BS 5682-2015 Dimensions of probes and terminal units for medical gas supply systems Requirements《医疗供气系统用探测器和终端装置尺寸 要求》.pdf

1、BSI Standards PublicationBS 5682:2015Dimensions of probes andterminal units for medicalgas supply systems RequirementsPublishing and copyright informationThe BSI copyright notice displayed in this document indicates when the documentwas last issued. The British Standards Institution 2015Published by

2、 BSI Standards Limited 2015ISBN 978 0 580 85407 1ICS 11.040.10The following BSI references relate to the work on this document:Committee reference CH/121/6Draft for comment 14/30295295 DCPublication historyFirst published December 1978Second edition May 1984Third edition September 1998Fourth (curren

3、t) edition June 2015Amendments issued since publicationDate Text affectedBS 5682:2015 BRITISH STANDARDContentsContents iiiForeword iv1 Scope 12 Normative references 13 Terms and definitions 14 General requirements 25 Probes 26 Terminal units 47 Marking and colour-coding 6Bibliography 8List of figure

4、sFigure 1 Probe dimensions 3Figure2Terminal unit indexing ring dimensions 6List of tablesTable 1 Diameters of indexing collars and identification symbols of probes 4Table 2 Diameters of indexing rings and identification symbols of terminalunits 5Table 3 Symbols and colour coding for probes and termi

5、nal units 7Summary of pagesThis document comprises a front cover, an inside front cover, pages i to iv,pages 1 to 8, an inside back cover and a back cover.ForewordPublishing informationThis British Standard is published by BSI Standards Limited, under licence fromThe British Standards Institution, a

6、nd came into effect on 30 June 2015. It wasprepared by Subcommittee CH/121/6, Medical gas supply systems, under theauthority of Technical Committee CH/121, Anaesthetic and respiratoryequipment. A list of organizations represented on this committee can beobtained on request to its secretary.Supersess

7、ionThis British Standard supersedes BS 5682:1998, which is withdrawn.Information about this documentThis is a full revision of the standard, which takes account of productdevelopment and changes in products since the last edition. Its principal changesare:a) introduction of dimensions for probes and

8、 terminal outlets forhelium/oxygen mixtures;b) specifications for the dimensions of the terminal outlets for all specifiedmedical gases.Presentational conventionsThe provisions of this standard are presented in roman (i.e. upright) type. Itsrequirements are expressed in sentences in which the princi

9、pal auxiliary verb is“shall”.Commentary, explanation and general informative material is presented insmaller italic type, and does not constitute a normative element.Requirements in this standard are drafted in accordance with Rules for thestructure and drafting of UK standards, subclause J.1.1, whi

10、ch states,“Requirements should be expressed using wording such as: When tested asdescribed in Annex A, the product shall .”. This means that only those productsthat are capable of passing the specified test will be deemed to conform to thisstandard.Contractual and legal considerationsThis publicatio

11、n does not purport to include all the necessary provisions of acontract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legalobligationsBS 5682:2015 BRITISH STANDARD1 ScopeThis British Standard specifies dimensions for probes and term

12、inal units for thesupply of medical gases (including vacuum).It is applicable to probes and terminal units for the following medical gases: oxygen; nitrous oxide; oxygen/nitrous oxide mixture; medical air 400 kPa; medical air 700 kPa and above; helium/oxygen mixture; and vacuum.This standard does no

13、t include specifications for probes and terminal units for: nitrogen for driving surgical tools; carbon dioxide; or oxygen 93.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in thisdocument and are indispensable for its application. For dated references

14、, onlythe edition cited applies. For undated references, the latest edition of thereferenced document (including any amendments) applies.BS EN ISO 18082, Anaesthetic and respiratory equipment Dimensions ofnon-interchangeable screw-threaded (NIST) low-pressure connectors for medicalgasesBS EN ISO 535

15、9, Anaesthetic and respiratory equipment Low-pressure hoseassemblies for use with medical gasesBS EN ISO 6506-1, Metallic materials Brinell hardness test Test methodBS EN ISO 9170-1:2008, Terminal units for medical gas pipeline systems Terminal units for use with compressed medical gases and vacuumI

16、SO 32, Gas cylinders for medical use Marking for identification of content3 Terms and definitionsFor the purposes of this British Standard, the terms and definitions given inBS EN ISO 9170-1 and the following apply.3.1 direct probeintegral part of a medical device that connects to a terminal unit3.2

17、 probegas-specific male component designed for acceptance by and retention in thesocket of a terminal unitSOURCE: BS EN 9170-1:2008, 3.113.3 probe insertportion of a probe pushed into and secured within the bore (lumen) of the hoseNOTE Probe inserts are also known as probe tails or probe spigots.BRI

