DACH Healthcare solutions

Why Ultrapolymers stands out

One-stop shop for Healthcare Products

Products• One of the largest Pan-European polymer distributors

for the major polymer producers

Experience• Technical expertise to advise and support during new

product development including material selection, Moldflow® analysis and part design

Confidence• Dedicated team focusing on medical market

applications and changes in regulatory directives

Reliability• Comprehensive portfolio of high quality products

sourced from the leading polymer producers ensures a wide range of innovative materials specifically for healthcare applications with a backup service based on many years of experience

Innovation• We can support your project through some or all

stages of the design, development and regulatory process from concept generation to commercialisation

Global Reach• Working with partner distribution channels to provide

strategic service to global customers

Engineering Plastics

MBSSBC

SMMAPC

MABSS-TPEPMMA

PB-1

Commodity PlasticsABSSANPS

PPHDPELDPE

amorphous semi-crystalline

Distributed by Ultrapolymers, specifically for medical usePlease visit our website to find your local contact details and country-specific supply restrictions and/or additions

Suppliers

Purell Luran HD Terlux HD Novodur HD NAS Zylar Styrolux K-Resin Styroflex Styrolution PS Trirex FD Sumipex

PE PP PB-1 SAN MABS ABS SMMA MBS SBC SBC S-TPE PS PC PMMA

Sterilisation compatibility

Autoclave Ø Ø

Irradiation Gamma ØØ

E-Beam ØØ

Gas ETO

Regulatory conformity

Bio- compatibility

USP Class VI

ISO 10993

DMF

Transparency

Special features · Notification of change· Grades offering improved ESCR, toughness, stiffness

· Notification of change · Grades offering improved impact, stiffness and clarity

· Notification of change ∙ Free of plasticizers and phthtalates

∙ Very good compatibility with PP, enhanced softness, flexibility, elasticity and kink resistance, excellent transparency

· Notification of change· Clarity and rigidity

· Notification of change· Clarity and toughness

· Notification of change· Colourability and

toughness

· Notification of change

· Clarity and rigidity

· Notification of change

· Clarity and toughness

· Notification of change

· Toughness

∙ Notification of change

∙ Excellent transparency and gloss

∙ Impact toughness and stiffness

· Notification of change

· Soft touch and flexibility

· Clarity and rigidity ∙ Excellent clarity ∙ Superior low temperature impact resistance

∙ Intrinsically V-2

· Highest light transmission values (92 %)

· Material with the lowest refraction of light

· Excellent scratch resistance

Special grades availableØ �LDPE: resistant at lower temperatures / HDPE:

resistant excluding fast autoclavingØØ Resistant but crosslinking

may occur

Ø �For autoclave sterilisation, please consult your technical manager

ØØ �All sterilisation data based on blend with PP

Gamma testing in progress

Styrenic based materials: yellowing from gamma or E-beam radiation is possibleMore info available on request

No testing data for E-beam

Purell is a trade mark of “LyondellBasell” and is used under license by Basell Sales & Marketing Company B.V.

Purell Luran HD Terlux HD Novodur HD NAS Zylar Styrolux K-Resin Styroflex Styrolution PS Trirex FD Sumipex

PE PP PB-1 SAN MABS ABS SMMA MBS SBC SBC S-TPE PS PC PMMA

Sterilisation compatibility

Autoclave Ø Ø

Irradiation Gamma ØØ

E-Beam ØØ

Gas ETO

Regulatory conformity

Bio- compatibility

USP Class VI

ISO 10993

DMF

Transparency

Special features · Notification of change· Grades offering improved ESCR, toughness, stiffness

· Notification of change · Grades offering improved impact, stiffness and clarity

· Notification of change ∙ Free of plasticizers and phthtalates

∙ Very good compatibility with PP, enhanced softness, flexibility, elasticity and kink resistance, excellent transparency

· Notification of change· Clarity and rigidity

· Notification of change· Clarity and toughness

· Notification of change· Colourability and toughness

· Notification of change

· Clarity and rigidity

· Notification of change

· Clarity and toughness

· Notification of change

· Toughness

∙ Notification of change

∙ Excellent transparency and gloss

∙ Impact toughness and stiffness

· Notification of change

· Soft touch and flexibility

· Clarity and rigidity ∙ Excellent clarity ∙ Superior low temperature impact resistance

