This International Standard 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.
This International Standard 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.
ISO 15798:2010 Referenced Document
EN 980 Graphical Symbols for Use in the Labelling of Medical Devices
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*， 2018-08-01 Update
ISO 10993-2 Biological evaluation of medical devices — Part 2: Animal welfare requirements*， 2022-11-03 Update
ISO 10993-6 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation*， 2016-12-01 Update
ISO 10993-9 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products*， 2019-11-26 Update
ISO 11135-1 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 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices AMENDMENT 2: Revision to 4.3.4 and 11.2
ISO 11137-2 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Amendment 1*， 2022-06-13 Update
ISO 11137-3 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control*， 2017-06-01 Update
ISO 11607-1 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1
ISO 13408-1 Aseptic processing of health care products — Part 1: General requirements*， 2023-06-01 Update
ISO 14155-1 Clinical investigation of medical devices for human subjects - Part 1: General requirements
ISO 14155-2 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plants
ISO 14630 Non-active surgical implants - General requirements*， 2012-12-01 Update
ISO 14971 Medical devices - Application of risk management to medical devices*， 2019-12-01 Update
ISO 15223-1 Medical devices-Symbols to be used with information to be supplied by the manufacturer-Part 1: General requirements
ISO 15223-2 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 2: Symbol development, selection and validation
ISO 17665-1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 22442-1 Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management*， 2020-09-15 Update
ISO 22442-2 Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling*， 2020-09-15 Update
ISO 22442-3 Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents