SIST EN ISO 8321-1:2000

Optics and optical instruments - Contact lenses - Part 1: Specification for rigid corneal and scleral contact lenses (ISO 8321-1:1991)

Specification of minimum requirements.

Optik und optische Instrumente - Kontaktlinsen - Teil 1: Grundanforderungen für harte Korneal- und Skleralkontaktlinsen (ISO 8321-1:1991)

Dieser Teil der ISO 8321 legt Anforderungen für Kontaktlinsen fest, die von einem Hersteller gemäß den Bestellwerten eines Anpassers geliefert werden. Anhang A beschreibt eine empfohlene Schreibweise für die Bestellwerte von Kontaktlinsen.

Optique et instruments d'optique - Lentilles de contact - Partie 1: Spécification des lentilles cornéennes et des verres scléraux rigides (ISO 8321-1:1991)

La CEI 60352-8:2011 est applicable aux connexions par compression comportant des contacts à ressort métalliques, utilisées dans les équipements de télécommunication et autres systèmes électroniques employant des techniques similaires. Des informations sur les matériaux et des résultats en retour d'expérience industrielle sont inclus en plus des méthodes d'essais, pour assurer des connexions électriquement stables dans les conditions d'environnement prescrites. La présente norme a pour objet de déterminer la bonne adaptation des connexions par compression dans des conditions électriques, mécaniques et atmosphériques spécifiées et de fournir un moyen de comparaison des résultats d'essai lorsque les outils utilisés pour réaliser les connexions sont de conception ou de fabrication différente.

Optika in optični instrumenti - Kontaktne leče - 1. del: Specifikacija za trde roženične (kornealne) in beločnične (skleralne) kontaktne leče (ISO 8321-1:1991)

General Information

• Status: Withdrawn
• Publication Date: 31-Dec-1999
• Withdrawal Date: 31-Oct-2002
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 01-Nov-2002
• Due Date: 01-Nov-2002
• Completion Date: 01-Nov-2002
• Ref Project: EN ISO 8321-1:1996 - Optics and optical instruments - Contact lenses - Part 1: Specification for rigid corneal and scleral contact lenses (ISO 8321-1:1991)

Relations

• Replaced By: SIST EN ISO 8321-1:2002 - Ophthalmic optics - Specifications for material, optical and dimensional properties of contact lenses - Part 1: Rigid corneal and scleral contact lenses (ISO 8321-1:2002)
• Effective Date: 01-Nov-2002

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 8321-1:2000
01-januar-2000
2SWLNDLQRSWLþQLLQVWUXPHQWL.RQWDNWQHOHþHGHO6SHFLILNDFLMD]DWUGH
URåHQLþQHNRUQHDOQHLQEHORþQLþQHVNOHUDOQHNRQWDNWQHOHþH,62
Optics and optical instruments - Contact lenses - Part 1: Specification for rigid corneal
and scleral contact lenses (ISO 8321-1:1991)
Optik und optische Instrumente - Kontaktlinsen - Teil 1: Grundanforderungen für harte
Korneal- und Skleralkontaktlinsen (ISO 8321-1:1991)
Optique et instruments d'optique - Lentilles de contact - Partie 1: Spécification des
lentilles cornéennes et des verres scléraux rigides (ISO 8321-1:1991)
Ta slovenski standard je istoveten z: EN ISO 8321-1:1996
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 8321-1:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8321-1:2000

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SIST EN ISO 8321-1:2000

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SIST EN ISO 8321-1:2000

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SIST EN ISO 8321-1:2000

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SIST EN ISO 8321-1:2000

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SIST EN ISO 8321-1:2000
IS0
INTERNATIONAL
8321-I
STANDARD
First edition
1991-08-M
Optics and optical instruments - Contad
lenses -
Part 1:
Specification for rigid cornea1 and scleral contact
lenses
Optique et instruments d’optique - Lentilles de contact -
Partie 1: Spkification des lentilles corneennes et ‘des verres scl&raux
rigides
Reference number
IS0 8321-1:1991(E)

