《BS-EN-ISO-8185-2007.pdf》由会员分享，可在线阅读，更多相关《BS-EN-ISO-8185-2007.pdf（66页珍藏版）》请在三一文库上搜索。
1、BRITISH STANDARD BS EN ISO 8185:2007 Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems The European Standard EN ISO 8185:2007 has the status of a British Standard ICS 11.040.10 ? Licensed Copy: London South Bank University, London South Bank
2、 University, Sat Aug 18 09:36:05 GMT+00:00 2007, Uncontrolled Copy, (c) BSI BS EN ISO 8185:2007 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 August 2007 BSI 2007 ISBN 978 0 580 53753 0 National foreword This British Standard is the UK i
3、mplementation of EN ISO 8185:2007. It supersedes BS EN ISO 8185:1998 which is withdrawn. The UK participation in its preparation was entrusted by Technical Committee CH/121, Anaesthetic and respiratory equipment, to Subcommittee CH/121/5, Lung ventilators, tracheal tubes and related equipment. A lis
4、t of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from leg
5、al obligations. Amendments issued since publication Amd. No. DateComments Licensed Copy: London South Bank University, London South Bank University, Sat Aug 18 09:36:05 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8185 July 2007 ICS 11.040.10Sup
6、ersedes EN ISO 8185:1997 English Version Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007) Humidificateurs respiratoires mdicaux - Exigences spcifiques des systmes dhumidification respiratoires (ISO 8185:2007) Anfeuchter fr
7、 Respirationsluft fr medizinische Zwecke - Besondere Anforderungen an Anfeuchtersysteme fr Respirationsluft (ISO 8185:2007) This European Standard was approved by CEN on 24 June 2007. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving
8、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 Management Centre or to any CEN member. This European Standard exists in three official versio
9、ns (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 Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium,
10、Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STAN
11、DARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2007 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 8185:2007: E Licensed Copy: London South Bank
12、University, London South Bank University, Sat Aug 18 09:36:05 GMT+00:00 2007, Uncontrolled Copy, (c) BSI Foreword This document (EN ISO 8185:2007) has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment“ in collaboration with Technical Committee CEN/TC 215 “Respira
13、tory 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 January 2008, and conflicting national standards shall be withdrawn at the
14、 latest by January 2008. This document supersedes EN ISO 8185:1997. This document has 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 info
15、rmative Annex ZA, which is an integral part of this document. 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, Cyprus, Czech Republic, Denmark, Estonia, Finlan
16、d, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 8185:2007 has been approved by CEN as EN ISO 8185:
17、2007 without any modifications. EN ISO 8185:2007 Licensed Copy: London South Bank University, London South Bank University, Sat Aug 18 09:36:05 GMT+00:00 2007, Uncontrolled Copy, (c) BSI Reference number ISO 8185:2007(E) INTERNATIONAL STANDARD ISO 8185 Third edition 2007-07-01 Respiratory tract humi
18、difiers for medical use Particular requirements for respiratory humidification systems Humidificateurs respiratoires mdicaux Exigences spcifiques des systmes dhumidification respiratoires EN ISO 8185:2007 Licensed Copy: London South Bank University, London South Bank University, Sat Aug 18 09:36:05
19、GMT+00:00 2007, Uncontrolled Copy, (c) BSI ii Licensed Copy: London South Bank University, London South Bank University, Sat Aug 18 09:36:05 GMT+00:00 2007, Uncontrolled Copy, (c) BSI iii Contents Page Foreword. v Introduction. vi 1 Scope . 1 2 Normative references. 2 3 Terms and definitions. 2 4 Ge
20、neral requirements and general requirements for tests 4 5 Classification. 4 6 Identification, marking and documents 5 7 Power input . 7 8 Basic safety categories 7 9 Removable protective means 7 10 Environmental conditions 7 11 Not used. 8 12 Not used. 8 13 General. 8 14 Requirements related to clas
21、sification. 8 15 Limitation of voltage and/or energy 8 16 Enclosures and protective covers 8 17 Separation . 8 18 Protective earthing, functional earthing and potential equalization. 8 19 Continuous leakage currents and patient auxiliary currents. 8 20 Dielectric strength 9 21 Mechanical strength. 9
22、 22 Moving parts 9 23 Surface, corners and edges. 9 24 Stability in normal use 9 25 Expelled parts . 9 26 Vibration and noise. 9 27 Pneumatic and hydraulic power 9 28 Suspended masses 9 29 X-Radiation 10 30 Alpha, beta, gamma, neutron radiation and other particle radiation 10 31 Microwave radiation
23、. 10 32 Light radiation (including lasers) 10 33 Infra-red radiation. 10 34 Ultraviolet energy 10 35 Acoustical energy (including ultrasonics). 10 EN ISO 8185:2007 Licensed Copy: London South Bank University, London South Bank University, Sat Aug 18 09:36:05 GMT+00:00 2007, Uncontrolled Copy, (c) BS
24、I iv 36 Electromagnetic compatibility.11 37 Locations and basic requirements11 38 Marking, accompanying documents.11 39 Common requirements for category AP and category APG equipment.11 40 Requirements and tests for category AP equipment, parts and components thereof11 41 Requirements and tests for
25、category APG equipment, parts and components thereof.11 42 Excessive temperatures.11 43 * Fire prevention12 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection12 45 Pressure vessels and parts subject to pressure.13 46 Human error.13 47 Electrostatic
26、 charges13 48 Biocompatibility 13 49 Interruption of power supply .13 50 Accuracy of operating data14 51 * Protection against hazardous output.14 52 Abnormal operation and fault conditions.15 53 Environmental tests16 54 General.16 55 Enclosure and covers.16 56 Components and general assembly .16 57
27、Mains parts, components and layout17 58 Protective earthing Terminals and connections.17 59 Construction and layout.18 101 * Humidification system output.18 102 Liquid container 18 103 Alarm systems.18 Annex AA (informative) Rationale.20 Annex BB (normative) * Determination of the accuracy of the di
