Ophthalmic implants – Intraocular lenses – Part 8: Fundamental requirements (ISO 11979-8:2006)

Abstract

11979-8:2006 specifies fundamental requirements for all types of intraocular lenses intended for surgical implantation into the anterior segment of the human eye, excluding corneal implants and transplants.

DIN EN ISO 11979-8:2011-09 (E)
Ophthalmic implants – Intraocular lenses – Part 8: Fundamental requirements (ISO
11979-8:2006 + Amd.1:2011)
Contents Page
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC …………………………………………………………………………..
1 Scope ……………………………………………………………………………………………………………………………..5
2 ……………………………………………………………………………………………………………………………………….5
3 Terms and definitions ……………………………………………………………………………………………………..6
4 Safety and performance ………………………………………………………………………………………………….6
5 Optical and mechanical properties ………………………………………………………………………………….6
6 Biocompatibility ……………………………………………………………………………………………………………..6
7 Clinical evaluation …………………………………………………………………………………………………………..6
8 Manufacturing …………………………………………………………………………………………………………………6
9 Sterilization …………………………………………………………………………………………………………………….7
9.1 General …………………………………………………………………………………………………………………………..7
9.2 Bacterial endotoxins ……………………………………………………………………………………………………….7
10 Packaging and shelf-life ………………………………………………………………………………………………….7
11 Labelling and information ……………………………………………………………………………………………….7
12 Documentation ……………………………………………………………………………………………………………….7
………………………………………………………………………………………………………………………………………..8
Bibliography …………………………………………………………………………………………………………………………………….
Normative references ……………………………………………………………………………………………………………………….

Ophthalmic optics – Spectacle lenses – Fundamental requirements for uncut finished lenses (ISO 14889:2003)

DIN EN 14139:2010-11 (E)
Ophthalmic optics – Specifications for ready-to-wear spectacles
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….3
1 Scope ……………………………………………………………………………………………………………………………..4
2 Normative references ……………………………………………………………………………………………………..4
3 Terms and definitions ……………………………………………………………………………………………………..4
4 Performance requirements ……………………………………………………………………………………………..4
4.1 General …………………………………………………………………………………………………………………………..4
4.2 General requirements ……………………………………………………………………………………………………..4
4.3 Optical power range ………………………………………………………………………………………………………..5
4.4 Optical power tolerances ………………………………………………………………………………………………..5
4.5 Reference points and prismatic power tolerances ……………………………………………………………5
4.5.1 Design reference points ………………………………………………………………………………………………….5
4.5.2 Prismatic power tolerances …………………………………………………………………………………………….5
5 Marking on the spectacles, indications on packaging, instruction for use ………………………..5
5.1 Marking …………………………………………………………………………………………………………………………..5
5.2 Indications on packaging and warnings …………………………………………………………………………..5
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices …………………………………………..7

Ophthalmic optics – Spectacle lenses – Fundamental requirements for uncut finished lenses (ISO 14889:2003)

Abstract

ISO 14889:2013 specifies fundamental requirements for uncut finished spectacle lenses. It is not applicable to protective spectacle lenses.

ISO 14889:2013 takes precedence over the corresponding requirements of other standards, if differences exist.

DIN EN ISO 14889:2014-03 (E)
Ophthalmic optics – Spectacle lenses – Fundamental requirements for uncut finished
lenses (ISO 14889:2013)
Contents Page
Foreword ………………………………………………………………………………………………………………………………………. 3
1 Scope …………………………………………………………………………………………………………………………….. 4
2 Normative references ……………………………………………………………………………………………………… 4
3 Terms and definitions …………………………………………………………………………………………………….. 4
4 Fundamental requirements for spectacle lenses …………………………………………………………….. 4
4.1 Performance ………………………………………………………………………………………………………………….. 4
4.2 Design …………………………………………………………………………………………………………………………… 4
4.3 Materials ………………………………………………………………………………………………………………………… 5
4.4 Mechanical strength ……………………………………………………………………………………………………….. 5
4.5 Transmittance ………………………………………………………………………………………………………………… 5
5 Test methods …………………………………………………………………………………………………………………. 6
5.1 General ………………………………………………………………………………………………………………………….. 6
5.2 Inflammability ………………………………………………………………………………………………………………… 6
5.3 Test for mechanical strength ………………………………………………………………………………………….. 6
6 Identification ………………………………………………………………………………………………………………….. 8
6.1 Identification of the spectacle lens to be stated on the package of each individual
spectacle lens or in an accompanying document ……………………………………………………………. 8
6.2 Information to be made available ……………………………………………………………………………………. 9
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC ………………………………………………………………………. 10

Ophthalmic instruments – Fundamental requirements and test methods – Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006)

Abstract

ISO 15004-1:2006 specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments. ISO 15004-1:2006 is also applicable to low-vision aids and tonometers, but not to other ophthalmic instruments which are used in contact with the globe of the eye.