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SIST EN ISO 8321-1:2000
IS0 83214:1991(E)
IS0 (the International Organization for Standardization) is a worldwide
federation of national standards bodies (IS0 member bodies). The work
of preparing International Standards is normally carried out through IS0
technical committees. Each member body interested in a subject for
which a technical committee has been established has the right to be
represented on that committee. International organizations, govern-
mental and non-governmental, in liaison with ISO, also take part in the
work. IS0 collaborates closely with the International Electrotechnical
Commission (IEC) on all matters of electrotechnical standardization.
Draft International Standards adopted by the technical committees are
circulated to the member bodies for voting. Publication as an Inter-
national Standard requires approval by at least 75 O/o of the member
bodies casting a vote.
International Standard IS0 8321-1 was prepared by Technical Committee
ISO/TC 172, Optics and optical instruments, Sub-Committee SC 8,
Ophthalmic optics.
4
IS0 8321, consists of the following parts, under the general, title Optics
and optical instruments - Contact lenses:
- Fart 1: Specification for rigid cornea! and scleral contact lenses
- Fart 2: Specification for soft cornea1 and scleral contact lenses
Annexes A and B of this part of IS0 8321 are for information only.
0 IS0 1991
All rights reserved. No part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without
permission in writing from the publisher.
International Organization for Standardization
Case Postale 56 l CH-1211 Gekve 20 + Switzerland
Printed In Switzerland
ii

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SIST EN ISO 8321-1:2000
IS0 83214:1991(E)
INTERNATIONAL STANDARD
Optics and optical instruments - Contact lenses -
Part I:
Specification for rigid cornea1 and scleral contact lenses
3 Definitions
1 Scope
This part of IS0 8321 specifies requirements for
For the purposes of this part of IS0 8321, the defi-
contact lenses as supplied by a manufacturer ac-
nitions given in IS0 8320 apply.
cording to a prescription from a practitioner. A re-
commended method for presenting the prescription
of contact lenses is described in annex A.
This part of IS0 8321 applies to rigid cornea1 and
scleral contact lenses including those manufactured
4 Recommendation for method of
of gas permeable materials. It does not apply to soft
prescription
contact lenses in a dry state. Annex B covers re-
lated aspects that cannot be the basis for require-
ments in this part of IS0 8321. The prescription for each lens is assumed to be in
accordance with the recommended method de-
scribed in annex A .
2 Normative references
The following standards contain provisions which,
through reference in this text, constitute provisions
of this part of IS0 8321. At the time of publication,
the editions indicated were valid. All standards are
5 Requirements for dimensions and
subject to revision, and parties to agreements based
on this part of IS0 8321 are encouraged to investi-
optical properties
gate the possibility of applying the most recent edi-
tions of the standards indicated below. Members of
IEC and IS0 maintain registers of currently valid
International Standards.
5.1 Tolerances
IS0 8320:1986, Optics and optical instruments -
Contact lenses - Vocabulary and symbols.
When tested as described in 5.2 and 5.3 the dimen-
sional and optical properties shall be as prescribed,
IS0 9340:--l), Optics and optical instruments - Con-
within the appropriate tolerances detailed in tables
tact lenses - Determination of strains.
1 and 2.
IS0 9341:- l) , Optics and optical instruments - Con- For fenestration, truncation, displacement and
tact lenses - Determination of inclusions and surface scleral thickness, values shall not differ from the
imperfections. prescribed values by more than IO %.
1) To be published.

