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BS EN ISO 15004-1:2020

BS EN ISO 15004-1:2020

$86.31

Ophthalmic instruments. Fundamental requirements and test methods – General requirements applicable to all ophthalmic instruments

Published By Publication Date Number of Pages
BSI 2020 14
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This document specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments and to devices for enhancing low vision. This document is also applicable to tonometers, but not to other ophthalmic instruments which are used in contact with the globe of the eye.

This document is not applicable to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye.

This document specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments and to devices for enhancing low vision. This document is also applicable to tonometers, but not to other ophthalmic instruments which are used in contact with the globe of the eye.

This document is not applicable to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye.

PDF Catalog

PDF Pages PDF Title
2 National foreword
4 European foreword
6 Foreword
7 1 Scope
2 Normative references
3 Terms and definitions
8 4 Fundamental requirements
4.1 General
4.2 Design
4.3 Performance
4.4 Combination of different devices
9 4.5 Materials
4.6 Protection against contaminants
4.7 Scales and displays
4.8 Thermal hazards
4.9 Mechanical hazards
5 Environmental conditions
6 Particular requirements for active ophthalmic instruments
6.1 Electrical safety
6.2 Inapplicable clauses of IEC 60601‑1
10 6.3 Optical radiation hazard
7 Test methods
7.1 General
7.2 Ignitability
7.3 Surface temperatures
7.4 Electrical safety
8 Information supplied by the manufacturer
8.1 Accompanying documents
8.2 Marking
12 Annex A (informative) Product-related International Standards for ophthalmic instruments
13 Bibliography

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BS EN ISO 15004-1:2020
$86.31