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ISO/TR 22979:2006

Ophthalmic implants -- Intraocular lenses -- Guidance on assessment of the need for clinical investigation of intraocular lens design modifications

General information

Withdrawn from 27.04.2017
ICS Groups
11.040.70 Ophthalmic equipment
Directives or regulations
None

Standard history

Status
Date
Type
Name
27.04.2017
Main
ISO/TR 22979:2017
Main
ISO/TR 22979:2006
ISO/TR 22979:2006 provides guidance on the application of Parts 3, 7 and 9 of the ISO 11979 series of International Standards for intraocular lenses (IOLs). It addresses factors to be considered in a risk analysis of the significance of modifications to anterior and posterior chamber, monofocal and multifocal, intraocular lenses. It also suggests methods of data analysis and interpretation that can be used to determine the need for and the design of a clinical investigation.

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PDF
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Paper
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Standard monitoring
English (PDF 158 KB)

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English