ISO 16672:2020
Ophthalmic implants — Ocular endotamponades
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.
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Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 Design attributes
5.1 General
5.2 Chemical description and contaminants
5.3 Density
5.4 Gaseous expansion
5.5 Interfacial tension
5.6 Kinematic viscosity
5.7 Dynamic viscosity
5.8 Molecular mass distribution
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
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
6.3 Clinical investigation
7 Sterilization
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 supplied by the manufacturer
Annex A (normative) Intraocular implantation test
Annex B (informative) Clinical investigation
Annex C (informative) Method for quantifying incompletely fluorinated contaminants in perfluorocarbon liquids
Bibliography
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Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 Design attributes
5.1 General
5.2 Chemical description and contaminants
5.3 Density
5.4 Gaseous expansion
5.5 Interfacial tension
5.6 Kinematic viscosity
5.7 Dynamic viscosity
5.8 Molecular mass distribution
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
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
6.3 Clinical investigation
7 Sterilization
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 supplied by the manufacturer
Annex A (normative) Intraocular implantation test
Annex B (informative) Clinical investigation
Annex C (informative) Method for quantifying incompletely fluorinated contaminants in perfluorocarbon liquids
Bibliography