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H Y P O D E R M I C N E E D L E
M A N U FAC T U R E R
N E E D L E H U B , C O V E R A N D
S H I E L D
• Compliance to ISO 6009 color coding for single use hypodermic
needle
• Biocompatibility of all component materials
• Good mechanical and visual properties after sterilization (e.g.
ETO / Gamma radiation)
• Facilitated 510(k) submission with formulations
registered under Device Master File MAF 1833
• Pre-tested raw materials to biocompatibility
ISO10993, US and Eu Pharmacopeia, ICH-Q3D
extractable metals
• Enhanced stability with gamma stabilizing
package
• Minimized risk of change with change control
beyond CAS number level
• Ensured uninterrupted supply from multiple ISO
13485-2016 certified sites
• MEVOPURTM ISO 6009 Standard / Customized
Solutions
KEY REQUIREMENTS
WHY AVIENT?
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Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
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Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
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NOR AZIMAH BINTI ABDUL AZIZ
REGISTRAR OF COMPANIES
MALAYSIA
(ACT 777)
This is to certify that
CERTIFICATE OF INCORPORATION ON CHANGE OF
NAME OF COMPANY
Dated at SEBERANG JAYA, PULAU PINANG this 25th day of August
2021.
This certificate is generated from MYDATA SSM Services as at 31/08/2021 12:30:12 1 1/
Date: Tue Aug 31 12:30:12 2021 Printing Date: 31/08/2021User Id: mooileen
https://www.avient.com/sites/default/files/resources/Polyolefins%2520Product%2520Selection%2520Guide.pdf
This product selection guide provides
detailed information to help you select
the Maxxam product that’s right for
your application.
4
INJECTION MOLDING POLYPROPYLENE
Product Code - - - PP5113 B44 F5134T2-4 PP5130 B63 F5134T4-1
Filler Percentage - % - 13 20 30 40
Tensile Strength Yield psi ASTM D638 5000 4800 4600 4500
MPa ISO 527 33 33 32 31
Tensile Elongation Yield % ASTM D638 6 4 3 2
ISO 527
Break % ASTM D638 60 30 15 10
ISO 527
Flexural Modulus 73°F (23°C) psi ASTM D790 300,000 360,000 400,000 460,000
MPa ISO 178 2300 2450 2900 3300
Notched Izod
Impact
73°F (23°C) ft-lb/in ASTM D256 0.65 0.60 0.55 0.50
kJ/m2 ISO 180 3.50 3.3 3.00 2.75
Heat Deflection 66 psi °F ASTM D648 230 240 260 275
°C ISO 75 110 116 127 135
264 psi °F ASTM D648 130 140 150 175
°C ISO 75 54 60 66 79
Specific Gravity 73°F (23°C) - ASTM D792 0.99 1.04 1.15 1.25
ISO 1183
Linear Shrinkage
Range
1/8 in wall % - 1.2–1.6 1.0–1.4 0.8–1.2 0.6–1.0
3.2 mm wall % - 1.2–1.6 1.0–1.4 0.8–1.2 0.6–1.0
Product Code - - - PP6113 A77-SM
PP6120
B16-2
PP6130
B11
PP6135
B40-UV
Filler Percentage - % - 13 20 30 35
Tensile Strength Yield psi ASTM D638 4350 3500 2600 3700
MPa ISO 527 30 24 18 26
Tensile Elongation Yield % ASTM D638 5 4 7 6
ISO 527
Break % ASTM D638 35 70 150 70
ISO 527
Flexural Modulus 73°F (23°C) psi ASTM D790 290,000 280,000 280,000 390,000
MPa ISO 178 2000 1950 1750 2700
Notched Izod
Impact
73°F (23°C) ft-lb/in ASTM D256 0.7 2.7 4.5 0.65
kJ/m2 ISO 180 4.0 14 24 3.5
Heat Deflection 66 psi °F ASTM D648 239 215 225 250
°C ISO 75 115 102 107 123
264 psi °F ASTM D648 140 125 130 150
°C ISO 75 60 52 54 60
Specific Gravity 73°F (23°C) - ASTM D792 0.99 1.05 1.15 1.18
ISO 1183
Linear Shrinkage
Range
1/8 in wall % - 1.1–1.5 .9–1.3 0.7–1.1 0.5–0.9
3.2 mm wall % - 1.1–1.5 .9–1.3 0.7–1.1 0.5–0.9
Maxxam™ Talc-Filled
Copolymer Polypropylene
• Scratch & mar resistant
• UL approved
• FDA certifiable
• Natural, black or colors
• High flow grades
• UV stabilized
• UL approved
• FDA certifiable
• Natural, black or colors
• High flow grades
• UV stabilized
• Recycled content
Maxxam™ Talc-Filled
Homopolymer Polypropylene
Offers a moderate level of impact
strength and improved stiffness
and heat deflection performance.
