https://www.avient.com/sites/default/files/2025-01/ISO 13485 Shanghai %28ZhangJiang%29%2C China.pdf
MSC Certificate
Place and date: For the issuing office:
Høvik, 23 January 2025 DNV Product Assurance AS
Veritasveien 1, 1363 Høvik, Norway
Cecilie Gudesen Torp
Management Representative
Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid.
ICP-4-5-i5-ISO13485-f1 rev2
ACCREDITED UNIT: DNV Product Assurance AS, Veritasveien 1, 1363 Høvik, Norway - TEL: +47 67 57 99 00. www.dnv.com
MANAGEMENT SYSTEM
CERTIFICATE
Certificate no.:
240625-2017-AQ-RGC-NA-PS
Initial certification date:
14 September 2017
Valid:
08 February 2025 – 07 February 2028
This is to certify that the management system of
PolyOne-Shanghai, China
88 Guoshoujing Road, Z.J.Hi-Tech Park, Pudong Shanghai, China (Unicode:
91310000607342402D)
has been found to conform to the Quality Management System standard:
ISO 13485:2016
This certificate is valid for the following scope:
Design, Manufacture, Sales and Distribution of Medical Colour and Additive Concentrates
Used for the Plastic Parts of Medical Devices
http://www.dnv.com
https://www.avient.com/sites/default/files/2023-11/SEM TPE Product Selector Guide _N. America only_2023.pdf
THERMOPLASTIC
ELASTOMERS
North America Portfolio
PRODUCT SELECTION GUIDE
Appearance Hardness Specific
Food
Contact UL 94 Suitable
ASTM
(Shore)
ASTM
reSound™ REC Recycled Content Series
VX2800-9003 C Natural 47A 0.94 - - PP ✔ -
25% post-consumer recycled (PCR) content
(PVB from windshields and laminated glass);
1.77 cradle-to-gate product carbon footprint (PCF)
VX2800-9004 C Natural 54A 0.95 - - PP ✔ - 25% PCR content (PVB from windshields
and laminated glass)
VX2800-0001 I Black 65A 0.89 - - PP ✔ - 25% post-industrial recycled (PIR) content
VX2800-0001 I Natural 65A 0.89 - - PP ✔ - 25% PIR content
VX2800-0001 C Black 65A 0.89 - - PP ✔ - 25% PCR content (ocean plastics)
VX2800-0002 I Black 65A 0.88 - - PP ✔ - 40% PIR content
VX2800-0003 C Gray 65A 0.88 ✔ - PP ✔ - 25% PCR/PIR content (food packaging)
with application specific FDA rating
VX0100-0001 AR I Black 79A 1.05 - - PC, ABS, PC/ABS ✔ - 30% PIR content
reSound™ BIO Bio-based Series
RS7900-0001 30N Natural 31A 1.00 - - PP ✔ - 35% bio-derived content (Gen 1 biomass)
RS7900-0001 45N Natural 48A 1.11 - - PP ✔ - 35% bio-derived content (Gen 1 biomass)
RS7900-0001 60N Natural 59A 1.11 - - PP ✔ - 35% bio-derived content (Gen 1 biomass)
RS7900-0001 70N Natural 69A 1.09 - - PP ✔ - 35% bio-derived content (Gen 1 biomass)
RS2800-0001 30N Natural 33A 0.85 - - PP ✔ - 50–60% bio-derived content (Gen 1 biomass)
RS2800-0001 45N Natural 49A 0.85 - - PP ✔ - 50–60% bio-derived content (Gen 1 biomass)
RS2800-0001 60N Natural 63A 0.87 - - PP ✔ - 50–60% bio-derived content (Gen 1 biomass)
RS2800-0001 70N Natural 71A 0.86 - - PP ✔ - 50–60% bio-derived content (Gen 1 biomass)
reSound™ Ultra-Low Carbon Footprint Series
RS0200-9001 80 Natural 80A 0.87 - - PP, LDPE ✔ - -0.40 cradle-to-gate PCF
RS0200-9001 60 Natural 60A 0.86 - - PP, LDPE ✔ - -0.03 cradle-to-gate PCF
Avient’s specialty thermoplastic elastomers (TPEs)
are formulated to meet countless performance,
application and aesthetic demands.
