IS/ISO 11979 : Part 7 : 2024 Ophthalmic Implants - Intraocular Lenses - Part 7 Clinical Investigations of Intraocular Lenses for the Correction of Aphakia

ICS 11.040.70

MHD 05

(Superseding IS/ISO 11979-9 : 2006)

NATIONAL FOREWORD

This Indian Standard (Part 7) (Second Revision) which is identical to ISO 11979-7 : 2024, 'Ophthalmic implants - Intraocular lenses: Part 7 Clinical investigations of intraocular lenses for the correction of aphakia' issued by the International Organization for Standardization was adopted by 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 was first published in 2011 as IS/ISO 11979-7 : 2006 'Ophthalmic Implants - Intraocular lenses: Part 7 Clinical Investigations'. The first revision of this standard was published in 2021 as IS/ISO 11979-7 : 2018 Ophthalmic Implants - Intraocular lenses: Part 7 Clinical investigations'. The second revision has been undertaken to align it with latest edition of ISO 11979-7.

This Indian standard supersedes IS/ISO 11979-9 : 2006 as ISO 11979-9 : 2006 + Amd 1 : 2014 has been replaced by ISO 11979-7 : 2018, ISO 11979-7 : 2018 is replaced by latest edition of ISO 11979-7 : 2024. After publication of this standard IS/ISO 11979 (Part 9) : 2006 and IS/ISO 11979 (Part 7) : 2018 stands withdrawn.

This Indian Standard is published in seven parts. The other parts in this series are:

Part 1 Vocabulary

Part 2 Optical properties and test methods

Part 3 Mechanical properties and test methods

Part 4 Labelling and information

Part 5 Biocompatibility

Part 6 Shelf life and transport stability testing

Part 8 Fundamental requirements

Part 10 Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes

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'; and

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.