Importance Of Plastic Materials For Medical Devices

1528 Words4 Pages

Plastic Materials for Medical devices

July 2015
Table of Contents

Abstract 1
1. Medical Plastics Market overview 1
2. Polymer materials 2
3. Healthcare Domain requirements 3
3.1 Sterilization compatibility 4
3.2 Biocompatibility 5
3.3 Benefits of Medical Polymer knowledge 6
4. Summary 6
5. How will your use case bring value to IGATE business/vertical 6
6. References 6
7. About the Authors 6

Abstract
Polymers popularly coined as “plastics” have proved their importance in different areas like FMCG, pharma, automobiles, etc. Plastics are versatile materials with unique properties like high strength to weight ratio, good aesthetics; good Processability, balanced engineering properties and optimum cost led its entry into medical
Modern healthcare would be impossible without plastics medical products we tend to take for granted: disposable

Syringes, intravenous blood bags and heart valves, etc. Plastics packaging is particularly suitable for medical applications, thanks to their exceptional barrier properties, light weight, low cost, durability, transparency and compatibility with other materials.

Figure 4: Polymer Families
3. Healthcare domain requirements
Medical devices demands for specific properties in addition to general properties like mechanical & electrical. Sterilization and biocompatibility plays prime role in selection healthcare polymer. Material knowledge and its selection process is the key step in product design and development process. Following are few design requirements enlisted for medical devices design:
 Sterilization
 Biocompatibility
 Good chemical resistance
 Colour
 Texture
 Reusable / Disposable
 Duration of contact
 Mechanical
Plastics react differently to various sterilization methods. The most common sterilization methods are radiation (gamma/e-beam), chemical (ETO) and autoclave (steam). The majority of thermoplastic polymers can withstand exposure to toxic Ethylene oxide (ETO) without significant changes to their properties or colour during sterilization.
However, plastics subjected to radiation sterilization will be affected, and it may change the mechanical properties of the material such as tensile strength, impact strength and elongation by chain scission or cross-linking. It is also important to note that multiple exposures to radiation are cumulative. In terms of mechanical performance, PC is generally resistant to radiation, but it will discolor with radiation exposure. The key to selection is highly resistant plastics which can perform well after sterilization. Figure 6: sterilization methods

Table 1: Medical polymers resistant for radiation process
# Radiation process Resistant Materials
1 E-beam sterilization Styrenic, Olefins, PC, Acrylics, Blends
2 Gamma sterilization PC, acrylics, sulphides,

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