Certification | Devices of I category | Equipment of category II and III | News

In order to circulate in Europe, some products must demonstrate that they comply with minimum safety requirements defined by specific European Directives and/or Regulations. These legislative documents establish procedures to assess the devices to guarantee safety, and they provide for the placing of the CE marking testifying to the compliance with the applicable essential requirements. As for personal protective equipment of Category I – such as sunglasses, swimming goggles and skiing goggles – and some medical devices of class I – such as spectacle frames, reading glasses, ophthalmic lenses – Certottica carries out technical tests in its laboratory issuing a test report which can be used to support the product Technical Documents, and it offers help to manufacturers in preparing the technical documents.

In this sector Certottica can boast a 20-year long experience which has made it become a leader at national and international level in carrying out laboratory tests to support and assist companies.

As for Personal Protective Equipment (PPE) of Category I – sunglasses, skiing goggles and swimming goggles – Certottica’s laboratories work in compliance with both European standards and the international standards listed below (the list is not complete):

       •       EN 174:2001 “Personal eye-protection - Ski goggles for downhill skiing”;
       •       ISO 12312-1:2013/Amd 1:2015 “Eye and face protection—Sunglasses and related eyewear — Part 1: Sunglasses for general use”;
       •       EN 16805:2015 “Diving equipment. Diving mask. Requirements and test methods”;
       •       BS 5883:1996 “Specification for Surface swimming goggles”.
       •       ASTM F 659:2010 “Standard Specification for Skier Goggles and Faceshields”;
       •       ANSI Z80.3-2015 “Ophthalmic – Non-prescription Sunglasses and Fashion Eyewear – Requirements”;
       •       AS/NZS 1067:2003/Amdt 1:2009 “Sunglasses and fashion spectacle;

As for Medical devices of Class I - spectacle frames, reading glasses, ophthalmic lenses- Certottica ‘s laboratories work in compliance with European standards and also with the international standards listed below:

       •       ISO 12870:2012 “Ophthalmic optics — Spectacle frames — Requirements and test methods”;
       •       ISO 8980-1:2004 “Ophthalmic optics — Uncut finished spectacle lenses — Part 1: Specifications for single-vision and multifocal lenses”;
       •       ISO 8980-2:2004 “Ophthalmic optics — Uncut finished spectacle lenses — Part 2: Specifications for progressive power lenses”;
       •       ISO 8980-3:2013 “Ophthalmic optics — Uncut finished spectacle lenses — Part 3: Transmittance specifications and test methods”;
       •       ISO 8980-4:2006 “Ophthalmic optics — Uncut finished spectacle lenses — Part 4: Specifications and test methods for antireflective coatings”;
       •       ISO 8980-5:2005 “Ophthalmic optics — Uncut finished spectacle lenses — Part 5: Minimum requirements for spectacle lens surfaces claimed to be abrasion-resistant”;
       •       EN 14139:2010 “Ophthalmic optics Specifications for ready-to-wear spectacles”;
       •       ISO 16034:2002/AC:2006 “Ophthalmic optics-Specifications for single-vision ready-to-wear near vision spectacles”.

On equipment made of metal material, Certottica’s chemical laboratory carries out the nickel release test in compliance with the following standards:
       •       EN 16128:2015 “Reference method for the testing of spectacles frames and sunglasses for nickel release”
       •       EN 12472:2005 “Method the simulation of wear and corrosion for the detection of nickel release from coated items”;
       •       EN 1811:1998 + A1/2008 “Reference test method for release of nickel from products intended to come into direct and prolonged contact with the skin”;

Qualified staff offers technical assistance also regarding specific problems requiring “custom made” solutions and therefore other specific laboratory tests.
Indeed, we carry out tests such as Cass Test and AWT, besides chemical tests on equipment such as metal and plastic frames, leather inserts and textiles, cases and customs jewellery, both in compliance with European standards and the international standards listed below (the list is not complete).

       •       EN 1122:2002 “Plastics - Determination of cadmium - Wet decomposition method”
       •       ASTM E1645-01 (2016) “Standard Practice for Preparation of Dried Paint Samples by Hotplate or Microwave Digestion for Subsequent Lead Analysis”
       •       ASTM E1613-12 “Standard Test Method for Determination of Lead by Inductively Coupled Plasma Atomic Emission Spectrometry (ICP-AES), Flame Atomic Absorption Spectrometry (FAAS), or Graphite Furnace Atomic Absorption Spectrometry (GFAAS) Techniques”
       •       EN 71-3:2014 “Safety of toys - Migration of certain elements”
       •       CPSC-CH-E1001-08.3 “Total Lead in Metal”
       •       CPSC-CH-E1002-08.3 “Standard Operating Procedure for determining total Lead (Pb) in non-metal children’s products”-      
       •       CPSC-CH-E1003-09.1 “Standard Operating Procedure for determining total Lead (Pb) in Paint and Other Similar Surface Coatings”
       •       CPSC-CH-C1001-09.3 “Standard Operating Procedure for determination of phthalates”
       •       ISO 17234-1:2015 “Chemical test of determination of certain azo colorants in dyed leathers”
       •       EN ISO 17075:2008 “Leather: Determination of Chromium (VI) content”
       •       ISO 17072-1:2011 “Leather: Chemical determination of metal content-Part 1: Extractable metals”
       •       ISO 17072-2:2011 “Leather: Chemical determination of metal content-Part 2: Total metal content”
       •       ISO 17226-2:2008 “Leather: Chemical determination of formaldehyde content-Part 2: method using colorimetric analysis”
       •       ISO 4045:2008 “Leather: Chemical test of determination of pH”
       •       ISO 11642:2013 “Leather: Tests for colour fastness – Colour fastness to water””
       •       ISO 14184-1:2011 “ Textiles: Determination textiles of formaldehyde - Part 1: Free and hydrolysed formaldehyde (water extraction method)”
       •       EN 14362-1:2012 “ Textiles: Methods for determination of certain aromatic amines derived from azo colorants - Part 1: Detection of the use of certain azo colorants accessible with and without extracting the fibres”
       •       ISO 3071:2006 “ Textiles: Determination of pH of aqueous extract”
       •       ISO 105 E04:2013 “Textiles-Test for colour fastness. Part E04: Colour fastness to perspiration”

Certottica offers a complete service supporting companies, having qualified staff both to prepare documents and to carry out laboratory tests.

For further information contact the Sales Department dialling 0039.0437.573157