Appearance Hardness Specific
Food
Contact UL 94 Suitable
ASTM
Shore
ASTM
(D792)
Consumer Electronics Series
Versaflex™ CE 3120-40 Natural 42A 0.92 - - PC, ABS, PC/ABS,
COPE ✔ - Good compression set—ideal for
device cases or electronic grips
Versaflex™ CE 3120-65 Natural 66A 1.15 - HB PC, ABS, PC/ABS,
COPE ✔ - Chemical and abrasion resistant; 4.69 cradle-to-gate
PCF—ideal for device cases or electronic grips
Versaflex™ CE 3140-65N Natural 65A 1.00 - - PC, ABS, PC/ABS,
COPE ✔ - 5G transparent materials—ideal for
device cases or gaskets
Versaflex™ CE 3140-90N Natural 90A 1.01 - - PC, ABS, PC/ABS,
COPE ✔ - 5G transparent materials—ideal for
device cases or gaskets
Versaflex™ CE 3620 Black/
Natural 65A 1.00 - HB PC, ABS, PC/ABS,
COPE ✔ - Chemical and abrasion resistant, hydrolitically
stable—ideal for electronic grips/gaskets or wearables
Engineering Resin Overmolds
Versaflex™ OM 1060X-1 Natural 60A 0.93 ✔ - PC, ABS, PC/ABS ✔ - Versatile OM resin—ideal for grips/gaskets
Versaflex™ OM 9-801N Natural 47A 1.04 ✔ HB
PC, ABS, PC/ABS,
PPO, POM, COPE,
PMMA, HIPS
✔ - Soft touch/rubber feel—ideal for grips/gaskets
Versaflex™ OM 9-802CL Clear 40A 0.92 ✔ - PC, ABS, PC/ABS,
COPE ✔ - Soft touch/rubber feel—ideal for grips/gaskets
Versaflex™ OM 6059-9 Black 58A 1.10 - HB PA 6 and 6,6 ✔ - Superior adhesion—ideal for grips,
Versaflex™ OM 6160-1 Black/
Natural 60A 1.11 ✔ HB PA 6 and 6,6 ✔
Superior adhesion—ideal for grips,
Versaflex™ OM 6240-1 Natural 43A 1.09 - - PA 6 and 6,6 ✔ - Superior adhesion — ideal for grips,
Versaflex™ OM 6258-1 Natural 62A 1.09 - - PA 6 and 6,6 ✔ - Superior adhesion—ideal for grips,
Versaflex™ OM 6258-9 Black 62A 1.09 - HB PA 6 and 6,6 ✔ - Superior adhesion—ideal for grips,
Versaflex™ OM 6275-9 Black 75A 1.10 - - PA 6 and 6,6 ✔ - Superior adhesion—ideal for grips,
Versollan™ OM1255NX Black 59A 1.05 - HB PC, ABS, PC/ABS,
PC/PBT, COPE ✔ - Superior adhesion—ideal for power tool grips
Versollan™ RU 2205-1 Natural 65A 1.16 - HB PC, ABS, PC/ABS,
COPE ✔ ✔ High performance, rubber feel
Appearance Hardness Specific
Food
Contact UL 94 Suitable
ASTM
Shore
ASTM
(D792)
Special Series
Versaflex™ VDT 4202-40B Black 40A 1.00 - - PP ✔ ✔
Vibration dispersion—ideal for washer/dryer
feet or shin guards
Versaflex™ G2800-17 Pink 18 OO 0.85 - - - ✔ - Skin-like feel—ideal for adult toys
Versaflex™ SP 2820-55N Natural 55A 0.91 ✔ - - ✔ ✔ Superior puncture and tear resistance—ideal for dog toys
Versaflex™ XP 2850 Natural 55A 0.88 ✔ - - ✔ ✔ Wet grip—ideal for water sports or grips
Versaflex™ GP 2810-40N AM US Translucent 45A 0.87 ✔ - - ✔ - Antimicrobial
Versaflex™ CE 3120-65 AM Natural 67A 1.15 - - PC, ABS, PC/ABS,
COPE ✔ - Antimicrobial for consumer electronics
