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6
3. Safety
Use this instrument only in strict accordance with the
instructions contained in this manual.
3.1 Standards applied
The Keeler Applanation Tonometer is designated as Class I
non-invasive measuring device under EC Directive 93/42 EEC for
medical equipment products.
The CE mark on this product indicates it has been tested to
and conforms to the provisions noted within the 93/42 EEC
Medical Device Directive.
It also complies with the Ophthalmic Instruments Standard, ISO
8612. Tonometer and ISO 15004-1 fundamental requirements
and methods.
Classification
CE Directive 93/42 EEC: Class IIa
FDA: Class II
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