1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 11979-1:2012Ophthalmic implants Intraocular lensesPart 1: VocabularyBS EN ISO 11979-1:2012 BRITISH STANDARDNational forewordThis British Standard is the UK implementati
2、on of EN ISO 11979-1:2012. It supersedes BS EN ISO 11979-1:2006 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/172/7, Eye implants.A list of organizations represented on this committee can be obtained on request to its secretary.This publication do
3、es not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2012. Published by BSI Standards Limited 2012ISBN 978 0 580 70882 4 ICS 01.040.11; 11.040.70 Compliance with a British Standard cannot confer imm
4、unity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2012.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11979-1 September 2012 ICS 01.040.11; 1
5、1.040.70 Supersedes EN ISO 11979-1:2006English Version Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:2012) Implants ophtalmiques - Lentilles intraoculaires - Partie 1: Vocabulaire (ISO 11979-1:2012) Ophtalmische Implantate - Intraokularlinsen - Teil 1: Vokabular (ISO 119
6、79-1:2012) 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 for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and biblio
7、graphical 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 three official versions (English, French, German). A version in any other language made by translation under the responsi
8、bility 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 bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republ
9、ic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALI
10、SATION EUROPISCHES KOMITEE FR NORMUNG 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: EBS EN ISO 11979-1:2012EN ISO 11979-1:2012 (E) 3 Foreword This docume
11、nt (EN ISO 11979-1:2012) has been prepared by Technical Committee ISO/TC 172 “Optics and photonics“ 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 pub
12、lication of an identical text or by endorsement, at the latest by March 2013, and conflicting national standards shall be withdrawn at the latest by March 2013. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC sh
13、all not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 11979-1:2006. According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria, Belgium,
14、 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, Spain, Sweden, Switzerlan
15、d, Turkey and the United Kingdom. Endorsement notice The text of ISO 11979-1:2012 has been approved by CEN as a EN ISO 11979-1:2012 without any modification. BS EN ISO 11979-1:2012BS EN ISO 11979-1:2012ISO 11979-1:2012(E/F) ISO 2012 All rights reserved/Tous droits rservs iiiForeword ISO (the Interna
16、tional Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has be
17、en established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical stan
18、dardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies fo
19、r voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or al
20、l such patent rights. ISO 11979-1 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments. This third edition cancels and replaces the second edition (ISO 11979-1:2006), which has been technically revised. ISO 11979 consists of the f
21、ollowing parts, under the general title Ophthalmic implants Intraocular lenses: Part 1: Vocabulary Part 2: Optical properties and test methods Part 3: Mechanical properties and test methods Part 4: Labelling and information Part 5: Biocompatibility Part 6: Shelf-life and transport stability Part 7:
22、Clinical investigations Part 8: Fundamental requirements Part 9: Multifocal intraocular lenses Part 10: Phakic intraocular lenses BS EN ISO 11979-1:2012ISO 11979-1:2012(E/F) iv ISO 2012 All rights reserved/Tous droits rservsAvant-propos LISO (Organisation internationale de normalisation) est une fdr
23、ation mondiale dorganismes nationaux de normalisation (comits membres de lISO). Llaboration des Normes internationales est en gnral confie aux comits techniques de lISO. Chaque comit membre intress par une tude a le droit de faire partie du comit technique cr cet effet. Les organisations internation
24、ales, gouvernementales et non gouvernementales, en liaison avec lISO participent galement aux travaux. LISO collabore troitement avec la Commission lectrotechnique internationale (CEI) en ce qui concerne la normalisation lectrotechnique. Les Normes internationales sont rdiges conformment aux rgles d
25、onnes dans les Directives ISO/CEI, Partie 2. La tche principale des comits techniques est dlaborer les Normes internationales. Les projets de Normes internationales adopts par les comits techniques sont soumis aux comits membres pour vote. Leur publication comme Normes internationales requiert lappr
26、obation de 75 % au moins des comits membres votants. Lattention est appele sur le fait que certains des lments du prsent document peuvent faire lobjet de droits de proprit intellectuelle ou de droits analogues. LISO ne saurait tre tenue pour responsable de ne pas avoir identifi de tels droits de pro
27、prit et averti de leur existence. LISO 11979-1 a t labore par le comit technique ISO/TC 172, Optique et photonique, sous-comit SC 7, Optique et instruments ophtalmiques. Cette troisime dition annule et remplace la deuxime dition (ISO 11979-1:2006), qui a fait lobjet dune rvision technique. LISO 1197
28、9 comprend les parties suivantes, prsentes sous le titre gnral Implants ophtalmiques Lentilles intraoculaires: Partie 1: Vocabulaire Partie 2: Proprits optiques et mthodes dessai Partie 3: Proprits mcaniques et mthodes dessai Partie 4: tiquetage et informations Partie 5: Biocompatibilit Partie 6: Du
29、re de conservation et stabilit pendant le transport Partie 7: Investigations cliniques Partie 8: Exigences fondamentales Partie 9: Lentilles intraoculaires multifocales Partie 10: Lentilles intraoculaires phaques BS EN ISO 11979-1:2012INTERNATIONAL STANDARD NORME INTERNATIONALE ISO 11979-1:2012(E/F)
