ISO 18665:2022 pdf download.Traditional Chinese medicine — Herbal decoction apparatus.
This document specifies the general requirements of herbal decoction apparatus with design pressures less than 0,1MPa. It includes both hermetic and non-hermetic decoction apparatus.
This document is applicable to herbal decoction apparatus for individual herbal formula prescriptions and for commercial use as well as private use. It also applies to the decocting part of the integrated apparatus of decoction and package.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO/IEC Guide 37:2012, Instructions for use of products by consumers
ISO 780, Packaging — Distribution packaging — Graphical symbols for handling and storage of packages
ISO 16528-1:2007, Boilers and pressure vessels — Part 1: Performance requirements
ISO 16528-2:2007, Boilers and pressure vessels — Part 2: Procedures for fulfilling the requirements of ISO 16528-1
ISO 21469:2006, Safety of machinery — Lubricants with incidental product contact — Hygiene requirements
IEC 60204-1:2016, Safety of machinery — Electrical equipment of machines — Part 1: General requirements 3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1 herbal decoction apparatus
device that produces the herbal liquid by extracting medicinal herb pieces with water and heat
3.2 hermetic decoction apparatus
container that is airtight during decoction with the decoction pressure higher than the atmospheric pressure
3.3 non-hermetic decoction apparatus
container that is non-airtight and open to the atmosphere with decoction pressure equal to atmospheric pressure
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 and 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 any non-metal decoction container that comes into contact with the decoction, as well as that 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 and with a 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 watertight.
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 Electrical safety
4.4.1 The continuity of the protective grounding circuit of the electrical system shall be in accordance with the rules given in IEC 60204-1:2016, 8.2.3.
4.4.2 The insulation resistance of the electrical system shall be in accordance with the rules given in IEC 60204-1:2016, 18.3.ISO 18665 pdf download.ISO 18665 pdf download
