https://www.avient.com/sites/default/files/2021-11/0514-02-dec2021.pdf
No. 0514.02) Revised 09/21/2021 Page 1 of 2
SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017
POLYMER DIAGNOSTICS INC.
33587 Walker Road
Avon Lake, OH 44012
Ana De La Ree Phone: 440-930-3271
CHEMICAL
Valid To: December 31, 2021 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:
Analysis of Volatile Contaminants from Polymers
(Chromatography)
VDA 277
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
Oxygen Index ASTM D2863
FT1 Flame Test UL1581, Clause 1060;
UL2556/CSA C22.2 No 2556, Clause 9.3
Cable Flame Test UL1581, Clause 1061
VW1 Flame Test UL1581, Clause 1080;
UL2556/CSA C22.2 No 2556, Clause 9.4
FT2/FH Flame Test UL1581, Clause 1100;
UL2556/CSA C22.2 No 2556, Clause 9.1
FV-1 Flame Test UL1581, Clause 1060;
UL2556/CSA C22.2 No 2556, Clause 9.5
Thin Material Burning Test UL-94
Glow Wire Test
IEC 60695 2-10, 2-11, 2-12, 2-13
RVCM in PVC
ASTM D4443
(A2LA Cert.
Avon Lake, OH
for technical competence in the field of
Chemical Testing
This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 17025:2017
General requirements for the competence of testing and calibration laboratories.
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).
https://www.avient.com/sites/default/files/2020-09/versaflex-pf-technical-bulletin-sept-2020-es-la.pdf
MERCADOS Y APLICACIONES
Las fórmulas de Versaflex PF, personalizables
en función del nivel de adherencia deseado,
se coextruyen con películas protectoras para
proporcionar la cantidad justa de protección
durante la fabricación, el montaje, el envío, el
almacenamiento y la instalación de productos
acabados en muchos sectores y aplicaciones
de uso final, como las siguientes:
• Películas ópticas y paneles de visualización
para productos electrónicos de consumo
Electrodomésticos.
• Construcción y materiales de construcción.
• Mobiliario y gabinetes.
• Automoción y otros medios de transporte.
100/0 90/10 80/20 70/30 60/40 40/60 30/70 20/80 10/90 0/100
0,9
1,1
2,0
2,4
2,8
3,7
3,8
4,9
0
1
2
3
4
6
7
8
6,5
1,6
MD6727
MD6748
MD6700
MD6666
9512
MD6649
MD6741
0
2
4
6
8
10
12
% de MD6741/MD6700
El grado de adherencia puede personalizarse para superficies de sustrato.
RESISTENCIA AL DESPRENDIMIENTO
EN ACERO INOXIDABLE
Grosor de la película:
LDPE de 51 micras/Versaflex PF de 25 micras.
https://www.avient.com/sites/default/files/2023-10/LubriOne Product Selection Guide.pdf
% ASTM D570 0.8 – 0.050–1.0 0.3 0.4 0.4 0.050 – 0.050 – – –
Mechanical Properties
Tensile Modulus(1) MPa ASTM D638 2650 9650 9790 8050 7380 1250 965 1770 2420 8620 4140 –
Tensile Strength(1) (Yield) MPa ASTM D638 61.4 119 122 119 94 47 35 40 45 108 72.4 90
Tensile Elongation(1) (Break) % ASTM D638 3.0–5.0 1.0–3.0 1.5 3 2 35 40 30 26 3 – –
Flexural Modulus MPa ASTM D790 2760 6890 6890 7380 6410 1300 1080 1740 1790 6690 4840 5500
Flexural Strength MPa ASTM D790 108 172 214 182 167 55 41.4 62.7 68.3 165 110 130
Coefficient of Friction ASTM D1894
vs.