18、TISH STANDARD BS 5682:2015 The British Standards Institution 2015 13.4 remote probepart of a hose assembly that connects to a terminal unit3.5 terminal unitoutlet assembly (inlet for vacuum) of a medical gas supply system at which theoperator makes connections and disconnectionsSOURCE: BS EN ISO 917

19、0-1:2008, 3.154 General requirementsThe safety, materials, design and construction of the probes and terminal unitsshall be in accordance with BS EN ISO 9170-1.5 Probes5.1 The probes shall conform to the dimensions detailed in Figure 1, and Table1. The shoulder of the probe-indexing collar shall hav

20、e a diameter no greaterthan diameter A and shall not extend beyond 46 mm from the tip of the probe.NOTE The restriction on the distance from the tip of the probe to the shoulderof the probe indexing collar is to allow access to the mechanism for releasing theprobe from the terminal unit when install

21、ed.5.2 Remote probes shall be provided with a probe insert to suit the appropriatehose as specified in BS EN ISO 5359.5.3 Direct probes shall be either an integral part of a medical device, notintended to be dismantled by the user, or shall incorporate the body of theappropriate non-interchangeable

22、screw-threaded (NIST) connector as specified inBS EN ISO 18082.5.4 The coupling between a direct probe and a medical device shall permitaccess to the probe release mechanism on the terminal units.NOTE See note to 5.1.5.5 With the exception of the locating slot, the gas-specific indexing collar ofthe

23、 Probe shall be a fully formed annulus.5.6 The gas-specific indexing collar and probe shall be machined or formed froma single piece in order to maintain the concentricity of the component, i.e. thecollar shall not be comprised of a separately manufactured component.5.7 The material used for probes

24、shall have a minimum hardness value of 120HBW 2.5/62.5 when tested in accordance with BS EN ISO 6506-1.NOTE 1 The mechanical properties of the probes are specified to minimize the riskof cross-connection in conditions of normal use and reasonably foreseeable misuse.NOTE 2 Hardness equivalence tables

25、 are provided in BS EN ISO 6506-4.NOTE 3 Stainless steels and nickel or chromium plated brasses are consideredsuitable hardwearing materials for probes.BRITISH STANDARDBS 5682:20152 The British Standards Institution 2015Figure 1 Probe dimensionsNOTE 1 All dimensions in millimetresNOTE 2 Surface fini

26、sh Ra 1.6 unless otherwise specified.NOTE 3 Tolerances on angular dimensions 1 unless otherwise specifiedBRITISH STANDARD BS 5682:2015 The British Standards Institution 2015 3Figure 1 Probe dimensionsNOTE 4 All diametersunless otherwise stated.Table 1 Diameters of indexing collars and identification

27、 symbols of probesService Identifica-tion symbolDiameter AmmDiameter BmmHelium/oxygen mixture(O2content 30%)He/O219.80 to 19.90 16.62 to 16.72Oxygen O220.57 to 20.67 17.40 to 17.50Not Allocated N/A 21.38 to 21.48 18.20 to 18.30Medical air Air 800 22.18 to 22.28 19.00 to 19.10Oxygen/nitrous oxidemixt

28、ure 50%/50% (V/V)O2/N2O 22.99 to 23.09 19.79 to 19.89Nitrous oxide N2O 23.75 to 23.85 20.57 to 20.67Vacuum Vac 24.56 to 24.66 21.39 to 21.49Medical air, 400 kPa Air 25.35 to 25.45 22.16 to 22.266 Terminal units6.1 Terminal units shall meet the requirements of BS EN ISO 9170-1.6.2 Each gas-specific t

29、erminal unit shall accept only the specified probe. Noother probe shall be retained by the terminal unit or open the terminal unitcheck valve.6.3 Compliance with gas specificity shall be checked by attempting to connectgas-specific probes (for all other medical gases listed in Table 1) to the termin

30、alunit under the following conditions:a) pressurized to 4 bar(g) (with no evidence of gas flow);b) at temperatures of -20oC, +23oC and +60oC (2oC);c) at an applied axial force of 1 000 N (10 N);d) repeated 10 times.NOTE Where polymer materials are used, consideration should be given to thepossible e

31、ffects of moisture absorption relevant to mechanical properties of thepolymer.6.4 Terminal unit index ring dimensions shall conform to Figure 2 and Table 2.The diameters forming the terminal unit indexing annulus shall be continuouswith no cut outs.6.5 Terminal units designed for use with medical de

