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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 ISO 15004-1:2006 ophthalmic instruments-
Fundamental requirements and test methods and BS EN ISO
14971:2007 Medical Devices - Application of Risk Management
to Medical Devices.
Classification
CE Regulation 93/42 EEC: Class 1m (Measuring function)
FDA: Class II
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