BS ISO 18665-2015 Traditional Chinese medicine Herbal decoction apparatus《中国传统医学 草药煎煮装置》.pdf

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1、BSI Standards PublicationBS ISO 18665:2015Traditional Chinese medicine Herbal decoction apparatusBS ISO 18665:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 18665:2015.The UK participation in its preparation was entrusted to TechnicalCommittee CH/100, Hea

2、lthcare and medical equipment (Europeanand International).A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The Bri

3、tish Standards Institution 2015.Published by BSI Standards Limited 2015ISBN 978 0 580 82631 3ICS 11.040.99; 23.020.30; 27.060.30Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy

4、Committee on 30 November 2015.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dBS ISO 18665:2015 ISO 2015Traditional Chinese medicine Herbal decoction apparatusMdecine traditionnelle chinoise Appareil dcoction herbe-mdicinaleINTERNATIONAL STANDARDISO18665First edition2015-11

5、-01Reference numberISO 18665:2015(E)BS ISO 18665:2015ISO 18665:2015(E)ii ISO 2015 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2015, Published in SwitzerlandAll rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by a

6、ny means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401

7、CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS ISO 18665:2015ISO 18665:2015(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Requirements 24.1 Material . 24.2 Surface quality . 24.3 Performance 24.4

8、 Electrical safety 24.5 Machinery safety . 35 Test methods . 45.1 Material test . 45.2 Surface quality test 45.3 Performance test . 45.3.1 Hermetic container test . 45.3.2 Pipeline system and valve test . 45.3.3 Pipeline diameter test . 45.3.4 Loading test 45.3.5 Leakage test of lubricating system .

9、 55.3.6 Decocting timing error test . 55.3.7 Working temperature test . 55.4 Electrical safety test 55.5 Machinery safety test 66 Inspection rules . 66.1 Delivery inspection 66.2 Pattern inspection 66.2.1 Pattern inspection conditions 66.2.2 Pattern inspection items . 66.2.3 Sampling 66.2.4 Conformi

10、ty test 77 Labels, instructions for use, and storage . 77.1 Labels 77.2 Instructions for use . 77.3 Storage . 7Bibliography 8 ISO 2015 All rights reserved iiiContents PageBS ISO 18665:2015ISO 18665:2015(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of n

11、ational standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. Inter

12、national organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those inte

13、nded for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www

14、.iso.org/directives).Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document w

15、ill be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expres

16、sions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 249, Traditional Chinese medicine.iv ISO

17、 2015 All rights reservedBS ISO 18665:2015ISO 18665:2015(E)IntroductionThis International Standard has been developed in response to worldwide demand for herbal decoction apparatus traded internationally. There is a wide variety of herbal decoction apparatus currently available commercially, but the

18、re are no standards guiding their manufacture. Increased use of decoctions as a means of administering herbal medicine, as well as growing patients expectations and concerns regarding safety and quality, have given rise to the need to improve the safety and quality of herbal decoction apparatus thro

19、ugh implementation of an International Standard.There are two main types of herbal decoction apparatus in common use. According to the structure of herbal decoction apparatus, it can be divided into hermetic decoction apparatus and non-hermetic decoction apparatusThe primary aim of this Internationa

20、l Standard is to ensure the safety and quality of both non-hermetic decoction apparatus and hermetic decoction apparatus. ISO 2015 All rights reserved vBS ISO 18665:2015BS ISO 18665:2015Traditional Chinese medicine Herbal decoction apparatus1 ScopeThis International Standard specifies the general re

21、quirements of herbal decoction apparatus with design pressures less than 0,1MPa. It includes both hermetic and non-hermetic decoction apparatus. It is applicable to the herbal decoction apparatus for individual herbal formula prescriptions and for commercial use as well as private use. It also appli

22、es to the decocting part of the integrated apparatus of decoction and package.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated r

23、eferences, the latest edition of the referenced document (including any amendments) applies.ISO/IEC Guide 37:2012, Instructions for use of products by consumersISO 780, Packaging Distribution packaging Graphical symbols for handling and storage of packagesISO 16528-1:2007, Boilers and pressure vesse

24、ls Part 1: Performance requirementsISO 16528-2:2007, Boilers and pressure vessels Part 2: Procedures for fulfilling the requirements of ISO 16528-1ISO 21469:2006, Safety of machinery Lubricants with incidental product contact Hygiene requirementsIEC 60204-1:2009, Safety of machinery Electrical equip

25、ment of machines Part1: General requirements3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.3.1herbal decoction apparatusdevice that produces the herbal liquid by extracting medicinal herb pieces with water and heat3.2hermetic decoction apparatusco

26、ntainer that is hermetic during decoction with the decoction pressure higher than the atmospheric pressure3.3non-hermetic decoction apparatuscontainer that is non-hermetic and open to the atmosphere with decoction pressure equal to atmospheric pressureINTERNATIONAL STANDARD ISO 18665:2015(E) ISO 201