32、vices fitted with a directprobe shall include a non-removable anti-swivel device to locate the probelocating slot and maintain the vertical orientation of the device directly attachedto the probe. In all other circumstances the anti-swivel device shall be excluded.NOTE 1 The anti-swivel device may b

33、e fitted after the terminal unit has beeninstalled.BRITISH STANDARDBS 5682:20154 The British Standards Institution 2015NOTE 2 Devices, such as flow meters, that plug directly into static terminal outlets(e.g. medical supply units) need to be in a specified orientation to work correctly.They also inc

34、orporate a direct probe, which has a locating slot that corresponds witha locating pin in the terminal unit to prevent the device from rotating. This meansof preventing rotation is unnecessary in terminal outlets for any gases that do notrequire a flow device or that are not mounted vertically, as i

35、n ceiling pendants andbooms and where only remote probes are used. Hence the option to not install thepins.6.6 The terminal unit indexing annulus shall be manufactured from a materialwith mechanical properties to meet the requirements of the force test (see 6.2).6.7 The probe retaining mechanism sha

36、ll not lock before the indexing collarreaches the minimum engagement length of 2 mm. The check valve shall notopen before the index collar begins engagement. Diameter C and D shall remainwithin the tolerance for the full depth of the probe insertion that the terminalunit socket design allows.NOTE If

37、 the two outer faces formed by the annulus are not coplanar, the 2 mmminimum engagement is measured from the face nearer to the check valve.Table 2 Diameters of indexing rings and identification symbols of terminal unitsService Identifica-tionsymbolDiameter CmmDiameter DmmHelium/oxygen mixture(O2con

38、tent 30%)He/O216.27 to 16.57 19.95 to 20.25Oxygen O217.05 to 17.35 20.72 to 21.02Not allocated N/A 17.85 to 18.15 21.53 to 21.83Medical air,700 kPa and aboveAir-800 18.65 to 18.95 22.33 to 22.63Oxygen/nitrous oxidemixture 50%/50% (V/V)O2/N2O 19.44 to 19.74 23.14 to 23.44Nitrous oxide N2O 20.22 to 20

39、.52 23.90 to 24.20Vacuum Vac 21.04 to 21.34 24.71 to 25.01Medical air,400 kPaAir 21.81 to 22.11 25.50 to 25.80BRITISH STANDARD BS 5682:2015 The British Standards Institution 2015 5Figure 2 Terminal unit indexing ring dimensions7 Marking and colour-coding7.1 MarkingProbes and terminal units shall be

40、marked in accordance with BS EN ISO 9170-1.Probe indexing collars shall be permanently and legibly marked with thenumber and date of this British Standard, i.e. BS 5682:2015.1)7.2 Colour codingColour coding (if used) shall be in accordance with Table 3. Materials for colourcoding shall be permanent

41、(e.g. vitreous enamel). Paints shall not be used forcolour coding.1)Marking BS 5682:2015 on or in relation to a product represents a manufacturersdeclaration of conformity, i.e. a claim by or on behalf of the manufacturer that theproduct meets the requirements of this British Standard. The accuracy

42、of the claim issolely the claimants responsibility. Such a declaration is not to be confused withthird-party certification of conformity.BRITISH STANDARDBS 5682:20156 The British Standards Institution 2015Table 3 Symbols and colour coding for probes and terminal unitsService Identifica-tion symbolCo

43、lour RALnumberRAL designationHelium/oxygenmixture (O2content 30%)He/O2Brown/white8008/9010 Olivebrown/purewhiteOxygen O2White 9010 Pure whiteNitrous oxide N2O Blue 5010 Gentian blueOxygen/nitrousoxide mixture50%/50% (V/V)O2/N2O Blue/white 5010/9010 Gentianblue/pure whiteMedical air,400 kPaAir Black/

44、white9005/9010 Jet black/purewhiteMedical air,700 kPa and aboveAir-800 Black/white9005/9010 Jet black/purewhiteVacuum Vac Yellow 1018 Zinc yellowA)In accordance with ISO 32 (except vacuum)B)The colours specified are in accordance with the register RAL 840 HR, obtainablefrom: RAL, Sieburger Strasse 3

45、9, D-53757 Sankt Augustin, GermanyBRITISH STANDARD BS 5682:2015 The British Standards Institution 2015 7BibliographyBS EN ISO 6506-4, Metallic materials Brinell hardness test Test methodRAL 840 HR, Cylinder identification colour coding and identification obtainablefrom:RAL, Siegburger Strasse 39, D-

46、53757 Sankt Augustin, GermanyBRITISH STANDARDBS 5682:20158 The British Standards Institution 2015This page deliberately left blankBSI is the national body responsible for preparing British Standards and other standards-related publications, information and services.BSI is incorporated by Royal Chart

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