Steel – Static 0.25 0.46 0.18 0.15 0.12 0.19 0.11 0.14 0.13 0.24 0.17 0.17
Impact
Notched Izod Impact (23°C,
3.18 mm, Injection Molded) J/m ASTM D256A 41 64(6) 110 107 107 70 80 37 37 75 – 69
Thermal Properties
Heat Deflection Temperature ASTM D648
0.45 MPa °C 215(6) – 250 215 216 184 152 151(6) 153(6) 218(6) – –
1.8 MPa °C 65(6) 239(7) 244(6) 210 210 75 94 81.1(6) 88 197(6) – 135(5)
Electrical Properties
Surface Resistivity ohms/sq ASTM D254 – – – 1.30x1012 1.9x1012 5.2x1012 – – – – – 1.0x109
Dielectric Strength (Short Time) kV/mm – – 8.5 – – – – – – – – –
Flammability
Flame Rating Class UL 94 HB – – HB HB HB – HB – – – –
LubriOne™ Internally Lubricated Formulations
NOTES (1) Type I, 5.1mm/min
(2) Type I, 21.3 mm/min
(3) Type I, 50 mm/min
(4) Type I, 5.1mm/min, Break
(5) 3.2 mm thick, Unannealed
(6) 6.35 mm thick, Unannealed
(7) 3.2 mm thick, Annealed
PRODUCT DESCRIPTION UNITS TEST
METHOD
5024 RS HI
5021 RS S1
5021 RS X2
5019 X1
LB6700-
5001 RS AF
Black
NN-
000/01M
Black SO
REC
LB6600-
5030 RS
Grey
LB3300-
5010 RS
LB3300-
5005 RS
REC
LB3220-
5001 RS C
Natural X1
5010 GP
Grey
5006 RS PE
5004 RS PE
LB4200-
5022 Black
LB4200-
5023
Base Polymer PA 6 PA6/PA66 PA66 PBT PC PKE POM
Lubricant UHMWPE1 UHMWPE UHMWPE UHMWPE UHMWPE MoS22 Graphite UHMWPE UHMWPE UHMWPE Graphite UHMWPE UHMWPE MoS2 UHMWPE
Filler type GF10 GF30 GF30 GF50 GF50 Unfilled GF33 GF20 MI20 GF10 Unfilled GF20 GF30 Unfilled Unfilled
General Properties
Specific Gravity g/cm3 ISO 1183 1.18 1.35 1.39 1.55 1.58 1.14 1.44 1.42 1.46 1.23 1.26 1.34 1.43 1.4 1.35
Mechanical Properties
Tensile Modulus (23°C) MPa ISO 527-1 4250 9500 9000 15500 16600 3500 10600 6300 3330 4000 1630 5300 9250 2470 2150
Tensile Strength (Yield, 23°C) MPa ISO-527-2 97 150 160 205 200 85 164 102 55 60 60 108 99.1 55 50
Tensile Elongation (Break, 23°C) % ISO-527-2 12 2.5 3 2.7 2.4 3.4 2.0 4.2 8 2.5 46 3.7 1.5 11 11
Flexural Strength (23°C) MPa ISO 178 103 – – 285 265 108 215 127 78 85 38 155 117 73 68
Flexural Modulus (23°C) MPa ISO 178 3250 – – 12400 11100 2690 9000 4700 3000 3100 1380 4600 5450 2210 2070
Impact
Charpy Notched Impact Strength
(23°C, Injection Molded) kJ/m^2 ISO 179 14 12 10 15 10 3 6 7.7 4.3 12 15 10 7.6 8 5
Charpy Unnotched Impact
Strength (23°C, Injection Molded) kJ/m^2 ISO 179 82 55 61 75 60 65 50 47 69 - NB 63 36 NB NB
Thermal Properties
Deflection Temperature Under Load
1.8 Mpa, Unannealed °C ISO 75-2/A 107 – – 204 – 73 235 – – – 90 210 204 86 80
Cofficient of Friction (CoF) & Wear Rate
CoF vs.
