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BS EN ISO 16672:2021

BS EN ISO 16672:2021

$142.49

Ophthalmic implants. Ocular endotamponades

Published By Publication Date Number of Pages
BSI 2021 24
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This document applies to ocular endotamponades (OE), a group of non-solid surgically invasive medical devices introduced into the vitreous cavity of the eye to flatten and position a detached retina onto the retinal pigment epithelium (RPE), or to tamponade the retina.

With regard to the safety and efficacy of OE, this document specifies requirements for their intended performance, design attributes, pre-clinical and clinical evaluation, sterilization, product packaging, product labelling and the information supplied by the manufacturer.

PDF Catalog

PDF Pages PDF Title
2 National foreword
4 European foreword
6 Foreword
7 1 Scope
2 Normative references
3 Terms and definitions
9 4 Intended performance
5 Design attributes
5.1 General
5.2 Chemical description and contaminants
10 5.3 Density
5.4 Gaseous expansion
5.5 Interfacial tension
5.6 Kinematic viscosity
5.7 Dynamic viscosity
5.8 Molecular mass distribution
11 5.9 Particulates
5.10 Refractive index
5.11 Spectral transmittance
5.12 Surface tension
5.13 Vapour pressure
6 Design evaluation
6.1 General
12 6.2 Evaluation of biological safety
6.2.1 General
6.2.2 Bacterial endotoxins test
6.2.3 Intraocular implantation test
6.2.4 Ethylene oxide
13 6.3 Clinical investigation
7 Sterilization
8 Product stability
9 Integrity and performance of the delivery system
14 10 Packaging
10.1 Protection from damage during storage and transport
10.2 Maintenance of sterility in transit
11 Information supplied by the manufacturer
16 Annex A (normative) Intraocular implantation test
17 Annex B (informative) Clinical investigation
20 Annex C (informative) Method for quantifying incompletely fluorinated contaminants in perfluorocarbon liquids
22 Bibliography

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BS EN ISO 16672:2021
$142.49