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1、BRITISH STANDARD BS ISO 11195:1995 Implementation of ISO 11195:1995 Gas mixers for medical use Stand-alone gas mixers ICS 11.040.10 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 01:53:35 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 11195:1995 This British Standard, having been prepared
2、 under the direction of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 March 1996 BSI 04-2000 The following BSI references relate to the work on this standard: Committee reference CH/44 Draft for comment 94/501980 DC ISBN
3、 0 580 25537 9 Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Committee CH/44, Anaesthetic machines, breathing attachments, medical gas pipeline systems and hose assemblies, upon which the following bodies were represented: Associ
4、ation of Anaesthetists of Great Britain and Ireland Association of British Health-care Industries British Anaesthetic and Respiratory Equipment Manufacturers Association Department of Health Medical Sterile Products Association The following body was also represented in the drafting of the standard,
5、 through subcommittees and panels: Guild of Hospital Pharmacists Amendments issued since publication Amd. No.DateComments Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 01:53:35 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 11195:1995 BSI 04-2000i Contents Page Committees responsibleInsi
6、de front cover National forewordii Forewordiii Text of ISO 111951 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 01:53:35 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 11195:1995 ii BSI 04-2000 National foreword This British Standard reproduces verbatim ISO 11195:1995 and implements it a
7、s the UK national standard. This British Standard is published under the direction of the Health and Environment Sector Board whose Technical Committee CH/44 has the responsibility to: aid enquirers to understand the text; present to the responsible international committee any enquiries on interpret
8、ation, or proposals for change, and keep UK interests informed; monitor related international and European developments and promulgate them in the UK. NOTEInternational and European Standards, as well as overseas standards, are available from Customer Services, BSI, 389 Chiswick High Road, London W4
9、 4AL. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comp
10、rises a front cover, an inside front cover, pages i and ii, the ISO title page, pages ii to iv, pages 1 to 7 and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Licens
11、ed Copy: sheffieldun sheffieldun, na, Sun Nov 26 01:53:35 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 01:53:35 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO 11195:1995(E) ii BSI 04-2000 Contents Page Forewordiii Introduction1 1Scope1 2Normative
12、references1 3Definitions1 4Gas connectors1 5Normal operating conditions2 6Reverse gas flow2 7Inlet filter2 8Flow controls2 9Leakage to atmosphere2 10Low-pressure flexible connecting hose assemblies2 11Accuracy of operating data2 12Gas supply failure2 13Electrical safety3 14Marking3 15Accompanying do
13、cuments3 Annex A (normative) Test methods for alarm system, delivered gas and leakage to atmosphere6 Annex B (informative) Rationales6 Figure 1 Example of test arrangement for checking oxygen concentration of delivered gas5 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 01:53:35 GMT+00:00 20
14、06, Uncontrolled Copy, (c) BSI ISO 11195:1995(E) BSI 04-2000iii Foreword ISO (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 co
15、mmittees. Each member 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 th
16、e International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the m
17、ember bodies casting a vote. International Standard ISO 11195 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 1, Breathing attachments and anaesthetic machines. Annex A forms an integral part of this International Standard. Annex B is for inform
18、ation only. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 01:53:35 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv blank Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 01:53:35 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO 11195:1995(E) BSI 04-20001 Introduction This International St
19、andard specifies basic requirements for stand-alone gas mixers intended for medical use. A known hazard associated with the use of gas mixers is the reverse flow of gas from one gas inlet to another, resulting in the contamination of one gas supply system with another gas and the delivery of an inco
20、rrect gas mixture that can cause patient injury. As a consequence of this hazard, particular attention has been paid in this International Standard to minimizing reverse flow. It is recognized that innovations in design may appear which offer performance advantages and yet may conflict with specific
21、 design aspects of this International Standard. Such innovations are not to be discouraged. If techniques and technologies advance beyond those in current usage, they should nevertheless meet the safety and performance requirements given in this International Standard. If these techniques and techno
22、logies differ significantly from those specified, this International Standard may be amended or revised to encompass them. 1 Scope This International Standard gives requirements for the performance and safety of stand-alone gas mixers intended for medical use and intended for connection to a medical
23、 gas supply system. Rationales for some of the requirements are given in Annex B. This International Standard does not apply to a) blocks of flowmeters with separate controls for the flow of each gas; b) gas mixers which mix oxygen with ambient air; c) gas mixers which depend on other medical device
24、s for functions required by this standard. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publication, the editions indicated were valid. All standards are subject to revisi
25、on, and parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 32:1977, Gas cylinders for
26、 medical use Marking for identification of content. ISO 3744:1994, Acoustics Determination of sound power levels of noise sources using sound pressure Engineering method in an essentially free field over a reflecting plane. ISO 5359:1989, Low-pressure flexible connecting assemblies (hose assemblies)
27、 for use with medical gas systems. ISO 7767:1988, Oxygen analyzers for monitoring patient breathing mixtures Safety requirements. ISO 9703-1:1992, Anaesthesia and respiratory care alarm signals Part 1: Visual alarm signals. ISO 9703-2:1994, Anaesthesia and respiratory care alarm signals Part 2: Audi
