DPS
Drejtoria e Përgjithshme e Standardizimit
0 Items
My account
E-albania
Phone: +355 4 222 62 55
E-mail: info@dps.gov.al
Address: Address: "Reshit Collaku" Str., (nearby ILDKPKI, VI floor), Po.Box 98, Tiranë - Albania
Main menu

SSH EN ISO 16671:2015

Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015)

Mar 29, 2016

General information

60.60     Mar 29, 2016

DPS

DPS/KT 316

European Norm

11.040.70  

English  

Buying

Published

Language in which you want to receive the document.

Scope

ISO 16671:2015 defines requirements with regards to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling, and the information supplied by the manufacturer.
ISO 16671:2015 applies to ophthalmic irrigating solutions (OIS), used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological, or metabolic function.

Related directives

Directives related to this standards.

93/42/EEC

Medical devices

Directive 93/42/EEC

Life cycle

PREVIOUSLY

WITHDRAWN
SSH EN ISO 16671:2005

NOW

PUBLISHED
SSH EN ISO 16671:2015
60.60 Standard published
Mar 29, 2016

Related project

Adopted from EN ISO 16671:2015