Examination glove standards and Malaysian product ...

23
Examination glove standards and Malaysian product certification by Dr Abdul Kadir

Transcript of Examination glove standards and Malaysian product ...

Page 1: Examination glove standards and Malaysian product ...

Examination glove standards and Malaysian product

certification

by

Dr Abdul Kadir

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Malaysia’s export of rubber medical gloves

Source: Global Trade Atlas

1,081,19

1,471,71

2,11 2,03

0.0

0.5

1.0

1.5

2.0

2.5

2004 2005 2006 2007 2008 2009

US$ billion

45,0 45,949,1

48,651,5

% share of world’s export

50,7

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Malaysia’s export of surgical gloves

Source: Global Trade Atlas

% share of world’s export

518571

616 618

751713

0

100

200

300

400

500

600

700

800

2004 2005 2006 2007 2008 2009

US$ million

33,630,9 31,4 33,9

34,6 31,2

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0,901,00

1,26

1,48

1,82 1,79

0.00.20.40.60.81.01.21.41.61.82.0

2004 2005 2006 2007 2008 2009

US$ billion

Malaysia’s export of examination gloves

Source: Global Trade Atlas

% share of world’s export

48,1 49,653,1

51,1

53,5 55,2

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Malaysia exports rubber gloves to over 180

countries around the world

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327 355

452

556

663620

0

100

200

300

400

500

600

700

2004 2005 2006 2007 2008 2009

US$ million

30,329,8

30,7

32,5

31,530,5

% share of Malaysia’s export

Malaysia’s export of medical gloves to EU

Source: Global Trade Atlas

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1.031.19

1.40

1.681.56

0.0

0.2

0.4

0.6

0.8

1.0

1.2

1.4

1.6

1.8

2005 2006 2007 2008 2009

US$ billion

34,437,9

39,6

39,539,8

EU imports of medical gloves

% imports from Malaysia

Source: Global Trade Atlas

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European Committee for Standardization

ASTM International

International Organization for Standardization

Major developers and publishers of standards

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Major medical examination glove standards

→European standards on medical gloves for single use EN 455-1:2000 Freedom from holes EN 455-2:2009 Physical properties EN 455-3:2006 Biological evaluation EN 455-4:2009 Shelf life determination

→ASTM D 3578:2005 Standard specification for rubber examination gloves

→ISO 11193-1:2008 Single use medical examination gloves – Part 1: Specification for gloves made from rubber latex or rubber solution

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Freedom from holes

DimensionsPhysical props.

Leach. protein

Powder residue

(P)

Powder amount

(PF)

Shelf life

EN

ASTM

ISO

Requirements of EN, ASTM and ISO standards on medical gloves

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Inspection level

AQL Volume of water (cm3)

Observation

EN 455–1 G-1 1,5 1000 +/- 50 1st: Immediately2nd: After 2 – 3 min

ASTM D3578 G-1 2,5 Minimum 1000 1st: Immediately2nd: After 2 min

ISO 11193–1 G-1 2,5 1000 +/- 50 1st: Immediately2nd: After 2 – 4 min

Freedom from holes

This makes EN 455-1 the most stringent of the three standards.

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PropertyInspection

levelAQL Unaged Aged

Cutter width

EN 455–2 Force at break

13 samples from each lot

9,0 N 6,0 N 3,0 mm

ASTM D3578 Tensile strength

S-2 4,0 18 MPa 14 MPa Not specified

ISO 11193–1 Force at break

S-2 4,0 7,0 N 6,0 N 4,0 mm

Applicable during shelf

life

Physical properties for NR gloves

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T = FA

where:T is tensile strengthF is force at breakA is cross-sectional area

of test specimen

F

F

bw

A = b * w

Relationship between force at break and tensile strength

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Force

Extension

3 mm

4 mm

Tensile strength

Extension

3 mm & 4 mm

Cutter width

Tensile strength is material property

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Force at break (N) Tensile strength (MPa)

Unaged Aged Unaged AgedCutter width

EN 455–2 9,0 6,0 25 16,7 3,0 mm

ASTM D3578 18 14 Not specified

ISO 11193–1 7,0 6,0 14,6 12,5 4,0 mm

Note: Tensile strength is calculated from the force at break for gloves of typical thickness of 0.12mm.

Can be met by thicker

gloves

Is EN 455-2 force at break requirement too high?

Applicable during shelf life.

Too high?Too low?

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Harmonization of EN and ISO standards

EN and ISO standards are far apart, with the ISO standard requirements for physical properties well below those of EN

Harmonization of ISO and EN standards on medical gloves could provide some rationalization of the current disparate standards

The Vienna Agreement signed between CEN and ISO in 1991 promotes cooperation between CEN and ISO

A consensus global standard could only be achieved through the work of the Global Harmonization Task Force (GHTF)

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The SMG scheme is a voluntary third party product certification scheme for NR examination gloves, both powdered and powder-free

The SMG specification establishes requirements for:

Freedom from holes

Physical properties

Protein content

Powder content

The scheme is operated by the Malaysian Rubber Board, an ISO/IEC Guide 65 body, authorized by Standards Malaysia

The rigorous certification procedure offers the assurance that SMG gloves comply with the requirements of the SMG specification

POWDER-FREE

POWDERED

Standard Malaysian Glove scheme

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SMG EN 455–2 ASTM D3578

Unaged force at break, N 9 9 18 MPa = 6,5 N

Unaged elongation at break, % 650 Not specified 650

Aged force at break, N 6 6 14 MPa = 5,0 N

Aged elongation at break, % 500 Not specified 500

Note: Cutter width to be changed from 4 mm to 3 mm to meet EN requirements.

Standard Malaysian Glove (SMG) physical properties to be revised to meet both EN and

ASTM standards

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Inspection level AQLG-1 1.5

The requirement is the same as in

EN455-1.

Freedom from holes requirementof SMG gloves

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Dimension Size (mm)

Palm widthExtra-small Small Medium Large Extra-large

< 80 80 ± 10 95 ± 10 110 ± 10 > 110

Length 240 mm minimum

Thickness at palm and

finger0.08 mm minimum

EN455-2 does not specify minimum thickness.

Dimension requirements of SMG gloves

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Powder-free Powdered

Protein, μg/dm2 50 200

Powder, mg/glove 2 150

EN455-3 requires monitoring of

process limit of leachable protein.

EN455-3 considers gloves containing

more than 2 mg of powder as

powdered gloves.

Protein and powder limits of SMG gloves

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• Malaysia is the world’s leading exporter of medical gloves

• The many standards that are applicable lead to higher cost to both Malaysian producers and importers/users of Malaysian gloves

• SMG examination gloves are certified for compliance with the EN, ASTM and ISO standards

Conclusion

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THANKYOU