Eyewear Testing to European Directives

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The presentation was delivered by our eyewear expert Candia Tse and cover such important points as:

• Classification of eyewear products for the purposes of compliance
• EU legislations regulating eyewear safety
• What REACH regulations mean for eyewear brands

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Eyewear Testing to European Directives

  1. 1. We Bring Trust and Ethical Standards to Trade Globally
  2. 2. Product InspectionsLaboratory Testing Supplier Audit Programs info@asiainspection.com – AsiaInspection ©   2 Eyewear Testing to European Directives Candia TSE Managing Director, AI ETIC
  3. 3. Product InspectionsLaboratory Testing Supplier Audit Programs info@asiainspection.com – AsiaInspection ©   3 Eyewear Compliance: EU Regulations  93/42/EEC – Medical Devices Directive (new directive number 2007/47/EC)  89/686/EC – Personal Protection Equipment Directive  CE Marking Directive  1907/2006/EC – REACH directive • Nickel directive 94/27/EEC • Cadmium directive 91/338/EEC • Phthalates directive 2005/84/EC • Total lead content, etc.
  4. 4. Product InspectionsLaboratory Testing Supplier Audit Programs info@asiainspection.com – AsiaInspection ©   4 Medical devices (ophthalmic) Personal protection devices (eye protection) Ophthalmic products Spectacle frames Spectacle lenses Reading glasses Mounted spectacles Driving use lenses Prescription spectacles Eye protection products Safety spectacles Safety goggles / face shields Sunglasses Ski / sports use goggles Driving use lenses Filtering lenses Eyewear Product Categories
  5. 5. Product InspectionsLaboratory Testing Supplier Audit Programs info@asiainspection.com – AsiaInspection ©   5 Medical Devices 93/42/EEC (new directive number 2007/47/EC) Personal protection equipment 89/686/EC (PPE) for protection needs Eyewear Product Categories  Class 1a non-sterile medical devices for corrective needs  Ophthalmic optics • Spectacle frames • Ophthalmic lenses (single-vision, bi-focal and mutli-focal, progressive lenses, anti-abrasion hard coating, anti-reflective coating) • Mounted spectacle lenses • Reading glasses for near-vision use  Class 1 eye protection: simple and basic designs: such as sunglasses for general use  Class II eye and face protection: such as ski goggles, safety spectacles & goggles, face shields, goggles for snow mobiles / motorcycles, etc.  Class III eye and face protection: such as eye and face protection devices providing higher level of protection, such as against infrared radiation and welding use.
  6. 6. Product InspectionsLaboratory Testing Supplier Audit Programs info@asiainspection.com – AsiaInspection ©   6 Sometimes eyewear can be included under Medical Devices AND PPE devices, in which case both directives apply Such as:  Safety Spectacles (PPE) for prescription use – spectacles with prescription corrective effect on mounted lenses that also provide protection against certain hazards (e.g. high-speed particles).  Sunglasses (PPE) for prescription use – sunglasses with prescription corrective effect on the mounted lenses that also provide protection against sunglare (protection against UV and light damage). Dual-Purpose Eyewear
  7. 7. Product InspectionsLaboratory Testing Supplier Audit Programs info@asiainspection.com – AsiaInspection ©   7 Spectacles Sunglasses Reader Prescription frame Physiological compatibility EN ISO 12870-2014 clause 4.3 EN ISO 12312.1- 2013 clause 4.2 EN 14139-2010 clause 4.1 EN ISO 21987 Nickel Release EN ISO 12870-2014 clause 8.8 Clause 4.2 note 1 See EN ISO 12870 See EN ISO 12870 Test method 1) pr EN 12471 pre-test 2) ISO/TS 24348 nickel release 3) EN12472 +EN16128: 2011 or 2015 See EN ISO 12870 See EN ISO 12870 See EN ISO 12870 Related to REACH Directive 1907/2006 See ANNEX 17 Nickel release See ANNEX 17 Nickel Release See ANNEX 17 Nickel Release See ANNEX 17 Nickel Release SVHC – restricted substances of very high concern (168 in total). Substances containing SVHC should not be used. REACH DIRECTIVE 1907/2006/EC Annex XVII – Entry 27: Nickel • EN16128-2011 (or latest EN16128-2015): limit 0.5ug/cm2/week for eyewear products has metal parts prolonged and direct contact with skin • EN1811-2011+A1:2015: limit 0.5 ug/cm2/week for other products with prolonged and direct contact with skin is excluding EYEWEAR products. Nickel Release Testing