Versalloy™ XL 9045-1 Natural 44A 0.88 ✔ - - ✔ - Excellent flow for long, thin flow paths—
Versalloy™ XL 9055-1 Natural 53A 0.89 ✔ - PP ✔ - Excellent flow for long, thin flow paths—
Versalloy™ XL 9055X-9 Black 53A 0.89 ✔ HB PP ✔ - Excellent flow for long, thin flow paths—
Versalloy™ XL 9070-1 Natural 70A 0.89 ✔ - PP ✔ - Excellent flow for long, thin flow paths—
Versalloy™ XL 9070X-9 Black 70A 0.89 ✔ HB PP ✔ - Excellent flow for long, thin flow paths;
2.54 cradle-to-gate PCF—ideal for grips or thin wall parts
Dynaflex™ G7702-9001-02 Black 37A 1.10 - - PP ✔ ✔ High temperature performance—ideal for seals and gaskets
Dynalloy™ DT 7910W White 45A 0.93 ✔ - - ✔ ✔ Low compression—ideal for dairy tubing
Versaflex™ CL 2000X Clear 3A 0.87 ✔ - - ✔ ✔ Ultra soft
Versaflex™ CL 2003X Clear 33 OO 0.87 ✔ - - ✔ ✔ Gel feel
Versaflex™ CL30 Clear 30A 0.89 ✔ - PP ✔ ✔ High clarity, high tackiness
Versaflex™ CL40 Clear 43A 0.89 ✔ HB - ✔ ✔ High clarity, high tackiness
General Purpose Series
Versaflex™ GP 2810 Translucent 20A–60A 0.88 ✔ - - ✔ ✔ Unfilled
Versaflex™ GP 2810 Translucent 70A–90A 0.89 ✔ HB - ✔ ✔ Unfilled
Dynaflex™ G7920 Natural/Black 20A 1.01 ✔ - PP ✔ ✔ Filled
Dynaflex™ G7900 Natural/Black 30A–90A 1.05–1.20 ✔ HB PP ✔ ✔ Filled
Appearance Hardness Specific
Compression Set
@ 23°C
Compression Set
@ 100°C
Food
Contact
ISO
10993 USP VI UL 94 Suitable
ASTM
Shore A
(D792) ASTM % ASTM %
Tubing
Versaflex™ G2705 N Translucent 60 0.89 20 - ✔ ✔ ✔ ✔ PP ✔ ✔
High resiliance, low compression set, and good puncture
sealing–ideal for medical and biopharma tubing
Versaflex™ HC BT218 Translucent 67 0.89 19 69 - ✔ ✔ ✔ - - ✔ Weldable and kink resistant—ideal for biopharma tubing
Versalfex™ HC BIO BT218 Translucent 70 0.88 18 58 - ✔ ✔ - - - ✔
Weldable and kink resistant; 40% bio-derived content
(Gen 1 biomass)—ideal for biopharma tubing
Versaflex™ HC MT317 Translucent 68 0.89 17 69 - ✔ ✔ ✔ - - ✔
Flexible and kink resistant, high service temperature
—ideal for medical and biopharma tubing
Versalloy™ HC 9220-70 Natural 70 0.95 17 51 - ✔ ✔ - PP ✔ ✔
High temperature resistance—ideal for
peristaltic pump tubing
Syringe Components
Versaflex™ HC 2110-35N Natural 35 0.89 19 47 - ✔ ✔ - LDPE, PP ✔ - Good puncture sealing and elevated temperature
performance—ideal for septums
Versaflex™ HC 2110-57B Black 57 1.01 20 37 - ✔ ✔ - - ✔ - Low coefficient of friction and elevated temperature
performance—ideal for plungers and stoppers
Engineering Resin Overmolds
Versaflex™ OM 1040X-1 Translucent 42 0.92 22 - ✔ ✔ ✔ - PC, ABS, PC/ABS ✔ - Good compression set at room temperature—
ideal for seals and grips
Versaflex™ OM 3060-1 Clear 59 0.90 33 - ✔ ✔ ✔ HB PC, ABS, PC/ABS,
