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Ophthalmic implants - Ophthalmic viscosurgical devices
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Available format(s): Hardcopy, PDF
Superseded date: 10-03-2022
Language(s): English
Published date: 29-10-2017
Publisher: National Standards Authority of Ireland
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.Only cited Standards give presumption of conformance to New Approach Directives/Regulations.Dates of withdrawal of national standards are available from NSAI.
Foreword1 Scope2 Normative references3 Terms and definitions4 Intended performance5 Design attributes6 Design evaluation7 Sterilization8 Product stability9 Integrity and performance of the delivery system10 Packaging11 Information to be supplied by the manufacturerAnnex A (normative) Intraocular implantation testAnnex B (informative) Patient numbers for clinical investigation of intraocular pressureBibliography
This International Standard is applicable to ophthalmic viscosurgical devices (OVDs), a class of nonactive surgical implants with viscous and/or viscoelastic properties, intended for use during surgery in the anterior segment of the human eye.
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