Chemically coupled
• Natural or black
• High flow grades
• Provides heat stabilization
• Excellent balance of properties
• Natural, black or custom colors
Product Code - - - PX5430 B1 PX5435 B1 PX5440 B1 PX5450 B1
Reinforcement Type - - - Glass Glass Glass Glass
Reinforcement % - % - 30 35 40 50
Specific Gravity 73°F (23°C) - ISO 1183 1.13 1.18 1.23 1.35
Tensile Strength Yield MPa ISO 527 102 105 113 130
Flexural Modulus 73°F (23°C) MPa ISO 178 6500 8000 9400 11,500
Notched Izod Impact 73°F (23°C) kJ/m2 ISO 180 9.4 9.3 11.0 12.0
Heat Deflection 264 psi °C ISO 75 152 152 153 154
Product Code - - - PP5120 B270-LO
MFR g/10 min ISO 1133 12
Tensile Modulus MPa ISO 527 3320
Tensile Stress Yield MPa ISO 527 32
Tensile Elongation Yield % ISO 527 4.6
Tensile Elongation Break % ISO 527 17
Flexural Modulus MPa ISO 178 3000
Charpy Impact 73°F (23°C) kJ/m2 ISO 179/1eU 38
Heat Aging 150°C h VW 44045 700 hr
VOC µg/g VDA 278 23.5
Fog µg/g VDA 278 30.5
Carbon Emissions µgC/g VDA 277 18
Odor Grade VDA 270 B3 3
• High flow grades
• UV stabilized
PROPERTY CONDITION UNITS METHOD PRODUCT EXAMPLES
INJECTION MOLDING POLYPROPYLENE
PROPERTY CONDITION UNITS METHOD PRODUCT EXAMPLES
10
Maxxam™ Filled
& Reinforced
Polypropylene
A range of melt flows to process well in
sheet extrusion, thermoforming, profile
extrusion and blow molding operations
FDA certifiable
• Natural, black or colors
• UV stabilized
Product Code - - - PE4125 B1
Reinforcement
Type
- - - Talc
Reinforcement
%
- % - 25
Specific
Gravity
73°F (23°C) - ASTM D792 1.15
ISO 1183
Tensile
Strength
Yield psi ASTM D638 4050
MPa ISO 527 28
Tensile
Elongation
Yield % ASTM D638 10
ISO 527
Break % ASTM D638 40
ISO 527
Flexural
Modulus
73°F (23°C) psi ASTM D790 270,000
MPa ISO 178 1850
Notched
Izod Impact
73°F (23°C) ft-lb/in ASTM D256 3.5
kJ/m2 ISO 180 20.0
Heat
Deflection
66 psi °F ASTM D648 190
°C ISO 75 88
264 psi °F ASTM D648 115
°C ISO 75 46
PROPERTY CONDITION UNITS METHOD PRODUCT EXAMPLES
12
www.polyone.com
Copyright © 2019, PolyOne Corporation.
https://www.avient.com/sites/default/files/resources/Lockport_IATF%252016949%25202016_EXP%25205-2021.pdf
For and on behalf of BSI:
Chief Operating Officer Assurance - Americas
Certification Date: 2018-05-10 Latest Issue: 2018-05-10 Expiry Date: 2021-05-09
BSI Certificate Number: 691920
IATF Number: 0303891
Page: 1 of 2
This certificate remains the property of BSI and shall be returned immediately upon request.
