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1、BRITISH STANDARD BS EN ISO 8185:1998 BS 5724-2-24: 1998 Incorporating Corrigendum No. 1 Humidifiers for medical use General requirements for humidification systems The European Standard EN ISO 8185:1997 has the status of a British Standard ICS 11.040.10 ? Licensed Copy: sheffieldun sheffieldun, na,
2、Fri Nov 17 09:58:48 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 8185:1998 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 March 1998 BSI 19 Februa
3、ry 2003 ISBN 0 580 29252 5 National foreword This British Standard is the English language version of EN ISO 8185:1997, including Corrigendum July 2002. It is identical with ISO 8185:1997, including Corrigendum May 2001. It supersedes BS 5724-2-24:1989 which will be withdrawn on 13 June 1998. The UK
4、 participation in its preparation was entrusted by Technical Committee CH/46, Lung Ventilators and related equipment, to Subcommittee CH/46/1, Heat and moisture exchangers and humidifiers, which has the responsibility to: A list of organizations represented on this subcommittee can be obtained on re
5、quest to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI
6、 Electornic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obli
7、gations. 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 international and European developments and promulgate them in the UK. Summary
8、of pages This document comprises a front cover, an inside front cover, page i, a blank page, the EN ISO title page, page 2, the ISO title page, pages ii to v, a blank page, pages 1 to 42, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when the do
9、cument was last issued. Amendments issued since publication Amd. No.DateComments 14088 Corrigendum No. 1 19 February 2003 Correction to 56.3 of Section 10 and replacement of the formula for vapour pressure in Annex O Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:58:48 GMT+00:00 2006, Unc
10、ontrolled Copy, (c) BSI BS EN ISO 8185:1998 BSI 19 February 2003 i Contents Page National forewordInside front cover EN foreword 2 ISO forewordv Text of ISO 81851 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:58:48 GMT+00:00 2006, Uncontrolled Copy, (c) BSI blank Licensed Copy: sheffield
11、un sheffieldun, na, Fri Nov 17 09:58:48 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8185 November 1997 ICS 11.040.10Incorporating Corrigendum July 2002 Descriptors: See ISO document English version Humidifiers for medical use General requiremen
12、ts for humidification systems (ISO 8185:1997) Humidificateurs mdicaux Exigences gnrales relatives aux systmes dhumidification (ISO 8185:1997) This European Standard was approved by CEN on 26 September 1997. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the
13、 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 Standard exists in
14、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 standards bodies of
15、 Austria, Belgium, Czech Republic, Denmark, Finland, France, 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 Ce
16、ntral 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 ISO 8185:1997 E Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:58:48 GMT+00:00 2006, Uncontrolled Copy, (c) BSI
17、EN ISO 8185:1997 BSI 19 February 2003 2 Foreword The text of the International Standard ISO 8185:1997 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” in collaboration with Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment”, the Secretar
18、iat 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 May 1998, and conflicting national standards shall be withdrawn at the latest by June 1998. This European Standard has
19、been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and 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. According to the CEN/CEN
20、ELEC Internal Regulations, the national standards organizations of the following countries 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, Sw
21、itzerland and the United Kingdom. Endorsement notice The text of the International Standard ISO 8185:1997 was approved by CEN as a European Standard without any modification. NOTENormative references to International Standards are listed in Annex ZB (normative). Licensed Copy: sheffieldun sheffieldu
22、n, na, Fri Nov 17 09:58:48 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Incorporating Corrigendum 2001-05-15 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:58:48 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 8185:1997 ii Contents Page Forewordv Section 1. General Introduction1 1.1Scope1
23、 1.2Normative references2 1.3Definitions2 1.4General requirements4 1.5General requirements for tests4 1.6Classifications4 1.7Identifications, marking and documents4 1.8Power input6 Section 2. Environmental conditions 2.1Basic safety requirements7 2.2Removable protective means7 2.3Environmental condi
24、tions7 Section 3. Protections against electric shock hazards 3.1General9 3.2Requirements related to classification9 3.3Limitation of voltage and/or energy9 3.4Enclosures and protective covers9 3.5Separation9 3.6Protective earthing, functional earthing and potential equalization9 3.7Continuous leakag
25、e current and patient auxiliary currents9 3.8Dielectric strength9 Section 4. Protection against mechanical hazards 4.1Mechanical strength11 4.2Moving parts11 4.3Surface, corners and edges11 4.4Stability in normal use11 4.5Expelled parts11 4.6Vibration and noise11 4.7Pneumatic and hydraulic power11 4
26、.8Suspended masses11 Section 5. Protection against hazards from unwanted or excessive radiation 5.1Electromagnetic compatibility13 Section 6. Protection against hazards of ignition of flammable anaesthetic mixtures 6.1Locations and basic requirements15 6.2Marking, accompanying documents15 6.3Common
27、requirements for category AP and category APG equipment15 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:58:48 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 8185:1997 BSI 19 February 2003 iii Page 6.4Requirements and tests for category AP equipment, parts and components thereof15 6.5R
