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/knowledge-base/article/deep-black-shades-polyester-textiles?ind[]=21537
DIN EN ISO 105-B06
DIN EN ISO 105-C04
DIN EN ISO 105-P02
DIN EN ISO 105-X12
https://www.avient.com/knowledge-base/article/deep-black-shades-polyester-textiles?sust[]=1139
DIN EN ISO 105-B06
DIN EN ISO 105-C04
DIN EN ISO 105-P02
DIN EN ISO 105-X12
https://www.avient.com/knowledge-base/article/deep-black-shades-polyester-textiles?rtype[]=1164
DIN EN ISO 105-B06
DIN EN ISO 105-C04
DIN EN ISO 105-P02
DIN EN ISO 105-X12
https://www.avient.com/products/vivo-formulations-healthcare/neusoft-thermoplastic-polyurethanes
USP Class VI and ISO 10993-4/5 compliant
ASTM ISO Shore A/D
ASTM/ISO %
https://www.avient.com/news/avient-highlight-bio-based-polymer-solutions-pharmapack-2024
Like other Mevopur products, they are formulated with raw materials tested to ISO 10993-1 and USP , European Pharmacopeia 3.1.3 and 3.1.5, USP and ICH Q3D.
Certified for USP Class VI and ISO 10993, the new Versaflex HC BIO BT218 grade is commercially available globally.
Versaflex™ HC Thermoplastic Elastomers series HC3810: translucent TPE formulations offering excellent colorability for injection molded parts and over-molding, developed to comply with ISO 10993-4 and -5, REACH SVHC, and RoHS
https://www.avient.com/sites/default/files/2023-04/Colorant Chromatics Transcend Healthcare Colorants Product Bulletin.pdf
KEY CHARACTERISTICS
• Can be formulated for PESU, PPSU, and PSU
• 43 standard colors as well as custom colors
available
• Ultra-high heat resistance
• Based on raw materials pretested per ISO 10993
• Range of brilliant, vibrant colors
• Based on raw materials compliant
with food contact
• Customizable with functional additive solutions
• Based in polysulfone resins for ultra-high
performance; may be formulated for other
resin types
• Low minimum order quantities available
MARKETS AND APPLICATIONS
Transcend colorants are formulated specifically for
the healthcare market, and ideal for applications
such as:
• Dental tools and equipment
• Surgical robots
• Surgical lighting
• Diagnostic equipment
PRODUCT BULLETIN & COLOR CARD
Colors may vary from actual color shown.
NAME COLOR FAMILY COLOR CODE
TRANSPARENTS
Transparent Blue Violet Violet PPT6730-4005
Transparent Aquamarine Blue PPT6730-5018
Transparent Teal Green Green PPT6730-564C
Transparent Optimal Yellow Yellow PPT6730-458C
Transparent Energy Orange Orange PPT6730-150C
Transparent Crimson Red PPT6730-2009
Transparent True Gray Gray PPT6730-7001
OPAQUES
Linen White White PPO6730-9010
Hygienic White White PPO6730-9001
Ice Gray Gray PPO6730-5C
True Gray Gray PPO6730-424C
Shadow Gray PPO6730-446C
Gunmetal Gray PPO6730-426C
Black Black PPO6730-6C
Powder Blue Blue PPO6730-2127C
Smoky Blue Blue PPO6730-7682C
Bright Azure Blue PPO6730-653C
Cobalt Blue PPO6730-5002
Navy Blue PPO6730-5004
Aquamarine Blue PPO6730-7699C
Blue Violet Violet PPO6730-7456C
Emerald Green PPO6730-6016
Clover Green PPO6730-7723C
Optimal Yellow Yellow PPO6730-459C
Energy Orange Orange PPO6730-2000
Crimson Red PPO6730-3000
Colors may vary from actual color shown.
https://www.avient.com/products/polymer-colorants/healthcare-colorants/mevopur-healthcare-colorants-and-formulations
Standard colors for use in needle hubs (ISO 6009)
Global network of ISO 13485 certified manufacturing sites
ISO 6009 color range
https://www.avient.com/sites/default/files/2022-05/DOC 1879.pdf
Varies by Site; refer to ISO Cert
https://www.avient.com/company/policies-and-
governance/global-iso-certificate-library
How often are 3rd party audits conducted?
Procedures for requirements
within ISO 9001 sites defined by business unit and
Approved
Corporate : Template/Form
Document #: DOC-01879 Revision: 8
Document
Owners:
Brian Hoar Effective Date: May 13, 2022
Title: QF-02 Quality Standard Response
Page 14 of 19
Only the electronic version of this document in ETQ is the controlled version of the document.
IATF and ISO 13485
managed within ETQ Reliance.
https://www.avient.com/knowledge-base/article/securing-supplies-medical-plastic-solutions
For the plastics used in these medical applications, this can mean compliance with the relevant chapters of the International Organization for Standardization (ISO), the United States Pharmacopeia Class VI (USP VI) the European Pharmacopeia (EP 3.1), and the International Conference on Harmonization (ICH Q3D) standards and guidelines.
All four sites are ISO 13485 certified and use a harmonized raw material range as the base for globally available Mevopur standard portfolios and for custom formulations.
The raw materials are pre-tested to the relevant chapters of ISO 10991, USP 661, USP Class VI, EP 3.1 and to the ICH Q3D guidelines to help manufacturers increase the certainty of regulatory compliance for their devices and packaging.