SIST EN ISO 14534:2000

SLOVENSKI STANDARD
SIST EN ISO 14534:2000
01-januar-2000
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Ophthalmic optics - Contact lenses and contact lens care products - Fundamental
requirements (ISO 14534:1997)
Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Grundlegende Anforderungen
(ISO 14534:1997)
Optique ophtalmique - Lentilles de contact et produits d'entretien des lentilles de contact
- Prescriptions fondamentales (ISO 14534:1997)
Ta slovenski standard je istoveten z: EN ISO 14534:1997
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 14534:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 14534:2000
INTERNATIONAL ISO
STANDARD 14534
First edition
1997-12-15
Ophthalmic optics — Contact lenses and
contact lens care products — Fundamental
requirements
Optique ophtalmique — Lentilles de contact et produits d'entretien des
lentilles de contact — Prescriptions fondamentales
A
Reference number
ISO 14534:1997(E)

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SIST EN ISO 14534:2000
ISO 14534:1997(E)
Foreword
ISO (the International 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 been 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 standardization.
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.
Optics and optical instruments
International Standard ISO 14534 was prepared by ISO/TC 172, ,
Subcommittee SC 7, Ophthalmic optics and instruments.
Annex A of this International Standard is for information only.
For the purposes of this International Standard, the CEN annex regarding fulfilment of
European Council Directives has been removed.
©  ISO 1997
All rights reserved. Unless otherwise specified, 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 • CH-1211 Genève 20 • Switzerland
Internet central@iso.ch
X.400 c=ch; a=400net; p=iso; o=isocs; s=central
Printed in Switzerland
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SIST EN ISO 14534:2000
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ISO ISO 14534:1997(E)
Introduction
Currently contact lenses and contact lens care products are regulated in different ways in
different countries. This International Standard was mandated by the Commission of the
European Communities to CEN and has been developed by a joint ISO/CEN working group to
ensure a global input. Different requirements may currently be needed in specific countries
outside the European Union. It is hoped that the adoption of this International Standard will be
yet another step toward mutual recognition.
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SIST EN ISO 14534:2000
©
INTERNATIONAL STANDARD  ISO ISO 14534:1997(E)
Ophthalmic optics — Contact lenses and contact lens care products —
Fundamental requirements
1 Scope
This International Standard specifies safety and performance requirements for contact lenses,
contact lens care products and other accessories for contact lenses.
This International Standard does not specify electrical safety and electromagnetic compatibility
considerations that might arise from the use of electrical equipment in conjunction with contact
lenses and/or contact lens care products.
2 Normative references
The following standards contain provisions which, through reference in this text, constitute
provisions of this International Standard. At the time of publication, the editions indicated were
valid. All standards are subject to revision, and parties to agreements based on this
International Standard are encouraged to investigate the possibility of applying the most recent
editions of the standards indicated below. Members of IEC and ISO maintain registers of
currently valid International Standards.
1
Optics and optical instruments - Contact lenses and contact lens care products -
ISO 11978: – ,
Information to be supplied by the manufacturer for contact lens wearers.
ISO 10993-1:1997, Biological evaluation of medical devices - Part 1: Evaluation and testing.
3 Definitions
For the purposes of this International Standard, the following definitions apply:
3.1 contact lens
Any lens designed to be worn on the front surface of the eye.
NOTE The term contact lens includes plano lenses, afocal lenses and trial lenses.

