TÜV SÜD PSB Pte Ltd Certificate No. : LA-2007-0383-G · TÜV SÜD PSB Pte Ltd Certificate No. :...

TÜV SÜD PSB Pte Ltd Certificate No. : LA-2007-0383-G

Testing Group (Part 4 of 4)

No. 1 Science Park Drive

Singapore 118221 Issue No. : 17

Date : 02 April 2017

Page : 1 of 12

FIELD OF TESTING : Mechanical Testing

MATERIALS / PRODUCTS TESTED

TESTS / PROPERTIES STANDARD METHODS SIGNATORY

A CONSUMER

PRODUCT

1. Male Latex Condoms a. Design ) ISO 4074 : 2015 ) WBH / YPK/

- Integral bead ) WHO Specification 2010 ) CSL

- Lubrication ) )

- Dimensions (Length, Width, Thickness)

)

)

)

)

b. Bursting volume and ) )

pressure ) )

c Freedom from holes ) )

d Visible Defects ) )

e Package integrity of ) )

individual container ) )

f Packaging and labelling ) )

a. Design ) NZS 7106 : 1998 ) WBH/YPK/

b. Dimensions(Length and width) ) ) CSL

c. Bursting pressure ) )

d Tensile properties ) )

e Freedom from holes ) )

f Packing and labellin ) )

Certificate No. : LA-2007-0383-G Issue No. : 17

(Part 4 of 4)

Date : 02 April 2017 Page : 2 of 12

MATERIALS / PRODUCTS

TESTED TESTS / PROPERTIES STANDARD METHODS SIGNATORY

2. Female condom a Design ) ISO 25841 : 2014 ) WBH / YPK/

- General ) [WHO Specification ) CSL

- Product insertion feature ) 2012] )

- Retention features ) )

- Lubrication ) )

- Dimensions ) )

b Bursting volume and pressure ) )

c Freedom from holes ) )

d Visible defects ) )

e Packaging and labelling ) )

3 Nipple, Baby Bottle a. Visual and tactile examination ) BS EN 14350-1 : 2004 ) WBH/ YPK

) )

b. Small Parts ) )

) )

c. Volume ) )

- Volume labelling ) )

- Volume accuracy ) )

) )

d. Resistance to tearing ) )

) )

e. Additional requirements for ) )

Re-usable products ) )

- Resistance to boiling water ) )

- Print adhesion to markings ) )

and decorations ) )

- Thermal shock ) )

) )

f. Additional requirements for ) )

sealing discs ) )

) )

g. Requirements for matches ) )

components ) )

- Include Protrusions ) )

- Include Straws ) )

) )

h. Requirements for protrusions ) )


(Part 4 of 4)




i. Requirements for straw ) )

k. Consumer packaging ) )

l. Product information ) )

4. Pacifier a. General (exclude preparation ) BS EN 1400 :2013 ) WBH/ YPK

samples for chemical tests) ) +A1:2014 )

) )

b. Printing and decals ) )

) )

c. Construction properties and ) )

tests (General) ) )

) )

d. Teat ) )

) )

e. Shield ) )

) )

f. Shield ventilation ) )

) )

g. Ring ) )

) )

h. Plug ) )

) )

i.

j.

k.

l.

m

n.

Knobs, plugs and/or covers

made from non-flexible

materials

Openings

Impact resistance

Puncture resistance

Tear resistance

Knob, plug and/or cover

retention

)

)

)

)

)

)

)

)

)

)

)

)

)

)

)

)

)

)

)

)

)

)

)

)

)

)

)

)


(Part 4 of 4)




1.

o.

Bite endurance of elastomeric

components

)

)

)

)

)

)

p. Integrity ) )

5. Small Parts/ Shield a. Size requirements and test ) 16 CFR Part 1501.4 ) WBH/ YPK

Procedure ) )

b. Shield ) 16 CFR Part 1511 )

6. All Textile/ Garments 1. Colourfastness Test ) WBH

And Mosquito Net a. Washing ) ISO 105-C06:2010 )

) AATCC 61:2010 )

)

b. Crocking/ Rubbing ) ISO 105 X12:2001 )

) AATCC 8:2007 )

)

c. Light, Xenon Arc lamp test ) ISO 105-B02:2013 )

) AATCC 16:2004 )

2. Dimensional stability to ) ISO 3759:2011 – )

washing ) Method of Preparation )

) ISO 6330:2012 )

) Method of Washing )

) ISO 5077:2007 – )

) Method of calculations )

)

3. Construction Test )

a. Fabric count ) BS EN 1049-2:1994 )

) ISO 7211-2:1984 )

)

b. Fabric Weight ) BS EN 12127:1998 )

) BS 2471:2005 )

)

4. Abrasion Resistance ) ISO 5470-1:1999 )

Taber abrader method ) ASTM D4060-14 )