28、equirements and tests for category APG equipment, parts and components thereof15 Section 7. Protection against excessive temperatures and other safety hazards 7.1Excessive temperatures17 7.2Fire prevention17 7.3Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and di
29、sinfection17 7.4Pressure vessels and parts subject to pressure17 7.5Human error17 7.6Electrostatic charges17 7.7Materials in applied parts in contact with body of patient17 7.8Interruption of power supply17 Section 8. Accuracy of operating data and protection against hazardous output 8.1Accuracy of
30、operating data19 8.2Protection against hazardous output19 Section 9. Abnormal operating and fault conditions; environmental tests 9.1Abnormal operation and fault conditions21 9.2Environmental tests21 Section 10. Constructional requirements 10.1 General23 10.2 Enclosure and covers23 10.3 Components a
31、nd general assembly23 10.4 Mains parts, components and layout23 10.5 Protective earthing Terminals and connections23 10.6 Construction and layout23 Section 11. Additional requirements specific to humidifiers 11.1 Humidifier output25 11.2 Maximum pressure drop25 11.3 Liquid container25 11.4 Noise mea
32、surement25 11.5 Temperature sensors and temperature sensor ports25 11.6 Humidifier leakage26 Annex M (normative) Test of anaesthetic agents for non-flammability27 Annex N (normative) Temperature display accuracy28 Annex O (informative) Specific enthalpy calculations29 Annex P (normative) Humidifier
33、output calculations29 Annex Q (normative) Temperature sensors and mating ports31 Annex R (normative) Standard temperature sensor31 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:58:48 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 8185:1997 iv Page Annex S (informative) Rationale state
34、ment33 Annex T (informative) Bibliography39 Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of EU Directives40 Annex ZB (normative) Normative references to international publications with their relevant European publications42 Figure S.1
35、 Heat transfer, relative to 37?C, saturated36 Figure N.1 28 Figure Q.1 31 Figure R.1 32 Figure R.2 32 Figure S.1 Heat transfer, relative to 37?C, saturated 36 Table ZA.1 Correspondence between this European Standard and EU Directives40 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:58:48
36、GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 8185:1997 BSI 19 February 2003 v Foreword ISO (the International Organization for Standardization) is a world-wide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out thro
37、ugh ISO technical committees. 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 collabor
38、ates closely with the 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
39、 least 75 % of the member bodies casting a vote. International Standard ISO 8185 was prepared by Technical Committee ISO TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 3, Lung ventilators and related equipment. This second edition cancels and replaces the first edition (ISO 8185:1988
40、), which has been technically revised. Annex M, Annex N, Annex P, Annex Q and Annex R form an integral part of this International Standard. Annex O, Annex S and Annex T are for information only. Descriptors: Medical equipment, anaesthetic equipment, artificial breathing apparatus, humidifiers, class
41、ification, specifications, safety requirements, performance, marking, instructions for use. Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:58:48 GMT+00:00 2006, Uncontrolled Copy, (c) BSI blank Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:58:48 GMT+00:00 2006, Uncontrolled Co
42、py, (c) BSI EN ISO 8185:1997 BSI 19 February 2003 1 Section 1. General Introduction Humidifiers are used to raise the water content of gases delivered to patients. Gases available for medical use do not contain sufficient moisture and may damage or irritate the respiratory tract or dessicate secreti
43、ons of patients whose supraglottic airways have been bypassed. Heat may be employed to increase the water output of the humidifier. In addition, many humidifiers utilize heated delivery tubes in order to increase operating efficiency and reduce excessive water and heat loss. Ventilator and anaesthes
44、ia delivery tubes in common use may not withstand the heat generated by humidifiers and heated delivery tubes mechanisms. Many humidifier manufacturers use off-the-shelf electrical connectors for their electrically heated delivery tubes. However, since different manufacturers have used the same elec
45、trical connector for different power outputs, electrically heated delivery tubes may be physically, but not electrically, interchangeable. Improper electrically heated delivery tubes use has caused overheating, circuit melting, patient and care-giver burns, and fires. Reduction of the relative humid
46、ity at the patient connection port may cause dessication of tracheobronchial secretions (see reference 20, Annex T). It was not found practical to specify the interface requirements for electrical connectors to ensure compatibility between humidifiers and delivery tubes produced by different manufac
47、turers. Since the safe use of a humidifier is dependent on the interaction of the humidifier with its many accessories, this International Standard sets total-system performance requirements, including accessories such as delivery tubes (both heated and nonheated), temperature sensors, and devices i
48、ntended to control the environment within these delivery tubes. A rationale for the most important requirements is given in Annex S. It is considered that a knowledge of the reasons for the requirements will not only facilitate the proper application of this International Standard, but will expedite
49、 any subsequent revision. 1.1 Scope Clause 1 of IEC 60601-1:1988 applies with the following amendment: ISO 8185 is one of a series of International Standards based on IEC 60601-1; in IEC 60601-1 (the “General Standard”), this type of International Standard is referred to as a “Particular Standard”. As stated in 1.3 of IEC 60601-1:1988, the requirements of this International Standard take precedence over those of IEC 60601-1. Humidifiers may be gas