Eyewear Testing to European Directives

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Eyewear Testing to European Directives
Candia TSE
Managing Director, AI ETIC

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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.

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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

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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.

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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

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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

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Spectacle Frames
Sunglasses & Sunglare Filters
TESTING FOR MANDATORY REQUIREMENTS

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

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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

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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

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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)

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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

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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

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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

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 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.

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 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
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.

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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
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”

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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)

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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.

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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.

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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.

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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

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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.

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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

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REACH Directive 2006/1907 (EU)
TESTING FOR RELEVANT REQUIREMENTS

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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

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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
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

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Thank You
We FOCUS on eyewear products
CONTACT US
Room 1408
Texaco Center
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ph: 852-35292238
fax: 852-21171202
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Eyewear Testing to European Directives

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