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AAMI/IEC 80601-2-58:2014

Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal and vitrectomy devices for ophthalmic surgery

standard by Association for the Advancement of Medical Instrumentation/International Electrotechnical Commission , 09/10/2014

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About This Item

 

Full Description

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.
 

Product Details

Published:
09/10/2014
ISBN(s):
1570205620
ANSI:
ANSI Approved
Number of Pages:
34
File Size:
1 file , 330 KB
Same As:
IEC 80601-2-58 Ed. 2.0 b:2014
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. AAMI/IEC 80601-2-58:2014

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    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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  2. AAMI/IEC 80601-2-58:2008


    Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal and vitrectomy devices for ophthalmic surgery

    • Historical Version
 

Amendments, rulings, supplements, and errata

  1. AAMI/IEC 80601-2-58:2014/A1:2016


    Amendment 1 to 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