PC/PETG, PC/PBT ✔ - Good compression set at room temperature
and UV stability—ideal for seals and grips
Versaflex™ OM 8940X-1 Clear 40 0.92 20 - ✔ ✔ - - PK, COPE, PC, ABS,
PC/ABS ✔ - Excellent chemical resistance to alcohols and
disenfectants—ideal for grips on medical devices
Versaflex™ OM 4052 Translucent 56 1.01 27 - ✔ - - - PC, ABS, PC/ABS ✔ -
Excellent chemical resistance to skin oils,
like sebum, and hand lotion—ideal for
consumer healthcare applications
Versaflex™ OM 4063 Translucent 64 1.12 30 - ✔ - - PC, ABS, PC/ABS ✔ -
Excellent chemical resistance to skin oils,
like sebum, and hand lotion—ideal for
consumer healthcare applications
General Purpose Applications
Versaflex™ CL E85 Clear 85 0.90 20 72 ✔ ✔ ✔ - - - ✔ High clarity without plasticizers—ideal for extrusion
Versaflex™ HC 3810 Series Translucent 20–90 0.88 16 54 - ✔ - - - ✔ - Formulated without animal derivatives,
excellent colorability—ideal for seals and labware
Versaflex™ G2705 N Translucent 60 0.89 20 - ✔ ✔ ✔ - PP ✔ ✔
High resiliance, low compression set,
and good puncture sealing
Versalloy™ HC 9220-70 Natural 70 0.95 17 51 - ✔ - - PP ✔ ✔ High temperature resistance
Versalloy™ HC 9210 Series Natural 55 & 70 0.89 20 44 - - ✔ - - ✔ -
Formulated without animal derivatives—
ideal for injection molding long thin flow paths,
smooth surface aesthetics
Versaflex™ CL2242 Clear 43 0.89 23 - ✔ ✔ ✔ - - ✔ - High clarity maintained after boiling cleaning processes
Versaflex™ CL2250 Clear 50 0.89 20 - ✔ ✔ ✔ - - ✔ - High clarity maintained after boiling cleaning processes
FEATURED TPES FOR HEALTHCARE APPLICATIONS
H
EALTH
CARE
GENERAL PROPERTIES REGULATORY BONDING PROCESS FEATURES
Appearance Hardness Specific
Gravity Weatherability* VOC FOG Odor** UL 94 Suitable
ASTM
Shore A
Internal QUV
1000hrs (Delta E)
VDA 278
μg/g (ppm)
VDA 278
μg/g (ppm)
Recycled Content Series
reSound™ REC OF 7310-80 Black/
Natural (Gray) 80 0.90 0.35 75 379 3 (VDA 270) - PP ✔
35% PCR/PIR content (food packaging)—
ideal for automotive interior applications
reSound™ REC OF 7310-90 Black/
Natural (Gray) 90 0.91 0.11 160 557 3 (VDA 270) - PP ✔
45% PCR/PIR content (food packaging)—
ideal for automotive interior applications
General Purpose Series
OnFlex™ G7705 B Black 42 1.20 - - - - - PP ✔ ✔ Easy processing for a wide variety of applications
OnFlex™ G7705 N Natural 44 1.18 - - - - - PP ✔ ✔ Easy processing for a wide variety of applications
OnFlex™ G7720 B Black 57 1.16 0.55 - - - HB PP ✔ ✔ Easy processing for a wide variety of applications
OnFlex™ G7720 N Natural 55 1.17 3.72 - - - HB PP ✔ ✔ Easy processing for a wide variety of applications
OnFlex™ G7820 N Natural 92 1.14 - - - - - PP ✔ ✔ Easy processing for a wide variety of applications
