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ČESKÁ TECHNICKÁ NORMA |
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ICS 11.040.70 |
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Srpen 1998 |
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Oční optika - Kontaktní čočky - |
ČSN 19 5210 |
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Ophthalmic optics - Contact lenses - Determination of the shelf-life
Optique ophtalmique - Lentilles de contact - Determination de la durée de conservation
Augenoptik - Kontaktlinsen - Bestimmung der Lagerdauer
Tato norma přejímá anglickou verzi evropské normy EN ISO 11987:1997. Evropská norma EN ISO 11987:1997 má status české technické normy.
This standard implements the English version of the European Standard EN ISO 11987:1997. The European Standard EN ISO 11987:1997 has the status of a Czech Standard.
© Český normalizační institut, 1998
Podle zákona č. 22/1997 Sb. smějí být české technické normy rozmnožovány a rozšiřovány jen se souhlasem Českého normalizačního institutu.
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53043 |
Národní předmluva
Citované normy
ISO 8321-1:1991 zavedena v ČSN EN ISO 8321-1 Optika a optické přístroje - Kontaktní čočky - Část 1: Požadavky na tvrdé korneální a sklerální kontaktní (19 5202)
ISO 8599:1994 zavedena v ČSN EN ISO 8599 Optika a optické přístroje - Kontaktní čočky - Stanovení stupně spektrální a světelné propustnosti (19 5206)
ISO 9337-1 dosud nezavedena
ISO 9338:1996 dosud nezavedena
ISO 9341:1996 zavedena v ČSN ISO 9341 Optika a optické přístroje - Kontaktní čočky - Stanovení vměstků a povrchových vad tvrdých kontaktních čoček (19 5204)
ISO 10338:1996 zavedena v ČSN EN ISO 10338 Optika a optické přístroje - Kontaktní čočky - Stanovení křivosti (19 5209)
Vypracování normy
Zpracovatel: VELNOR spol. s.r.o., Brno, IČO 44016174, Ing. Eva Velešíková
Pracovník Českého normalizačního institutu: Luboš Ptáček
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EUROPEAN STANDARD |
EN ISO 11987 |
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NORME EUROPÉENNE |
December 1997 |
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EUROPÄISCHE NORM |
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ICS 11.040.70
Descriptors: see ISO document
English version
Optics and optical instruments - Contact lenses - Determination of shelf-life (ISO 11987:1997)
Optique et instruments d'optique - Lentilles de contact - Détermination de la durée de conservation (ISO 11987:1997)
Augenoptik - Kontaktlinsen - Bestimmung der Lagerdauer (ISO 11987:1997)
This European Standard was approved by CEN on 30 October 1997.
CEN members are bound to comply with the CEN/CENELEC Internal Regulation which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Central Secretariat: rue de Stassart, 36 B-1050 Brussels
Ó 1997 CEN All rights exploitation in any form and by any means reserved worldwide for CEN national Members.
Ref. No. EN ISO 11987:1997 E
Foreword
The text of the International Standard ISO 11987 has been prepared by Technical Committee ISO/TC 172 „Optics and optical instruments" in collaboration with Technical Committee CEN/TC 170 „Ophthalmic optics", the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by June 1998, and conflicting national standards shall withdrawn at the latest by June 1998.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of the International Standard ISO 11987:1997 was approved by CEN as a European Standard without any modification.
NOTE: Normative references to International Standards are listed in annex ZA (normative). A-deviations are given in Annex ZB (informative).
Annex ZA (normative)
Normative references to international publications with their relevant European publications
This European Standard incorporates by dated reference, provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revision of any of these publications apply to this European Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies.
Publications Year Title EN Year
ISO 8321-1 1991 Optics and optical instruments - Contact EN ISO 8321-1 1996
lenses - Part 1: Specification for rigid
corneal and scleral contact lenses
ISO 8599 1994 Optics and optical instruments - EN ISO 8599 1996
Contact lenses - Determination of the
spectral and luminous transmittance
ISO 10338 1996 Optics and optical instruments - Contact EN ISO 10338 1997
lenses - Determination of curvature
ANNEX ZB (informative)
A-deviations
A-deviation: National deviation due to regulations, the alteration of which is for the time being outside the competence of the CEN/CENELEC member.
This European Standard does not fall under any Directive of the EC. In the relevant CEN/CENELEC countries these A-deviations are valid instead of the provisions of the European Standard until they have been removed.
The legislative situation in Germany requires the unit „dioptre" be designated by the symbol „dpt" instead of „D".
This is to avoid conflict with the rules of ISO 1000 being the basic International Standard on symbols and units and with the respective basic resolution of the CGPM (International Conference on Weights and Mesures).
Identification of the regulation:
Gesetz über die Einheiten im Mebwesen vom 02. 07. 1969 in der Fassung der Bakanntmachung vom 22. 04. 1985; and
Ausführungsverordnung zum Gesetz über Einheiten im Mebwesen (Einheitenverordnung - EinhV) vom 13. 12. 1985, § 1 und Anlage 1, Nr. 9
Ophthalmic optics - Contact lenses - Determination of shelf - life
1 Scope
This international Standard describes the testing required in order to determine the stability of contact lenses, once placed in their final packaging, during storage and distribution.
NOTE The results obtained can be used for determining the 'expiry date '.
-- Vynechaný text --
Zdroj: www.cni.cz