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BS EN ISO 15798:2022

BS EN ISO 15798:2022

$142.49

Ophthalmic implants. Ophthalmic viscosurgical devices

Published By Publication Date Number of Pages
BSI 2022 32
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This document is applicable to ophthalmic viscosurgical devices (OVDs), a class of surgical invasive medical devices 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 intraocular tissues and to manipulate tissues during surgery. This document 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.

PDF Catalog

PDF Pages PDF Title
2 undefined
5 European foreword
Endorsement notice
9 Foreword
12 1 Scope
2 Normative references
13 3 Terms and definitions
14 4 Intended performance
15 5 Design attributes
5.1 General
5.2 Characterization of the components
5.3 Characterization of the finished product
5.3.1 General
16 5.3.2 Absolute complex viscosity
5.3.3 Chemical and biological contaminants
5.3.4 Concentration
5.3.5 Elasticity
5.3.6 Molecular mass distribution
5.3.7 Osmolality
17 5.3.8 Particulates
5.3.9 pH
5.3.10 Refractive index
5.3.11 Shear viscosity
5.3.12 Spectral transmittance
18 5.4 Usability
6 Design evaluation
6.1 General
6.2 Evaluation of biological safety
6.2.1 General
19 6.2.2 Bacterial endotoxins test
6.2.3 Clearance of residual OVD from the anterior chamber
6.2.4 Degradation and toxicokinetics
6.2.5 Evaluation of inflammation and intraocular pressure
6.3 Clinical evaluation
6.3.1 General
20 6.3.2 Clinical investigation design
6.3.3 Corneal endothelial cell density
6.3.4 Postoperative inflammation
21 6.3.5 Post-operative intraocular pressure change
6.3.6 Adverse events
7 Sterilization
22 8 Product stability
9 Integrity and performance of the delivery system
10 Packaging
10.1 Protection from damage during storage and transport
10.2 Maintenance of sterility in transit
11 Information to be supplied by the manufacturer
24 Annex A (normative) Intraocular implantation test
27 Annex B (informative) Patient numbers for clinical investigation of intraocular pressure
28 Annex C (informative) Analyses of OVD clinical data
30 Bibliography

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BS EN ISO 15798:2022
$142.49