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POM Resin for Medical Devices Compatible with ISO 10993-5, USP <87>, and USP <88>Class VI

The advantages of resin materials for medical devices

Resin materials are used as components in various 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.

POM resin TENAC™ medical use examples

Asahi Kasei recommends our TENAC™ polyacetal (POM) resins as material for medical devices.

Polyacetal (POM) resins tenac

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.

In the polyacetal business field, Asahi Kasei is the world's only manufacturer* of both homopolymers (TENAC™) and copolymers (TENAC™ -C) with our own proprietary technology. 

*Source: Fuji Keizai “2023 Engineering Plastics Market Outlook and Global Strategy”  

Homopolymers (TENAC™) and copolymers (TENAC™ -C) 
Homopolymers (TENAC™) and copolymers (TENAC™ -C) 

TENAC™, as a material for medical devices, boasts a track record of use in lancets, which require good moldability and puncture performance (spring characteristics), as well as in infusion pump guides that demand high resistance to friction and abrasion.

POM Resin for Medical Devices Compatible 
with ISO 10993-5, USP <87>, and USP <88> Class VI
tenac Q5010

Medical POM homopolymer TENAC™ Q5010 Features and Applications

We have newly added TENAC™ Q5010 to our lineup of POM resins for medical devices. 
TENAC™ Q5010 is a medium-viscosity homopolymer.

TENAC™ Q5010 Regulatory and Standard Compliance:

  • ISO 10993-5, USP <87>, and USP <88> Class VI biocompatibility / cytotoxicity
  • FDA Drug Master File (DMF).

The anticipated medical device applications for this resin include mechanical components in insulin pens and inhalers for asthma medication, valve parts, gears, and so on.

*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.

Click here for the data sheet of TENAC™ Q5010

Proposed uses for TENAC™ Q5010 (image)
Proposed Application (Image)

Related information

TENAC™ polyacetal resins

TENAC™ has excellent self-lubricating nature, fatigue behavior, and oil resistance. It is used in gears, bearings, automotive interiors and fuel parts.