https://www.avient.com/sites/default/files/2022-07/Lewiston 308872_en_13485_21%5B43%5D.pdf
Normative base
EN ISO 13485:2016 Medical devices –
Quality Management System
Reg. no. 45484 Validity 01.03.2022 – 28.02.2025
Issue 01.03.2022
Swiss Made
Swiss Association for Quality
and Management Systems (SQS)
Bernstrasse 103, 3052 Zollikofen, Switzerland
sqs.ch
F.
https://www.avient.com/company/sustainability/sustainability-report/metrics/planet-data-and-metrics
⁴Certificates can be found at https://www.avient.com/company/policies-and-governance/global-iso-certificate-library
https://www.avient.com/industries/healthcare/catheter-materials-medical-tubing/medical-tubing
Medical-grade thermoplastic elastomers that meet various regulatory requirements, such as ISO 10993 and USP Class VI
https://www.avient.com/resource-center?document_type=221&document_subtype=0&industry=0&product_family=0&product_name=0&op=FILTER RESULTS&form_id=resource_filter_form&page=3
Discover how our Versaflex™ HC TPEs provided the ultra-soft and gel-like feel, optimized performance, and complied with FDA and ISO 10993 requirements.
https://www.avient.com/resource-center?document_subtype=0&document_type=221&form_id=resource_filter_form&industry=0&op=FILTER RESULTS&product_family=0&product_name=0&page=3
Discover how our Versaflex™ HC TPEs provided the ultra-soft and gel-like feel, optimized performance, and complied with FDA and ISO 10993 requirements.
https://www.avient.com/industries/healthcare/medical-packaging/pharmaceutical-packaging
White colorants for polyolefin containers and closures pre-tested to USP, EP, and ISO protocols
https://www.avient.com/resources/safety-data-sheets?page=4561
Geon(TM) DB5261 Neutral TT Iso Stable
https://www.avient.com/company/policies-and-governance/it-systems-use-policy
Global ISO Certificate Library
https://www.avient.com/company/policies-and-governance
Global ISO Certificate Library
https://www.avient.com/news/avient-highlight-achievements-global-growth-latest-innovations-plastindia-2023
First, the Pune production site achieved GMP Certification in 2022 and became the first specialty formulator of polymer materials in India to become certified with an ISO 22000 Food Safety Management System.