30、 ISO 2012 All rights reserved/Tous droits rservs 1Ophthalmic implants Intraocular lenses Part 1: Vocabulary Implants ophtalmiques Lentilles intraoculaires Partie 1: Vocabulaire 1 Scope 1 Domaine dapplication This part of ISO 11979 defines terms applicable to intraocular lenses and to the methods use
31、d to evaluate them. NOTE Terms are given alphabetically. La prsente partie de lISO 11979 dfinit les termes applicables aux lentilles intraoculaires et aux mthodes dessai utilises pour les valuer. NOTE Les termes sont donns par ordre alphabtique de la version anglaise. 2 Terms and definitions 2 Terme
32、s et dfinitions 2.1 accelerated shelf-life study stability study designed to increase the rate of chemical or physical degradation of a product by using exaggerated storage conditions (e.g. temperature, humidity) to determine kinetic degradation parameters to predict the tentative expiration dating
33、period 2.1 tude en acclr de la dure de conservation modalits de stabilit dfinies pour augmenter la vitesse de dgradation physique ou chimique dun produit en utilisant des conditions de stockage exagres (par exemple temprature, humidit) afin de dterminer des paramtres cintiques de dgradation pour dfi
34、nir une date de premption provisoire 2.2 accommodating intraocular lens AIOL intraocular lens which provides continuous focusing from far point to near point by changing the dioptric power of the eye 2.2 lentille intraoculaire accommodative LIOA lentille intraoculaire qui assure une mise au point co
35、ntinue dun point loign vers un point proche en modifiant la puissance dioptrique de lil 2.3 accommodative amplitude difference in refractive power between the near point and the far point of the eye 2.3 amplitude daccommodation diffrence de puissance de rfraction entre le point proche et le point lo
36、ign de lil 2.4 additional wrapping container used in addition to the primary packaging and which could be used to maintain sterility of the intraocular lens 2.4 emballage complmentaire emballage utilis en complment de lemballage primaire et qui peut ventuellement servir maintenir la strilit de la le
37、ntille BS EN ISO 11979-1:2012ISO 11979-1:2012(E/F) 2 ISO 2012 All rights reserved/Tous droits rservs2.5 addition power difference between the distance power and the near power of the lens portion, measured under specified conditions 2.5 puissance additionnelle diffrence entre la puissance de vision
38、de loin et la puissance de vision de prs de la partie de la lentille, mesure dans des conditions spcifiques 2.6 anterior chamber lens anterior chamber intraocular lens intraocular lens designed to be placed entirely in the anterior chamber of the eye 2.6 lentille de chambre antrieure lentille intrao
39、culaire de chambre antrieure lentille intraoculaire destine tre place entirement dans la chambre antrieure de lil 2.7 aspheric intraocular lens intraocular lens having at least one surface with a monotonically continuously variable curvature from the vertex to the periphery 2.7 lentille intraoculair
40、e asphrique lentille intraoculaire ayant au moins une surface prsentant une courbure variation continue monotone depuis le sommet jusqu la priphrie 2.8 axis mark indicator of the meridian of lowest optical power 2.8 repre daxe indicateur du mridien ayant la plus faible puissance optique 2.9 best-cas
41、e subject subject with no pre-operative ocular pathology, no macular degeneration detected at any time, and no previous surgery for the correction of refractive errors 2.9sujet idal dexprience sujet ne prsentant pas de pathologie oculaire pr-opratoire ni de dgnrescence maculaire, et sans antcdent ch
42、irurgical pour la correction derreurs de rfraction 2.10 body central part of an intraocular lens incorporating the optic See Figure 1. 2.10corps partie centrale dune lentille intraoculaire comprenant loptique Voir Figure 1. 2.11 clear optic diameter of a circle concentric with the optical axis of an
43、 intraocular lens, containing only features of the intraocular lens belonging to the optical design See Figure 1. 2.11diamtre optique libre diamtre dun cercle dont le centre est situ sur laxe optique dune lentille intraoculaire, ne comprenant que des lments appartenant la structure optique de la len
44、tille intraoculaire Voir Figure 1. 2.12 cumulative adverse events total number of adverse events that have occurred at any time up to a specified time point post-operatively 2.12effets indsirables cumuls nombre total deffets indsirables survenus pendant une dure post-opratoire dfinie BS EN ISO 11979
45、-1:2012ISO 11979-1:2012(E/F) ISO 2012 All rights reserved/Tous droits rservs 32.13 custom-made device any device specifically made in accordance with a duly qualified medical practitioners written prescription, which gives, under his responsibility, specific design characteristics and is intended fo
46、r the sole use of a particular patient NOTE Mass-produced devices, which need to be adapted to meet the specific requirements of the medical practitioner, are not considered to be custom-made devices. 2.13dispositif sur mesure tout dispositif destin lusage exclusif dun patient dtermin et rpondant au
47、x exigences dune prescription crite dun mdecin dment qualifi dfinissant, sous sa propre responsabilit, les caractristiques particulires de conception du dispositif en question NOTE Les dispositifs produits en srie, ncessitant une adaptation pour convenir aux besoins spcifiques du mdecin, ne sont pas
48、 considrs comme des dispositifs sur mesure. 2.14 cut-off wavelength minimum wavelength at which the transmission reaches and remains below a defined level 2.14longueur donde de coupure longueur donde minimale laquelle la transmission atteint un niveau dfini et reste en dessous 2.15 cylindrical power difference in dioptric power between the meridians with the highest and the lowest dioptric powers 2.15 puissance cylindrique diffrence de puissance dioptrique entre les mridiens de puissance dioptrique maximale et de puissance dioptrique minimale 2.16 device history record