ISO 15004-1:2006 is not applicable to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye.

DIN EN ISO 15004-1:2009-07 (D)
Ophthalmische Instrumente – Grundlegende Anforderungen und Prüfverfahren – Teil
1: Allgemeine Anforderungen an ophthalmische Instrumente (ISO 15004-1:2006);
Deutsche Fassung EN ISO 15004-1:2009
Inhalt Seite
Vorwort …………………………………………………………………………………………………………………………………………….3
1 Anwendungsbereich ……………………………………………………………………………………………………………..4
2 Normative Verweisungen ………………………………………………………………………………………………………4
3 Begriffe …………………………………………………………………………………………………………………………………4
4 Grundlegende Anforderungen (an nichtaktive und aktive ophthalmische Instrumente) …………..5
4.1 Allgemeines ………………………………………………………………………………………………………………………….5
4.2 Konstruktion …………………………………………………………………………………………………………………………5
4.3 Leistung………………………………………………………………………………………………………………………………..5
4.4 Kombination verschiedener Geräte………………………………………………………………………………………..5
4.5 Materialien…………………………………………………………………………………………………………………………….5
4.6 Schutz gegen Kontamination…………………………………………………………………………………………………6
4.7 Skalen und Anzeigen …………………………………………………………………………………………………………….6
4.8 Thermische Gefährdungen…………………………………………………………………………………………………….6
4.9 Mechanische Gefährdungen ………………………………………………………………………………………………….6
5 Umweltbedingungen (für nichtaktive und aktive ophthalmische Instrumente)…………………………6
5.1 Umweltbedingungen beim Gebrauch……………………………………………………………………………………..6
5.2 Lagerbedingungen ………………………………………………………………………………………………………………..7
5.3 Transportbedingungen ………………………………………………………………………………………………………….7
6 Besondere Anforderungen an aktive ophthalmische Instrumente…………………………………………..8
6.1 Elektrische Sicherheit……………………………………………………………………………………………………………8
6.2 Nicht anwendbare Abschnitte von IEC 60601-1:2005………………………………………………………………8
6.3 Gefährdung durch optische Strahlung …………………………………………………………………………………..8
7 Prüfverfahren ………………………………………………………………………………………………………………………..8
7.1 Entflammbarkeit ……………………………………………………………………………………………………………………8
7.2 Oberflächentemperaturen ……………………………………………………………………………………………………..8
7.3 Umweltbedingungen ……………………………………………………………………………………………………………..8
7.4 Prüfung der elektrischen Sicherheit……………………………………………………………………………………….9
8 Vom Hersteller bereitzustellende Informationen …………………………………………………………………..10
8.1 Begleitdokumente ……………………………………………………………………………………………………………….10
8.2 Kennzeichnung……………………………………………………………………………………………………………………10
Anhang A (informativ) Produktbezogene Internationale Normen für ophthalmische Instrumente……….11
Anhang ZA (informativ) Zusammenhang zwischen dieser Europäischen Norm und den
grundlegenden Anforderungen der EG-Richtlinie 93/42 EWG ……………………………………………….12

Ophthalmic implants – Ophthalmic viscosurgical devices (ISO 15798:2010)

Abstract

ISO 15798:2013 is applicable to ophthalmic viscosurgical devices (OVDs), a class of non-active surgical implants with viscous and/or viscoelastic properties, intended for use during surgery in the anterior segment of the human eye. OVDs are designed to create and maintain space, to protect intra-ocular tissues and to manipulate tissues during surgery.

ISO 15798:2013 specifies requirements with regard to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling and information supplied by the manufacturer of these devices.