28、tory alarm signals. IEC 601-1:1988, Medical electrical equipment Part 1: General requirements for safety. 3 Definitions For the purposes of this International Standard, the following definitions apply. 3.1 stand-alone gas mixer; gas mixer device which receives separate supplies of oxygen and other m
29、edical gas(es) and which delivers the mixed gases in concentrations adjustable by the operator and which is not an integral component of any other medical device 3.2 medical gas supply system 1) Non-flammable medical gas pipeline system comprising a central supply system, control equipment, a pipeli
30、ne distribution system and terminal units at the point where non-flammable medical gases or vacuum may be required. 2) Any other installation having no permanent pipeline system but employing a medical gas supply source complete with pressure regulators. 3.3 gas-specific having characteristics which
31、 prevent interchangeability, thereby allowing assignment to one gas or vacuum service only 3.4 alarm indicator of an abnormal state or output of a gas mixer 4 Gas connectors Gas inlet connectors shall be gas-specific and shall be either screw-threaded (i.e. NIST or DISS) or quick-connect; they shall
32、 comply with ISO 5359. NOTE 1The outlet connector is not specified because of the diversity of application of gas mixers. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 01:53:35 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO 11195:1995(E) 2 BSI 04-2000 5 Normal operating conditions 5.1 Norma
33、l operating conditions shall be with the gas mixer connected to inlet gas supplies at all pressures and pressure differentials in the range stated by the manufacturer and at any setting of the mixer control with either flow or no-flow conditions. 5.2 The gas mixer shall have an auditory alarm to ind
34、icate that the inlet pressure conditions are outside the range of normal operating conditions specified by the manufacturer see 15.2 p). If electrically powered, the alarm signal shall be a medium priority alarm complying with ISO 9703-2. NOTE 2The gas mixer need not be provided with a high-pressure
35、 alarm if the upper limit of the input pressure specified by the manufacturer is higher than the normal maximum pressure provided by a medical gas pipeline. The maximum gas pressure which a medical gas pipeline conforming with ISO 7396:1987, Non-flammable medical gas pipeline systems, will deliver i
36、n normal use is proposed, in the forthcoming new edition, to be 600 kPa. 6 Reverse gas flow 6.1 Means shall be provided so that the reverse flow of gas from each gas inlet to every other shall not exceed 10 ml/h (0,0169 kPa l/min) under normal operating conditions or under any single fault condition
37、 which is not alarmed. Test according to A.3. 6.2 Means shall be provided so that the reverse gas flow from each gas inlet to every other shall not exceed 100 ml/min (10,13 kPa l/min) during any single fault condition which is indicated by an alarm. Test according to A.3. 6.3 The manufacturer shall
38、maintain documentation of methods by which compliance with 6.1 and 6.2 has been verified, together with data supporting the validity of the methods. 7 Inlet filter Each gas inlet shall be provided with a filter having a pore size not exceeding 100 4m. 8 Flow controls For a rotary flow adjustment con
39、trol, a counter-clockwise rotation shall cause an increase in flow and, conversely, a clockwise rotation shall cause a decrease in flow. The stem of each rotary flow control valve shall be captive, so that it cannot be disengaged from its housing without the use of tools. 9 Leakage to atmosphere Exc
40、ept for gas which is vented (bled) from the mixer by design, gas mixers shall not leak to atmosphere by more than 50 ml/min (5,065 kPa l/min) when tested according to A.4. 10 Low-pressure flexible connecting hose assemblies All external, operator-detachable inlet low-pressure hose assemblies supplie
41、d with the gas mixer shall comply with ISO 5359. 11 Accuracy of operating data 11.1 When tested according to A.2, the oxygen concentration of the delivered gas shall be within 5 % (V/V) of the indicated value. The tolerance shall not result in an oxygen concentration of less than 20 % (V/V). The acc
42、uracy requirement shall apply only to marked concentration values and not between markings, unless otherwise stated by the manufacturer. 11.2 When tested according to A.2, the gas mixer shall continue to function within the specified tolerances throughout the range of input pressure variation stated
43、 by the manufacturer see 15.2 a). 12 Gas supply failure 12.1 Gas supply failure alarm NOTE 3See also 15.1 e). 12.1.1 General 12.1.1.1 The gas mixer shall have an alarm to indicate failure of any one gas supply, whether the supply is derived from cylinders or from a pipeline system. This alarm shall
44、be either gas-powered or electrically-powered. If electrically-powered, it shall comply with the requirements for a high priority alarm given in ISO 9703-1 and ISO 9703-2. The auditory alarm shall be automatically de-activated when the gas supply is restored. 12.1.1.2 Electrically-powered alarms sha
45、ll be operative in the case of electrical power failure, except when an electrical power failure alarm is fitted. Means shall be provided for testing the alarm systems. 12.1.1.3 When tested in accordance with A.1, the alarm shall be activated at the gas supply pressure stated by the manufacturer see
46、 15.1 e). 12.1.2 Gas mixers intended for mixing oxygen and nitrous oxide 12.1.2.1 When tested in accordance with A.5, the auditory alarm shall be of at least 7 s duration and, when tested as described in ISO 3744, its A-weighted sound pressure level shall be at least 2 dB above a background white no
47、ise of 55 dB. 12.1.2.2 If the alarm is gas-powered, the energy required to operate it shall be derived from the oxygen supply pressure. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 01:53:35 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO 11195:1995(E) BSI 04-20003 12.1.2.3 It shall not be p
48、ossible to shut off or re-set the alarm without first restoring the gas supply pressure to above the alarm point. 12.1.3 Gas mixers intended for mixing oxygen and any gas other than nitrous oxide When tested in accordance with A.5, the auditory alarm shall be of at least 60 s duration and, when test
49、ed as described in ISO 3744, its A-weighted sound pressure level shall be at least 2 dB above a background white noise of 55 dB. NOTE 4The alarm may be silenced after activation. 12.2 Cut-off devices for gases other than air and oxygen in the event of oxygen supply failure 12.2.1 The gas mixer shall be fitted with a gas cut-off, which shall be activated when the oxygen supply pressure falls below the value stated in the instructions for use, and shall operate in one of the following ways: a) cut off the supply of all gases other than air and oxy
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