An electronic certificate can be authenticated online.
An electronic certificate can be authenticated online.
https://www.avient.com/sites/default/files/2023-07/Avient-2022-Sustainability-Report.pdf
To find more details about our certifications, visit our ISO
Certifications Librar y.
This methodology was developed
in accordance with ISO 14067:2018 for product carbon footprint and is aligned with ISO 14040/140440 for life cycle analysis.
ZERO
Major Non-Conformances
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Microsoft Word - IATF 16949 North Baltimore[80].doc
ABS Quality Evaluations
Certificate Of Conformance
This is to certify that the Quality Management System of:
Avient Corporation Engineered Materials Division
Avient Corporation
733 E.
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.
Page 1 of 2
ABS Quality Evaluations
IATF 16949:2016
Certificate Of Conformance
ANNEX
Certificate No:
IATF No:
38972
0422162
Avient Corporation Engineered Materials Division
At Below Facilities:
Facility: Corporate
33587 Walker Road
Avon Lake, OH 44012
U.S.A.
https://www.avient.com/sites/default/files/2021-12/certificate-of-registration-avient-s.a-r.l.-sweden-filial-nov-29-2021.pdf
e-Certificate of registration
Swedish Companies Registration Office
BRANCH
D1a- 6858922
Registration number
Date of registration of the company
Document created on
Date of registration of current name
Page
516411-5031
2018-08-28
2021-11-30 17:11
2021-11-29
1 (3)
Pending matter(s)
The register indicates pending matter(s) regarding a change to
the registered information at the time this certificate was created.
e-Certificate of registration
Swedish Companies Registration Office
BRANCH
D1a- 6858922
Registration number
Date of registration of the company
Document created on
Date of registration of current name
Page
516411-5031
2018-08-28
2021-11-30 17:11
2021-11-29
2 (3)
Registration number: 516411-5031
Business name: Avient S.à r.l., Sweden Filial
Address:
Drottninggatan 56
411 07 GÖTEBORG
County and municipality: Västra Götaland, Göteborg
Note:
MANAGING DIRECTOR
630516 Palm, Christoph, Gruss Strooss 35, L-9991 WEISWAMPACH,
LUXEMBURG
AUDITORS
556053-5873 Ernst & Young Aktiebolag, Box 7850, 103 99 STOCKHOLM
Represented by: 850807-5135
PRINCIPALLY RESPONSIBLE AUDITOR
850807-5135 Edman, Mikael Thomas Gunnar, c/o Ernst & Young AB,
401 82 GÖTEBORG
SIGNATORY POWER
Signatory power alone by
Palm, Christoph
FINANCIAL YEAR
Registered financial year: 0101 - 1231
DATE OF REGISTRATION OF CURRENT AND PREVIOUS BUSINESS NAMES
2021-11-29 Avient S.à r.l., Sweden Filial
2018-08-28 PolyOne S.à.r.l., Sweden Filial
INFORMATION ABOUT THE FOREIGN COMPANY
B226205
Avient S.á.r.l.
19, Route de Bastogne
L-9638 Pommerloch
LUXEMBURG
Registered office of the foreign company:
Pommerloch
Name of the register in which the foreign company is registered:
e-Certificate of registration
Swedish Companies Registration Office
BRANCH
D1a- 6858922
Registration number
Date of registration of the company
Document created on
Date of registration of current name
Page
516411-5031
2018-08-28
2021-11-30 17:11
2021-11-29
3 (3)
RCS, Registre de Commerce,
Luxembourg Business Register
LUXEMBURG
Foreign company's financial year:
0101 - 1231
The above information is an extract from the Trade and Industry
Register Bolagsverket, the Swedish Companies Registration Office.