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 testRequirement

subclause

Test

method

subclause

Sequence Sample 1 Sample 2Samples 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 applieda This test is optionalb 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

testingRequirements

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 ●

9Impact 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

testingRequirements

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

TestTurnaround 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 to2 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 puton 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 sunglassesVery limited reduction of sunglare

IEC 60417-5955

1 Light tint sunglassesLimited protection against sunglare

ISO 7000-2948

2General purpose

sunglassesGood protection against sunglare

ISO 7000-2949

3General purpose

sunglassesHigh 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 Concernsfor 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

http://echa.europa.eu/candidate-list-table



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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

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Eyewear Testing to European Directives