DIN EN ISO 15798:2014-02 (E)
Ophthalmic implants – Ophthalmic viscosurgical devices (ISO 15798:2013)
Contents Page
Foreword ………………………………………………………………………………………………………………………………………………………………………………………………………………3
1 Scope ………………………………………………………………………………………………………………………………………………………………………………………………………4
2 Normative references ………………………………………………………………………………………………………………………………………………………………..4
3 Terms and definitions ……………………………………………………………………………………………………………………………………………………………….5
4 Intended performance ……………………………………………………………………………………………………………………………………………………………..6
5 Design attributes …………………………………………………………………………………………………………………………………………………………………………..7
5.1 General ………………………………………………………………………………………………………………………………………………………………………………….. 7
5.2 Characterization of the components …………………………………………………………………………………………………………………… 7
5.3 Characterization of the finished product …………………………………………………………………………………………………………. 7
6 Design evaluation …………………………………………………………………………………………………………………………………………………………………………9
6.1 General ………………………………………………………………………………………………………………………………………………………………………………….. 9
6.2 Evaluation of biological safety ………………………………………………………………………………………………………………………………… 9
6.3 Clinical evaluation ………………………………………………………………………………………………………………………………………………………..10
7 Sterilization ……………………………………………………………………………………………………………………………………………………………………………………12
8 Product stability …………………………………………………………………………………………………………………………………………………………………………13
9 Integrity and performance of the delivery system ……………………………………………………………………………………………13
10 Packaging …………………………………………………………………………………………………………………………………………………………………………………………13
10.1 Protection from damage during storage and transport…………………………………………………………………………13
10.2 Maintenance of sterility in transit ………………………………………………………………………………………………………………………13
11 Information to be supplied by the manufacturer ………………………………………………………………………………………………13
Annex A (normative) Intraocular implantation test ………………………………………………………………………………………………………….15
Annex B (informative) Patient numbers for clinical investigation of intraocular pressure ………………..18

Annex ZA Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC 19
…………………………………………………………………………………………………………..

Ophthalmic optics – Mounted spectacle lenses (ISO 21987:2009)

Abstract

ISO 21987:2009 specifies requirements for mounted spectacle lenses relative to the prescription order.

DIN EN ISO 21987:2010-02 (E)
Ophthalmic optics – Mounted spectacle lenses (ISO 21987:2009)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….3
1 Scope ……………………………………………………………………………………………………………………………..4
2 Normative references ……………………………………………………………………………………………………..4
3 Terms and definitions ……………………………………………………………………………………………………..4
4 Classification ………………………………………………………………………………………………………………….5
5 Requirements …………………………………………………………………………………………………………………5
5.1 Reference temperature ……………………………………………………………………………………………………5
5.2 Lenses used in manufacturing complete spectacles ………………………………………………………..5
5.3 Optical requirements ………………………………………………………………………………………………………5
5.4 Thickness tolerance ………………………………………………………………………………………………………..9
5.5 Positioning tolerances …………………………………………………………………………………………………….9
6 Test methods ………………………………………………………………………………………………………………..10
6.1 General …………………………………………………………………………………………………………………………10
6.2 Measurement method for the back vertex power of single-vision lenses and the distance
portion of multifocal and progressive-power lenses and near portion of degressivepower
lenses …………………………………………………………………………………………………………………11
6.3 Measurement method for cylinder axis ………………………………………………………………………….11
6.4 Addition power measurement ………………………………………………………………………………………..11
6.5 6.6 Material and surface quality ……………………………………………………………………………………..13
6.7 Prism imbalance (relative prism error) measurement method for pairs of single-vision
and multifocal lenses …………………………………………………………………………………………………….13
7 Marking for progressive-power and degressive-power lenses ………………………………………..13
7.1 Permanent marking ……………………………………………………………………………………………………….13
7.2 8 Identification ………………………………………………………………………………………………………………14
9 Reference to ISO 21987 …………………………………………………………………………………………………14
Annex A (informative) Material and surface quality ……………………………………………………………………….15
Annex B (informative) Recommendations on mounting …………………………………………………………………16
Annex C (informative) Alternative methods for measuring prism imbalance (relative prism error)
for pairs of single-vision and multifocal lenses ………………………………………………………………18
Bibliography …………………………………………………………………………………………………………………………………20
Requirements of EU Directive 93/42/EEC ………………………………………………………………………………………21
Annex ZA (informative) Relationship between this European Standard and the Essential Nonpermanent
marking ……………………………………………………………………………………………………….14
Method for measuring position and tilt ………………………………………………………………………………………….13