This International Standard is applicable to ophthalmic viscoelastic substances, a class of non-active surgical implants with viscous and/or viscoelastic properties intended for use in surgical procedures in the anterior portion of the human eye. Viscoelastic substances have been developed to create and maintain space, protect intraocular tissues, and manipulate tissue during surgical procedures. With respect to safety, this International Standard specifies requirements for the intended function, design features, preclinical and clinical evaluations, sterilization, packaging, labeling and information provision by the manufacturer of these devices, as well as testing procedures.
EN ISO 15798:2013 Referenced Document
EN 1041:2008 Information supplied by the manufacturer of medical devices
ISO 10993-16:2010 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-2:2006 Biological evaluation of medical devices - Part 2: Animal welfare requirements
ISO 10993-6:2007 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
ISO 10993-9:2009 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
ISO 11137-3:2006 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects
ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 13408-1:2008 Aseptic processing of health care products - Part 1: General requirements
ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
ISO 14630:2012 Non-active surgical implants - General requirements
EN ISO 15798:2013 history
2022EN ISO 15798:2022 Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2022)
2013EN ISO 15798:2013 Ophthalmic implants - Ophthalmic viscosurgical devices
2010EN ISO 15798:2010 Ophthalmic implants - Ophthalmic viscosurgical devices
2001EN ISO 15798:2001 Ophthalmic Implants - Ophthalmic Viscosurgical Devices Incorporating corrigendum March 2005