∙ Intrinsically V-2

· Highest light transmission values (92 %)

· Material with the lowest refraction of light

· Excellent scratch resistance

Special grades availableØ �LDPE: resistant at lower temperatures / HDPE:

resistant excluding fast autoclavingØØ Resistant but crosslinking

may occur

Ø �For autoclave sterilisation, please consult your technical manager

ØØ �All sterilisation data based on blend with PP

Gamma testing in progress

Styrenic based materials: yellowing from gamma or E-beam radiation is possibleMore info available on request

No testing data for E-beam

Purell is a trade mark of “LyondellBasell” and is used under license by Basell Sales & Marketing Company B.V.

Approvals and Testing

• Medical Device Regulation 2017/745 on Medical Devices and Regulation 2017/746 on In-Vitro Diagnostic Devices Regulations entered into force at the end of May 2017. The Regulations will have a staggered transitional period with some aspects becoming legally binding after 6 months, full application of the MDR after 3 years and full application of the IVDR after 5 years. The MDR and IVDR represent a significant develop- ment and strengthening of the existing regulatory system for medical devices in Europe and will replace the original Directives which have been in place for over 25 years, that all devices sold in Europe must fully comply with in order to carry the CE mark. This directive also used ISO 10933/EN30993 (Biological Evaluation of Medical Devices) as a method for testing devise in contact with the body.

• United States Pharmacopeia (USP) details the requirements for devices sold in the USA. Within this USP is the most widely recognised standard with which all plastics intended for use in medical devices must comply. It describes the requirements for Biological Reactivity Tests, In Vivo. Plastics are categorised in Classes I to VI – Class VI being the most stringent. Each class corresponds to a summary set of tests to be performed when the intended end application is a medical device in need of classification.

• ISO 10993 & USP Class VI – If a product is known to comply with both these standards, this substantially aids a device manufacturer during product submission. ISO 10993, European in its origin, is the internationally harmonised standard today. The degree of detail in its testing criteria allows for it to be widely recognised in

the USA as well. The relevance of each section within ISO 10993 is determined by category of intended use and contact criteria.

• VDI Guideline – Our materials conform with the VDI guideline 2017, which defines the plastic material’s requirements and properties across the entire value chain and thereby assures its suitability for healthcare applications. The relevant core criteria include formulation constancy, biocompatibility and supply reliability – always with the objective of making medical products even more safe for the patient.

• Drug Master File (DMF) – A device manufacturer will need to obtain a DMF Listing for a medical device sold in the USA. Similarly, polymer producers have created a DMF Listing for their polymer grades intended for healthcare applications, listing polymer constituents. As part of the submission process, the device manufacturer will need to make reference to the plastic raw material and its constituent parts. The polymer producer owns the DMF and it is filed at the FDA (Food and Drug Administration), who will use it to refer to during device submissions.

• Letter of Authorisation (LoA) – By requesting a LoA from the polymer producer, a device manufacturer can then make reference to the polymer DMF along with the device testing results. The LoA allows the FDA to consult the specific DMF file and give information to the end-user, ensuring no proprietary info is disclosed in the process.

• Food Contact vs Healthcare – “FDA Approved” generally conveys an indication that a polymer is approved for food contact under FDA Regulation 21CFR 177.1520. Whilst somewhat detailed and of some significance, this standard does not carry any definitions for the plastic or medical device and related suitability for medicinal use. As such FDA food contact approval constitutes only a small part of the overall requirements for FDA Medical & Healthcare related requirements.

www.ultrapolymers.com LinkedIn Ultrapolymers Group

Disclaimer: The data indicated above are the results of our investigations and correspond to the state-of-the-art. Ultrapolymers Group and affiliated companies can’t guarantee the relevance or accuracy of this information and accept no responsibility in this regard. No liability, warranty or guarantee of product performance is created by this document. It is the buyer’s responsibility to determine whether Ultrapolymers products are appropriate for Buyer’s use and to ensure that Buyer’s workplace and disposal practices are in compliance with applicable laws and regulations.

A Ravago company

InfoCorporate

2019

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GERMANY

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T + 49 (0) 821 / 272 33 0

F + 49 (0) 821 / 27233 80

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AUSTRIA

Ultrapolymers

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