https://www.avient.com/sites/default/files/2020-09/versaflex-pf-technical-bulletin-sept-2020-pt-br.pdf
VERSAFLEX™ PF
Camada de aderência para para
películas protetoras de superfície
BOLETIM TÉCNICO
Propriedades Versaflex PF
MD6727
Versaflex PF
DM6741
Versaflex PF
DM6649
Versaflex PF
9512
Versaflex PF
MD6666
Versaflex PF
DM6748
Versaflex PF
DM6700
Características Baixa aderência
Baixa aderência;
usado para personalizar
aderência com MD6700
Aderência de
baixa a média Oferta de valor Aderência média
Gel/resíduos baixos Estrutura de baixa aderência Alta aderência
Resistência a descolamento Baixa Baixa a média Média Média a alta Média a alta Alta Alta
Aplicações Películas ópticas Eletrodomésticos Plásticos Construção/metais
expostos Metais acabados Aço/metais pintados Metais expostos
MFR a 190 °C/2,16 kg -- 4,5 17 5,4 21 4,8 6,5
MFR a 230 °C/2,16 kg 10 20 -- -- -- -- --
Gravidade específica, g/cc 0,92 0,91 0,92 0,92 0,94 0,94 0,94
Dureza, Shore A 50 49 37 38 37 31 30
G' a 23°C, Pa 28,0 x 105 10,4 x 106 8,3 x 105 -- 9,9 x 105 11,8 x 105 10,0 x 105
DMA Tg, °C -29 -30 -9 10 11 15 21
Película LDPE/Versaflex PF1 Descolamento de 180°, N/25 mm
Aço inoxidável
após 20 min a 25 °C 0,5 2,2 3,2 6,1 6,7 8,5 8,6
após 7 dias a 25°C 0,6 2,7 4,3 5,5 8,2 8,3 10,3
PMMA2
após 20 min a 25 °C 1,1 1,7 3,8 4,9 6,9 8,3 8,8
após 20 min a 75 °C 2,8 4,1 5,1 6,9 9,0 10,7 11,8
após 7 dias a 75°C 4,0 4,4 5,9 9,8 8,4 9,8 10,3
Policarbonato3
após 20 min a 25 °C 1,4 2,2 3,8 6,8 6,3 8,4 7,0
após 20 min a 75 °C 3,4 4,8 6,7 8,8 8,8 10,0 11,8
após 7 dias a 75°C 4,6 6,5 7,5 10,6 11,6 10,6 13,8
1 Espessura da película: LDPE 51 mícrons/Versaflex PF 25 mícrons
2 Arkema Plexiglas™ V052-100 (Plexiglas é uma marca comercial da Arkema France Corp).
3 Sabic Lexan™ L52-111 (Lexan é uma marca comercial da Sabic Innovative Plastics)
PROPRIEDADES FÍSICAS DE FORMULAÇÕES DE CAMADA DE ADERÊNCIA VERSAFLEX PF SELECIONADAS
DESCRIÇÃO DO PRODUTO
As formulações Versaflex™ PF são
especialmente desenvolvidas para a fabricação
de películas protetoras de superfície
coextrudadas de fácil aplicação, mantêm a
aderência com espessura mínima, descolam
suavemente e são removidas completamente,
sem nenhum ou com pouco resíduo.
OS BENEFÍCIOS DO VERSAFLEXTM
PF PARA PELÍCULAS PROTETORAS
DE SUPERFÍCIE:
• Aderência personalizável
• Processo de fabricação de etapa única
(coextrusão)
• Baixas emissões de compostos orgânicos
voláteis (COV) durante a fabricação
• Elimina operações secundárias de
revestimento e secagem
• Elimina produtos químicos líquidos
perigosos em comparação com os sistemas
de solventes
• Reduz custos de conversão em comparação
com revestimento
• Reduz o consumo de energia
MERCADOS E APLICAÇÕES
As formulações Versaflex PF, personalizáveis
com base no nível desejado de aderência, são
coextrudadas com películas protetoras para
fornecer apenas a quantidade certa de proteção
durante a fabricação, montagem, envio,
armazenamento e instalação de produtos
acabados em muitas indústrias e aplicações
de uso final, incluindo:
• Películas ópticas e painéis de exibição
de eletrônicos para o consumo
• Eletrodomésticos
• Construção e materiais de construção
• Móveis e armários
• Automotivo e outros transportes
100/0 90/10 80/20 70/30 60/40 40/60 30/70 20/80 10/90 0/100
0,9
1,1
2,0
2,4
2,8
3,7
3,8
4,9
0
1
2
3
4
6
7
8
6,5
1,6
MD6727
MD6748
MD6700
MD6666
9512
MD6649
MD6741
0
2
4
6
8
10
12
% de MD6741/MD6700
O grau de aderência pode ser personalizado para superfícies de substrato.
