60.55 Ratification completed (DOR) Nov 17, 2024
CEN
CEN/TC 170 Ophthalmic optics
European Norm
11.040.70 Ophthalmic equipment
Draft
This document specifies fundamental requirements and their test methods for unglazed spectacle frames designed for use with prescription lenses. It is applicable to spectacle frames at the point of sale by the manufacturer or supplier to the retailer.
This document is applicable to:
— all mass-produced spectacle frame types, including rimless mounts, semi-rimless mounts and folding spectacle frames;
— spectacle frames made with additive manufacturing, for example, 3D printing;
— spectacle frames made from natural organic materials;
— the frame or mount of clip-ons designed specifically for attachment to particular models of spectacle frame, but not to their lenses or filters to which ISO 16034 or ISO 12312-1 apply;
— prescription inserts designed for attachment to particular models of, for example, eye protector, sunglass or diving mask.
Parts of this document are applicable to custom-made frames – see 3.1.3 and Table 1.
NOTE See Annex A for recommendations on the design of spectacle frames and terms to be used when describing metal frames.
This document is not applicable to spectacle frames used in eye protection, where ISO 16321-1 applies, or to sunglasses with afocal filters, where ISO 12312-1 applies.
Legislation related to this standard
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
PUBLISHED
EN ISO 12870:2018
IN_DEVELOPMENT
FprEN ISO 12870
60.55
Ratification completed (DOR)
Nov 17, 2024