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SIST EN ISO 8321-1:2000
IS0 83214:1991(E)
5.2 Methods of test 5.3 Test environment
Each dimension and optical property specified shall
be determined using a calibrated measuring instru- Lenses shall be tested while in the physico-chemical
environment stated by the manufacturer (see
ment with a precision better than one-half of the
clause 8).
tolerance specified for the property.
2

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SIST EN ISO 8321-1:2000
IS0 8321-1:1991(E)
Table 1 - Dimensional tolerances of cornea1 lenses and scleral lenses
Dimensions in millimetres
Comeal
--___I___ -----
Dimension Scleral
Poly(methyl methacfytate)
Gas permeable
[ PMMA]
Back optic zone radius + 0,025 + 0,05 + 0,010
- - -
--
-m--------------p---^--.-- --.-- -------
Back optic zone radii of toroidal sur-
faces
where 0 < rl?rr < 0,2 + 0,025 + 0,05 +0,12
- - -
where 0,2 < AY G 0,4 + 0,035 + 0.06 +0,13
--_ - -
where 0,4 < A\V < 0,6 + 0,055
+ 0,07 +0,15
- -- -
where M > 0,6 + 0,075
+ 0,09 +0,17
- - -
(see notes 1 and 2)
-- -.------- evp__ ,-
Back optic zone diameter
+ - 0,20 + 0,20 + 0,20
- -
(see note 3)
--- -- --- ----- --_,
-
-
Back scleral radius (of preformed
+0,10
-
lens)
-7 .II_-- --
- -
Basic or primary optic diameter
+ 0,20
-
. .
-. ,---p-.
Back or front peripheral radius (where +0,10 +0,10 +0,10
-
measurable)
---. -- - -a-----,.
Back peripheral diameter + 0,20 + 0,20 + 0,20
- - -
(see note 3)
(for preformed lenses)
---- --P--P- ---- I--------. -_-
Total diameter (see note 2) +0,10 +0,10 + 0,25
- - -
------ I---.--.--.-.*-
-----. -----
Front optic zone diameter + 0,20 + 0,20 + 0,20
- - -
(see note 3)
__-_------- --. ----.------ -we------.- I.
Bifocal segment height -0,lO to +0,20 -0,lO to +0,20 -0,lO to +0,20
---- . ----------.-- ------ _--- - ---- _. - -.----
Centre thickness
+ 0,02 + 0,02 +0,10
- - -
--------- - .--.------ --.-- v-p---. ,--.--.
- -
Vertex clearance from cast (for im- + 0,02
-
pression scleral lenses)
. --- _---
NOTES
1 or is the difference between the radii of the two principal meridians.
2 The tolerance applies to each meridian.
3 These tolerances apply only to lenses with spherical surfaces and distinct curves; they are for a finished lens and
any blending may make measurement difficult.

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SIST EN ISO 8321-1:2000
IS0 8321-=1:1991(E)
6.4 Edge profile
6 Requirements for finish
When examined under x IO magnification, the edge
6.1 Inclusions and surface imperfections
profile shall appear to be as prescribed, uniform in
section and free from blemishes.
When examined as described in IS0 9341, the lens
shall be free of inclusions or surface imperfections
which interfere with its intended functional use.
7 Requirements for delivey of lenses from
6.2 Strain
the manufacturer to the practitioner
When examined as described in IS0 9340, the
cornea1 lens or its shell or the cornea1 portion of a
7.1 Lenses shall be delivered in the state most
scleral lens or its shell shall appear uniform not
appropriate for their intended functional use.
counting the marginal zone not more than 0,3 mm
wide.
7.2 The manufacturer shall label the immediate
container with at least the following information:
6.3 Fenestrations
The front and back edges of the holes shall appear a) the lens prescription;
finished in the style prescribed by the practitioner
when examined under x5 magnification. b) the lens batch code.
Table 2 - Optical tolerances of cornea1 lenses and scleral lenses
Cornea1 or scleral (including
Dimension
gas permeable)
Back vertex power in the weaker meridian
0 to + 5,OO D +0,12 D
- -
over + 5,OO D to + 10,OO D +0,18 D
- - -
over + 10,OO 0 to + 15,OO D +0,25 D
- - -
+0,37 D
over + 15,OO 0 to + 20,OO D
- - -a
+0,50 0
over +20,00 0.
--
------.
Prismatic error (measured at geometrical
centre of the optic zone)
+0,25 A
Back vertex power 0 to 6 D
-
+0,50 A
Back vertex power over 6 D -
-----__I___-pw
Prescribed prism +0,25 A
...