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Medical MaterialUniverse

Materials for medical products, devices, and supplies

This data module is an extended version of the MaterialUniverse data module providing additional properties and information that help you to design medical or food contact products, devices, and supplies. The data has particular depth in its coverage of polymers, but also covers medical metals and ceramics.

For more on the application of this data, read our example solution:

Selecting polymers for medical device applications >>>

You can read a short case study of the use of the medical data within CES Medical Selector.

Details of the data and its relevance

Design requirement How the medical data module helps Design significance
Materials selection Covers nearly all types of plastic and thermoplastic elastomer used in medical devices today AND those not currently used. Rapid evaluation of almost all possible materials options – early in design to avoid requalification costs.
What materials are available in medical grades? Identifies materials available in ISO 10993 or USP Class VI grades, plus their tradenames. Enables faster and more certain regulatory approval of a device (FDA 501(k)) or a drug (NDA)
What materials are available in food contact grades? Identifies materials available in FDA 22 CFR 177, EEC/EU, NSF 51/61 or BfR food contact grades. Indicates the possibility of passing medical biocompatibility testing.
Sterilizability

Sterilizability rankings for: Ethylene oxide (EtO); Steam autoclave; Radiation: gamma or electron-beam.

References and notes on the effect of degradation due to sterilization.

This is an essential constraint for most medical devices.  Disposables must withstand one or two cycles; other equipment repeated sterilization.
Transparent materials Broad coverage of transparent and translucent plastics.

The healthcare industry attaches a premium to product transparency. It is essential for drug delivery devices, medical packaging, tubing, and fluid containers.

Durability to chemicals and UV light

Chemical resistance ratings of materials to 190 chemicals; Environmental stress cracking (ESC) resistance index for thermoplastics; UV resistance ratings.

Reduce recalls, redesign, re-approval.  Avoid going down a material route where ESC (a common failure mode in plastic components) or degradation due to fluid environments or sunlight become problems.

Low temperatures

Impact strength @ -30C; Minimum service temperature.

Some medical devices are stored at deep freeze, dry ice, or even liquid nitrogen temperature. Screen out materials that embrittle at low storage temperatures.

Barrier properties or permeability

Permeability to: Oxygen, water vapor, carbon dioxide (CO2), nitrogen (N2)

Protect efficacy of packaged drugs and medical supplies in blister packs, bottles, containers, bags, etc.
Environmental impact

Estimates for embodied and processing energy, CO2 footprint, recycling.

Company environmental policies.  Assist compliance with environmental regulation.
Mechanical, thermal, and electrical The full range of mechanical, thermal, and electrical design properties. Nearly all products have mechanical, thermal, or electrical design constraints.
Cost

Relative cost of raw materials and forming processes.

Cost reduction is an objective of nearly all product design.  Cost avoidance early in product design is the most effective means to drive out cost.