1、January 2013Translation by DIN-Sprachendienst.English price group 12No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS
2、 01.040.11; 11.040.70!$im“1937074www.din.deDDIN EN ISO 11979-1Ophthalmic implants Intraocular lenses Part 1: Vocabulary (ISO 11979-1:2012);English version EN ISO 11979-1:2012,English translation of DIN EN ISO 11979-1:2013-01Ophthalmische Implantate Intraokularlinsen Teil 1: Vokabular (ISO 11979-1:20
3、12);Englische Fassung EN ISO 11979-1:2012,Englische bersetzung von DIN EN ISO 11979-1:2013-01Implants ophtalmiques Lentilles intraoculaires Partie 1: Vocabulaire (ISO 11979-1:2012);Version anglaise EN ISO 11979-1:2012,Traduction anglaise de DIN EN ISO 11979-1:2013-01SupersedesDIN EN ISO 11979-1:2006
4、-10www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 22 pages01.13 DIN EN ISO 11979-1:2013-01 2 A comma is used as the decimal marker. National foreword This document (ISO 11979-1:2012) has been prepared by Technical Committee ISO/TC 172
5、“Optics and photonics”, Subcommittee SC 7 “Ophthalmic optics and instruments” in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics” (both secretariats are held by DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Feinmechanik und Optik
6、(Optics and Precision Mechanics Standards Committee), Working Committee NA 027-01-20 AA Intraokulare Medizinprodukte. DIN EN ISO 11979 consists of the following parts, under the general title Ophthalmic implants Intraocular lenses: Part 1: Vocabulary Part 2: Optical properties and test methods Part
7、3: Mechanical properties and test methods Part 4: Labelling and information Part 5: Biocompatibility Part 6: Shelf-life and transport stability Part 7: Clinical investigations Part 8: Fundamental requirements Part 9: Multifocal intraocular lenses Part 10: Phakic intraocular lenses In Germany, use of
8、 the symbol “dpt” for dioptre (expressed in m1) is legally required and this symbol is to be used rather than the symbol D used in other countries. Amendments This standard differs from DIN EN ISO 11979-1:2006-10 as follows: a) Clause 2 “Terms and definitions” has been revised to include accommodati
9、ng (2.2), multifocal (2.36), aspheric (2.7) and toric (2.72) intraocular lenses; b) in German, the term Brechkraft has been changed to Brechwert (dioptric power); c) in German, the term Typ der optischen Form has been changed to Optik-Formfaktor (optic shape factor); d) in German, the term Anstellhh
10、e has been changed to Wlbungshhe (vault height); e) in German, the term Nebenwirkung has been changed to unerwnschtes Ereignis (adverse event) (in accordance with Directive 93/42/EEC); f) the standard is no longer divided into subclauses depending on subject related criteria; all terms are now liste
11、d in alphabetical order on the basis of the English version of the ISO reference document. As a guidance to find the corresponding terms in the German language, National Annex NB contains a bilingual glossary in alphabetical order both in German and English; g) the text of ISO 11979-1:2012 has been
12、adopted in its entirety. Previous editions DIN EN ISO 11979-1: 2000-07, 2006-10 DIN EN ISO 11979-1:2013-01 3 National Annex NA (informative) Bibliography DIN EN ISO 11979-2, Ophthalmic implants Intraocular lenses Part 2: Optical properties and test methods DIN EN ISO 11979-3, Ophthalmic implants Int
13、raocular lenses Part 3: Mechanical properties and test methods DIN EN ISO 11979-4, Ophthalmic implants Intraocular lenses Part 4: Labelling and information DIN EN ISO 11979-5, Ophthalmic implants Intraocular lenses Part 5: Biocompatibility DIN EN ISO 11979-6, Ophthalmic implants Intraocular lenses P
14、art 6: Shelf-life and transport stability DIN EN ISO 11979-7, Ophthalmic implants Intraocular lenses Part 7: Clinical investigations DIN EN ISO 11979-8, Ophthalmic implants Intraocular lenses Part 8: Fundamental requirements DIN EN ISO 11979-9, Ophthalmic implants Intraocular lenses Part 9: Multifoc
15、al intraocular lenses DIN EN ISO 11979-10, Ophthalmic implants Intraocular lenses Part 10: Phakic intraocular lenses DIN EN ISO 11979-1:2013-01 4 National Annex NB (informative) Glossary Terms, sorted alphabetically in German Term, German Term, English No. A Achsenmarkierung axis mark 2.8 Addition a
16、ddition power 2.5 Akkommodationsbreite accommodative amplitude 2.3 akkommodierende Intraokularlinse accommodating intraocular lens 2.2 anhaltendes unerwnschtes Ereignis persistent adverse event 2.55 Anzeige des Meridians mit dem niedrigsten Brechwert indicator of meridian with lowest dioptric power