(Part 4 of 4)


MATERIALS /

PRODUCTS TESTED TESTS / PROPERTIES STANDARD METHODS SIGNATORY

5. Pilling Resistance )

a. Pilling box tester ) ISO 12945-1:2000 )

)

b. Martindale tester ) ISO 12945-2:2000 )

) ASTM D4970/D4970M- )

) 10e1 )

)

6. Tearing strength )

a. Tongue (singer tear)

method

) ISO 13937-2:2000 )

)

)

7. Tensile strength and )

Elongation of fabrics ) ISO 13934-1:1999 )

a. Strip method ) ASTM D5035-11 )

)

8. Bursting Strength )

a. Hydraulic method ) ISO 13938-1:1999 )

b. Pneumatic method ) ISO 13938-2:1999

) ASTM D3786/ D3786-13

)

7. Toy a. General requirements ) BS EN 71-1 : 2014 ) WBH

b. Small Parts Cylinder ) )

c. Torque test ) )

d. Tension test ) )

e. Drop test ) )

f. Tip over test ) )

g. Impact test ) )

h. Compression test ) )

i. Soaking test ) )

j. Accessibility of a part or ) )

component ) )

k. Sharpness of edge ) )

l. Sharpness of points ) )

m. Leakage of liquid-filled ) )

toys ) )

n. Geometric shape of certain ) )

toys ) )

o. Plastic sheeting ) )


(Part 4 of 4)


MATERIALS /


p. Small balls ) )

q. Test for play figures ) )

r. Packaging ) )

s. Warnings, markings and ) )

instructions for use ) )

a. General ) ISO 8124-1 : 2014 ) WBH

b. Small parts test ) )

c. Test for shape and size of ) )

certain toys ) )

d. Small balls test ) )

e. Test for pre-school play ) )

figures ) )

f. Accessibility of a part or ) )

component ) )

g. Sharp-edge test ) )

h. Sharp-point test ) )

i. Determination of thickness ) )

of plastic film and sheeting ) )

j. Leakage of liquid-filled ) )

Toys ) )

k. Drop test ) )

l. Tip-over test for large and ) )

bulky toys ) )

m Torque test ) )

n. Tension test ) )

o. Compression test ) )

Safety requirements ) WBH

a. Material quality ) 16 CFR 1500.44 )

) ASTM F963-11 Sect 4.1 )

)

b. Flammability ) 16 CFR 1610 – for textiles )

) ASTM F963-11 Sect 4.2 )

)

c. Small objects ) 16 CFR 1501 )

) 16 CFR 1500.50 )

) 16 CFR 1500.19 )

) ASTM F963-11 Sect 4.6 )


(Part 4 of 4)


MATERIALS /


d. Accessible Edges ) 16 CFR 1500.49 )

) ASTM F963-11 Sect 4.7 )

)

e. Accessible points ) 16 CFR 1500.48 )

) ASTM F963-11 Sect 4.9 )

)

f. Pacifiers (except ) 16 CFR 1511 )

chemical Test) )ASTM F963-11 Sect 4.20 )

)

g. Teethers and teething toys ) 16 CFR 1510 )

)ASTM F963-11 Sect 4.22 )

)

h. Rattles ) 16 CFR 1510 )

)ASTM F963-11 Sect 4.23 )

)

i. Squeeze toys ) 16 CFR 1510 )

)ASTM F963-11 Sect 4.24 )

)

j. Balloons ) 16 CFR 1500.19 )

)ASTM F963-11 Sect 4.31 )

)

k Certain toys with spherical )ASTM F963-11 Sect 4.32 )

ends )

)

l Marbles ) 16 CFR 1500.19 )

)ASTM F963-11 Sect 4.33 )

)

m Balls Labelling requirements ) 16 CFR 1500.18(a)(17) )

Instructional Literature ) 16 CFR 1500.19 )

Producer’s Markings )ASTM F963-11 Sect 4.33 )

)

n Normal use testing )ASTM F963-11 Sect 8.5 )

)

o Abuse testing (except tests )ASTM F963-11 Sect 8.5 )

for tire removal and snap-in (except Sect 8.11-8.13) )

wheel and axle assembly )

removal, Flexure test, and )

test for mouth actuated- )

toys) )


(Part 4 of 4)


MATERIALS /


p Impact tests )ASTM F963-11 Sect 8.7 )

)

q Drop test )ASTM F963-11 Sect 8.7.1 )

)

r Tipover test for large, bulky )ASTM F963-11 Sect 8.7.2 )

toys ) )

)

s Torque tests for removal )ASTM F963-11 Sect 8.8 )

of components ) )

)

t Tension test for removal of )ASTM F963-11 Sect 8.9 )

components ) )

