ISO 18369-2 specifies the tolerance limits for the major optical and physical parameters of hard cornea, hard scleral and soft contact lenses at the time of manufacture. These tolerances may not apply for other purposes such as shelf life studies.
There are three meaningful methods for determining the conformity of contact lens parameters to specified tolerances:
Eligibility may be based on supplied lens lots or supplier data for third party audits.
When examined as specified in ISO 18369-3, the contact lens must not show any inclusions or surface defects that could interfere with its intended functional use.
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