17、2.25 asphrische Intraokularlinse aspheric intraocular lens 2.7 astigmatisch neutralisierende Linse null lens 2.43 Augenimplantationsprfung ocular implantation test 2.44 B beschleunigte Haltbarkeitsuntersuchung accelerated shelf-life study 2.1 bestmgliche Prfperson best-case subject 2.9 Brechwert des
18、 Auges optical power of the eye 2.47 Brechwert fr den Fernvisus distance power 2.19 Brechwert fr den Nahvisus near power 2.40 Brechwert dioptric power 2.18 C Chargenbericht device history record 2.16 Cut-off-Wellenlnge cut-off wavelength 2.14 D Dezentrierung der Optik optic decentration 2.48 Dioptri
19、enstrke (zu vermeiden) dioptric power 2.18 E einteilige Intraokularlinse one-piece intraocular lens 2.45 F Fernpunkt far point 2.22 Fertigprodukt-Charge finished intraocular lens lot 2.23 fr die klinische Prfung bestimmtes Medizin-produkt device intended for clinical investigation 2.17 G Gesamtdurch
20、messer overall diameter 2.51 DIN EN ISO 11979-1:2013-01 5 Term, German Term, English No. H Haltbarkeit shelf-life 2.63 Haptik haptic 2.24 Hersteller manufacturer 2.31 Hinterkammer-Intraokularlinse posterior chamber intraocular lens 2.58 Hinterkammerlinse posterior chamber lens 2.58 I Implantationspr
21、fung auerhalb des Auges non-ocular implantation test 2.42 in situ in situ 2.26 Integritt der Verpackung package integrity 2.52 Intraokularlinse intraocular lens 2.27 Intraokularlinsenmodell intraocular lens model 2.28 K Kippung der Optik optic tilt 2.50 Konfiguration fr den Brechwert fr den Fernvisu
22、s distance power configuration 2.20 Konfiguration fr den Brechwert fr den Nahvisus near power configuration 2.41 kumulierte unerwnschte Ereignisse cumulative adverse events 2.12 L Lagerbehlter storage container 2.68 Linsenkrper body 2.10 M Materialdegradationsprfung material degradation test 2.32 me
23、hrteilige Intraokularlinse multi-piece intraocular lens 2.37 Meridian mit dem hchsten Brechwert meridian of highest dioptric power 2.33 Meridian mit dem niedrigsten Brechwert meridian of lowest dioptric power 2.34 monofokale Intraokularlinse monofocal intraocular lens 2.35 multifokale Intraokularlin
24、se multifocal intraocular lens 2.36 N Nahpunkt near point 2.39 Nd-YAG-Laser-Expositionsprfung Nd-YAG laser exposure test 2.38 O Optik optic 2.46 Optik-Formfaktor optic shape factor 2.49 P paraxiale Brennweite paraxial focal length 2.53 Pfeilhhe sagittal distance 2.61 phake Intraokularlinse phakic in
25、traocular lens 2.56 Photostabilittsprfung test of photostability 2.71 Positionierungsbohrung positioning hole 2.57 Primrverpackung primary package 2.59 Prfmaterial test material 2.70 DIN EN ISO 11979-1:2013-01 6 Term, German Term, English No. Prfperson, die aus der Nachbeobachtung herausfllt lost to
26、 follow-up subject 2.30 R reduzierte Brennweite reduced focal length 2.60 S Sagittalhhe sagittal distance 2.61 Scheitel vertex 2.74 Schlaufe loop 2.29 selbstklebendes Etikett self-adhesive label 2.62 Sonderanfertigung eines Medizinprodukts custom-made device 2.13 sphrische Intraokularlinse spherical
27、 intraocular lens 2.65 sphrisches quivalent spherical equivalent 2.64 sphrisches quivalent spherical equivalent power 2.64 Stabilitt stability 2.66 Sterilisationscharge sterilization load 2.67 subjektive Refraktion subjective refraction 2.69 T torische Intraokularlinse toric intraocular lens 2.72 U
28、Ursprungsmodell einer Intraokularlinse parent intraocular lens model 2.54 V Verfallsdatum expiration date 2.21 Vorderkammer-Intraokularlinse anterior chamber intraocular lens 2.6 Vorderkammerlinse anterior chamber lens 2.6 W wirksame Optik clear optic 2.11 Wlbungshhe vault height 2.73 Z zustzliche V
29、erpackung additional wrapping 2.4 Zylinder cylindrical power 2.15 Zylinderwert cylindrical power 2.15 DIN EN ISO 11979-1:2013-01 7 Terms, sorted alphabetically in English Term, English Term, German No. A accelerated shelf-life study beschleunigte Haltbarkeitsuntersuchung 2.1 accommodating intraocula
30、r lens akkommodierende Intraokularlinse 2.2 accommodative amplitude Akkommodationsbreite 2.3 additional wrapping zustzliche Verpackung 2.4 addition power Addition 2.5 anterior chamber lens Vorderkammerlinse 2.6 anterior chamber intraocular lens Vorderkammer-Intraokularlinse 2.6 aspheric intraocular
31、lens asphrische Intraokularlinse 2.7 axis mark Achsenmarkierung 2.8 B best-case subject bestmgliche Prfperson 2.9 body Linsenkrper 2.10 C clear optic wirksame Optik 2.11 cumulative adverse events kumulierte unerwnschte Ereignisse 2.12 custom-made device Sonderanfertigung eines Medizinprodukts 2.13 c
