https://www.avient.com/resources/safety-data-sheets?page=5566
Shipment Notification - under "Material Header" MSDS - labeled as the "Product Number" (in Section 1)
https://www.avient.com/news/avient-site-taiwan-earns-iso-13485-accreditation-fourth-source-mevopur-medical-grade-materials
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Avient Site in Taiwan Earns ISO 13485 Accreditation; Fourth Source for MEVOPUR™ ‘Medical-Grade’ Materials
Caption: Avient Corporation today announced the ISO 13485:2016 certification of its production site in Taoyuan, Taiwan (near Taipei).
ISO 13485 certification is the culmination of two years’ work to create a completely segregated, dedicated healthcare operation similar to other MEVOPUR plants.
https://www.avient.com/resources/safety-data-sheets?page=2221
Shipment Notification - under "Material Header" MSDS - labeled as the "Product Number" (in Section 1)
https://www.avient.com/resources/safety-data-sheets?page=209
Shipment Notification - under "Material Header" MSDS - labeled as the "Product Number" (in Section 1)
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?
https://www.avient.com/news/new-lsfoh-formulation-avient-helps-prevent-environmental-stress-cracking-armored-cables
The new formulation surpasses all specifications associated with the BS 7655-6.1:1997 standard, including the most stringent LTS 1 classification, even for complex designs and armored cables.
https://www.avient.com/sites/default/files/resources/PolyOne%2520Standard%2520Quality%2520Response_2016_6_9.pdf
Avon Lake, OH 44012
P: +1 (440) 930-3000
I: +1 (866) 737-2066
F: +1 (440) 930-3064
Dear Valued Customer:
Thank you for your inquiry regarding the quality system at PolyOne.
ISO certificates can be found at
www.polyone.com under Quick Links > ISO
List.
Yes.
5.2 Supplier Management
1.
https://www.avient.com/sites/default/files/2024-10/ECCOH_ LSFOH 5983 Formulation - Power Cable Jacket - Application Snapshot.pdf
CABLE
MANUFACTURER
J A C K E T F O R P O W E R C A B L E
• High tear resistance > 11 N/mm
• High environmental stress cracking resistance (ESCR)
• Cost efficient solution
• Hot pressure resistance above 80°C
• Provided a jacket solution that complies with
LTS1 requirements as per the BS 7655-6.1
standard
• Enabled use in over-armored cables operating
at a maximum conductor temperature of 90°C
• Supported our customer in optimizing the
processing of the new material
ECCOH LSFOH 5983 Formulation
KEY REQUIREMENTS
WHY AVIENT?
https://www.avient.com/content/colormatrix-global-email-disclaimers
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https://www.avient.com/sites/default/files/2024-12/ISO 22000-2024. Avient Sta. Clara 308865_en_46389 %2811%29.pdf
Normative base
ISO 22000:2018 Food Safety Management Systems - Requirements
for any organization in the food chain
Reg. no. 46389
Page 1 of 1
Validity 25. 02. 2024 – 24. 02. 2027
Issue 20. 12. 2023
A.Grisard, President SQS F.