EN ISO 11979-1:1999
(Main)Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:1999)
Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:1999)
Migrated from Progress Sheet (TC Comment) (2000-07-10): TC Res.21/1998: Parts 1,3,5,6,7 and 8 no longer be dealt under V.A--> SPD Unit ++ are requested to allocate the same prEN reference to these parts (TA/980518) ++ TC res. 24/1999: Part 1 goes on under V.A. ISO lead (TA/990408)
Ophtalmische Implantate - Intraokularlinsen - Teil 1: Vokabular (ISO 11979-1:1999)
Dieser Teil von ISO 11979 enthält die Definitionen von Begriffen betreffend Intraokularlinsen und deren Prüfverfahren. Zusätzlich zu allgemeinen Begriffen wurden weitere Begriffe, entsprechend den verschiedenen Teilen von ISO 11979, in Abschnitten zusammengefaßt. Die Begriffe werden in den Abschnitten jeweils in alphabetischer Reihenfolge angegeben.
Implants ophtalmiques - Lentilles intraoculaires - Partie 1: Vocabulaire (ISO 11979-1:1999)
Očesni vsadki (implantati) - Intraokularne leče - 1. del: Slovar (ISO 11979-1:1999)
General Information
Relations
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Ophtalmische Implantate - Intraokularlinsen - Teil 1: Vokabular (ISO 11979-1:1999)Implants ophtalmiques - Lentilles intraoculaires - Partie 1: Vocabulaire (ISO 11979-1:1999)Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:1999)11.040.70Oftalmološka opremaOphthalmic equipment01.040.11Zdravstveno varstvo (Slovarji)Health care technology (Vocabularies)ICS:Ta slovenski standard je istoveten z:EN ISO 11979-1:1999SIST EN ISO 11979-1:2000en01-julij-2000SIST EN ISO 11979-1:2000SLOVENSKI
STANDARD
SIST EN ISO 11979-1:2000
SIST EN ISO 11979-1:2000
SIST EN ISO 11979-1:2000
AReference numberISO 11979-1:1999(E)INTERNATIONALSTANDARDISO11979-1First edition1999-12-01Ophthalmic implants — Intraocularlenses —Part 1:VocabularyImplants ophtalmiques — Lentilles intraoculaires —Partie 1: VocabulaireSIST EN ISO 11979-1:2000
ISO 11979-1:1999(E)©
ISO 1999All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronicor mechanical, including photocopying and microfilm, without permission in writing from the publisher.International Organization for StandardizationCase postale 56 · CH-1211 Genève 20 · SwitzerlandInternetiso@iso.chPrinted in SwitzerlandiiContents1 Scope.12 General terms and definitions.13 Terms related to optical properties and their test methods (ISO 11979-2).24 Terms related to mechanical properties and their test methods (ISO 11979-3).35 Terms related to labelling and information (ISO 11979-4).46 Terms related to biocompatibility (ISO 11979-5).47 Terms related to shelf-life and transport stability (ISO 11979-6).58 Terms related to clinical investigation (ISO 11979-7).5Alphabetical index.7SIST EN ISO 11979-1:2000
© ISOISO 11979-1:1999(E)iiiForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISOmember bodies). The work of preparing International Standards is normally carried out through ISO technicalcommittees. Each member body interested in a subject for which a technical committee has been established hasthe right to be represented on that committee. International organizations, governmental and non-governmental, inliaison with ISO, also take part in the work. ISO collaborates closely with the International ElectrotechnicalCommission (IEC) on all matters of electrotechnical standardization.International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.Draft International Standards adopted by the technical committees are circulated to the member bodies for voting.Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.International Standard ISO 11979-1 was prepared by ISO/TC 172, Optics and optical instruments, SubcommitteeSC 7, Ophthalmic optics and instruments.ISO 11979 consists of several parts, under the general title Ophthalmic implants — Intraocular lenses:¾ Part 1:
Vocabulary¾ Part 2:
Optical properties and test methods¾ Part 3:
Mechanical properties and test methods¾ Part 4:
Labelling and information¾ Part 5:
Biocompatibility¾ Part 6:
Shelf-life and transport stability¾ Part 7:
Clinical investigations¾ Part 8:
Fundamental requirementsSIST EN ISO 11979-1:2000
ISO 11979-1:1999(E)© ISOivIntroductionThis part of ISO 11979 contains definitions of terms related to intraocular lenses and methods to evaluate them.In addition to general terms, terms have been grouped in clauses corresponding to the various parts of ISO 11979.The terms are presented alphabetically in each clause.NOTE
