BS EN ISO 18082-2014 Anaesthetic and respiratory equipment Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases《麻醉剂和呼吸设备 医疗气体用非交替式螺栓-螺纹.pdf

1、BSI Standards PublicationBS EN ISO 18082:2014Anaesthetic and respiratoryequipment Dimensions ofnon-interchangeable screw-threaded (NIST) low-pressureconnectors for medical gasesBS EN ISO 18082:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO18082:2014. I

2、t supersedes BS EN 15908:2010 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/121/1, Breathing attachments and anaestheticmachines.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does

3、not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 78342 5ICS 11.040.10Compliance with a British Standard cannot confer immunity fromlegal obl

4、igations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 June 2014.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 18082 June 2014 ICS 11.040.10 Supersedes EN 15908:2010English V

5、ersion Anaesthetic and respiratory equipment - Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases (ISO 18082:2014) Matriel respiratoire et anesthsique - Raccords basse pression tte filete non interchangeables (NIST) pour gaz mdicaux (ISO 18082:2014) Ans

6、thesie- und Beatmungsgerte - Mae von nichtverwechselbaren Verbindungsstcken mit Schraubgewinde (NIST) fr niedrigen Druck zur Verwendung mit medizinischen Gasen (ISO 18082:2014) This European Standard was approved by CEN on 22 May 2014. CEN members are bound to comply with the CEN/CENELEC Internal Re

7、gulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN me

8、mber. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.

9、 CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Polan

10、d, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation i

11、n any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 18082:2014 EBS EN ISO 18082:2014EN ISO 18082:2014 (E) 3 Foreword This document (EN ISO 18082:2014) has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” in collaboration wit

12、h Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” the secretariat of which is held by BSI. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by December 2014, and conflicting nat

13、ional standards shall be withdrawn at the latest by December 2014. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document super

14、sedes EN 15908:2010. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of M

15、acedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 18082:2014 has been approved by

16、 CEN as EN ISO 18082:2014 without any modification. BS EN ISO 18082:2014ISO 18082:2014(E) ISO 2014 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope . 12 Terms and definitions . 13 Dimensions and allocation of NIST connectors 24 Marking .115 Test for durability of markings .11Bibl

17、iography .12BS EN ISO 18082:2014ISO 18082:2014(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each m

18、ember body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International

19、Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different typ

20、es of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directivesAttention 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 r

21、esponsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received. www.iso.org/patentsAny trade name used in this document is information given fo

22、r the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions 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 UR

23、L: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 1, Breathing attachments and anaesthetic machines.This is the first edition of this International Standard that contains the requirements for non-i

24、nterchangeable screw threaded (NIST) connectors for use with medical gases previously included in ISO 5359:2008 and ISO 5359:2008/Amd.1:2011.iv ISO 2014 All rights reservedBS EN ISO 18082:2014ISO 18082:2014(E)IntroductionThis International Standard has been prepared in response to the need for a saf

25、e method of connecting medical equipment intended to administer medical gases to patients or power medical devices. Medical gases are stored in cylinders or cryogenic vessels, or can be produced on site; several medical devices (e.g. pressure regulators, hose assemblies, flow-metering devices, lung

26、ventilators, anaesthetic workstations) can be fitted between the source of supply and the medical device. At each interface gas-specific connectors are needed to ensure that the intended medical gas is administered to the patient.While the desirability of achieving agreement on a single Internationa

27、l Standard for screw-threaded connectors has never been in doubt, the present pattern of usage has made such agreement impossible.Nevertheless, fears that proliferation of individual national standards or practices will eventually result in potentially dangerous cross-connection between components f

28、or different gases have led to the choice of several different connector systems, all of which are intended to be incompatible with each other.This International Standard specifies the dimensions and the allocation of non-interchangeable screw threaded (NIST) connectors for use with medical gases.Th

29、is International Standard does not specify the dimensions and the allocation of diameter index safety system (DISS) connectors specified in CGA V-59, sleeve indexed system (SIS) connectors specified in AS 28967, and quick connectors designed for terminal units specified in ISO 9170-15. ISO 2014 All

30、rights reserved vBS EN ISO 18082:2014BS EN ISO 18082:2014Anaesthetic and respiratory equipment Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases1 Scope1.1 This International Standard specifies the dimensions, the allocation and marking of non-interchan

