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1、BRITISH STANDARD BS EN 475:1995 Medical devices Electrically-generated alarm signals The European Standard EN 475:1995 has the status of a British Standard Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 04 07:39:49 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 475:1995 This British Standard,
2、 having been prepared 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 August 1995 BSI 02-1999 The following BSI references relate to the work on this standard: Committee reference HCC/16 Draft for co
3、mment 91/51846 DC ISBN 0 580 24534 9 Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Committee HCC/16, Medical alarms and signals, upon which the following bodies were represented: Association of Anaesthetists of Great Britain and
4、Ireland Association of British Paediatric Nurses Association of Renal Technicians British Anaesthetic and Respiratory Equipment Manufacturers Association British Association of Critical Care Nurses British Association of Otolaryngologists British Paediatric Association Department of Health Electro M
5、edical Trade Association Limited Experimental Psychology Society Institute of Hospital Engineering Institute of Physical Sciences in Medicine (IPSM) Intensive Care Society Medical Research Council Ministry of Defence Neonatal Nurses Association Royal College of Midwives Amendments issued since publi
6、cation Amd. No.DateComments Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 04 07:39:49 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 475:1995 BSI 02-1999i Contents Page Committees responsibleInside front cover National forewordii Foreword2 Text of EN 4753 Licensed Copy: sheffieldun sheffield
7、un, na, Sat Nov 04 07:39:49 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 475:1995 ii BSI 02-1999 National foreword This British Standard has been prepared by Technical Committee HCC/16 and is the English language version of EN 475:1995 Medical devices Electrically-generated alarm signals, prepar
8、ed by Technical Committee 259, Medical alarm signals, of the European Committee for Standardization (CEN). It supersedes BS 7618-1:1992, which is withdrawn. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their
9、 correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Cross-references Publication referred toCorresponding British Standard ISO 3744:1981aBS 4196 Sound power levels of noise sources Part 4:1981 Engineering methods for determination of so
10、und power levels for sources in free-field conditions over a reflecting plane a ISO 3744:1981 has been superseded by ISO 3744:1994. The corresponding British Standard is BS ISO 3744:1994. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, the EN title page
11、, pages 2 to 11 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. Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 04 07:39:49 GMT+00:00 2006, Uncontrolled Copy,
12、(c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 475 February 1995 ICS 11.040.10 Descriptors: Medical equipment, warning systems, electric equipment, acoustic signals, visual signals, definitions, characteristics, tables (data) English version Medical devices Electrically-generated alarm
13、 signals Dispositifs mdicaux Signaux dalarme lectriques Medizinische Gerte Elektrisch erzeugte Alarmsignale This European Standard was approved by CEN on 1995-02-10. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Stan
14、dard 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 Central Secretariat or to any CEN member. This European Standard exists in three official versions (English, French,
15、 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 Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Denmark, Finland, Fran
16、ce, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CEN European Committee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 19
17、95 Copyright reserved to CEN members Ref. No. EN 475:1995 E Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 04 07:39:49 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 475:1995 BSI 02-1999 2 Foreword This European Standard was prepared by Technical Committee CEN/TC 259, Medical alarms and signals,
18、 of which the secretariat is held by BSI. This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EC Directive(s). This European Standard shall be given the status of a national s
19、tandard, either by publication of an identical text or by endorsement, at the latest by August 1995, and conflicting national standards shall be withdrawn at the latest by August 1995. This European Standard is related to ISO 9703-1:1992 and ISO 9703-2:1994 prepared by Technical Committee TC 121, An
20、aesthetic and respiratory equipment, of the International Organization for Standardization (ISO), and the contribution of ISO/TC 121 in the preparation of this European Standard is acknowledged. Annex A is informative and contains the “Bibliography”. Annex B is informative and contains the “Rational
21、e”. According to the CEN/CENELEC Internal Regulations, the following countries are bound to implement this European Standard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom. C
22、ontents Page Foreword2 Introduction3 1Scope3 2Normative references3 3Definitions3 4Requirements for signals4 Annex A (informative) Bibliography9 Annex B (informative) Rationale9 Figure 1 Illustration of temporal characteristics of auditory signals6 Table 1 Characteristics of bursts of high and mediu
23、m priority auditory signals7 Table 2 Characteristics of the pulse for high and medium priority auditory signals7 Table 3 Characteristics of high, medium and low priority visual indications8 Table 4 Characteristics of the low priority auditory signal8 Licensed Copy: sheffieldun sheffieldun, na, Sat N
24、ov 04 07:39:49 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 475:1995 BSI 02-19993 Introduction Medical practice in hospitals is increasingly dependent on medical devices for observation and treatment of patients. Auditory signals and lights are frequently used to indicate the patients physiological
25、 status and the functional state of the medical device. The auditory signals used are frequently too loud and not sufficiently distinctive, and it is often difficult to identify which medical device is signalling. The purpose of this European Standard is to specify signals, some of which comprise bo
26、th auditory and visual components, to be used to draw attention to the fact that the medical device has detected a disturbance and to indicate the degree of urgency. This European Standard was developed from contributions from clinicians, engineers and applied psychologists. The approach taken is in
27、tended to rationalize the current situation and to limit the proliferation of different auditory signals in order to avoid confusion. Work based on psychoacoustic principles in other environments has contributed to the development of this standard, and auditory signals similar to those specified in
