Source: https://infostore.saiglobal.com/en-us/standards/iso-11979-9-2006-595337_saig_iso_iso_1363772/
Timestamp: 2020-07-11 12:11:42
Document Index: 223154849

Matched Legal Cases: ['ART 9', 'art 9', 'ART 8', 'ART 1', 'ART 2', 'ART 3', 'ART 7']

ISO 11979-9 : 2006 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES | SAI Global
ISO 11979-9 : 2006
4.2 Tolerances and dimensions
5 Optical requirements
5.2 Dioptric power
5.3 Imaging quality
5.4 Additional optical characterization
6 Clinical investigation
6.2 Additional requirements for the clinical
Annex A (normative) Optical characterization
Annex B (informative) Clinical investigation
Annex C (informative) Determination of sample sizes
for the clinical investigation
Applies to any intraocular lens whose optic provides two or more powers and whose primary indication is the correction of aphakia with the added benefit of useful vision at more than one distance (e.g. far and near).
ISO/DIS 11979-9 : 60.00 (2006)
ISO 11979-7 : 2014
DIN EN ISO 11979-9 : 2014 Identical
DS EN ISO 11979-9 : 2006 AMD 1 2014 Identical
NF EN ISO 11979-9 : 2006 AMD 1 2014 Identical
UNE EN ISO 11979-9 : 2007 Identical
NBN EN ISO 11979-9 : 2006 AMD 1 2014 Identical
NEN EN ISO 11979-9 : 2006 AMD 1 2014 Identical
NS EN ISO 11979-9 : 2006 AMD 1 2014 Identical
I.S. EN ISO 11979-9:2006 Identical
PN EN ISO 11979-9 : 2010 AMD 1 2014 Identical
SN EN ISO 11979-9 : 2006 AMD 1 2014 Identical
UNI EN ISO 11979-9 : 2014 Identical
I.S. EN ISO 11979-9:2006&A1:2014 Identical
IS/ISO 11979 : Part 9 : 2006(R2017) Identical
BS EN ISO 11979-9 : 2006 Identical
EN ISO 11979-9 : 2006 + A1 2014 Identical
DIN EN ISO 11979-9 E : 2014 Identical
UNE EN ISO 11979-8 : 2017 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 8: FUNDAMENTAL REQUIREMENTS (ISO 11979-8:2017)
ISO 11979-1 : 2006 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 1: VOCABULARY
ISO 11979-2 : 2014 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 2: OPTICAL PROPERTIES AND TEST METHODS
ISO 11979-3 : 2012(R2018) OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 3: MECHANICAL PROPERTIES AND TEST METHODS
ISO 11979-7 : 2014 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS OF INTRAOCULAR LENSES FOR THE CORRECTION OF APHAKIA