31、geable screw-threaded (NIST) connectors intended to be used at operating pressures up to 1 400 kPa, and for vacuum systems at pressures not greater than 60 kPa absolute.1.2 This International Standard specifies NIST connectors intended for use with the following medical gases: oxygen; nitrous oxide;

32、 medical air; helium; carbon dioxide; xenon; specified mixtures of the gases listed above; oxygen-enriched air; air for driving surgical tools; nitrogen for driving surgical tools;and for use with vacuum.NOTE Low-pressure hose assemblies for medical gases and vacuum are specified in ISO 53593.1.3 Th

33、e information to be supplied by the manufacturer is excluded from the scope of this International Standard because information about the use of NIST connectors is supplied by the manufacturer of each medical device to which the connectors are permanently fitted.NOTE Environmental aspects are dealt w

34、ith in each International Standard concerning medical devices fitted with NIST connectors.2 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.2.1gas-specifichaving characteristics which prevent connections between different gas servicesSOURCE: ISO 7396

35、-1:2007, 3.14INTERNATIONAL STANDARD ISO 18082:2014(E) ISO 2014 All rights reserved 1BS EN ISO 18082:2014ISO 18082:2014(E)2.2medical gasany gas or mixture of gases intended for administration to patients for anaesthetic, therapeutic, diagnostic or prophylactic purposes, or for surgical tool applicati

36、onsSOURCE: ISO 4135:2001, 1.1.12.3non-interchangeable screw-threaded connectorNIST connectorrange of male and female components intended to maintain gas specificity by the allocation of a set of different diameters and a left- or right-hand screw thread to the mating components for each particular g

37、asSOURCE: ISO 9170-1:2008, 3.103 Dimensions and allocation of NIST connectorsThe dimensions of the NIST body, nipple and nut shall comply with Figures 1, 2, 3 and 4 and Tables 2, 3 and 4.Allocation of NIST connectors shall comply with Table 1.Compliance shall be verified by measurement and visual in

38、spection.2 ISO 2014 All rights reservedBS EN ISO 18082:2014ISO 18082:2014(E)Table 1 NIST connector allocation Right-hand threadConnector referenceGasA1A2A3A4A5A6A7A8A9A10Medical air/oxygen mixtureOxygen/nitrous oxide mixture O2= 50 % (volume fraction)Medical airNitrous oxideNitrous oxide/oxygen mixt

39、ures N2O 7 % (volume fraction)HeliumMedical air/helium/carbon monoxide CO 7 % (volume fraction) CO2/O2Xenon XeMedical air/helium/carbon monoxide CO 1 % (volume frac-tion)LFTdSpecial gas mixtureeaTo be defined by national authorities.bExcept for oxygen/nitrous oxide mixtures O2= 50 % (volume fraction

40、).cNational languages may be used for air and vacuum.dLung function test.eFor limited experimental applications. Symbols for special gas mixtures should conform to the chemical symbols of the components. ISO 2014 All rights reserved 11BS EN ISO 18082:2014ISO 18082:2014(E)Bibliography1 ISO 48, Rubber

41、, vulcanized or thermoplastic Determination of hardness (hardness between 10 IRHD and 100 IRHD)2 ISO 4135:2001, Anaesthetic and respiratory equipment Vocabulary3 ISO 5359, Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases1)4 ISO 7396-1:2007, Medical gas

42、pipeline systems Part 1: Pipeline systems for compressed medical gases and vacuum5 ISO 9170-1:2008, Terminal units for medical gas pipeline systems Part 1: Terminal units for use with compressed medical gases and vacuum6 ISO 15001, Anaesthetic and respiratory equipment Compatibility with oxygen7 AS

43、2896:1998, Medical gas systems - Installations and testing of non flammable medical gas pipeline systems8 BS 4518, Specification for metric dimensions of toroidal sealing rings (“O” rings) and their housings9 CGA V-5, Diameter Index Safety System (Non-Interchangeable Low Pressure Connections for Med

44、ical Gas Applications)2)1) To be published. Revision of ISO 5359:2008 and ISO 5359:2008/Amd.1:2011.2) Compressed Gas Association Inc. (CGA), 1725 Jefferson Davis Highway, Arlington, VA 22202, USA.12 ISO 2014 All rights reservedBS EN ISO 18082:2014This page deliberately left blankThis page deliberate

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