Ophthalmic implants – Ophthalmic viscosurgical devices (ISO 15798:2010)
Abstract
ISO 15798:2013 is applicable to ophthalmic viscosurgical devices (OVDs), a class of non-active surgical implants 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 intra-ocular tissues and to manipulate tissues during surgery.
ISO 15798:2013 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.
DIN EN ISO 15798:2014-02 (E)
Ophthalmic implants – Ophthalmic viscosurgical devices (ISO 15798:2013)
Contents Page
Foreword ………………………………………………………………………………………………………………………………………………………………………………………………………………3
1 Scope ………………………………………………………………………………………………………………………………………………………………………………………………………4
2 Normative references ………………………………………………………………………………………………………………………………………………………………..4
3 Terms and definitions ……………………………………………………………………………………………………………………………………………………………….5
4 Intended performance ……………………………………………………………………………………………………………………………………………………………..6
5 Design attributes …………………………………………………………………………………………………………………………………………………………………………..7
5.1 General ………………………………………………………………………………………………………………………………………………………………………………….. 7
5.2 Characterization of the components …………………………………………………………………………………………………………………… 7
5.3 Characterization of the finished product …………………………………………………………………………………………………………. 7
6 Design evaluation …………………………………………………………………………………………………………………………………………………………………………9
6.1 General ………………………………………………………………………………………………………………………………………………………………………………….. 9
6.2 Evaluation of biological safety ………………………………………………………………………………………………………………………………… 9
6.3 Clinical evaluation ………………………………………………………………………………………………………………………………………………………..10
7 Sterilization ……………………………………………………………………………………………………………………………………………………………………………………12
8 Product stability …………………………………………………………………………………………………………………………………………………………………………13
9 Integrity and performance of the delivery system ……………………………………………………………………………………………13
10 Packaging …………………………………………………………………………………………………………………………………………………………………………………………13
10.1 Protection from damage during storage and transport…………………………………………………………………………13
10.2 Maintenance of sterility in transit ………………………………………………………………………………………………………………………13
11 Information to be supplied by the manufacturer ………………………………………………………………………………………………13
Annex A (normative) Intraocular implantation test ………………………………………………………………………………………………………….15
Annex B (informative) Patient numbers for clinical investigation of intraocular pressure ………………..18
Annex ZA Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC 19
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