Ophthalmic implants. Intraocular lenses. Guidance on assessment of the need for clinical investigation of intraocular lens design modifications1 Scope This document provides guidance on the application of all parts of the ISO 11979 series of International Standards for intraocular lenses (IOLs).[1 9] It addresses factors to be considered in the risk management process of modifications to anterior and posterior chamber IOLs in accordance with ISO 14971.[11] It also suggests methods of data analysis and interpretation that can be used to determine the need for a clinical investigation and its

vulnerabilities

This is possible through user-feedback collected via surveys

This British Standard does not apply to products covered by BS EN 10025

Safety requirements and/or measures in BS EN 617 apply to equipment used in all environments

compliant with ISO/IEC 15962

The cables are suitable for continuous use where the maximum stabilized conductor temperature does not exceed 150 °C

Minimum elongation at break

BS EN 3475-511 specifies a procedure for measuring cable-to-cable abrasion resistance

and four-port screw-in cartridge valves generally used in industrial

d) observation for nuclear-test detection

NOTE: BS EN 16815 does not specify CANopen devices

even if re-treaded