BS EN ISO 15798:2010

BS EN ISO 15798:2010 Ophthalmic implants. Ophthalmic viscosurgical devices

BS EN ISO 15798 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.

BS EN ISO 15798 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.

BS EN ISO 15798:

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

6 Design evaluation

6.1 General

6.2 Evaluation of biological safety

6.3 Clinical evaluation

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 intra-ocular pressure

Bibliography