)

u Compression test )ASTM F963-11 Sect 8.10 )

)

v Packaging film thickness )ASTM F963-11 Sect 8.21 )

8 Cords and

drawstrings on

children’s clothing

a

b

c

d

e

f

g

h

General

Head, neck and upper

chest area on garments for

young children

Head, neck and upper

chest area on garments for

older children and young

persons

Chest and waist area

Lower edge of garments

which hang below the

crotch

Back area

Sleeves

Other parts of the garment

) EN 14682:2014

)

)

)

)

)

)

)

)

)

)

)

)

)

)

) WBH/ CSL

)

)

)

)

)

)

)

)

)

)

)

)

)

)


(Part 4 of 4)




B MEDICAL

PRODUCTS

a. c Watertightness )

b. Tensile Properties

- Force at break

- Elongation at break

- Force required to

produce 300%

elongation

- Accelerated ageing

)

)

)

)

)

)

)

c. Packaging )

d. Marking )

a. Freedom from Holes

) ASTM D5151 -

06(2015)

b. Physical Dimensions

- Width

- Length

- Thickness

) ASTM D3767-03(2014)

)

)

)

c. Physical Properties - Tensile strength - Ultimate elongation - Stress at 500%

elongation - Accelerated ageing

) ASTM D412-06a(2013)

)

)

)

)

d. Packaging and Package Marking

) ASTM D573-04(2015)

)


(Part 4 of 4)


MATERIALS /


2. Rubber/PVC

Examination Gloves

a. Classification/material/

sampling

) ISO 11193-1 : 2008 +

A1 : 2012

) YPK /WBH

)

)

)

)

)

)

)

)

)

)

)

)

)

)

)

)

) ISO 11193-2 : 2006

b. Dimensions

- Width - Thickness - Length

)

)

)

)

c. Watertightness

)

)

d. Tensile Properties

- Force at break

- Elongation at break


)

)

)

)

)

e. Packaging

)

)

f. Marking )

a. Classification/material/

sampling

) ASTM D3578-05(2010)

)

) YPK/WBH

)

)

)

)

)

)

)

)

)

)

)

)

)

)

)

)

)

)

b. Freedom from Holes

) ASTM D5151-06(2011)

c. Physical Dimensions

- Width

- Length

- Thickness

) ASTM D3767-03(2014)

)

)

)

d. Physical Properties

- Tensile strength

- Ultimate elongation

- Stress at 500%

elongation


) ASTM D412-06a(2013)

)

)

)

)

)


(Part 4 of 4)


MATERIALS /


3. Medical Gloves for

Single Use

a. Dimension

- Length

- Width

) BS EN 455-2 : 2015

)

)

) YPK / WBH

)

)

b. Strength

- Force at break

- Challenge testing

) ) )

) ) )

c. Labelling ) )

d. Freedom from holes ) BS EN 455-1 : 2000 )

4. Catheter a. Surface ) ISO 10555-1:2013 ) YPK/ WBH/ CSL b. Peak Tensile force ) ) c. Freedom from leakage ) ) d Hub ) )

e Flow rate ) ) f

g. h.

Side holes, Distal tip Designation of nominal size Information to be supplied by manufacturer

) ) ) ) )

) ) ) ) )

5. Conical fittings a Gauging ) ISO 594-1:1986 and ) YPK/ WBH/ CSL b Liquid leakage ) ISO 594-2:1998 )

c. Air leakage ) ) d Separation force ) ) e Unscrewing torque ) ) f Ease of assembly ) ) g. Resistance to overriding ) ) h. Stress cracking ) ) 6. Medical packaging a. Seal strength ASTM F88/F88M-15 )YPK/WBH/ CSL b. Dye penetration )ASTM F1929-15

)ASTM F3039-15

c. Gross leak (bubble test) Visual inspection

)ASTM F2096-11 )ASTM F1886/F1886M-09

d. Leak test (Bubble emission)

) ASTM D 3078-02(2013)

( ) : Specifications


(Part 4 of 4)


Approved signatories

Note :

This laboratory is accredited in accordance with the recognised International Standard ISO/IEC 17025:2005.

A laboratory's fulfilment of the requirements of ISO/IEC 17025:2005 means the laboratory meets both the

technical competence requirements and management system requirements that are necessary for it to

consistently deliver technically valid test results. The management system requirements in ISO/IEC

17025:2005 (Section 4) are written in language relevant to laboratory operations and meet the principles of

ISO 9001:2008 Quality Management Systems — Requirements and are aligned with its pertinent

requirements.

WBH - Wong Bee Hui

YPK - Yeo Poh Kwang

CSL - Shareen Chan

TÜV SÜD PSB Pte Ltd Certificate No. : LA-2007-0383-G · TÜV SÜD PSB Pte Ltd Certificate No. :...

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