  8. 8. Product InspectionsLaboratory Testing Supplier Audit Programs info@asiainspection.com – AsiaInspection ©   8 Spectacle Frames Sunglasses & Sunglare Filters TESTING FOR MANDATORY REQUIREMENTS
  9. 9. EN ISO 12870-2014 test plan for spectacle frames Sample 1 Sample 2 Sample 3-4 Sample 5 1. Construction YES 2. Dimensional tolerance YES Prepare for 1st retest if available on ANY ONE failed item of the physical and mechanical test. 3. Dimensional stability YES 4. Resistance to perspiration YES 5. Resistance to ignition YES 6. Bridge deformation YES 7. Lens retention YES 8. Endurance YES 9. Nickel release Coated metal parts of spectacle frame YES if frame has metal parts prolonged contact with skin - 10. Resistance to optical radiation OPTIONAL subject to the mfr / buyer’s requirement to include or not Test Plan for Spectacle Frames
  10. 10. Product InspectionsLaboratory Testing Supplier Audit Programs info@asiainspection.com – AsiaInspection ©   10 Frame size by tracer or spectacle-caliper Frame mechanical tests Resistance to ignition, Resistance to perspiration and Thermal Stability Mainly test the frame durability and minimum requirements for daily wear (simulation for 2 years wear and normal use) Photos of Major Frame Tests
  11. 11. Product InspectionsLaboratory Testing Supplier Audit Programs info@asiainspection.com – AsiaInspection ©   11 Testing Sequence Identification of test Requirement subclause Test method subclause Sequence Sample 1 Sample 2 Samples 3 & 4 Construction 4.2.1 4.2.1 1 • Dimensional tolerance 4.3;4.4 4.4 2 • Dimensional stability 4.6 8.2 3 • Resistance to perspiration 4.7 8.3 4 • Bridge deformation 4.8.1 8.4 5 • Lens retention 4.8.2 8.4 6 • Endurance 4.8.3 8.5 7 • Resistance to ignition 4.9 8.6 8 • Resistance to optical radiation 4.10 8.7 9 •a Nickel release 4.2.3 8.8 10 •a • Indicates that the test shall be applied a This test is optional b This test is a requirement in some countries
  12. 12. Product InspectionsLaboratory Testing Supplier Audit Programs info@asiainspection.com – AsiaInspection ©   12 Sample quantity required 3 + 2 nickel release if applicable TestTurnaround time 1 week to 2 weeks include nickel release When to conduct the test? - Pre-production stage to confirm construction and fundamental requirements are met - Pre-shipment stage to confirm the products are compliance to the harmonized test & quality standard refer to European Directive What if conformity to the specified standard? CE marking can be put on the products and distributed to the European nations What if non-conformity found? Re-test after improvement made Test an additional sample in the falled test and subsequent tests This sample passes the tests Acceptable Not acceptable Test two samples Both samples pass their listed tests Both samples fall a test One sample falls any single test while the other sample passes all listed test YES NO Flow chart for compliance (excluding testing for nickel release)
  13. 13. Product InspectionsLaboratory Testing Supplier Audit Programs info@asiainspection.com – AsiaInspection ©   13 Marking of Spectacle Frames Marking Location Identification of manufacturer or his/her agent or supplier Not specified Model identification Not specified Color identification Not specified Horizontal boxed lens size with box symbol □ On the front, whenever practicable Distance between lenses On the front, whenever practicable Overall lenght of side On the side Specified order of marking of the dimensions of the front Horizontal boxed lense size Box symbol Distance between lenses NOTE1: All dimensions are given in ISO 8624. NOTE2: Marking of horizontal boxed lens size and distance between lenses is optional for three-piece rimless mounts. NOTE3: National legislation in some countries may require additional information, e.g. country of origin, to be marked on the frame. 50 □ 20
