《BS-EN-1819-1998.pdf》由会员分享,可在线阅读,更多相关《BS-EN-1819-1998.pdf(18页珍藏版)》请在三一文库上搜索。
1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 1819 : 1998 The Eur
2、opean Standard EN 1819 : 1997 has the status of a British Standard ICS 11.040.10 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Laryngoscopes for tracheal intubation Particular requirements Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:49:09 GMT+00:00 2006, Uncont
3、rolled Copy, (c) BSI This British Standard, 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 February 1998 BSI 1998 ISBN 0 580 29493 5 BS EN 1819 : 1998 Amendments issued since pu
4、blication Amd. No.DateText affected National foreword This British Standard is the English language version of EN 1819 : 1997. It supersedes BS 6578 : Part 1 : 1985 and BS 6578 : Part 2 : 1985 which will be withdrawn on 13 June 1998. The UK participation in its preparation was entrusted to Technical
5、 Committee CH/45, Tracheal tubes and related equipment, which has the responsibility to: aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related
6、 international and European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be
7、 found in the BSI Standards Catalogue under the section entitled International Standards Correspondence Index, or by using the Find facility of the BSI Standards Electronic Catalogue. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This
8、document comprises a front cover, an inside front cover, the EN title page, pages 2 to 14, an inside back cover and a back cover. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:49:09 GMT+00:00 2006, Uncontrolled Copy, (c) BSI CEN European Committee for Standardization Comite Europe en de
9、Normalisation Europa isches Komitee fu r Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1997 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1819 : 1997 E EUROPEAN STANDARDEN 1819 NORME EUROPE ENNE EUROPA ISCHE NO
10、RM October 1997 ICS 11.040.10 Descriptors: Medical equipment, endoscopy apparatus, laryngoscopes, definitions, specifications, design, handles, blades, bulbs: electric, lamp caps, screw threads, dimensions, tests, cleaning, sterilization, marking, labelling English version Laryngoscopes for tracheal
11、 intubation Particular requirements Laryngoscopes pour intubation trache ale Prescriptions particulie res Laryngoskope fu r Trachealintubation Besondere Anforderungen This European Standard was approved by CEN on 1997-09-26. CEN members are bound to comply with the CEN/CENELEC Internal Regulations w
12、hich 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 Central Secretariat or to any CEN member. This European S
13、tandard 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 Central Secretariat has the same status as the official versions. CEN members are the national s
14、tandards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:49:09 GMT+00:00 2006, Uncontrol
15、led Copy, (c) BSI Page 2 EN 1819 : 1997 BSI 1998 Foreword This European Standard has been prepared by 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 pub
16、lication of an identical text or by endorsement, at the latest by April 1998, and conflicting national standards shall be withdrawn at the latest by June 1998. This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, an
17、d supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative annex ZA, which is an integral part of this standard. This European Standard is based on ISO 7376-1 : 1994 Laryngoscopic fittings Part 1: Conventional hook-on type handle-blade fittings, ISO
18、7376-2 : 1984 Laryngoscopic fittings Part 2: Miniature electric lamps screw threads and sockets and ISO 7376-3 : 1996 Laryngoscopic fittings Part 3 : Fibre-illuminated re-usable rigid laryngoscopes, prepared by TC 121 of the International Organization for Standardization (ISO). However, the requirem
19、ents for different systems given in ISO 7376-3 are not included. Annexes A and B are normative and form part of this European Standard. Annexes C, D, E and ZA are for information only. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries
20、are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Contents Page Foreword2 Introduction3 1Scope3 2Normative
21、references3 3Definitions3 4General requirements4 5Performance requirements4 6Lamps for conventional blades5 7Lamps for fibre-illuminated laryngoscopes5 8Sockets for conventional blades5 9Cleaning, disinfection and sterilization6 10Marking and labelling6 11Accompanying documents6 Annexes A(normative)
22、 Test methods11 B(normative) Conventional marking of laryngoscope blades to indicate type and size11 C(informative) Rationale12 D(informative) Recommendations for design and materials12 E(informative) Bibliography12 ZA(informative) Clauses of this European Standard addressing essential requirements
23、or other provisions of EU Directives12 Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:49:09 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 3 EN 1819 : 1997 BSI 1998 Introduction This European Standard gives requirements for laryngoscopes for tracheal intubation, hereinafter referred to a
24、s laryngoscopes, during anaesthesia, intensive care, emergency care and similar procedures. Laryngoscopes are manufactured in several forms, including single-piece handle and blade construction, and detachable blade and handle. In the latter case the light source to illuminate the larynx during use
25、is either a lamp attached to the blade or a lamp in the handle with a light guide in the blade. The form and dimensions of blades for laryngoscopes are selected by the user on the basis of clinical judgement and are not covered by this standard. A conventional system of indicating the size and form
26、of blades is given in annex B. Annex C gives rationales for some of the clauses of this standard, which are identified in the text by the inclusion of R after the clause number. 1 R Scope This standard specifies general requirements for laryngoscopes and critical dimensions for the handle and lamp o
27、f hook-on type laryngoscopes. This standard does not apply to: a) the blade form or handle design except for general requirements and the interchangeability aspects of the connection between the blade and the handle; b) the measurement and specification of the lamp illumination intensity; c) flexibl
28、e laryngoscopes, or laryngoscopes designed for surgery; d) laryngoscopes powered from mains electricity supply; e) laryngoscopes connected by light-transmitting cables to external light sources; f) custom-made devices. 2 Normative references This European Standard incorporates, by dated or undated r
