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AAMI/IEC 80601-2-58:2014
Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgeryMore info
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 finally to the patient.
| Author | ANSI/AAMI/IEC |
|---|---|
| Editor | AAMI |
| Document type | Standard |
| Format | File |
| Confirmation date | 2014-09-10 |
| ICS | 11.040.70 : Ophthalmic equipment |
| Replace | ANSI/AAMI/IEC 80601-2-58 (2008) |
| Cross references | IEC 80601-2-58 (2008-10), IDT |
| Year | 2014 |
| Document history | ANSI/AAMI/IEC 80601-2-58 (2014) |
| Country | USA |
| Keyword | ANSI 80601;ANSI/AAMI/IEC 80601;ANSI/AAMI/IEC 80601-2;80601;ANSI/AAMI/IEC 80601-2-58-2014 |