of this standard is to set appropriate requirements for the safety and performance of lens removal and vitrectomy devices for ophthalmic surgery to reduce the risk of detrimental impact on the medical treatment to an acceptable level for their intended use. The benefit of this standard is to the medical industry, manufacturers, medical regulators, hospitals, clinics, medical users and patients.
SDO AAMI: Assoc. for the Advancement of Medical Instrumentation
Document Number 80601-2-58
Publication Date July 24, 2025
Language en - English
Page Count 41
Revision Level
Supercedes
Committee
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