  14. 14. Product InspectionsLaboratory Testing Supplier Audit Programs info@asiainspection.com – AsiaInspection ©   14 EN 14139-2010 test plan for reading glasses Sample 1 Sample 2 Sample 3-4 Sample 5-6 A. Refractive properties YES i.e. declared optical power and tolerance, optical centration refer to declared PD and prismatic balance, etc. B. Frame requirement refers to EN ISO 12870-2014 1. Construction 2. Dimensional tolerance 3. Dimensional stability 4. Resistance to perspiration 5. Resistance to ignition 6. Bridge deformation 7. Lens retention 8. Endurance construction Dimensional tolerance Prepare for 1st retest if available on ANY ONE failed item of the physical and mechanical test. Stability Perspiration Ignition Bridge deformation & lens retention Endurance 9. Nickel release: Coated metal parts of spectacle frame YES if applicable - C. Lens requirements (refer to ISO14889) Test: 1) luminous transmittance; 2) resistance to optical radiation; 3) lens robustness, 4) ignition test on lenses, and if claimed to include 5) UV blocking … on sample 5 and 6 Single-vision Ready-to-wear Spectacles
  15. 15. Product InspectionsLaboratory Testing Supplier Audit Programs info@asiainspection.com – AsiaInspection ©   15 Refractive properties: - Spherical power - Astigmatic power - Prismatic imbalance and optical centration refers to declared PD Frame tests + Lens quality & Refractive properties Mechanical Strength of the lenses Photos of Ready-to-use READER-LENS Tests Mainly test the MOUNTED lenses are meeting the corrective requirement for reading use and the fundamental requirements on frame and lens Lens material & surface quality
  16. 16. Product InspectionsLaboratory Testing Supplier Audit Programs info@asiainspection.com – AsiaInspection ©   16  Frame requirements refer to EN ISO 12870-2014  Lens requirements refer to EN ISO 14889-2014  Refractive properties refer to EN 14139-2010 clause 4.3, 4.4 and 4.5  Product marking requirement refer to EN14139-2010 clause 5 Ophthalmic Optics – Specifications for Ready to Wear Spectacles Marking on the spectacles, indications on packaging, instructions for use 1. Marking Spectacles shall be permanently marked with the following minimum information: a) name or trade mark of manufacturer or distributor; b) manufacturer's declared spherical power in dioptres. NOTE: Additional marking of ready-to-wear spectacles according to EN ISO 12870 is optional. 2. Indications on packaging and warning Manufacturer's declared centration distance in millimetres shall be marked on the frame, hang tag or applied sticker. The name and address of the manufacturer shall be marked on the frame or be given on the hang tag or applied sticker or packaging or information provided with the device. For devices imported into the Community, the name and address of the authorized representative in the Community shall be marked on the frame or be given on the hang tag or applied sticker or packaging or information provided with the device.If the manufacturer or supplier claims compliance with this European Standard, its number and year shall be included either on the packaging or in the available literature.
  17. 17. Product InspectionsLaboratory Testing Supplier Audit Programs info@asiainspection.com – AsiaInspection ©   17  Frame requirements refer to EN ISO 12870-2014  Lens requirements refer to EN ISO 14889-2014  Refractive properties refer to EN 14139-2010 clause 4.3, 4.4 and 4.5  Product marking requirement refer to EN14139-2010 clause 5 Ophthalmic Optics – Specifications for Ready to Wear Spectacles Marking on the spectacles, indications on packaging, instructions for use 1. Marking Spectacles shall be permanently marked with the following minimum information: a) name or trade mark of manufacturer or distributor; b) manufacturer's declared spherical power in dioptres. NOTE: Additional marking of ready-to-wear spectacles according to EN ISO 12870 is optional. 2. Indications on packaging and warning Manufacturer's declared centration distance in millimetres shall be marked on the frame, hang tag or applied sticker. The name and address of the manufacturer shall be marked on the frame or be given on the hang tag or applied sticker or packaging or information provided with the device. For devices imported into the Community, the name and address of the authorized representative in the Community shall be marked on the frame or be given on the hang tag or applied sticker or packaging or information provided with the device.If the manufacturer or supplier claims compliance with this European Standard, its number and year shall be included either on the packaging or in the available literature.
