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1、BRITISH STANDARD BS 7711-1: 1994 Respiratory therapy equipment Part 1: Specification for tubing and connectors UDC 615.816.2:615.477.82 Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:29:52 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 7711-1:1994 This Britis
2、h Standard, having been prepared under the direction of the Health Care Standards Policy Committee, was published under the authority of the Standards Board and comes into effect on 15 January 1994 BSI 06-1999 The following BSI references relate to the work on this standard: Committee reference HCC/
3、44 Draft for comment 92/58528 DC ISBN 0 580 22344 2 Committees responsible for this British Standard The preparation of this British Standard was entrusted by the Health Care Standards Policy Committee (HCC/-) to Technical Committee HCC/44, upon which the following bodies were represented: Associati
4、on of Anaesthetists of Great Britain and Ireland Association of British Health Care Industries Association of Veterinary Anaesthetists of Great Britain and Ireland British Anaesthetic and Respiratory Equipment Manufacturers Association Department of Health Medical Sterile Products Association Amendm
5、ents issued since publication Amd. No.DateComments Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:29:52 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 7711-1:1994 BSI 06-1999i Contents Page Committees responsibleInside front cover Forewordii 1Scope1 2Referenc
6、es1 3Nipples1 4Weight-bearing screw-threaded union fittings1 5Tubing1 6Marking3 Annex A (normative) Test methods5 Annex B (informative) Information on method of testing security of connections10 Figure 1 Nipple for respiratory therapy equipment2 Figure 2 Weight-bearing screw-threaded union fitting4
7、Figure A.1 Test nipple made in stainless steel: fine-ground finish N65 Figure A.2 Example of apparatus for testing security of connection of termination to nipple6 Figure A.3 Apparatus for testing resistance to kinking7 Table A.1 Test conditions for static pressure tests9 Table A.2 Test conditions f
8、or tensile load tests9 Table A.3 Test conditions for extended use tests on light duty tubing9 Table A.4 Test conditions for resistance to kinking10 List of referencesInside back cover Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:29:52 GMT+00:00 2006, Uncon
9、trolled Copy, (c) BSI BS 7711-1:1994 ii BSI 06-1999 Foreword This Part of BS 7711 has been prepared under the direction of the Health Care Standards Policy Committee. This Part of BS 7711 is intended to ensure interchangeability of respiratory therapy equipment in domiciliary, ambulance and hospital
10、 practice, and thereby ensure that patients can receive treatment without discontinuity in all these environments. A survey carried out by the Department of Health and Social Security during 1986 revealed that there were then 57 differing types of connector and tubing in use on this type of equipmen
11、t. This standard reduces the range to two types of tubing used with a single design of connector nipple, and one type of weight-bearing connector. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct a
12、pplication. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, pages 1 to 10, an inside back cover and a back cover. This standard has been updated (see copyright
13、 date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:29:52 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 7711-1:1994 BSI 06-19991 1 Scope This
14、 Part of BS 7711 specifies a design of nipple to be used on equipment for the therapeutic administration of respirable gases in domiciliary, ambulance and hospital practice, for example, as the outlets of flowmeters and the inlets to masks or nebulizers. A weight-bearing screw-threaded union design
15、is also specified for use at the outlet of flowmeters to which devices such as humidifiers or nebulizers may be attached. It is intended that an adaptor will be provided so that tubing can be attached directly to the flowmeter when required. Two types of tubing, light and heavy duty, are specified (
16、see 5.2 and 5.3). The tubing and connections specified in this standard may be used with oxygen, air, or mixtures of these gases, including the output from oxygen concentrators. NOTEThis standard is not applicable to anaesthetic apparatus. 2 References 2.1 Normative references This Part of BS 7711 i
17、ncorporates, by reference, provisions from specific editions of other publications. These normative references are cited at the appropriate points in the text and the publications are listed on the inside back cover. Subsequent amendments to, or revisions of, any of these publications apply to this
