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

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

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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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. Annex 3

Zusätzliche Information

Autor Association for the Advancement of Medical Instrumentation (AAMI)
Veröffentlicht von AAMI
Document type Normen
Thema Electromedical Equipment
Ersetzt ANSI/AAMI/IEC 80601-2-58:2014 and ANSI/AAMI/IEC 80601-2-58:2014/A1:2016
Schlagwort ANSI/AAMI/IEC 80601-2-58:2024