ISO 15798:2022
Ophthalmic implants — Ophthalmic viscosurgical devices
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.
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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 Characterization of the components
5.3 Characterization of the finished product
5.3.1 General
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
5.3.8 Particulates
5.3.9 pH
5.3.10 Refractive index
5.3.11 Shear viscosity
5.3.12 Spectral transmittance
5.4 Usability
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 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
6.3.2 Clinical investigation design
6.3.3 Corneal endothelial cell density
6.3.4 Postoperative inflammation
6.3.5 Post-operative intraocular pressure change
6.3.6 Adverse events
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 to be supplied by the manufacturer
Annex A (normative) Intraocular implantation test
Annex B (informative) Patient numbers for clinical investigation of intraocular pressure
Annex C (informative) Analyses of OVD clinical data
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 Characterization of the components
5.3 Characterization of the finished product
5.3.1 General
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
5.3.8 Particulates
5.3.9 pH
5.3.10 Refractive index
5.3.11 Shear viscosity
5.3.12 Spectral transmittance
5.4 Usability
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 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
6.3.2 Clinical investigation design
6.3.3 Corneal endothelial cell density
6.3.4 Postoperative inflammation
6.3.5 Post-operative intraocular pressure change
6.3.6 Adverse events
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 to be supplied by the manufacturer
Annex A (normative) Intraocular implantation test
Annex B (informative) Patient numbers for clinical investigation of intraocular pressure
Annex C (informative) Analyses of OVD clinical data
Bibliography