1
To be published.
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3.2 trial lens
Lens used by the practitioner for the sole purpose of selecting the contact lens parameters.
3.3 contact lens care product
Contact lens accessory intended for use in maintaining the safety and performance of a contact
lens after opening and removal of the contact lens from its original shipping package.
NOTE This definition includes all devices recommended for use in the management of contact
lens hygiene, for hydrating contact lenses, or for alleviating discomfort of contact lens wear by
physical means.
3.4 other accessories for contact lenses
Item used for handling contact lenses or as part of a contact lens regimen excluding contact
lens care products, e.g. lens container (lens case) or suction cup used to aid the insertion of a
contact lens onto or removal from the surface of the eye.
NOTE This definition does not include the primary packaging (e.g. vials, blister packs or
mailers) intended by the manufacturer to be used only for shipment of the contact lenses.
3.5 intended purpose
Use for which a device is intended according to the information supplied by the manufacturer
on the labelling, in the instructions and/or in promotional materials.
3.6 performance
Suitability of a device to achieve its intended purpose.
3.7 hygienic management
Procedure by which contact lenses are maintained in a condition for safe re-use.
3.8 tamper-evident package
Package having an indicator or barrier to entry which, if damaged, breached or missing, can
reasonably be expected to provide visible evidence to practitioners or users that the package
may have been opened.
3.9 discard date
Specified period of time from first use when a product’s continued use should cease.
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4 Safety and performance
The intended purpose of a contact lens, contact lens care product, or other accessory for
contact lenses shall be documented.
The performance shall be demonstrated by an evaluation of existing information and human
use history and, if necessary, preclinical and clinical testing. In assessing safety and
performance, each of the following shall be considered and the decisions shall be documented:
a) functional characteristics, intended purpose and conditions of use;
b) specific requirements for rigid and hydrogel contact lenses;
NOTE 1  See for example ISO 8321-1 for rigid contact lenses and ISO 8321-2 for hydrogel
contact lenses.
c) microbiological properties, including bioburden, sterility, disinfection and preservation
activities (see clause 10);
d) biocompatibility, including extractable substances, cytotoxicity, irritation, sensitization, oral
toxicity, sterilization residues and degradation products (see ISO 10993-1);
e) clinical evaluation (see clause 8);
f) physical and chemical compatibility (including any preservative uptake and release)
between contact lenses and contact lens care products and other accessories for contact
lenses;
g) stability, including shelf-life and discard date (see clause 12);
h) other intended purposes (for example cleaning efficacy, measuring function).
NOTE 2  For test methods see annex A.
In the absence of a relevant International Standard, the manufacturer shall demonstrate that
the product is in accordance with claimed indications, by valid scientific evidence from
laboratory and/or clinical studies.
NOTE 3  Manufacturers of contact lenses and contact lens care products are reminded of
traceability requirements as mentioned in International Standards on quality management.
5 Risk analysis
A formal assessment of risk shall be carried out for each design of contact lens, contact lens
care product or other accessory for contact lenses.
Risk analysis shall be carried out using recognized methodology. The result of the risk analysis
shall be documented for all aspects of safety, performance and labelling.
NOTE See for example ISO 14971 or prEN 1441.
Each risk analysis shall be reviewed:
a) regularly;
b) whenever any changes are made to the product or its method of manufacture;
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c) whenever any changes are made to the packaging or labelling; or
d) whenever relevant new information becomes known to the manufacturer.
6 Design
The design shall be documented, validated and verified to demonstrate that the required
performance and safety are achieved when the product is used for its intended purpose.
7 Materials
Materials used for and during the manufacture of contact lenses, contact lens care products
and other accessories for contact lenses shall be chosen with regard to the properties
necessary to meet the requirements for safety, performance, manufacture, handling and
compatibility with other materials with which they may come into contact.
The reasons for choosing the selected materials shall be documented.
8 Clinical evaluation
The safety and/or performance of a product for its intended purpose shall be clinically evaluated
by one or more of the following methods:
a) compilation of relevant scientific literature currently available on the intended purpose
and performance of the device and the evaluation techniques employed;
b) experience during previous use;
c) clinical investigation.
NOTE Any clinical investigation should comply with principles of good clinical practice such as
laid down in ISO 14155, ISO 11980 and EN 540.
9 Manufacturing
Manufacturing processes shall be documented and controlled to ensure that the defined
product quality is achieved. The product shall fulfil the quality requirements defined in the
design documents or product specifications. These defined levels of chemical, physical or
biological parameters, especially concerning particulate and microbiological contaminants which
could adversely affect practitioner or user safety and also the functional safety and reliability of
the product, shall be met.
NOTE For guidance on quality management see A.1.
10 Microbiological requirements
NOTE See A.6 for additional information on International Standards concerning microbiology
and test methods.
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10.1 Contact lenses
10.1.1  Lenses delivered sterile
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Hydrogel lenses shall be supplied sterile. The sterility assurance level (S.A.L.) shall be 10 or
less.
Lenses delivered sterile shall be packaged in such a way that they remain sterile under normal
storage, transport and handling conditions until the primary package is opened or damaged.
10.1.2  Lenses delivered non-sterile
Lenses delivered non-sterile shall be manufactured and packaged by a process demonstrated
to yield, during its shelf-life, a product with an average bioburden of less than 100 cfu (colony-
forming units) per lens.
10.1.3  Trial lenses
Manufacturers of re-usable trial lenses shall provide instructions for their safe maintenance
between each use.
10.2 Contact lens care products
Contact lens care products in solid dosage form shall be manufactured and packaged by a
process demonstrated to yield, during its shelf-life, a product with an average bioburden of less
than 100 cfu per gram, unless otherwise justified, and which is free from the following
pathogens: Staphylococcus aureus, Pseudomonas aeruginosa and Escherichia coli.
Liquid contact lens care products shall be supplied sterile. They shall be either supplied
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terminally sterilized (S.A.L. of 10 or less) or prepared aseptically according to a validated and
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documented process (S.A.L. of 10 or less).
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NOTE 1 Products that are either terminally sterilized to a S.A.L. of 10 or less or aseptically
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prepared to a S.A.L. of 10 or less may be labelled sterile using the symbol
STERILE as specified in prEN 980.
Contact lens care solutions intended for use on more than one occasion shall be adequately
preserved (see clause 12).
Contact lens care products intended for the disinfection of contact lenses shall have an
adequate antimicrobial activity.
NOTE 2 ISO 14729 provides requirements and test methods for antimicrobial activity testing.
NOTE 3 Additional requirements may apply for the safe maintenance of trial lenses between
each use (see 10.1.3).
10.3 Other accessories for contact lenses
Products labelled sterile shall be sterilized by a validated method. The sterility assurance level
and the sterilization method shall be documented. (See 10.2.)
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11 Packaging
11.1 The packaging of contact lenses, contact lens care products, and other accessories for
contact lenses shall be so designed that it protects the products against foreseeable damage
and does not adversely affect their function, safety or performance under normal conditions of
storage, transport and handling (see clause 5).
11.2 The packaging for products which are labelled sterile shall maintain their sterility under
normal conditions of storage, transport and handling of the product until the primary package is
opened or damaged or until the expiry date has been reached.
11.3 The packaging for products which are not labelled sterile shall maintain the cleanliness of
the product under normal conditions of transport and storage prior to use or within the stated
shelf-life.
11.4 The packaging for all products which are labelled sterile and all contact lens care
products in solid dosage form shall be tamper-evident.
The packaging and/or label of the product shall distinguish between identical or similar products
which are sold in both sterile and non-sterile conditions.
12 Shelf-life and discard date
Shelf-life of contact lenses and contact lens care products shall be established on the basis of
testing that demonstrates that each product in the unopene
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