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ISO 15798:2010

Ophthalmic implants — Ophthalmic viscosurgical devices

Jan 15, 2010
95.99   Withdrawal of Standard   Sep 2, 2013

General information

95.99     Sep 2, 2013

ISO

ISO/TC 172/SC 7

International Standard

11.040.70  

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 15798:2001

WITHDRAWN
ISO 15798:2001/Cor 1:2003

NOW

WITHDRAWN
ISO 15798:2010
95.99 Withdrawal of Standard
Sep 2, 2013

REVISED BY

WITHDRAWN
ISO 15798:2013

National adoptions

SRPS EN ISO 15798:2012  
ISS

Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2010)

95.99   Withdrawal of Standard

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