Medical & Healthcare

Medical-Grade PVC and Co-Extruded Films for Medical Device Applications

Achilles USA manufactures medical-grade PVC, EVA, PVC/TPU blend, and multi-layer olefin films for medical device OEMs and healthcare product converters. Our films meet USP Class VI and ISO 10993 biocompatibility standards, are manufactured in Everett, Washington under strictly controlled conditions, and undergo 100% in-line optical inspection on every roll.

Full service engineering support is offered to make sure you get the right product for your application. All of our medical/health care films are made in the United States at our plant in Everett, Washington. Our reputation for quality and service leads the industry.

What are medical PVC films used for?

Medical-grade PVC and co-extruded films from Achilles USA are used in fluid management devices (TPN feeding bags, urine collection bags, hemodialysis cassettes), patient positioning and therapy products (surgical positioners, DVT compression pads, wound healing chambers), temperature management (core body warming systems, cold/hot packs), and hospital furniture (mattresses and cushions). Each application requires a specific formulation for biocompatibility, sterilization compatibility, and regulatory compliance.

Over the years, we have collaborated with clients to produce plastic films for many other applications, such as:

Hospital Mattresses/Cushions
Core Body Temperature Warming
Cold/Hot Packs
Wound Healing Chambers
Surgical Positioners
Urine Collection Bags
Hemodialysis Cassette
Infusion Pump Disposables

Materials

Flexible PVC film
- DEHP plasticizer
- DEHT plasticizer (non-phthalate)
- TOTM plasticizer (non-phthalate)
- DOA plasticizer (non-phthalate)
- DINCH plasticizer (non-phthalate)
PVC/TPU blend film
EVA film
Multi-layer olefin film for bioprocessing

Capabilities

Color: clear, opaque, tint
Finishes: hexagon, taffeta, suede, matte and double polish
Hand: 60 to 85 Shore A
Thickness: 0.004” to 0.020”, up to 0.080” laminated
Width: 2” to 80”

Specialized Features

USP Class VI biocompatibility
ISO 10993 biocompatibility
Non BPA
Non Bovine
Anti-microbial
Cold crack/impact resistance
ETO, Gamma and steam sterilization
Registration, Evaluation, Authorization and Restriction of Chemical Substances (REACH) compliance
ROHS 3 compliance
Consumer Product Safety Improvement Act (CPSIA) compliance
Regulation (EU) 2017/745 (EU MDR) compliance

Frequent Asked Questions

What is the difference between USP Class VI and ISO 10993 biocompatibility?

USP Class VI is a material-level pass/fail test that evaluates whether a plastic material causes adverse biological responses. ISO 10993 is a broader, risk-based framework that evaluates the final medical device based on contact type, contact duration, and clinical use. Achilles USA films are available with documentation for both standards. Many medical device OEMs use USP Class VI to qualify materials early in development, then apply ISO 10993 testing at the device level for regulatory submissions.
What sterilization methods are compatible with Achilles USA medical films?

Achilles USA medical-grade PVC films can offer compatibility with ETO (ethylene oxide), Gamma radiation, and steam sterilization. The right formulation depends on your sterilization method, as each process places different demands on the film's thermal stability, flexibility retention, and surface integrity. Our engineering team can specify the correct plasticizer and additive package for your sterilization requirement.
Are Achilles USA medical films free from DEHP and phthalates?

Yes. Achilles USA offers a full range of non-phthalate plasticizer options, including DEHT, TOTM, DOA, and DINCH, for medical device applications where DEHP-free or phthalate-free formulations are required by regulation, retailer specification, or customer preference. DEHP formulations remain available for applications where they are appropriate and permitted.
Does Achilles USA comply with EU MDR (EU 2017/745)?

Yes. Achilles USA films can comply with EU MDR (Regulation EU 2017/745) compliance documentation, along with REACH, RoHS 3, and CPSIA certifications. Full material traceability and regulatory documentation are available to support your technical file and CE marking process.