27、5 All rights reserved 1BS ISO 18665:2015ISO 18665:2015(E)4 Requirements4.1 Material4.1.1 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,

28、 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 quality4.2.1 The outside surface of the decoction apparatus shall be neat and easy to clean. The surfa

29、ce 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 m.4.2.3 The surface of a non-metal decoction container that is contact with the decoction as

30、 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 Performance4.3.1 The performance of the hermetic container of the herbal decoction apparatus shal

31、l 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 pi

32、pe 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

33、 the herbal decoction apparatus can be free set, automatically controlled and displayed with the measuring error values less than 1C.4.4 Electrical safety4.4.1 The continuity of the protective grounding circuit of the electrical system shall be in accordance with the rules given in IEC 60204-1:2009,

34、 8.2.3.4.4.2 The insulation resistance of the electrical system shall be in accordance with the rules given in IEC 60204-1:2009, 18.3.4.4.3 The voltage of the electrical system shall be in accordance with the rules given in IEC 60204-1:2009, 18.4.2 ISO 2015 All rights reservedBS ISO 18665:2015ISO 18

35、665:2015(E)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 s

36、ystem 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 safety4.5.1 The hermetic decoction apparatus shall give an alarm and stop he

37、ating automatically when the decocting temperature reaches 120C.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 apparatu

38、s, the hydraulic testing pressure of the decoction container shall be no less than 1,25 times the design pressure.4.5.4 For the non-hermetic decoction apparatus, a full water test shall be performed.4.5.5 A warning sign to indicate the presence of a hot surface, as specified in ISO 7010:20111), Tabl

39、e 2, W017, shall be put on the outside surface of the herbal decoction apparatus. See Figure 1.Figure 1 ISO 7010-W017: Warning; Hot surface1) This sign is available at https:/www.iso.org/obp/ui/#iso:grs:7010:2:W017. ISO 2015 All rights reserved 3BS ISO 18665:2015ISO 18665:2015(E)5 Test methods5.1 Ma

40、terial test5.1.1 Check the certificate of conformity of the material. When there is no certificate, the material shall be tested in accordance with the testing methods given in the corresponding material standard.5.1.2 Check the certificate of conformity of the lubricant.5.2 Surface quality test5.2.

41、1 Confirm that the outside surface quality meets the requirements in 4.2.1 with the naked eye.5.2.2 Test with the surface roughness measuring instrument to control that the surface roughness of the metal parts that are in contact with the decoction are less than 0,8 m (4.2.2).5.2.3 Confirm that the

42、surface of the non-metal parts that are in contact with the decoction meets the requirements in 4.2.3.5.2.4 Confirm that the marking of the externally connected pipelines meets the requirements of 4.2.4 with the naked eye.5.3 Performance test5.3.1 Hermetic container testThe hermetic container test s

43、hall be in accordance with the rules given in ISO 16528-1:2007, 7.4 and 7.5 and ISO 16528-2:2007, Clause 5.5.3.2 Pipeline system and valve testCheck the pipeline installation and the easy dismounting conditions. Place the herbal decoction apparatus on level ground and connect it to one end of the pi

44、peline of the packaging component. Place the other end of the pipeline lower than the decoction outlet. Add a nominal capacity of water to the decoction container, then perform the valve switch test. Open the valve to let the water flow until no more water comes out. Place a bowl at the outlet and t

45、hen incline the herbal decoction apparatus more than 10 degrees towards the outlet. Measure the water volume in the bowl with a 50 ml measuring cup and compare this value to the specified value.5.3.3 Pipeline diameter testMeasure the minimum bore diameter in the pipeline.5.3.4 Loading testAdd 50 % o

46、f nominal capacity of drinking water to the decoction container. With the decocting temperature in the hermetic condition set at the maximum working temperature, and the decocting time set at 40 min, start the apparatus. Conduct the loading test in accordance with 5.3.6, 5.3.7, 5.5.1 and 5.5.2.4 ISO

47、 2015 All rights reservedBS ISO 18665:2015ISO 18665:2015(E)5.3.5 Leakage test of lubricating systemAfter the loading test, clean the sealing part with clean white cotton cloth and check the leakage condition of the lubricating system.5.3.6 Decocting timing error testSet the decocting time on the mac

48、hine to 600 s. Using a stopwatch, simultaneously measure the decocting time elapsed. Calculate the decocting timing error according to Formula (1)=600600100t% (1)whereis the percentage of decocting time;600 is the decocting time set on the machine, expressed in seconds (s);t is the decocting time el

49、apsed as measured by the stopwatch, expressed in seconds (s).5.3.7 Working temperature test5.3.7.1 In the loading test, when the boiling lasts for 1 min in the non-hermetic decoction apparatus, check the margin of error values between the display temperature of the herbal decoction apparatus and 100 C.5.3.7.2 For the hermetic herbal decoction apparatus, observe whether the heating stops when the temperature reaches the setting temperature. The setting temperature is defined as the temperature that the operator sets on