BS ISO 18665:2015 pdf download – Traditional Chinese medicine — Herbal decoction apparatus.
4 Requirements 4.1 Material 4.1.1 Any material that is in direct contact with the decoction shall be non-toxic, corrosion resistant, non-shedding, high temperature resistant, and shall not cause chemical reactions, absorption with the decoction, or release of substances. It shall be in accordance with the corresponding hygienic standard. 4.1.2 The lubricant shall be in accordance with the rules given in ISO 21469:2006, Clause 5. 4.2 Surface quality 4.2.1 The outside surface of the decoction apparatus shall be neat and easy to clean. The surface coating after the anti-corrosion treatment of the parts shall be neat, smooth, and non-shedding. 4.2.2 The surface roughness of the metal parts that are in contact with the decoction shall be less than 0,8 µm. 4.2.3 The surface of a non-metal decoction container that is contact with the decoction as well as of the sealing elements shall be bright and clean, smooth and free of bubbles. 4.2.4 The material name and flow direction in the pipeline shall be marked where the external pipelines connect. 4.3 Performance 4.3.1 The performance of the hermetic container of the herbal decoction apparatus shall be in accordance with the rules given in ISO 16528-1:2007, 7.4 and 7.5 and ISO 16528-2:2007, Clause 5. 4.3.2 The pipeline system, easy to clean and dismantle as well as with flexible valves switch, shall have no blind pipe. The residues shall be less than 20 ml. 4.3.3 The minimum diameter for the pipe from decoction container to decoction outlet shall not be less than 15 mm. 4.3.4 The seal of the lubricating device of the decoction apparatus shall be dependable with no leakage. 4.3.5 The decocting time can be set with the timing error values no greater than 1 %. 4.3.6 The decocting temperature of the herbal decoction apparatus can be free set, automatically controlled and displayed with the measuring error values less than ± 1°C.
4.4.4 The push-buttons of the electrical system shall be in accordance with the rules given in IEC 60204-1:2009, 10.2. 4.4.5 The indicator lights and displays of the electrical system shall be in accordance with the rules given in IEC 60204-1:2009, 10.3. 4.4.6 The wiring of the electrical system shall be in accordance with the rules given in IEC 60204-1:2009, Clause 13. 4.4.7 The marking, warning signs and reference designations shall be in accordance with the rules in IEC 60204-1:2009, Clause 16. 4.5 Machinery safety 4.5.1 The hermetic decoction apparatus shall give an alarm and stop heating automatically when the decocting temperature reaches 120°C. 4.5.2 For the hermetic decoction apparatus, a safety valve shall be located on the top of the decoction container with the set pressure not higher than 1,05 times of the maximum working pressure. 4.5.3 For the hermetic decoction apparatus, the hydraulic testing pressure of the decoction container shall be no less than 1,25 times the design pressure.