ICS 11.040.70                          MHD 05

(Superseding IS 14323 : 1996)

Reaffirmed 2017

NATIONAL FOREWORD

This Indian Standard (Part 3) which is identical with ISO 11979-3 : 2006 ‘Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods’ issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on the recommendation of the Ophthalmic Instruments and Appliances Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.

This standard is published in ten parts. The other parts of this series are:

Part 1 Vocabulary

Part 2 Optical properties and test methods

Part 4 Labelling and information

Part 5 Biocompatibility

Part 6 Shelf-life and transport stability

Part 7 Clinical investigations

Part 8 Fundamental requirements

Part 9 Multifocal intraocular lenses

Part 10 Phakic intraocular lenses

The IS/ISO 11979 series will supersede IS 14323 : 1996 ‘Intraocular lenses - Specification’ and after the publication of this series of standards, IS 14323 shall be treated as withdrawn.

This standard contains methods for which requirements are given and methods for which no requirements are formulated. The former are considered essential for the safety or performance of the intraocular lens, while the latter provide essential information to the ophthalmic surgeon or are used for other purposes.

A special purpose is the use of mechanical data to assess the need for clinical investigation of modifications of existing models as described in IS/ISO 11979-7 : 2006 ‘Opthalmic implants - Intraocular lenses : Part 7 Clinical investigations’. Due to the wide variety of intraocular lens designs already on the market, it has not been possible to devise test methods that are applicable to every design under all circumstances, it can be anticipated that new materials currently under development will result in drastically new designs that will require modified or other test methods. As with all standards, it is then up to the parties using the standard to modify or develop corresponding methods, and give rationale and validation for them in a spirit, that is, consistent with this standard.

In cases where different tolerances have been given depending on material design, they reflect an existing situation with well-established products.

The text of ISO Standard has been approved as suitable for publication as an Indian Standard without deviations. Certain conventions are, however, not identical to those used in Indian Standards. Attention is particularly drawn to the following:

a) Wherever the words ‘International Standard’ appear referring to this standard, they should be read as ‘Indian Standard’.

b) Comma (,) has been used as a decimal marker while in Indian Standards, the current practice is to use a point (.) as the decimal marker.