ISO 10993-1, USP and (class VI), USP , European Pharmacopeia monographs 3.1.3 and 3.1.5, ICH Q3D and USP and evaluations reduce risk of non-compliance during regulatory submission​

This formulation meets the requirements of the ISO 15759 standard for medical infusion equipment, and can be steam autoclaved using temperatures up to 121°C.

Commercially available in the United States, it has been submitted for USP VI and ISO 10993-4,5 certifications.

Dedicated global technical centers and ISO 13485 certified manufacturing sites round out the service offer and provide consistent support for diagnostic devices.

Our PCF calculator is third-party certified by TÜV Rheinland and aligns with the ISO 14067:2018 Standard for quantifying and reporting the carbon footprint of a product.

No. 0562.01) 11/30/2023 Page 1 of 1 SCOPE OF ACCREDITATION TO ISO/IEC 17025:2017 AVIENT CORPORATION 733 East Water Street North Baltimore, OH 45872 Claire Holman Phone: (419) 257-1327 MECHANICAL Valid To: 2025年10月31日 Certificate Number: 0562.01 In recognition of the successful completion of the A2LA evaluation process, accreditation is granted to this laboratory to perform the following automotive plastics tests: Test Method: Test Name: ASTM D412 Tensile ASTM D523 Specular Gloss ASTM D618 (A) Conditioning of Plastics ASTM D624 (Die C) Tear Strength ASTM D638 Tensile Properties ASTM D792 (A) Density and Specific Gravity by Displacement ASTM D1004 Initial Tear Resistance ASTM D1203 (A) Volatile Loss ASTM D1895 (A) Apparent Density, Bulk Factor, Pourability ASTM D1921 Particle Size (Sieve Analysis) ASTM D2240 Durometer Hardness (Shore A and D) ASTM E1331 Color by Spectrophotometry Using Hemispherical Geometry FMVSS 571.302 Flammability FORD BN-102-01 (A) Low Temperature Flexibility FORD BO-131-03 Interior Odor ISO 3795 Determination of Burning Behavior of Interior Materials SAE J323 (A) Cold Cracking (Mandrel Bend) SAE J1351 Hot Odor for Insulation Materials SAE J1545 Instrumental Color Difference Measurement DOC-058151 Angle of Repose 1 Laboratory Developed Method For the tests to which this accreditation applies, please refer to the laboratory’s Mechanical Scope of Accreditation. Accredited Laboratory A2LA has accredited AVIENT CORPORATION North Baltimore, OH for technical competence in the field of Mechanical 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).

Tested to ISO 10993

They are tested to ISO 10993 standards, and can be customized with the addition of functional additives to enhance product performance.

MEVOPUR medical-grade materials are produced according to ISO13485-2016 protocols and supported by testing to ISO 10993-1, USP, European Pharmacopeia and ICH Q3D guidelines.

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