T/HNJK 01-2020 Abolished Group standards

T/HNJK 01-2020 Gel-patch health care product production specification

Publish Date: 2020-09-01 Implement Date: 2020-09-15 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/HNJK 01-2020

Standard Type: Group standards

Standard Status: Abolished

is_force_gb: no

CCS Name: Traditional Chinese medicine preparations

ICS Name: Medical and Health Technology (Vocabulary)

Publish Date: 2020-09-01

Implement Date: 2020-09-15

Scope

Scope: This standard specifies the terms and definitions, requirements, and main contents of the production technology for health care products in the form of plaster patches, including production processes, physical properties, product identification, inspection methods, content determination, marking, labeling, packaging, transportation, and storage. This standard applies to health care products in the form of plaster patches that are made by processing traditional Chinese medicines, extracts of traditional Chinese medicines, or fine powders with non-woven fabrics and other auxiliary materials through certain processes, and then evenly coated or adsorbed on related auxiliary materials (such as cloth, medical tapes, anti-seepage gaskets, leather, paper), covered with release paper; or made into liquids, with non-woven fabrics (or absorbent cotton, etc.) as carriers, soaked and packaged; or made into powder form, combined with extracts (or vinegar, alcohol, water, etc.), which can be used directly or in combination, and applied by medical tapes (or PU films, fresh-keeping films, etc.) to adhere to unsuitable parts of the human body or acupoints to improve sub-health conditions and have certain health care effects. This standard stipulates the production technology management norms for health care products in the form of plaster patches. These products are intended for direct or indirect application to the human skin surface, not for the prevention and treatment of diseases, and have daily health care, rehabilitation, and health promotion functions. They are products that have been used in folk medicine for a long time, are simple and safe to use, and have the functions of regulating bodily functions, alleviating physical discomfort symptoms, and promoting health, suitable for sub-healthy people to regulate and maintain health. Main technical contents: 4.1 Formulation requirements: The raw materials shall be clearly specified, and for those not recorded in the Pha