What standards do the medical industry need to meet when using self-adhesive coated paper?

The use of self-adhesive coated paper in the medical industry needs to meet a series of standards designed to ensure label durability, safety, legibility and compliance with regulatory requirements. Here are some of the main criteria and requirements:

First, material safety standards

1.Food contact material standards: Self-adhesive coated paper used in the medical industry, especially for the packaging and labeling of direct or indirect contact products such as drugs and medical devices, must meet the relevant standards for food contact materials, such as GB 4806 series standards. These standards specify the limits of hazardous substances in materials to ensure that they do not pose a hazard to human health during use.

2.ROHS standards: Restriction of Hazardous Substances (ROHS) standards limit the content of certain hazardous substances in electronic products. Although the ROHS standard is mainly for electronic products, some equipment or accessories used in the medical industry may also need to meet this standard, so self-adhesive coated paper and its adhesive should also avoid the use of restricted substances.

Second, Physical performance standards

1.Temperature resistance: Products in the medical industry may need to be stored and transported under different temperature conditions, so self-adhesive coated paper needs to have a certain temperature resistance. For example, some drugs need to be stored at low temperatures, which requires the label material to withstand low temperatures without falling off or deformation.

2.Water and oil resistance: In some medical applications, such as the packaging of liquid medicines or cleaners, the self-adhesive coated paper needs to have good water and oil resistance to prevent the label from falling off or blurring after contact with the liquid.

Third, Printing and readability standards

1.Wear resistance and tear resistance: Medical labels may be rubbed or squeezed during use, so the self-adhesive coated paper needs to have a certain wear resistance and tear resistance to ensure the integrity and readability of the label.

2.Printing quality: The printing quality of self-adhesive coated paper directly affects the clarity and readability of the label. The medical industry has very strict requirements on the information on the label, so the self-adhesive coated paper needs to have good printability to ensure that the printed text and patterns are clear and accurate.

3.Font and size: The text content on the medical label usually includes the product name, specifications, production date, expiration date and other key information, the font and size of these information need to meet the requirements of relevant regulations and standards to ensure that medical staff and patients can clearly identify.

Fourth, Compliance with regulations and standards

1.Medical device specifications, labels and packaging labeling management provisions: According to the Regulations on the Supervision and Administration of Medical Devices and its implementation rules, the labels and packaging labeling of medical devices must be true, complete, accurate, scientific, and consistent with product characteristics. Self-adhesive coated paper, as a commonly used material for medical device labels, must strictly comply with these regulations.

2.Other relevant regulations and standards: In addition, the self-adhesive coated paper used in the medical industry also needs to meet the requirements of other relevant regulations and standards, such as the relevant provisions of pharmaceutical packaging labels.

In summary, the use of self-adhesive coated paper in the medical industry needs to meet the requirements of material safety, physical properties, printing and readability, and compliance with regulations and standards. When selecting and using self-adhesive coated paper, these standards and requirements should be fully considered to ensure the quality and safety of the label.