https://www.avient.com/sites/default/files/2023-01/Mevopur Standard Colors Product Bulletin _ Color Card.pdf
KEY CHARACTERISTICS
• Globally harmonized formulations are
manufactured at four ISO 13485 certified
medical sites, providing global consistency
and increased security of supply
• Documented change control available
• A range of standard colors eliminates color
matching to expedite development time
• The portfolio includes compliant colors for
use in:
- Needle hub applications: ISO 6009
- Ophthalmic container closures
(American Academy of Ophthalmology)
REGULATORY SUPPORT
• A library of pre-tested raw materials including:
- ISO 10993-1 and USP biological
evaluation
- European Pharmacopeia 3.1.3/3.1.5
(polyolefin)
- USP (polyethylene)
- ICH Q3D elemental impurities
• Registered Drug Master File (Type III) and/or
Device Master File
• Food contact established with FDA/EU*
HEALTHCARE APPLICATIONS
• Medical devices such as catheters, surgical and
dental instruments, and drug delivery devices
• Pharmaceutical packaging including vials
and bottles
• Diagnostics for blood analysis or In Vitro
Diagnostics (IVD)
PRODUCT BULLETIN & COLOR CARD
* FDA/EU compliance information available upon request; exceptions may occur
Color Pantone
Reference PE Base PP Base Transparent
PP Base PEBA Base PC Base Transparent
PC Base* ABS Base*
White — PE0M176031 PP0M176045 ** AH0M415001 NC0M176058 ** SB0M665206
Yellow 102C PE1M176076 PP1M176060 PP1M176062 AH1M415002 NC1M176058 NC1M176059 SB1M664958
Orange 158C PE2M176044 PP2M176046 ** ** NC2M176044 NC2M664912 SB2M664939
Red 199C PE3M176131 PP3M176111 PP3M176113 AH3M415002 NC3M176116 NC3M176122 SB3M665037
Pink 196C PE3M176130 PP3M176109 ** AH3M415001 NC3M176117 NC3M665052 SB3M665039
Violet 2593C PE4M176023 PP4M176036 PP4M176039 AH4M415001 NC4M176038 NC4M176044 SB4M664978
Light Blue 292C PE5M176155 PP5M176169 ** AH5M415003 NC5M176142 ** SB5M665402
Mid Blue 285C PE5M176154 PP5M176171 PP5M176175 AH5M415002 NC5M176143 NC5M176146 SB5M665404
Dark Blue 288C PE5M176153 PP5M176173 ** ** NC5M176144 ** SB5M665406
Light Green 346C PE6M176128 PP6M176111 ** ** NC6M176118 ** SB6M665070
Bluish Green 3145C PE6M176126 PP6M176115 ** ** NC6M176119 ** SB6M665068
Medium Green 348C PE6M176127 PP6M176113 PP6M176118 AH6M415001 NC6M176120 NC6M176121 SB6M665072
Dark Gray 425C PE7M176066 PP7M176091 PP7M176094 ** NC7M176124 ** SB7M665297
Mid Gray Cool Gray 5C PE7M176067 PP7M176089 ** AH7M415001 NC7M176125 NC7M665175 SB7M665295
Beige 7502C PE8M176048 PP8M176058 ** ** NC8M176058 ** SB8M664871
Brown 463C/731C PE8M176049 PP8M176060 ** ** NC8M176059 ** SB8M664869
Black Black C PL9M176008 PP9M176017 ** ** NC9M176008 NC9M176009 SB9M664896
Colors may vary from actual color shown.
https://www.avient.com/sites/default/files/2022-12/Mevopur Healthcare Colorants and Formulations for Needle Hubs Application Bulletin.pdf
Mevopur™ Healthcare Colorants and Formulations
for Needle and Catheter Hubs
APPLICATION BULLETIN
* FDA/EU compliance information available upon request
To help our customers meet healthcare industry
standards, Avient offers a range of standard colors
for needle hubs, canula hubs and wings matching
the color coding of the ISO 6009 standard.
