Feb 01, 2024 Leave a message

Equirements And Standards For Medical Hot Melt Pressure-Sensitive Adhesives

 

 

Medical hot melt pressure-sensitive adhesives, when applied to medical products such as medical tapes, elastic bandages, wound dressings, surgical incision films, etc., must take into consideration various issues arising from contact with the skin. The requirements and standards are summarized as follows:

 

Low Allergenicity Medical hot melt pressure-sensitive adhesive products used should not cause irritation to the skin, such as redness, itching, or the development of small hives during use.

 

Breathability Hot melt pressure-sensitive adhesive products should exhibit excellent breathability to significantly reduce skin allergenicity. This property allows the skin to breathe and perspire normally even when covered by adhesive products, positively impacting skin perspiration, maintaining wound dryness, and expediting wound healing.

 

Adhesive Properties Human skin varies in terms of dryness, oiliness, hair density, and smoothness. Medical hot melt pressure-sensitive adhesive products should meet the needs of various skin types, maintaining adhesive strength when applied to the skin in humid or hot conditions, and adapting to skin perspiration and bodily fluid secretion without peeling off quickly.

 

Compatibility with the Skin

① Peel strength should not be too high: The peel strength of medical hot melt pressure-sensitive adhesive products applied to the skin should be within a certain limit to avoid discomfort caused by skin tightness. Excessive peel strength may lead to a painful sensation during removal and can easily pull out hair, causing skin damage.

② Good initial adhesion to the skin: As these materials are often used on or around wounds, they should have good initial adhesion, quickly adhering to the skin without the need for excessive pressure.

③ No residue after tearing: There should be no adhesive residue left on the skin after removal, especially around the edges of the adhesive material.

 

Adaptability to Sterilization Many adhesive patches and wound dressings used on wounds require sterilization. The adhesive products should not deteriorate due to disinfectants. Currently, gamma and electron beam sterilization have minimal impact on adhesives, while steam sterilization may cause changes.

 

Medical Testing is Essential

(1) Cytotoxicity test: Examines the potential presence of toxic substances leaching from the adhesive.

(2) Skin irritation test: Conducted to test for the possibility of skin irritation caused by leachables from the material after adhesive application.

(3) Skin sensitization test: Involves repeated testing on skin of different ages and individuals to assess potential allergic reactions.

 

 

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