32、ut-off wavelength Cut-off-Wellenlnge 2.14 cylindrical power Zylinder, Zylinderwert 2.15 D device history record Chargenbericht 2.16 device intended for clinical investigation fr die klinische Prfung bestimmtes Medizinprodukt 2.17 dioptric power Brechwert 2.18 distance power Brechwert fr den Fernvisu
33、s, Basis-Brechwert 2.19 distance power configuration Konfiguration fr den Brechwert fr den Fernvisus 2.20 E expiration date Verfallsdatum 2.21 F far point Fernpunkt 2.22 finished intraocular lens lot Fertigprodukt-Charge 2.23 H haptic Haptik 2.24 I indicator of meridian with lowest dioptric power An
34、zeige des Meridians mit dem niedrigsten Brech-wert 2.25 in situ in situ 2.26 intraocular lens Intraokularlinse 2.27 intraocular lens model Intraokularlinsenmodell 2.28 DIN EN ISO 11979-1:2013-01 8 Term, English Term, German No. L loop Schlaufe 2.29 lost to follow-up subject Prfperson, die aus der Na
35、chbeobachtung heraus-fllt 2.30 M manufacturer Hersteller 2.31 material degradation test Materialdegradationsprfung 2.32 meridian of highest dioptric power Meridian mit dem hchsten Brechwert 2.33 meridian of lowest dioptric power Meridian mit dem niedrigsten Brechwert 2.34 monofocal intraocular lens
36、monofokale Intraokularlinse 2.35 multifocal intraocular lens multifokale Intraokularlinse 2.36 multi-piece intraocular lens mehrteilige Intraokularlinse 2.37 N Nd-YAG laser exposure test Nd-YAG-Laser-Expositionsprfung 2.38 near point Nahpunkt 2.39 near power Brechwert fr den Nahvisus 2.40 near power
37、 configuration Konfiguration fr den Brechwert fr den Nahvisus 2.41 non-ocular implantation test Implantationsprfung auerhalb des Auges 2.42 null lens astigmatisch neutralisierende Linse 2.43 O ocular implantation test Augenimplantationsprfung 2.44 one-piece intraocular lens einteilige Intraokularlin
38、se 2.45 optic Optik 2.46 optical power of the eye Brechwert des Auges 2.47 optic decentration Dezentrierung der Optik 2.48 optic shape factor Optik-Formfaktor 2.49 optic tilt Kippung der Optik 2.50 overall diameter Gesamtdurchmesser 2.51 P package integrity Integritt der Verpackung 2.52 paraxial foc
39、al length paraxiale Brennweite 2.53 parent intraocular lens model Ursprungsmodell einer Intraokularlinse 2.54 persistent adverse event anhaltendes unerwnschtes Ereignis 2.55 phakic intraocular lens phake Intraokularlinse 2.56 positioning hole Positionierungsbohrung 2.57 posterior chamber lens Hinter
40、kammerlinse 2.58 posterior chamber intraocular lens Hinterkammer-Intraokularlinse 2.58 primary package Primrverpackung 2.59 R reduced focal length reduzierte Brennweite 2.60 S sagittal distance Pfeilhhe, Sagittalhhe 2.61 self-adhesive label selbstklebendes Etikett 2.62 DIN EN ISO 11979-1:2013-01 9 T
41、erm, English Term, German No. shelf-life Haltbarkeit 2.63 spherical equivalent sphrisches quivalent 2.64 spherical equivalent power sphrisches quivalent 2.64 spherical intraocular lens sphrische Intraokularlinse 2.65 stability Stabilitt 2.66 sterilization load Sterilisationscharge 2.67 storage conta
42、iner Lagerbehlter 2.68 subjective refraction subjektive Refraktion 2.69 T test material Prfmaterial 2.70 test of photostability Photostabilittsprfung 2.71 toric intraocular lens torische Intraokularlinse 2.72 V vault height Wlbungshhe 2.73 vertex Scheitel 2.74 DIN EN ISO 11979-1:2013-01 10 This page
43、 is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11979-1 September 2012 ICS 01.040.11; 11.040.70 Supersedes EN ISO 11979-1:2006English Version Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:2012) Implants ophtalmiques - Lentilles intraocula
44、ires - Partie 1: Vocabulaire (ISO 11979-1:2012) Ophtalmische Implantate - Intraokularlinsen - Teil 1: Vokabular (ISO 11979-1:2012) This European Standard was approved by CEN on 14 September 2012. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions
45、 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 CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in t
46、hree 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 CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards
47、bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia
48、, Spain, Sweden, Switzerland, Turkey and United Kingdom. Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11979-1:2012: EEUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EURO
49、PEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Contents Page Foreword . 3 1 Scope 4 2 Terms and definitions . 4 Bibliography 12 2DIN EN ISO 11979-1:2013-01 EN ISO 11979-1:2012 (E) Foreword This document (EN ISO 11979-1:2012) has been prepared by Technical Committee ISO/TC 172 Optics and photonics in colla
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