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OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY
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Published date: 12-01-2013
Publisher: Netherlands Standards
Foreword1 Scope2 Normative references3 Terms and definitions4 Intended performance5 Design attributes6 Design evaluation7 Sterilization8 Product stability9 Packaging10 Information supplied by the manufacturerAnnex A (informative) - Example of a suitable method for pH measurement and buffer capacity determinationAnnex B (normative) - Particulate contamination: visible particulatesAnnex C (informative) - Light obscuration test method for particulate contamination: subvisible particlesAnnex D (informative) - Microscopic test method for particulate contamination: subvisible particlesAnnex E (normative) - Intraocular irrigation testAnnex F (informative) - Clinical investigationBibliography
Specifies requirements with regards to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling, and the information supplied by the manufacturer.
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