  18. 18. Product InspectionsLaboratory Testing Supplier Audit Programs info@asiainspection.com – AsiaInspection ©   18 Sample quantity required Test Turnaround time When to conduct the test? What if conformity to the specified standard What if non- conformity found? 4 + 2 nickel release if applicable 1 week to 2 weeks include nickel release - Pre-production stage to confirm construction and fundamental requirements are met - Pre-shipment stage to confirm the products are compliance to the harmonized test & quality standard refer to European Directive CE marking can be put on the products and distributed to the European nations Re-test after improvement made Ophthalmic Optics – Specifications for Ready to Wear Spectacles Warning of the unsuitability for driving or road use shall be indicated by the symbol given in Figure 1. A legible notice is required in the national language of the intended destination in the form of an affixed label or swing tag, as follows: WARNING • For near-vision and reading use only • Not for regular use without the approval of an eyecare professional • Not for driving or vehicle operation • Not for distance vision • Not for use as eye protectionFigure 1 — Symbol “not suitable for driving and road use”
  19. 19. Product InspectionsLaboratory Testing Supplier Audit Programs info@asiainspection.com – AsiaInspection ©   19 EN ISO 12312.1-2013 +A1:2015 Sample 1 Sample 2 Sample 3-4 Sample 5-6 1. Construction & surface quality YES 2. Transmittance & UV, category No. YES - 3. Polarize filters (if applicable) YES if applicable 4. Suitable for driving & road use YES 5. Haze scattered light YES 6. Resistance to optical radiation YES 7. Optical powers YES 8. Prismatic imbalance YES 9. Resistance to ignition YES 10. Bridge deformation YES 11. Eye coverage YES 12. Impact resistance level 1 drop ball (or minimum robustness) YES 13. Resistance to perspiration 14. Endurance OPTIONAL - 15. Nickel release: YES if applicable Fashion Spectacles and Sunglasses for General Use (Non-prescription Use)
  20. 20. Product InspectionsLaboratory Testing Supplier Audit Programs info@asiainspection.com – AsiaInspection ©   20 Transmittance properties: UVA. UVB, Visible, Blue-light transmittance: Parameters for driving & road use Plane of polarization axis Measuring point for transmittance tests on mounted lenses: PD64mm for adult or 54mm for children refers to ISO4007 standard head-form Resistance to optical radiation (aging test) for UV stability Photos of Major Sunglass Tests Mainly test the transmittance properties to confirm it’s capacities to against harmful sunlight and it’s color-fastness against optical radiation.
  21. 21. Product InspectionsLaboratory Testing Supplier Audit Programs info@asiainspection.com – AsiaInspection ©   21 Resistance to high speed particles (level 3 impact strength) Drop Ball test (level 1 -16mm or level 2 – 22mm impact strength) Prismatic imbalance PLANO optical power test Wide angle scattered light (haze) Photos of Major Sunglass Tests Mainly test the optical properties of the mounted sunlenses are good for ready-use purpose and it’s protection capacities to against mechanical hazards.
  22. 22. Product InspectionsLaboratory Testing Supplier Audit Programs info@asiainspection.com – AsiaInspection ©   22 Testing Schedules for Sunglasses Order of testing Requirements According to clause / subclause Sunglasses number 1 2 3 4 5 to 6 7 to 8 1 Construction 4.1 ● 2 Filter material and surface quality 4.2 ● 3 Physiological compatibility 4.3 ●3 4 Transmittance and filter categories 5.2 ●1 5 General transmittance requirements 5.3 ●1 6 Refractive power 6 ● 7 Minimum robustness of filters 7.1 ●1 8 Frame deformation and retention of filters 7.2 ● 9 Impact resistance of the filter, strength 1 (optional specification) 7.3 ●1,2 10 Increased endurance of sunglasses (optional specification) 7.4 ● 11 Resistance to perspiration (optional specification) 7.5 ● 12 Impact resistance of the filter, strength 2 or 3 (optional specification) 7.6 ●4 13 Resistance to solar radiation 8 ●1 14 Resistance to ignition 9 ● 15 Resistance to abrasion (optional specification) 10 ●5 16 Coverage area 11.1 ● 17 Temporal protective requirements 11.2 ● • Testing to be carried out on the indicated specimen. Empty field: No testing specified. 1 One filter from the left and one filter from the right eye. 2 If this specification is met, testing according to 7.1 (minimum robustness) is not necessary. 3 Nickel release testing is conducted for those parts of metal and combination sunglass frames which come into direct and prolonged contact with the skin of the wearer. 4 Left filter from sample 8 and right filter from sample 7. 5 Left filter from sample 7 and right filter from sample 8.
