STN EN IEC 80601-2-58
| Name: | STN EN IEC 80601-2-58 |
| Validity: | Valid |
| Number of pages: | 48 |
| Language: |
EN
|
| Paper: | 18,90€ |
| Electronic version |
a) Only read (without ability to print and copy)
17,01€ b) Without ability to print, with ability to copy (printscreen) 18,90€ c) With ability to print and copy (printscreen) 24,57€ |
| Slovak title | Zdravotnícke elektrické prístroje. Časť 2-58: Osobitné požiadavky na základnú bezpečnosť a nevyhnutné prevádzkové vlastnosti prístrojov na odstraňovanie šošovky a prístrojov na vitrektómiu v očnej chirurgii |
| 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 |
| Release Date: | 01. 12. 2024 |
| Date of withdrawal: | |
| ICS: | 11.040.70 |
| Sorting character/National clasification code | 36 4800 |
| Level of incorporation: | idt EN IEC 80601-2-58:2024, idt IEC 80601-2-58:2024 |
| Official Journal | 11/24 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN 80601-2-58:2015-12 (36 4800) |
| Note in Official Journal: | |
| Subject of the standard: | IEC 80601-2-58:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery (as defined in 201.3.209 and 201.3.217) and associated ACCESSORIES that can be connected to this MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 7.2.13 of IEC 60601-1:2005 and IEC 60601 1:2005/AMD2:2020 and 8.4.1 of IEC 60601-1:2005. |
| Preview: | Náhľad normy (PDF) |