28、splayed temperature27 Annex CC (informative) Specific enthalpy calculations .29 Annex DD (normative) Temperature sensors and mating ports35 Annex EE (normative) * Determination of humidification system output 36 Annex FF (normative) * Standard temperature sensor.39 Annex GG (informative) Environment
29、al aspects.41 Annex HH (informative) Reference to the essential principals of safety and performance44 Annex II (informative) Terminology Index of defined terms 46 Bibliography .48 EN ISO 8185:2007 Annex ZA (informative) Relationship between this standard and the Essential Requirements of EU Directi
30、ve 93/42/EEC 50 Licensed Copy: London South Bank University, London South Bank University, Sat Aug 18 09:36:05 GMT+00:00 2007, Uncontrolled Copy, (c) BSI v Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). Th
31、e work of preparing International Standards is normally carried out through 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-gov
32、ernmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
33、The main task of technical committees is to prepare International Standards. 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 member bodies casting a vo
34、te. Attention 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 responsible for identifying any or all such patent rights. ISO 8185 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, S
35、ubcommittee SC 3, Lung ventilators and related equipment. This third edition cancels and replaces the second edition (ISO 8185:1997), which has been technically revised. It also incorporates the Technical Corrigendum, ISO 8185:1997/Cor. 1:2001. EN ISO 8185:2007 Licensed Copy: London South Bank Unive
36、rsity, London South Bank University, Sat Aug 18 09:36:05 GMT+00:00 2007, Uncontrolled Copy, (c) BSI vi Introduction This International Standard is a Particular Standard based on IEC 60601-1:1988, including Amendments 1 (1991) and 2 (1995), hereafter referred to as the General Standard. The General S
37、tandard is the basic standard for the safety of all medical electrical equipment used by, or under the supervision of, qualified personnel in the general medical and patient environment; it also contains certain requirements for reliable operation to ensure safety. The General Standard has associate
38、d Collateral Standards and Particular Standards. The Collateral Standards include requirements for specific technologies and/or hazards and apply to all applicable equipment, such as medical systems, EMC, radiation protection in diagnostic X-ray equipment, software, etc. The Particular Standards app
39、ly to specific equipment types, such as medical electron accelerators, high frequency surgical equipment, hospital beds, etc. NOTE Definitions of Collateral Standard and Particular Standard are found in IEC 60601-1:1988, 1.5 and A.2, respectively. To facilitate the use of this International Standard
40、, the following drafting conventions have been applied. This International Standard uses the same main Clause titles and numbering as the General Standard, to facilitate cross-referencing of the requirements. The changes to the text of the General Standard are specified by the use of the following w
41、ords. “Replacement” means that the indicated Clause or Subclause of the General Standard is replaced completely by the text of this International Standard. “Addition” means that the relevant text of this International Standard is supplementary to the requirements of the General Standard. “Amendment”
42、 means that existing text of the General Standard is modified as indicated by the text of this International Standard. To avoid confusion with any amendments to the General Standard itself, a particular numbering has been employed for elements added by this International Standard: subclauses, tables
43、 and figures are numbered starting from 101; additional list items are lettered aa), bb), etc. and additional annexes are lettered AA, BB, etc. In this International Standard, the following print types are used: requirements, compliance with which can be verified, and definitions: roman type; notes
44、and examples: smaller roman type; description of type of document change and test methods: italic type; terms defined in the General Standard IEC 60601-1:1988, Clause 2 or in this International Standard: bold type. Throughout this International Standard, text for which a rationale is provided in Ann
45、ex AA is indicated by an asterisk (*). EN ISO 8185:2007 Licensed Copy: London South Bank University, London South Bank University, Sat Aug 18 09:36:05 GMT+00:00 2007, Uncontrolled Copy, (c) BSI vii Humidifiers are used to raise the water content of gases delivered to patients. Gases available for me
46、dical use do not contain sufficient moisture and can damage or irritate the respiratory tract or desiccate secretions of patients whose upper airways have been bypassed. Reduction of the relative humidity at the patient connection port can cause desiccation of tracheo-bronchial secretions in the tra
47、cheal or tracheostomy tube, and consequently may cause narrowing or even obstruction of the airway 19. Heat can be employed to increase the water output of the humidifier. In addition, many humidifiers utilise heated breathing tubes in order to increase operating efficiency and reduce water and heat
48、 loss. Ventilator and anaesthesia breathing tubes in common use might not withstand the heat generated by humidifiers and heated breathing tube mechanisms. Many humidifier manufacturers use off-the-shelf electrical connectors for their electrically-heated breathing tubes. However, since different ma
49、nufacturers have used the same electrical connector for different power outputs, electrically-heated breathing tubes can be physically, but not electrically, interchangeable. Use of improper electrically-heated breathing tubes has caused overheating, circuit melting, patient and operator burns, and fires. It was not found practical to specify the interface requirements for electrical connectors to ensure compatibility between humidifiers and breathing tubes produced by diff