  23. 23. Product InspectionsLaboratory Testing Supplier Audit Programs info@asiainspection.com – AsiaInspection ©   23 Testing Schedule for Complete Clip-ons Order of testing Requirements According to clause / subclause Sunglasses number 1 2 3 4 5 to 6 1 Construction 4.1 ● 2 Filter material and surface quality 4.2 ● 3 Physiological compatibility 4.3 ●3 4 Transmittance and filter categories 5.2 ●1 5 General transmittance requirements 5.3 ●1 6 Refractive power 6 ● 7 Minimum robustness of filters 7.1 ●1 8 Impact resistance of the filter, strength 1 (optional specification) 7.3 ●1,2 9 Resistance to perspiration (optional specification) 7.5 ● 10 Resistance to solar radiation 8 ●1 11 Resistance to ignition 9 ● 12 Resistance to abrasion (optional specification) 10 ● 1 13 Coverage area 11.1 ● 14 Temporal protective requirements 11.2 ● • Testing to be carried out on the indicated specimen. Empty field: No testing specified. 1 One filter from the left and one filter from the right eye. 2 If this specification is met, testing according to 7.1 (minimum robustness) is not necessary. 3 Nickel release testing is conducted for those parts of metal and combination sunglass frames which come into direct and prolonged contact with the skin of the wearer. Sample quantity required Test Turnaround time When to conduct the test? What if conformity to the specified standard What if non- conformity found? 4 + 2 nickel release if applicable + 2 optional tests 1 week to 2 weeks include nickel release - Pre-production stage to confirm construction and fundamental requirements are met - Pre-shipment stage to confirm the products are compliance to the harmonized test & quality standard refer to European Directive CE marking can be put on the products and distributed to the European nations Re-test after improvement made
  24. 24. Product InspectionsLaboratory Testing Supplier Audit Programs info@asiainspection.com – AsiaInspection ©   24 Information and Labelling Information to be supplied with each pair of sunglasses The manufacturer shall provide information for the user with each pair of sunglasses. This information shall be in the form of markings on the frame or separate information on labels, packaging, etc., that accompanies the sunglasses at the point of sale. Where pictograms are used, an explanation of the significance of these pictograms shall also be available. NOTE: National regulations with respect to the content of the user information should be observed. The user information shall contain following items: a) Identification of model. b) Name and address of the manufacturer. c) Reference to this part of ISO 12312. d) Type of filter, if photochromic and/or polarizing. e) Number of the filter category (in both the faded and darkened states for photochromic filters) marked preferably on the frame or on the filter. f) Description of the filter category in the form of a symbol and/or verbal description as given in Table 5. The minimum height of the symbols shall be 5 mm. g) Restrictions of use, which shall include at least the following: 1- not for direct observation of the sun; 2- not for protection against artificial light sources e.g. solaria; 3- not for use as eye protection against mechanical impact hazards (for products not satisfying the requirements of 7.3 or 7.5); 4- any other restrictions deemed appropriate to be communicated by the manufacturer, e.g. increased or decreased transmittance of photochromic glasses due to high or low temperatures or to low light conditions. h) h) When the filter does not meet the necessary requirements for driving and for filter category 4, the following warning: “Not suitable for driving and road use” in the form of the symbols shown in Figure 2 and/or in writing. The minimum height of the symbol shall be 5 mm. i) When the filter has a luminous transmittance of less than 75 % and higher than 8 %, the following warning: “Not suitable for driving in twilight or at night” or “Not suitable for driving at night or under condition of dull light”. The same warning applies to photochromic filters for which the luminous transmittance in the faded conditions is less than 75 %. j) If relevant, instructions for care and cleaning if the wrong use of cleaning products might damage the sunglasses and a list of damaging products not suitable for cleaning.
