8.2. Conformity to international standards
1. Directives and standards
The VX22 is compliant with the following directive and standards:
▪ Directive 93/42/CE, amended by Directive 2007/47/CE: the VX22 is classified as Class I
Date of first marking: 01/2019
Product life time: 5 ans
▪ IEC60601-1 (ed.3.1.): Medical electrical equipment- Part 1: General requirements for
basic safety and essential electrical safety performance.
▪ IEC60601-1-2 (ed.4.): Medical electrical equipment- Partie 1-2: General requirements
for safety – Collateral standard: Electromagnetic compatibility-
▪ ISO 8596:2017: Ophthalmic optics – Visual acuity testing- standard optotype and his
presentation
▪ ISO 10938:2016 Ophthalmic optics – Chart displays for visual acuity measurement –
printed, projected and electronic
The VX22 letter test conforms to the publication "Recommended Standard Procedures for
the Clinical Measurement and Specification of Visual Acuity, Report of Working Group 39”
(Adv. Ophthal., vol. 41, pp. 103-148, Karger, Basel 1980).
2. Electromagnetic emissions
The VX22 is intended for use in the electromagnetic environement specified below. The customers or
the user of the VX22 should assure that it is used
The VX22 user RF energy only for its internal function.
Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic
equipment.
The VX22 is suitable for use in all establishments,
including domestic establishments and those
directly connected to the public low-voltage power
supply network that supplies buildings used for
purpose.
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