18、Part of BS 7711 only when incorporated in it by updating or revision. 2.2 Informative references This Part of BS 7711 refers to other publications that provide information or guidance. Editions of these publications current at the time of issue of this standard are listed on the inside back cover, b
19、ut reference should be made to the latest editions. 3 Nipples 3.1 Dimensions The dimensions of nipples for the attachment of tubing to respiratory therapy equipment shall conform to the dimensions given in Figure 1. 3.2 Performance When tested as described in A.2 nipples shall neither fracture nor d
20、istort by more than 2 mm. 4 Weight-bearing screw-threaded union fittings NOTEThis union design is intended for use at the outlet of flowmeter units and at the inlet of devices which are to be attached directly to the flowmeter. 4.1 Weight-bearing screw-threaded union fittings shall comprise a male 9
21、/16 in 18 UNF-2A thread conforming to BS 1580-1:1962 and BS 1580-2:1962, with internal conical form shown in Figure 2a. 4.2 The inlet of a respiratory therapy device intended to be directly attached to a weight-bearing screw-threaded union fitting shall comprise the mating nut and nipple shown in Fi
22、gure 2b. NOTEAdaptors having at one end the nut and nipple shown in Figure 2b and at the other end the nipple shown in Figure 1 may be provided with respiratory therapy flowmeters. 5 Tubing 5.1 General NOTEMaterial used for tubing should be: a) compatible with oxygen; b) non-toxic; c) not subject to
23、 leaching of plasticizers. 5.1.1 Resistance to gas flow of tubing When tested as described in A.3, the resistance to flow shall not exceed 0.9 kPa/m. 5.1.2 End sockets Tubing for respiratory therapy equipment shall terminate at each end with a socket able to produce a secure connection conforming to
24、 5.2.1 or 5.3.1 to the nipple specified in clause 3. NOTESockets may either be formed in the material of the tubing or may be joined to the tubing by e.g. welding or adhesives. 5.1.3 Security of joint between end socket and tubing When tested as described in A.4 if the end socket is joined to the tu
25、bing, the end socket shall not become detached from the tubing. 5.2 Light duty tubing NOTELight duty tubing is designed to be used with internal pressures not exceeding 10 kPa and to be attached to devices which operate at or near ambient temperature. 5.2.1 Security of connection of terminations to
26、nipple When tested as described in A.5, light duty tubing shall not become detached from the test nipple. NOTESee Annex B for information on the method of testing the security of connection between a termination and a nipple. 5.2.2 Resistance to kinking When tested as described in A.6, the flow thro
27、ugh the kinked tubing shall be not less than 75 % of the initial flow. Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:29:52 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 7711-1:1994 2 BSI 06-1999 NOTE 1The external diameter of all corrugations falls on the p
28、rofile of the nipple as shown. NOTE 2Nipples may have a corrugated form, provided that the dimensions in a) are retained. NOTE 3The axis of the nipple may be curved. Figure 1 Nipple for respiratory therapy equipment Licensed Copy: London South Bank University, London South Bank University, Fri Dec 0
29、8 10:29:52 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 7711-1:1994 BSI 06-19993 5.3 Heavy duty tubing NOTEHeavy duty tubing is designed to be used with high resistance devices, e.g. nebulizers, which may cause the pressure in the tubing to approach the gas supply pressure. Many of the devices to w
30、hich heavy duty tubing will be attached operate at elevated temperature up to 40 C, (e.g. air compressors). 5.3.1 Security of connection of terminations to nipple When tested as described in A.5, heavy duty tubing shall not become detached from the test nipple. 5.3.2 Resistance to kinking When teste
31、d as described in A.6, the flow through the kinked tubing shall be not less than 75 % of the initial flow. 6 Marking Tubing for respiratory therapy shall be supplied in sealed packages which shall be clearly and permanently marked or contain a document with the following information: a) description
32、of the contents, i.e. the words “tubing for respiratory therapy”, and a statement as to whether it is light or heavy duty tubing; b) the number and date of this standard (i.e. BS 7711-1:1994)1); c) guidance on the selection of the appropriate grade for specific applications; d) the word “STERILE”, i
33、f appropriate; e) if intended for single use only, the words “SINGLE USE”. NOTESymbol number 1051 of ISO 7000 may be used in addition. f) manufacturers name and/or trademark; g) batch identification or date of manufacture. NOTEThe method of packaging should be designed to minimize the risk of kinkin
34、g of the tubing occurring while in storage. 1) Marking BS 7711-1:1994 on or in relation to a product represents a manufacturers declaration of conformity, i.e. a claim by or on behalf of the manufacturer that the product meets the requirements of the standard. The accuracy of the claim is solely the