PERSONALIZAÇÃO DA ADERÊNCIA POR MEIO
DE COMBINAÇÕES DE VERSAFLEX PF
Espessura da película:
39 mícrons LDPE/13 mícrons Versaflex PF
F = Aderência final após
7 dias a 25° C
i = Aderência inicial após
20 minutos a 25° C
Re
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a
de
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a
ço
, N
/2
5
Re
si
st
ên
ci
a
a
de
sc
ol
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en
to
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a
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, N
/2
5
RESISTÊNCIA A DESCOLAMENTO EM AÇO INOXIDÁVEL
Espessura da película:
LDPE 51 mícrons/Versaflex PF 25 mícrons
www.avient.com
Copyright © 2020, Avient Corporation.
https://www.avient.com/sites/default/files/2024-03/QF-02 QMS Global Standard Response.PDF
Some have additional certifications such as
ISO 13485, ISO 14000, ISO 22000 and other third-party certified standards such as Responsible Care® and
IATF.
Record Retention
Production records are stored for a minimum of 1 year.
ERP records are kept for a minimum of 5 years.
https://www.avient.com/company/policies-and-governance/it-systems-use-policy
9
10
Annex 1 - ISO 13485 certification for Mevopur manufacturing sites North America
& EMEA.
https://www.avient.com/sites/default/files/2024-12/Terms and Conditions of Sale for Colombia %28English and Spanish Translation%29.pdf
Microsoft Word - Terms and Conditions of Sale for Colombia (English and Spanish Translation)
TERMS AND CONDITIONS
These Terms and Conditions govern the sale of Products to another
(“Buyer”) by Avient Corporation
and its affiliates (“Seller”).
1.
TÉRMINOS Y CONDICIONES
Estos Términos y Condiciones rigen la venta de Productos a
terceros ("Comprador") por parte de Avient Corporation y sus
afiliadas ("Vendedor").
1.
El Comprador deberá realizar todos los pagos
en virtud del presente documento en efectivo o su equivalente
de efectivo a valor nominal en los fondos, en el plazo y en el
lugar indicados en la factura del Vendedor.
https://www.avient.com/sites/default/files/2022-03/Asia SEM Healthcare Product Selection Guide %281%29.pdf
PP OVERMOLDING HARDNESS REGULATORY STERILIZATION CHARACTERISTICS
Dynaflex™ G2706 28A USP Class VI, ISO 10993,
Food contact EtO Soft translucent grade,
grippy feel
Dynaflex™ G2711 43A USP Class VI, ISO 10993,
Food contact EtO Highly colorable solution,
grippy feel, low compression set
Versaflex™
CL2242 & CL2250 42A/ 50A USP Class VI, ISO 10993,
US Food contact EtO Clear boilable grades;
ABS, PC bondable
Versaflex™ G2705 N 60A USP Class VI, ISO 10993,
Food contact EtO/Steam High resilience,
low compression set
Versaflex™ HC3810 20A-90A USP Class VI, ISO 10993 EtO General purpose, unfilled
ABS, PC OVERMOLDING HARDNESS REGULATORY STERILIZATION CHARACTERISTICS
Versaflex™ OM1040 40A USP Class VI, ISO 10993 EtO Translucent
Versaflex™ OM3060 60A USP Class VI, ISO 10993 EtO Clear
VERSAFLEX™ CL AND DYNAFLEX™ TPEs
OVERMOLDING FOR
ERGONOMICS
• Adds good tactile surface with soft-touch feel
• Available in a variety of color effects and
textures
• Improves grip, cushion, and comfort
• Enhances functional performance like sealing
properties, vibration damping, oxygen
barrier, and scratch and abrasion resistance
• Reduces assembly costs, good processability
• Offers excellent adhesion to a wide range of
substrates
• Glucometers
• Medical tools overmolds
• Injector pens
• Analysis devices
VERSALLOY™ HC & VERSAFLEX™ HC TPEs
SEALING & RESEALING
• Rubbery feel and soft touch
• No coring, good puncture, and
resealability in static stoppers
• Meets low coefficient of friction
requirements in dynamic seals