Automotive Fasteners & Interior Components
OnFlex™ AF 7210 Series Natural 40–90 1.00 - - - - - PP ✔ - Low odor and good UV resistance
OnFlex™ AF 7210 Black 40 1.00 0.49 113 845 2 (SAE J1351,
OnFlex™ AF 7210 Black 50 1.00 0.42 51 762 2 (SAE J1351,
OnFlex™ AF 7210 Black 60 1.00 0.21 112 1740 1 (SAE J1351,
OnFlex™ AF 7210 Black 70 0.99 0.22 105 1976 3 (SAE J1351,
OnFlex™ AF 7210 Black 80 1.00 0.32 74 4459 3 (SAE J1351,
OnFlex™ AF 7210 Black 90 1.00 - - - - - PP ✔ - Low odor and good UV resistance
HVAC & Interior Components
OnFlex™ LO 7120-45N Natural 45 1.15 3.21 41 521 2 (SAE J1351,
Dry) - PP ✔ - Significant reductions in VOCs and fogging
compared to traditional TPE technologies
GLS™ TPEs with Antimicrobial Technologies
OnFlex™ LO 7120-45B AM Black 45 1.13 0.52 - - - - PP ✔ - Imbedded antimicrobial technology
FEATURED TPES FOR TRANSPORTATION APPLICATIONS
TRANSPO
RTATIO
N * Values were taken on 3mm plaques following 1000hrs of continious exposure to UVA-340
** Samples were conditioned at 23C at 35% RH for 24 hrs.
https://www.avient.com/sites/default/files/2025-07/ISO IEC 17025 Mechanical Avon Lake.pdf
No. 0514.01) 12/11/2023 Page 1 of 1
SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017
AVIENT CORPORATION – ANALYTICAL SOLUTIONS
33587 Walker Road
Avon Lake, OH 44012
Stephanie Mims Phone: 440 930 3499
MECHANICAL
Valid To: September 30, 2025 Certificate Number: 0514.01
In recognition of the successful completion of the A2LA evaluation process, accreditation is granted to this
laboratory to perform the following rubber and plastics tests:
Test Description Test Method or Standard
Brittleness Temperature (Impact) ASTM D746; ISO 812
Charpy Impact ISO 179-1
Color Determination by Spectrophotometer ASTM D2244, E1331; ISO 7724
Conditioning of Plastics for Testing ASTM D618; ISO 291
Deflection Temperature Under Flexural Load ASTM D648; ISO 75-1, -2
Durometer Hardness (Shore A and D) ASTM D2240; ISO 7619-1
Flexural Properties ASTM D790; ISO 178
Flow Rate (Extrusion Plastometer) ASTM D1238 (Procedures A and B); ISO 1133
Impact Resistance (Izod) ASTM D256; ISO 180
Instrumented Impact ASTM D3763; ISO 6603-2
Specific Gravity/Density ASTM D792 (Method A); ISO 1183-1
Specular Gloss ASTM D523; ISO 2813
Tackiness of Interior Materials BO 061-01
Tear Resistance ASTM D624, D1004; ISO 34
Tensile Properties ASTM D412 (Method A), D638, D882;
ISO 37, 527-1, -2, -3, -4, -5
Xenon-Arc Exposure Testing ASTM D2565, G155; SAE J1885 (Withdrawn January
2008), J1960 (Withdrawn January 2008), J2412, J2527;
BO-116-01
For the tests to which this accreditation applies, please refer to the laboratory’s Mechanical Scope of Accreditation.
