ISO 15798:2010

Ophthalmic implants — Ophthalmic viscosurgical devices

Datum objavljivanja: 15. 1. 2010.

95.99 Povučen 2. 9. 2013.

Опште информације

Trenutna faza: 95.99 Effective date: 2. 9. 2013.

Inicijator: ISO

Pripada: ISO/TC 172/SC 7

Vrsta: Međunarodni standard

ICS: 11.040.70

Jezik: engleski francuski

Kupovina

Status: Povučen

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Apstrakt

ISO 15798:2010 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.
ISO 15798:2010 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.