  25. 25. Product InspectionsLaboratory Testing Supplier Audit Programs info@asiainspection.com – AsiaInspection ©   25 Information and Labelling Figure 2 - Symbol: “Not suitable for driving and road use” Table 5 – Description of filter categories and assigned symbols Filter category Description Usage Symbol 0 Light tint sunglasses Very limited reduction of sunglare IEC 60417-5955 1 Light tint sunglasses Limited protection against sunglare ISO 7000-2948 2 General purpose sunglasses Good protection against sunglare ISO 7000-2949 3 General purpose sunglasses High protection against sunglare ISO 7000-2950 4 Very dark special purpose sunglasses, very high sunglare reduction Very high protection against extreme sunglare, e.g. at sea, over snowfields, on high mountains, or in desert ISO 7000-2951 NOTE The wording and/or the pictograms may be used. ISO 7000-2952A ISO 7000-2952B
  26. 26. Product InspectionsLaboratory Testing Supplier Audit Programs info@asiainspection.com – AsiaInspection ©   26 REACH Directive 2006/1907 (EU) TESTING FOR RELEVANT REQUIREMENTS
  27. 27. Product InspectionsLaboratory Testing Supplier Audit Programs info@asiainspection.com – AsiaInspection ©   27 REACH Directive Annex XVII (17) Test required? 1. Nickel and its compounds (entry 27) 76/769/EEC, 94/27/EC. 2004/96/EC Updated requirement: EC 552/2009 Directly related to eyewear that includes metal parts in contact with skin. YES. Directly related to eyewear products. 2. Cadmium and its compounds (entry 23) Previous law: 76/769/EEC, 91/338/EEC New updates: EC 552/2009, EC 494/2011 EC 835/201 May be found in paint, coating, and plastic ONLY IF eyewear is declared as a fashion jewelry item 3. Lead (entry 63) 22 April 2014 EC 836/2012 May be found in paint, coating, plastic, and metal ONLY IF eyewear is declared as a fashion jewelry item 4. Phthalates (entry 51 and 52, total 6P) 76/769/EEC, 2005/84/EC Update EC 552/2009 May be found in soft plastic MANDATORY for children’s products 5. PAHs Polycyclic-aromatic hydrocarbons (entry 50) 76/769/EEC, 2005/69/EC New update: EC 552/2009 Applies to rubber. RECOMMENDED if any frame components are made of rubber. Azocolourants and Azo dyes (entry 43) 76/769/EEC, 2002/61/EC, 2003/3/EC, 2004/21/EC NEW update EC 552/2009 If frames include leather, PU, or fabric covering MANDATORY if the product contains leather / PU / fabric as covering material REACH Directive: Popular Concerns for Eyewear Products
  28. 28. Product InspectionsLaboratory Testing Supplier Audit Programs info@asiainspection.com – AsiaInspection ©   28 What is SVHC?  The list of (restricted) Substances of Very High Concern under the REACH directive  Number of substances on the Candidate List: 168 (last updated: 17/12/2015) http://echa.europa.eu/candidate -list-table
  29. 29. Product InspectionsLaboratory Testing Supplier Audit Programs info@asiainspection.com – AsiaInspection ©   29 SVHC Compliance How to achieve SVHC compliance?  Test the product for SVHC (expensive!) Most European buyers only test for SVHC: - randomly - when a new material is used - when a new vendor is under evaluation  Declare that your products contain no SVHC - Most buyers require this declaration from the supplier - List of materials and declaration of material safety are required
  30. 30. Product InspectionsLaboratory Testing Supplier Audit Programs info@asiainspection.com – AsiaInspection ©   30 Thank You We FOCUS on eyewear products CONTACT US Room 1408 Texaco Center 126-140 Texaco Road Tsuen Wan NT ph: 852-35292238 fax: 852-21171202 www.AsiaInspection.com

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