This accreditation demonstrates
technical competence for a defined scope and the operation of a laboratory quality management system
(refer to joint ISO-ILAC-IAF Communiqué dated April 2017).
Trace McInturff, Vice President, Accreditation Services
For the Accreditation Council
Certificate Number 0514.01
Valid to September 30, 2025
0514-01
SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017
Test Method or Standard
Test Description
0514-01c
https://www.avient.com/sites/default/files/2024-05/Avient Zertifikat englisch - 2024.pdf
SKZ Standart-Dokumentvorlage
This certificate is valid from: 23.05.2024 bis: 19.05.2027
Certificate No.: 000870.E/24.R
Würzburg, 23.05.2024
Benjamin Kirchgeßner
Certification Body
Certificate
The SKZ - Cert GmbH certifies to the company
Avient Th.
Bergmann GmbH
Adolf-Dambach-Str. 2-4
76571 Gaggenau
the introduction and application of a management system according to
ISO 50001:2018
scope:
Delelopment and production of technical Polymers; at the sites according to
appendix.
This certificate is valid from: 23.05.2024 bis: 19.05.2027
Certificate No.: 000870.E/24.R
Würzburg, 23.05.2024
Benjamin Kirchgeßner
Certification Body
Appendix to certification number: 000870.E/24.R
Avient Th.
https://www.avient.com/sites/default/files/2021-05/unterzertifikat-th.-bergmann.engl-.pdf
Robert Schmitt
Certification Body
This certificate is valid from: 20.05.2021 to: 19.05.2024
Certificate No.: 000461.1.E/21.R
This is a sub-certificate of the PolyOne Deutschland GmbH, Certificate No.: 000461.E/21.R.
Certificate
The SKZ-Cert GmbH Zertifizierungen certifies to the company
PolyOne Th.
Bergmann GmbH
Adolf-Dambach-Str. 2-4
76571 Gaggenau
the introduction and application of a management system according to
ISO 50001:2018
Scope:
DEVELOPMENT AND PRODUCTION OF TECHNICAL POLYMERS
The proof has been furnished by an audit.
https://www.avient.com/sites/default/files/2025-07/ISO IEC 17025 Chemical Avon Lake.pdf
No. 0514.02) 12/11/2023 Page 1 of 1
SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017
AVIENT CORPORATION – ANALYTICAL SOLUTIONS
33587 Walker Road
Avon Lake, OH 44012
Stephanie Mims Phone: 440-930-3499
CHEMICAL
Valid To: September 30, 2025 Certificate Number: 0514.02
In recognition of the successful completion of the A2LA evaluation process, accreditation is granted to this
laboratory to perform the following rubber and plastics tests:
Test Description:
Test Method or Standard:
FTIR (Fourier Transform Infrared) Spectroscopy
ASTM E1252 (Except 7.6, 11.2, and 11.4)
Flammability
Horizontal Burn of Self-Supporting Plastics ASTM D635; UL 94; IEC 60695-11-10
Horizontal Burn of Materials Used in Occupant
Compartments of Motor Vehicles
ASTM D5132; FMVSS 302 (49 CFR 571.302);
ISO 3785
Vertical Burn, 20 mm ASTM D3801; UL 94; IEC 60695-11-10
Vertical Burn, 125 mm ASTM D5048; UL 94; IEC 60695-11-20
Thin Material Burning Test UL-94
Glow Wire Test
IEC 60695 2-10, 2-11, 2-12, 2-13
Thermal Analysis
DSC (Differential Scanning Calorimetry) ASTM D3418, E794, E1356
TGA (Thermogravimetric Analysis) ASTM E1131
TMA (Linear Thermal Expansion of Solid
Materials by Thermomechanical Analysis)
ASTM E831; ISO 11359-2
Karl Fischer Moisture Content
ASTM D6869
For the tests to which this accreditation applies, please refer to the laboratory’s Chemical Scope of Accreditation.