• Low extractables
• Suitable to overmold onto polyolefins
• Sealing and resealing septum
• Seals and sanitary gaskets
• Syringe plungers and tips
MATERIAL DESCRIPTION HARDNESS REGULATORY STERILIZATION CHARACTERISTICS
Versalloy™
HC 9210-45N 45A USP Class VI EtO Good processability,
HC 9210-55N 55A USP Class VI EtO Good processability,
HC 9210-70N 70A USP Class VI EtO Good processability,
HC 9220-43N 43A USP Class VI,
ISO 10993-4/5 EtO Extrusion grade,
high temperature resistance
Versaflex™
HC 2110-35N 34A FDA, USP Class VI,
ISO 10993
Autoclave EtO
radiation Resealing, elevated comp set
Versaflex™
HC 2110-57B 57A FDA, USP Class VI,
ISO 10993
Autoclave EtO
radiation Low stiction
VERSAFLEX™ CL AND DYNAFLEX™ TPEs
HIGH CLARITY
GRADES WITHOUT
PLASTICIZERS
• Water clear grades formulated without
phthalate plasticizers
• Meets medical regulatory USP Class VI and
ISO 10993-4,5
• Food contact and FDA compliant
• Autoclave and radiation stable
• Low extractable
• High clarity (Haze 50 4.1, 100 4.5, 100 4, 70 6, 70
Tensile Modulus (MPa) 2200 2700 2600 2350 1820 1820
Flexural Strength (MPa) 80 90 104 86 68 68
Flexural Modulus (MPa) 2500 2700 2500 2300 1980 1590
HDT: 0.45, 1.8 (MPa) 110, 80 90, 80 100, 89 123, 100 123, 64 100, 70
UL-94 Rating @ 3.0 mm 5VA V-0 5VA V-0 HB V-0
UL-94 Rating @ 1.5 mm V-0 V-0 5VB V-0 HB V-0
UL-94 Rating @ 0.75 mm V-1 V-2 V-0 None None V-2
COMPETITIVE MATERIAL COMPARISON
ENGINEERED POLYMER FORMULATIONS
FOR HEALTHCARE
TRILLIANT™ HC THERMOPLASTICS
The family of Trilliant™ HC high-performance thermoplastics is formulated to meet the growing challenges
of medical devices and equipment.
MATERIAL DESCRIPTION BASE RESIN
Trilliant™ HC2020 Copolyester
Trilliant™ HC8910/8920 Polyketone/ABS blend
Trilliant™ HC2120 Tritan
Trilliant™ HC3120 PC
Trilliant™ HC5210 PP
Trilliant™ HC6010 PA6
Trilliant™ HC6610 PA66
Trilliant™ GRV-NP-110-W PA12
TRILLIANT™ HC THERMOPLASTICS
• Chemically resistant replacement for FR PC/ABS,
FR PC/PET & FR COPE, providing UL 94 Yellow
Card V-0 flame rating at 1.5 mm, V-1 at 0.75 mm
thicknesses for a broad color spectrum
• Outperforms PC/ABS, PC/PET and COPE in
resistance to common disinfectants
• Retains tensile strength after 72-hour exposure
to common hospital disinfectants, and shows
better long-term chemical resistance as
compared to PC blends and COPE
• Exhibits good impact and temperature resistance
• Available in natural grades, standard medical
colors, or custom pre-colored products
• Medical device housings
• MRI, X-ray, CT scanner components
• Surgical instruments such as staplers, dissectors,
scissors
• Auto-injector pen
TRILLIANT™ HC
ELECTRICALLY
CONDUCTIVE
FORMULATIONS
• Consistent conductivity ensures repeatable
part performance and minimizes failures
related to inconsistent electrical conductivity
• High flow and easy processing facilitate filling
of thin wall parts and multiple cavity tools,
which enable faster cycle times and lower
per-unit part costs
• Superior durability reduces breakage and
resultant scrap related costs
• Less tendency to flash results in improved
appearance and less fluid retention in or on
the tip, thus driving greater accuracy and less
potential for cross-contamination
• High strength produces parts with greater
stiffness and warp resistance, again
minimizing scrap-related costs
• Conductive pipette tips
TEST
TEMS
SPECIFIC
GRAVITY
MELT FLOW
RATE
(230OC,
2.16KG)
TENSILE
FLEXURAL
FLEXURAL
MODULUS
IMPACT
STRENGTH
NOTCHED,
IZOD
SURFACE
RESISTIVITY
Method ASTM D-792 ASTM D-1238 ASTM D-638 ASTM D-790 ASTM D-790 ASTM D-256 ASTM D-257
Unit -- g/10min MPa MPa MPa J/m Ohms/sq.