It always was and still is the intention of the Technical Committees ISO/TC 172/SC 7 and CEN/TC 170 to prepareidentical ISO and CEN (European Committee for Standardization) standards on intraocular lenses. However, during thepreparation of part 7 of this series, problems were encountered with normative references to the existing ISO 14155 andEN 540 horizontal standards on clinical investigation of medical devices, which are similar but not identical.ISO and CEN principles concerning normative references made it impossible to continue the preparation of identicalInternational and European Standards on the clinical investigation of intraocular lenses. As a result, two different standardsseries have had to be prepared. For this part of ISO 11979, identical versions exist for ISO and CEN (ISO 11979-1 andEN ISO 11979-1). For those parts where no identical versions exist, it is the intention of ISO/TC 172/SC 7 and CEN/TC 170 torevise these standards with the goal to end up with identical ones as soon as identical ISO and CEN horizontal standards onclinical investigations become available.SIST EN ISO 11979-1:2000
INTERNATIONAL STANDARD
© ISOISO 11979-1:1999(E)1Ophthalmic implants — Intraocular lenses —Part 1:Vocabulary1 ScopeThis part of ISO 11979 defines terms applicable to intraocular lenses and the methods used to evaluate them.2 General terms and definitions2.1anterior chamber (intraocular) lensintraocular lens designed to be placed entirely in the anterior chamber of the eye2.2bodycentral part of an intraocular lens incorporating the opticSee Figure 1.2.3clear opticdiameter of the circle, concentric with the optical axis of an intraocular lens, containing only features of theintraocular lens belonging to the optical designSee Figure 1.2.4hapticnon-optical, generally peripheral, component(s) of an intraocular lens intended to keep it in place in the eye2.5in situin equilibrium with aqueous humour at 35 °CNOTE 1The refractive index of aqueous humour is taken to be 1,336 at 546,07 nm.NOTE 2For practical testing purposes, physiological saline may in many cases be used as a substitute for aqueous humour.NOTE 3Actual testing may be carried out at other conditions if, by validated correction procedures, values can be shown toapply under in situ conditions.2.6intraocular lensIOLophthalmic lens intended for implantation inside the eye2.7loopperipheral extension on the body, serving to position the lens in the eyeNOTE
Loops are parts of the haptic (see 2.4), or may be the haptic.SIST EN ISO 11979-1:2000
ISO 11979-1:1999(E)© ISO22.8monofocal intraocular lensintraocular lens designed to provide one dioptric power2.9multifocal intraocular lensintraocular lens designed to provide two or more dioptric powers2.10multipiece intraocular lensintraocular lens assembled from separate loop and body componentsNOTE
An intraocular lens with a body and two loops is often referred to as a three-piece intraocular lens.2.11one-piece intraocular lensintraocular lens in which the haptic is an integral part of the body2.12opticimage-forming, generally central, component of an intraocular lens2.13overall diameterdiameter of the cylinder circumscribing an intraocular lens, be it haptic or optic, with the axis of the cylindercoincident with the optical axis of the intraocular lensSee Figure 1.2.14positioning holehole, whether penetrating or not, intended to be used for surgical manipulationSee Figure 1.2.15posterior chamber (intraocular) lensintraocular lens designed to be placed entirely in the posterior chamber of the eye3 Terms related to optical properties and their test methods (ISO 11979-2)3.1dioptric powerreciprocal of the reduced paraxial focal length in situ for light with a wavelength of 546,07 nmNOTE
The unit for expressing dioptric power is the reciprocal metre (m–1). The special name for this unit is “dioptre”, forwhich the symbol D is used.3.2paraxial focal lengthdistance between the back principal plane and the back paraxial focal point3.3reduced focal lengthfocal length divided by the refractive index of the surrounding mediumSIST EN ISO 11979-1:2000
© ISOISO 11979-1:1999(E)3Key1Overall diameter2Positioning holes3Clear optic4Body5Vault height6SagittaFigure 1 — Overall diameter, vault height, sagitta, clear optic, body and positioning hole4 Terms related to mechanical properties and their test methods (ISO 11979-3)4.1optic decentrationlateral displacement of the optic due to compression of the haptic(s), measured as distance between the geometriccentre of the clear optic and the centre of a cylinder of a specified diameter to which the intraocular lens is confined4.2optic tiltangle between the optical axis of the intraocular lens in the uncompressed state and that in the compressed state,with the intraocular lens being confined to a specified diameter4.3sagittamaximum distance between the planes, normal to the optical ax
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.