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Technical Requirements for Medical Protective Covers

2022-07-28 11:14

The technical requirements for medical protective covers primarily include material specifications, physical performance requirements, sterility requirements, and packaging and labeling requirements.

Material Requirements
Medical protective covers are typically made from non-toxic, non-irritating, and hypoallergenic materials, such as polyethylene (PE) plastic films. These materials should comply with relevant national standards, such as GB/T1040.3, to ensure their physical performance and chemical stability. The materials should also exhibit good transparency and toughness, allowing easy observation of the items inside the cover and minimizing the risk of damage during use.

Physical Performance Requirements
The dimensions of the protective cover shall meet the design requirements, and dimensional deviations should be within a reasonable range (e.g., ±5%). Physical properties such as tensile strength and elongation at break must comply with standard specifications to ensure the product’s durability and stability. The surface shall be free from defects including bubbles, punctures, water marks, streaks, exposed ribs, poor plasticization, fish eyes, and hard lumps.

Sterility requirements
Before leaving the factory, products must undergo rigorous sterilization processes, such as ethylene oxide sterilization, to ensure their sterility. After sterilization, the residual levels of sterilizing agents in the products should be kept within safe limits—for example, the residual ethylene oxide level should not exceed 10 μg/g.

Packaging and Labeling Requirements
Product packaging should be sealed, moisture-proof, and contamination-resistant to ensure the sterility of the product during transportation and storage. The packaging must clearly indicate key information such as the product name, specifications and model, date of manufacture, expiration date, and manufacturer’s details.

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