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Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.040 Medical equipment>11.040.70 Ophthalmic equipment>BS EN ISO 15798:2022 Ophthalmic implants. Ophthalmic viscosurgical devices
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immediate downloadReleased: 2022-07-19
BS EN ISO 15798:2022 Ophthalmic implants. Ophthalmic viscosurgical devices

BS EN ISO 15798:2022

Ophthalmic implants. Ophthalmic viscosurgical devices

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Standard number:BS EN ISO 15798:2022
Pages:32
Released:2022-07-19
ISBN:978 0 539 12121 6
Status:Standard
DESCRIPTION

BS EN ISO 15798:2022


This standard BS EN ISO 15798:2022 Ophthalmic implants. Ophthalmic viscosurgical devices is classified in these ICS categories:
  • 11.040.70 Ophthalmic equipment
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.