Back

EVS-EN ISO 11980:2009

Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations

General information

Withdrawn from 05.02.2013
Base Documents
ISO 11980:2009; EN ISO 11980:2009
ICS Groups
11.040.70 Ophthalmic equipment
Directives or regulations
None

Standard history

Status
Date
Type
Name
05.02.2013
Main
EVS-EN ISO 11980:2013
Main
EVS-EN ISO 11980:2009
Main
EVS-EN ISO 11980:1999
This International Standard gives guidelines for the clinical investigation (CI) of the safety and performance of contact lenses and contact lens care products.

Required fields are indicated with *

*
*
*
PDF
24.40 € incl tax
Paper
24.40 € incl tax
Browse standard from 2.44 € incl tax
Standard monitoring
English (PDF 285 KB)

Related products

Main

EVS-EN ISO 11980:2013

Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2012)
Newest version Valid from 05.02.2013
Main

EVS-EN ISO 15004-1:2020

Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2020)
Newest version Valid from 15.12.2020
Main

EVS-EN ISO 15004-2:2007

Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection
Newest version Valid from 05.04.2007
Main

EVS-EN ISO 14534:2015

Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
Newest version Valid from 04.03.2015

Customers who bought this item also bought

Main

EVS-EN 14931:2006

Pressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbaric therapy - Performance, safety requirements and testing
Newest version Valid from 08.08.2006

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