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It shall not be missing in any public building: an operative and ready for use hand fire extinguisher. Requirements, test methods and maintenance are regulated on an E...



БДС EN 80601-2-58:2015/A1:2019

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БДС EN 80601-2-58:2015/A1:2019
Status: Published
Lang: English
Pages: 17
Published: 2019-12-16
Related international standards
IDT
EN 80601-2-58:2015/A1:2019
CLC/TC 62
Price: 35.00 BGN

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The standard is available on PDF file.The standard is available on PDF file.

Bulgarian title

Електромедицински апарати. Част 2-58: Специфични изисквания за основна безопасност и съществени характеристики на устройства за смяна на лещи и устройства за витректомия в офталмологичната хирургия (IEC 80601-2-58:2014/A1:2016)

English title

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

Scope in Bulgarian

No information added

Scope in English

IEC 80601-2-58:2014 applies to the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery and associated accessories that can be connected to this medical electrical equipment, hereafter referred to as ME equipment. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. This second edition includes changes in order to take into account the comments submitted during the approval of the first edition as a European Medical Device Directive, as well as the comments from other National Committees during the finalization of the first edition of this standard.

Technical committee

ICS

Directive

No relation with a directive

Correnspondence with national standards

No relation with a national standard

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