This accreditation demonstrates
technical competence for a defined scope and the operation of a laboratory quality management system
(refer to joint ISO-ILAC-IAF Communiqué dated April 2017).
Trace McInturff, Vice President, Accreditation Services
For the Accreditation Council
Certificate Number 0514.02
Valid to September 30, 2025
0514-02
SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017
Test Method or Standard:
Test Description:
0514-02c
https://www.avient.com/sites/default/files/2021-07/mevopur-needle-hub-1-page-case-study.pdf
NEEDLE HUB
MANUFACTURER
N E E D L E H U B C O L O R S
• RAL and Pantone® colors available in palette to align with
ISO 6009 color standard
• Opaque and transparent polypropylene selections
available in both masterbatch and ready-to-use precolors
• Raw materials pre-tested to ISO 10993 and USP Class VI
medical device guidelines
• Certified formulations available globally
• Provided RAL and Pantone colors as
required
• Developed custom polypropylene
formulations to meet specific opacities
• Offered pre-tested raw materials and
produced in an ISO 13485 certified site,
minimizing risk across the value chain
• Provided global formulations transferrable
from our three ISO 13485 certified facilities
Mevopur™ Healthcare Colors
KEY REQUIREMENTS
WHY AVIENT?
AVIENT SOLUTION
COLOR + CERTIFICATION
LEARN MORE
© 2021, Avient Corporation, All Rights Reserved
https://www.avient.com/products/polymer-colorants/solid-color-masterbatches/mevopur-custom-colors-and-formulations
https://www.avient.com/sites/default/files/2023-11/ISO14001.2015.pdf
GenericCertificate_NewLayout
Certificate TH15/8915
The management system of
Avient (Thailand) Co., Ltd.
79 Moo 11, Soi Kingthong, Kingkaew Road, Rachatewa, Bangplee, Samutprakarn, 10540, Thailand
This document is an authentic electronic certificate for Client’ business purposes use only.
Printed version of the electronic certificate are permitted and will be considered as a copy.
Page 1 / 1
has been assessed and certified as meeting the requirements of
ISO 14001:2015
For the following activities
The Design and Manufacturing of Plastic Color Concentrated, Plastic Additive Concentrated and Pigment Powder for Thermoplastic &
Rubber Industries.
https://www.avient.com/news/medtec-china-2024-avient-announces-healthcare-tpu-manufacturing-expansion
Additionally, Avient’s ISO 13485 manufacturing site in Singapore for its Mevopur™ formulations recently achieved ISO/IEC 17025 accreditation for Biological Evaluation of Medical Devices–Part 5: Tests for In-Vitro Cytotoxicity.
Mevopur™ Healthcare Colorants and Functional Additives: formulations pre-tested to support compliance with regulatory requirements, such as USP Class VI, ISO 10993, EP3.1, USP661.1, and ICH Q3D and manufactured across a global network of ISO 13485-certified facilities or under GMP certifications.
PCF values are available for these products and are based upon a TUV-certified ISO-14067: 2018 process.
https://www.avient.com/sites/default/files/2021-04/shanghai-14001.pdf
China TEL: +86 21 32799000 Zhu Hai Ming Management Representative Lack of fulfilment of conditions as set out in the Certification Agreement may render this Certificate invalid.
TEL:+31(0)102922689. www.dnvgl.com/assurance Certificate No: 1614-2000-AE-RGC-RvA Initial certification date: 23 May, 2000 Valid: 23 May, 2021 – 23 May, 2024 This is to certify that the management system of PolyOne-Shanghai, China No. 88, Guo Shou Jing Road, Z.
Park, Pudong, Shanghai, China, 201203 has been found to conform to the Environmental Management System standard: ISO 14001:2015 This certificate is valid for the following scope: Design and Manufacture of Masterbatch