ST5200-8030
ESD BK001 1 5 27 52 1980 42 E3
ST5200-8035
ESD BK001 1 20 22 37 1460 150 E3
+86.21.60284888
www.avient.com
Copyright © 2021, Avient Corporation.
https://www.avient.com/sites/default/files/2024-03/Terms and Conditions of Sale for Sweden.pdf
1(7)
TERMS AND CONDITIONS ALLMÄNNA VILLKOR
These Terms and Conditions govern the sale of Products to an-
other (“Buyer”) by Avient Corporation and its affiliates
(“Seller”).
Om det finns
avvikelser mellan versionerna ska den engelska versionen ha
företräde framför den svenska versionen.
1.
April 1, 2024
med uteslutande av andra domstolar, avgöras av domstol i
Sverige med Stockholms tingsrätt som första instans.
22.
https://www.avient.com/sites/default/files/2024-12/ISO-14001_English_Shanghai Zhangjiang.pdf
Zwolseweg 1, 2994 LB, Barendrecht, Netherlands - TEL: +31(0)102922689. www.dnv.com/assurance
MANAGEMENT SYSTEM
CERTIFICATE
Certificate no.:
1614-2000-AE-RGC-RvA
Initial certification date:
23 May 2000
Valid:
24 May 2024 – 23 May 2027
This is to certify that the management system of
PolyOne-Shanghai, China
No. 88, Guo Shou Jing Road, Z.
Park, China (Shanghai) Pilot Free Trade Zone,
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 Colour and Additive Concentrates
http://www.dnv.com/assurance
https://www.avient.com/sites/default/files/2023-01/45324-Certificate-13JAN2023.pdf
ECert - 2023-01-13T114926.191.pdf
Page 1 of 2
Validity of this certificate is based on the successful completion of the periodic surveillance audits of the management system defined by the above scope and is contingent upon
prompt,written notification to ABS Quality Evaluations, Inc. of significant changes to the management system or components thereof.
ABS Quality Evaluations
This is to certify that the Quality Management System of:
Avient Corporation
Avient Corporation - McHenry, IL
831 Ridgeview Drive
ISO 13485:2016
The Quality Management System is applicable to:
Certificate No: 45324
Certification Date: 24 February 2014
Effective Date: 13 January 2023
Expiration Date: 23 January 2026
Revision Date: 13 January 2023 Dominic Townsend, President
DESIGN, MANUFACTURE AND DISTRIBUTION OF THERMOPLASTIC ELASTOMER RESINS & PELLETS FOR THE
MEDICAL DEVICE INDUSTRY
This certificate may be found on the ABS QE Website (www.abs-qe.com).
WITH ADDITIONAL FACILITIES LISTED ON ATTACHED ANNEX)
Certificate Of Conformance
has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by:
Page 2 of 2
ABS Quality Evaluations
Avient Corporation
ISO 13485:2016
Certificate Of Conformance
ANNEX
At Below Facilities:
Validity of this certificate may be confirmed at www.abs-qe.com/cert_validation.