BS EN ISO 11979-4:2008 (A1:2012) download.Ophthalmic implants Intraocular lenses
Part 4 : Labelling and information ( ISO 11979-4 : 2008 ).
I Scope
This pert of ISO 11971 specifies the labethng requw.m.nts for intraocular lenses (lOis) and the information to be provided within or on the packaging
NOTE The pal ci ISO 11979 atten,ts to henionize the recognized labelling requWemeiits far lOis throughout the ld Nver, there might be eddeonel nalloi tequwenwnes.
2 NormatIve references
The following referenced documents are indispenSable for the application of BS EN ISO 11979-4 For dated references, only the edition cited applies For undated references, the latest edition of the referenced document (mcludmg any amendments) applies
ISO 11979-1 Opmheknic wvlsnfs — Intraocular lenses — Pail I: Vocabutary IA) Ye elated (4
ISO 15223-I. Medical des — Symbols to ba used with medical dece labels. lab.lang and lnfrxmatrcn to be supplied — Pai’t I General reQuwements
EN 980, Symbols for use in the Iebeiltwg of medical devices
EN 1041, Infoirrnetlon supplied by the manufacturer wilh medical devices
3 Terms and definitIons
For the purposes of BS EN ISO 11979-4, the ferms and definitions given in 19011979-1 apply
4 Information provision
The general requirements for information provision provided with medical devices by manufacturers included mEN 1041 shall betakeniritoacceunt
5 Labelling
Table I lists mWiunal information that shall b. included with the labelling of lOis and whereabouts on the packaging it shall be given Table 2 lIsts Infomiation that shall be given in applicable cases
6 Package insert
The padiage rsert, In the fomi of a leaflet or simdar, shall be included ii the storage contaIner In such a way that can be consulted edhout damage to the sterile packaging It shall contari at least th following .tformabon
a) name or trade name and address of the manufaCturer
b) detailed descrlton of the lens Including maleflaIts) used,
c) method of sfenkzabon.
d) conditions of storage and transport (if appropr*te),
e) instructIons for the removal of the 101 from th. pflmary container.
f) instructions for use.
NOTE Eaicpei Direilwe 93l42EEC — nended by Dwecive 2OO7M7iC requss. de of isue the Iit.st mwiicn of the inStructionS for us. for nwcal devices sold in Eiop.
g) Ithcalton(s) of the drcum.tanoes under ed the 101 can be used,
h) contra-lidication(s) of the circumstances under whdi the 101 should not be used,
i) comphcation(s) that may occur;
j) warning not to implant tt’ie lOt. if the contaw wtiich rnatntains sterilify has been opened or damaged.
k) warning not to reuse the 101,
l) warning not to r-stenlize the IOL
m) for multifocal and phakic intraocular lenses, a summary of the results of the cleical investigation. if any;
n) for phaluc intraocular lenses, reocnviwndations for penod.c evahiabons after implantation based on risk analysis and?ot any cleucal Investigabon performed, and a restnction WI the indications for use W necessitated by the anatomical clearance analysis and clinical evaluation,
o) other apptopnate wwnlng(s).
7 Self-adhesive label
If suppled, a seW-adhesive label shall contain at least the Ioaowing information
a) name or ade name of the manufacturer,
b) trade name sndlor model designation of the product;
c) batch cod. or senal number (symbols may be used)
d) diopinc power
e) add power (for multifocal lOLa).
f) overal diameter (may be indicated by the symbol 0 or In a drawmg)
g) diameter of the body (mirwmum and maximum dimensions, ii non-arcular) his can be Indicated ii a drawing
8 Use of symbols
Symbols can be used metead of text where appcopnale When symbols are used, ISO 15223-1 or EN 980.
depending on region. apply
9 Additional information
Where UV bloclung Is staled, it shall be accompanied by the 10% cut-off wavelength m nanometres.