28、this standard have already been incorporated into some medical devices. Some of the criteria considered during development of the auditory signals included optimal signal recognition in a relatively noisy environment, maximum transmission of information at the lowest practicable sound pressure level
29、, ease of learning and retention by operators who have to respond to the various signals, and perceived urgency of the auditory signals. Four signals are specified, i.e. high priority, medium priority, low priority and information signals. The high and medium priority auditory signals are acoustical
30、ly related but are differentiated by their perceived urgency. 1 Scope This European Standard specifies the characteristics of electrically-generated signals intended for use with medical devices, either individually or as part of a centralized system. This European Standard applies only if a particu
31、lar device standard makes reference to it. It is expected that requirements for the application of the signals specified in this standard will be included in Particular Standards for particular medical devices. This European Standard does not specify: a) the medical devices on which alarms are to be
32、 provided; b) the conditions that actuate the alarms; c) the means of generating the signals; d) the characteristics of secondary alarm systems, i.e. alarm systems that are activated in case of a failure of the primary alarm system; e) the allocation of priorities to alarms. 2 Normative references T
33、his European Standard incorporates by dated or undated reference, provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publ
34、ications apply to this European Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies. ISO 3744:19811), Acoustics Determination of sound power levels of noise sources Engineering methods for free-field conditi
35、ons over a reflecting plane. 3 Definitions For the purposes of this standard, the following definitions apply. 3.1 alarm signal signal indicating the onset and/or duration of a condition that requires a response by the operator 3.2 high priority signal; warning signal signal indicating that immediat
36、e operator response is required 3.3 medium priority signal; cautionary signal signal indicating that prompt operator response is required 3.4 low priority signal; attention signal signal indicating that operator awareness is required 1) This reference will be replaced, when EN 31201 is published, by
37、 reference to EN 31201 Acoustics Noise emitted by machinery and equipment Measurement of emission sound pressure levels at the work station and at other specified positions Engineering method in an essentially free field over a reflecting plane. Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 04
38、 07:39:49 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 475:1995 4 BSI 02-1999 3.5 information signal a visual signal or an auditory signal or a combination of both, the purpose of which is to convey physiological or technical information 3.6 pulse brief sound having a specific frequency spectrum 3.
39、7 overall pulse duration (to) time over which the pulse amplitude exceeds 10 % of the maximum amplitude (See Figure 1.) 3.8 rise time (tr) time over which the pulse amplitude increases from 10 % to 90 % of maximum amplitude (See Figure 1.) 3.9 start of pulse point at which the pulse amplitude first
40、exceeds 90 % of the maximum amplitude (See Figure 1.) 3.10 end of pulse point at which the pulse amplitude first falls below 90 % of the maximum amplitude (See Figure 1.) 3.11 maximum amplitude average pulse amplitude during the effective pulse duration 3.12 effective pulse duration (td) time betwee
41、n start of pulse and end of pulse (see Figure 1.) NOTE Although to = tr + td + tf, this standard is written in terms of td because it is easier to measure. 3.13 fall time (tf) time over which the pulse amplitude decreases from 90 % to 10 % of maximum amplitude (See Figure 1.) 3.14 pulse frequency (f
42、o) fundamental frequency of a pulse 3.15 burst group of pulses with a distinctive rhythm 3.16 pulse spacing (ts) time between the start of one pulse and the start of the next pulse (See Figure 1.) 3.17 pulse spacing width (tw) time between consecutive pulses over which the pulse amplitude is below 1
43、0 % of the maximum amplitude 3.18 burst spacing (tb) time between the start of the first pulse in one burst and the start of the first pulse in the next burst (See Figure 1.) 3.19 repeat time time between the start of the first pulse of a burst or the first burst of a double burst and the start of t
44、he first pulse of the next burst or the first burst of the next double burst 3.20 duty cycle percentage of the total on-time of a visual indication with respect to the total period of the cycle 3.21 flashing frequency number of light flashes per unit time 4 Requirements for signals 4.1 Composition o
45、f high priority signal A high priority signal shall comprise a high priority auditory signal complying with Table 1 and Table 2 and a simultaneous high priority visual indication complying with Table 3. 4.2 Composition of medium priority signal A medium priority signal shall comprise a medium priori
46、ty auditory signal complying with Table 1 and Table 2 and a simultaneous medium priority visual indication complying with Table 3. 4.3 Composition of low priority signal A low priority signal shall comprise a continuously-displayed visual indication. If an indicator light is used, it shall comply wi
47、th Table 3. If the visual indication is accompanied by an auditory signal, the low priority auditory signal shall comply with Table 4 and shall not have the characteristics of the bursts of the high and medium priority auditory signals given in Table 1. Licensed Copy: sheffieldun sheffieldun, na, Sa
48、t Nov 04 07:39:49 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 475:1995 BSI 02-19995 4.4 Composition of information signal An information signal shall consist of an auditory signal or a visual indication, or a combination of both. If a visual indication other than an alphanumeric display or compute
49、r generated graphic display is used, it shall not be red. A green light shall only be used to indicate that the equipment is ready for action. If an auditory signal is used, it shall not have the characteristics of the bursts of the high or medium priority auditory signals given in Table 1. 4.5 Legibility and visibility of visual indications NOTEClause 4.5 applies only to those visual indications associated with alarm and information signals. Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 04 07:39:49 GMT+00:00 2006, Uncontrolled Co
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