29、eference, 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 publications apply to this European Standard only when incor
30、porated in it by amendment or revision. For undated references the latest edition of the publication referred to applies. EN 556 : 1994Sterilization of medical devices Requirements for medical devices to be labelled STERILE EN 868-1Packaging materials and systems for medical devices which are to be
31、sterilized Part 1: General requirements and test methods EN 980Graphical symbols for use in the labelling of medical devices EN 30993-1Biological evaluation of medical devices Part 1: Guidance on selection of tests (ISO 10993-1 : 1992 + Technical Corrigendum 1 : 1992) ISO 5864ISO inch screw threads
32、Allowances and tolerances ISO 7376-3Laryngoscopic fittings Part 3: Fibre-illuminated re-usable rigid laryngoscopes 3 Definitions For the purposes of this standard the following definitions apply. 3.1 blade Part of laryngoscope that is inserted into the mouth of a patient and is intended to permit di
33、rect vision of the larynx. 3.2 detachable blade Blade that can be separated from a handle by the user. 3.3 hook-on fittings Fittings that connect a detachable blade to its appropriate handle and that incorporate electrical contacts or optical fibre connection points. NOTE. The fitting on the blade i
34、s a hook and that on the handle is a pin that acts as a hinge. 3.4 conventional blade Detachable blade incorporating a lamp positioned to provide direct illumination of the larynx during use and having electrical connections in the hook-on fittings to the handle (see figure 1). NOTE. The lamp can ei
35、ther be mounted near the tip of the blade or be installed near the handle end of the blade and provided with a light guide to transmit light to illuminate the area of the larynx. 3.5 fibre-illuminated blade Rigid component shaped to provide a direct view of the larynx, and which incorporates optical
36、 fibres to transmit light from a source in the handle EN ISO 4135 : 1996. 3.6 single-piece laryngoscope Laryngoscope constructed with the blade and handle made in one piece. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:49:09 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 4 EN 1819 : 19
37、97 BSI 1998 3.7 engagement Mechanical attachment of the blade and handle such that the blade remains coupled to the handle in all positions. 3.8 operating position Position of the engaged blade and handle when the laryngoscope is ready for use. 3.9 locking mechanism Mechanism that retains the blade
38、in the operating position. 3.10 lamp Electric filament bulb intended to provide illumination during laryngoscopy EN ISO 4135 : 1996. 3.11 lamp shell Metallic outer housing of the lamp which provides electrical contact and mechanical engagement of the lamp by means of a male screw thread. 3.12 socket
39、 Component with a female screw thread attached to a laryngoscope blade and intended to provide electrical contact and mechanical engagement with a lamp. EN ISO 4135 : 1996. 3.13 handle Component held in the hand during use, one end forming the connection for the blade EN ISO 4135 : 1996. 4 General r
40、equirements 4.1 Design Except for single-piece laryngoscopes, the lamp shall light when the blade and handle are placed in the operating position (see figure 3). Single-piece laryngoscopes shall have a switch to control power to the lamp which latches in both on and off positions and is marked accor
41、dingly. 4.2 Materials for laryngoscope blades and single-piece laryngoscopes Materials shall be non-toxic and compatible under transient use with skin, mucosa in the pharyngeal area and related body fluids, in accordance with EN 30993-1. 4.3 Environmental requirements Laryngoscopes and their compone
42、nts shall be capable of meeting the requirements of clauses 5, 6, 10 and 11 after being exposed for 14 days in their storage and/or transport packaging in environmental conditions not outside the following ranges: a) ambient temperature range of 240 C to +70 C; b) relative humidity range of 10 % to
43、95 % non-condensing; c) atmospheric pressure range of 50 kPa to 106 kPa. Batteries are to be removed from handles during this exposure. 4.4 R Internal electrical power source If the handle is intended for use with rechargeable cells, a current limiting device shall be incorporated to prevent more th
44、an three times the normal current flowing in a single fault condition. NOTE. Power outputs from some rechargeable cells can fall rapidly as the remaining capacity decreases. This can result in a very rapid failure of illumination during use. The use of rechargeable cells is therefore not recommended
45、. 5 Performance requirements 5.1 Hook-on blade and handle fittings Detachable hook-on blade and handle combinations that engage shall lock and illuminate when in the operating position, and shall stay illuminated in any orientation. 5.2 Handle fittings 5.2.1 Handle dimensions The hook-on fitting for
46、ming part of the handle for use with a conventional blade shall conform to the dimensions of figure 4. The measurements shall be taken from the datum plane L, datum plane M and the hinge pin centre-line. 5.2.2 Electrical contact conventional system Electrical contacts forming parts of the hook-on fi
47、ttings of the handle and a conventional blade shall ensure that the lamp lights when the blade is placed in the operating position. Test by inspection. The electrical contact forming part of the hook-on fitting of a conventional blade of a laryngoscope shall be rigid and the electrical contact formi
48、ng part of the hook-on fitting of the handle shall be either flexible or spring-loaded. NOTE. The return electrical circuit is through unspecified parts of the hook-on joint. 5.2.3 Electrical contact fibre-illuminated system Electrical contacts forming part of the electrical circuit in the handle of
49、 a fibre-illuminated system shall ensure that the lamp lights when the blade is placed in the operating position. Test by inspection. 5.3 Blade fittings 5.3.1 A conventional blade shall not engage with a handle made in accordance with the green fibre-illuminated system as specified in ISO 7376-3. 5.3.2 A blade that engages a handle made in accordance with the green fibre-illuminated system as specified in ISO 7376-3 shall not engage with a handle of a conventional system. 5.3.3 Conventional blade hook-on fittings shall eng
链接地址:https://www.31doc.com/p-3739057.html