BS EN ISO 15798:2022
Ophthalmic implants. Ophthalmic viscosurgical devices
- Standard No.
- BS EN ISO 15798:2022
- Release Date
- 2022
- Published By
- British Standards Institution (BSI)
- Latest
- BS EN ISO 15798:2022
- Scope
- 1 Scope This document is applicable to ophthalmic viscosurgical devices (OVDs), a class of surgical invasive medical devices 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 intraocular tissues and to manipulate tissues during surgery. This document 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 15798:2022 Referenced Document
- EN 1041 Information supplied by the manufacturer of medical devices
- ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO 10993-6 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
- ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals; Technical Corrigendum 1
- ISO 10993-9 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
- ISO 11135 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices AMENDMENT 1: Revision of Annex E, Single batch release
- 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
- ISO 11137-3 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control
- 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 Clinical investigation of medical devices for human subjects - Good clinical practice
- ISO 14971 Medical devices - Application of risk management to medical devices
- 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
- ISO 22442-2 Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling
- 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
BS EN ISO 15798:2022 history
- 2022 BS EN ISO 15798:2022 Ophthalmic implants. Ophthalmic viscosurgical devices
- 2018 BS EN ISO 15798:2013+A1:2017 Ophthalmic implants. Ophthalmic viscosurgical devices
- 2013 BS EN ISO 15798:2013 Ophthalmic implants. Ophthalmic viscosurgical devices
- 0000 BS EN ISO 15798:2010