35、 claimants responsibility. Such a declaration is not to be confused with third party certification of conformity, which may also be desirable. Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:29:52 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 7711-1:1994 4 BS
36、I 06-1999 NOTE 1Elastomeric or deformable material may be incorporated to reduce torque required to achieve sealing NOTE 2Exterior of nut may be hexagonal, knurled or winged. Figure 2 Weight-bearing screw-threaded union fitting Licensed Copy: London South Bank University, London South Bank Universit
37、y, Fri Dec 08 10:29:52 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 7711-1:1994 BSI 06-19995 Annex A (normative) Test methods A.1 Apparatus A.1.1 Tensile testing machine capable of applying a force of at least 30 N with an accuracy of 5 %. A.1.2 Test gas supply, comprising either dry compressed air
38、 or oxygen. A.1.3 Equipment to control flow and pressure of the test gas supply to values of at least 10 1/min and 200 kPa respectively. A.1.4 T-piece connector for gas pathway. A.1.5 Equipment to measure ambient temperature and atmospheric pressure with an accuracy of 2 %. A.1.6 Pressure gauge(s) c
39、apable of measuring pressure with an accuracy of 5 %. A.1.7 Test nipple with construction and dimensions as shown in Figure A.1. A.1.8 Equipment for testing security of connection of termination to nipple as exemplified in Figure A.2. NOTEOther methods of force application are acceptable. A.1.9 Equi
40、pment for testing resistance to kinking as shown in Figure A.3. A.1.10 Flowmeter to measure flows of air between 4 1/min and 10 1/min with an accuracy of 5 %. A.1.11 Two tubular spacers, outside diameter 12 mm minimum and inside diameter (6.5 0.05) mm, and of lengths as follows: spacer a: (10.0 0.1)
41、 mm; spacer b: (8.0 0.1) mm. A.2 Method of test for strength of nipple A.2.1 Test conditions If the nipple is to be attached to, or forms part of, a device which is intended to operate at elevated temperature, perform the test at the maximum operating temperature of the device if stated by the manuf
42、acturer, or otherwise at (45 2) C. A.2.2 Procedure Securely fix the equipment end of the nipple and apply, using the tensile testing machine (A.1.1), a force at right angles to the axis of the nipple at a point not more than 2 mm from the distal end, increasing the force from zero to (10 0.1) N over
43、 a period of between 0.1 s and 1 s. Maintain the force for 60 s. Record if the nipple fractures. If it does not, record the amount by which the nipple distorts at right angles to its axis at the distal end to the nearest 0.2 mm. Remove the force. Figure A.1 Test nipple made in stainless steel: fine-
44、ground finish N6 Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:29:52 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 7711-1:1994 6 BSI 06-1999 Figure A.2 Example of apparatus for testing security of connection of termination to nipple Licensed Copy: London So
45、uth Bank University, London South Bank University, Fri Dec 08 10:29:52 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 7711-1:1994 BSI 06-19997 Figure A.3 Apparatus for testing resistance to kinking Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:29:52 GMT+00:0
46、0 2006, Uncontrolled Copy, (c) BSI BS 7711-1:1994 8 BSI 06-1999 A.2.3 Test report NOTEWhen a number of the test procedures are performed on the same sample(s) and a combined report is issued, items a) to e) need be stated only once. The test report shall give the following information: a) name of te
47、st house and signature of tester; b) date(s) of test; c) name and address of manufacturer; d) identification of product type; e) batch number(s) of items tested; f) reference to the test, e.g. BS 7711-1:1993: A.2; g) whether the test sample(s) failed the test by fracturing; h) if the test sample did
48、 not fracture, the amount of distortion expressed in millimetres to nearest 0.2 mm. A.3 Method of test for resistance to gas flow of tubing A.3.1 Procedure A.3.1.1 Connect one arm of a T-piece (A.1.4) to one end of a piece of the tubing to be tested of length at least 2 000 mm, measured to an accura
49、cy of 5 mm, laid flat and straight. Connect a pressure gauge (A.1.6) and, via a flowmeter (A.1.3), the test gas supply (A.1.2) to the other arms of the T-piece. A.3.1.2 Cause the test gas to flow through the tubing at a flow of (4 0.2) l/min and record the pressure shown on the pressure gauge. A.3.1.3 Measure and record the ambient temperature and atmospheric pressure and convert the pressure recorded in A.3.1.2 to pressure at 22 C and 101.3 kPa. Calculate the resistance to flow per metre of tubing. A.3.2 Te
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