KEY CHARACTERISTICS
• Manufactured at four ISO 13485 certified sites,
providing global consistency and increased
security of supply
• Documented change control beyond CAS
number, reducing risk of change
• Non-phthalate and formulated without
animal-derived substances
• Color can be combined with additives to
enhance performance and protection
REGULATORY SUPPORT
• Raw materials tested to:
- ISO 10993-1 and USP biological
evaluation
- European Pharmacopeia 3.1.3/3.1.5
(polyolefin)
- USP (polyethylene)
- ICH Q3D elemental impurities
• Registered Device Master File
• Food contact established with FDA/EU*
NOMINAL
OUTSIDE
DIAMETER OF
NEEDLE (MM)
COLOR
DESCRIPTION RAL PANTONE TRANSPARENT
PRODUCT CODE
OPAQUE
PRODUCT
CODE
0.4 Medium Grey 7035 423 C PP7M665125 PP7M665127
0.45 Brown 8017 7588 C PP8M665294 PP8M665296
0.5 Orange 2003 173 C PP2M665298 PP2M665300
0.55 Medium Purple 4005 7676 C PP4M665290 PP4M665292
0.6 Deep Blue 5010 288 C PP5M665894 PP5M665896
0.7 Black 9005 Black C PP9M664950 PP9M664952
0.8 Deep Green 6001 7483 C PP6M665687 PP6M665689
0.9 Yellow 1021 115 C PP1M665211 PP1M665213
1.1 Cream 1015 7401 C PP0M665290 PP0M665292
1.2 Pink 3015 502 C PE3M665725 PP3M665727
Healthcare use limitations apply—see below.
https://www.avient.com/sites/default/files/2020-10/mulch-films-case-study-french.pdf
BIODÉGRADABLE ET
COMPOSTABLE
F I L M S D E P A I L L A G E
• Conforme à la norme européenne EN17033 et certifiée OK
Compost
• Disponibles en noir ou blanc en standard
avec différentes certifications TÜV Austria
(OK Compost, etc
• Prise en charge totale de la certification du
produit final pour les normes EN13432 et
EN17033
• Formulé avec des pigments testés et
approuvés par un organisme certifié
OnColor™ Bio-Colorants
PRINCIPALES EXIGENCES
POURQUOI AVIENT ?
https://www.avient.com/sites/default/files/2021-12/avient-espana-s.l.pdf
ÍNDICE DE EPÍGRAFES SOLICITADOS:
Datos Generales
Situaciones Especiales
DATOS GENERALES
Indice
AVIENT ESPAÑA SOCIEDAD LIMITADA
07/11/1983
Poligono Industrial, s/nºBARBASTRO22300-HUESCA
Indefinida
B22019723 EUID: ES22010.000000526
Hoja HU-2192 Tomo 494 Folio 6
La fabricacion y comercializacion de productos quimicos y auxiliares, tanto
naturales como sinteticos, en relacion con las industrias del caucho, de
resinas, de plasticos y de pinturas, y todas aquellas operaciones
mercantiles que se relacionen con dicho objeto.
En caso de discordancia prevalece el contenido de asientos registrales sobre
el índice llevado por procedimientos informáticos.La Certificación expedida por el Registrador Mercantil será el único
medio para acreditar fehacientemente el contenido de los asientos y demás documentos archivados o depositados
en el Registro (Artículo 77 del Reglamento del Registro Mercantil).Queda totalmente prohibida la incorporación de los
datos que se contienen en este documento a bases o ficheros informatizados que puedan ser susceptibles de
consulta individualizada por personas físicas o jurídicas, y ello aunque se exprese la procedencia de la información
(Instrucción DGRN de 17 de febrero de 1998).
https://www.avient.com/industries/healthcare/labware-diagnostics/ivd-devices
Color and special effect masterbatches pre-tested to ISO, US Pharmacopeia, European Pharmacopoeia, and ICH Q3D protocols for differentiation and patient adherence support
Color and additive solutions based on biopolymers pre-tested to ISO, US Pharmacopeia, European Pharmacopeia, and ICH Q3D protocols to reduce product carbon footprint
https://www.avient.com/industries/healthcare/remote-monitoring-wearables/home-care-monitors
They can be overmolded onto a variety of substrates, are compliant with ISO 10993 & USP Class VI, and can be customized based on application need
Color and special effect masterbatches pre-tested to ISO, US Pharmacopeia, European Pharmacopeia, and ICH Q3D protocols for increased visual appeal and patient adherence to regular monitoring
https://www.avient.com/industries/healthcare/drug-delivery-systems/prefilled-syringes
Colors standardized to RAL and Pantone color systems to align with ISO 6009 standard
Solutions compliant with USP Class VI and ISO-10993 regulations
https://www.avient.com/sites/default/files/resources/CCG_ISO_9001_2015.pdf
https://www.avient.com/sites/default/files/2024-02/Suzhou (SEM) ISO 14001.pdf
https://www.avient.com/industries/healthcare/drug-delivery-systems/auto-injectors-and-drug-delivery-pens
ISO 13485 certified manufacturing sites
ISO 10993 and USP Class VI compliant solutions