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POM Resin for Medical Devices
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POM Resin for Medical Devices
POM Resin for Medical Devices
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Advantages of POM and other Materials for medical devices
Materials such as POM are used as parts for a variety of medical and healthcare products.
They have the advantage of being lighter and offering a higher degree of freedom in shaping compared to metals and glass.
Asahi Kasei recommends our TENAC™ polyacetal (POM) resins as material for medical devices.
POM resin for medical devices
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Polyacetal resin (Polyoxymethylene, abbreviated as POM) possesses properties ideal for medical device applications, including strength, rigidity, impact resistance, low wear, low friction, resilience, and creep resistance. Especially in various mechanical components, smooth and quiet operation can be expected.
POM is primarily a thermoplastic resin composed of the structure (-CH2O-).
POM resins come in two varieties: homopolymers consisting only of the structure (-CH2O-) which excel in strength and rigidity, and copolymers that include some (-CH2CH2O-) units, which have superior thermal stability.
Asahi Kasei manufactures both the homopolymer (TENAC™) and copolymer (TENAC™ -C) POM resin from the polymerization stage onwards, enabling us to supply the products according to the application.
Homopolymers (TENAC™) and copolymers (TENAC™ -C)
TENAC™ is a POM resin for medical devices that has been adopted for lancets, which require good moldability and good puncture performance (spring characteristics), and infusion pump guides, which require high friction and abrasion resistance.
POM Resin for Medical Devices Compatible
with ISO 10993-5, USP <87>, and USP <88> Class VI
Q5010
Medical POM homopolymer TENAC™ Q5010 Features and Applications
​TENAC™ Q5010 has been added to our lineup as a new POM resin for medical devices.
TENAC™ Medical POM Q5010 is a medium viscosity homopolymer.
Medical grade POM homopolymer TENAC™ Q5010 Compliance with regulations and standards
ISO 10993-5, USP <87>, and USP <88> Class VI biocompatibility / cytotoxicity
FDA Drug Master File (DMF).
Potential applications for medical POM homopolymer TENAC™ Q5010 include mechanical parts, valve parts and gears in insulin pens and asthma inhalers.
*Please do not use for the following purposes: parts for medical containers and packaging materials that come into contact with the body, mucous membranes, body fluids, or medicines; containers, packaging, utensils, and parts that come into contact with food, drinking water, etc.
Medical POM homopolymer TENAC™ Q5010 Proposed applications (image)
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Information on Materials for medical devices such as POM
International standards for Materials such as POM for medical devices: What are ISO10993 and ISO10993-5?
ISO 10993 is an international standard for the biological safety evaluation of medical devices.
ISO 10993-5 is a test that evaluates "cytotoxicity," measuring the effects on the survival and proliferation rates of cultured cells in order to determine the presence of toxicity in the medical device as a whole or its raw material chemicals towards living organisms.
International standards for Materials for medical devices such as POM: USP (United States Pharmacopeia) and USP Class VI
USP, or the United States Pharmacopeia, is a compendium of quality standards for pharmaceuticals in the United States, which includes test methods and criteria for purity.
USP <87> is a test that evaluates "cytotoxicity," while USP <88> is a test for "biocompatibility."
Under USP <88>, materials are classified into six different Classes, from Class I to Class VI, where Class VI is the most rigorous. Using materials that meet the USP Class VI standard ensures a high-quality level and can reduce biological risks.
POM Resin for Medical Devices
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Related information
TENAC™ polyacetal resins
Product
Excellent self-lubricating nature, fatigue behavior, and oil resistance. It is used in gears, bearings, automotive interiors and medical parts.