Overview
ISO 4904:2023 - Traditional Chinese medicine - Inner pack of decoction pieces defines international requirements for the inner pack (the package in direct contact with decoction pieces) used in Traditional Chinese Medicine (TCM). The standard covers packaging materials, physical properties, packing dose specifications, labels, QR codes and colour codes, and it applies across manufacturing, inspection, circulation, use, supervision and management. ISO 4904 promotes harmonized packaging, product safety, traceability and reduced trade barriers for decoction pieces.
Key Topics
- Scope and purpose: Requirements for inner packs that directly contact decoction pieces to ensure hygiene, quality and suitability for medicine.
- Physical properties: Conformance to ISO 15378 and ASTM film standards (D3981, D4635); bags must be airtight, clean, undamaged and visually smooth; continuous packaging connections ≥ 20 mm.
- Materials: Inner pack materials must be food/medical-grade, non-toxic, sterile, breathable/ moisture-resistant, recyclable or degradable. Chlorine-containing and recycled toxic materials are prohibited. Recommended materials include plant fibres or polypropylene composites.
- Packaging types: Suitable materials include polyethylene films, paper–plastic composites, aluminium foil composites, glass and metal containers for specific applications (e.g., essential‑oil‑rich or high‑cost items).
- Packing dose specifications: Defined set of 15 standard inner‑pack weights (from 1 g to >1 000 g) with permitted deviations (e.g., 1 g ±10%; 3 g & 5 g ±6%; 6–10 g ±5%; larger sizes ±3–4%). Principle: use the minimum number of specifications to meet clinical prescription needs.
- Special requirements: Double packaging for high‑cost or toxic/anesthetic/psychotropic decoction pieces, with prominent warning marks where applicable.
- Labelling and digital identifiers: Labels must comply with ISO 11615 and ISO 21371 and include trademark, standardized name (ISO 18668‑2), Latin binomial and part, place of production, preparation method, packing weight and barcode/QR code. ISO 4904 also sets requirements for QR code area and scan results, and for colour codes to indicate specifications.
Applications
- For TCM manufacturers and packagers to design compliant inner packaging and set packing weights.
- For quality control and inspection bodies to verify physical properties, material safety and weight deviations.
- For supply chain and traceability systems to implement QR codes and standardized labelling for distribution and regulatory compliance.
- For regulators, pharmacies and hospitals to ensure safe handling, storage and clinical use of decoction pieces.
Related standards
Keywords: ISO 4904:2023, Traditional Chinese medicine, inner pack, decoction pieces, packaging materials, packing specifications, labels, QR code, traceability, TCM packaging.
