DIN EN ISO 8185-2009 Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185 2007) English version of DIN EN ISO 81.pdf

1、July 2009DEUTSCHE NORM English price group 22No part of this standard may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.040.10!$XRh“1534769www

2、.din.deDDIN EN ISO 8185Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems(ISO 8185:2007)English version of DIN EN ISO 8185:2009-07Anfeuchter fr Respirationsluft fr medizinische Zwecke Besondere Anforderungen an Anfeuchtersysteme fr Respiratio

3、nsluft (ISO 8185:2007)Englische Fassung DIN EN ISO 8185:2009-07SupersedesDIN EN ISO 8185:2007-09See start of validitywww.beuth.deDocument comprises pages64DIN EN ISO 8185:2009-07 Start of validity This standard takes effect on 1 July 2009. DIN EN ISO 8185:2007-09 may be used in parallel until 21 Mar

4、ch 2010. National foreword This standard has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respirator equipment” in collaboration with Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” (Secretariat: BSI, United Kingdom). The DIN Standards corresponding to the

5、International Standards referred to in this document are as follows: ISO 3744 DIN EN ISO 3744 ISO 4135 DIN EN ISO 4135 ISO 5356-1 DIN EN ISO 5356-1 ISO 9360-1 DIN EN ISO 9360-1 ISO 9360-2 DIN EN ISO 9360-2 ISO 10524-1 DIN EN ISO 10524-1 IEC 60601-1 DIN EN 60601-1 (VDE 0750 Part 1) IEC 60601-1-2 DIN

6、EN 60601-1-2 (VDE 0750 Part 1-2 IEC 60601-1-6 DIN EN 60601-1-6 (VDE 0750 Part 1-6) IEC 60601-1-8 DIN EN 60601-1-8 (VDE 0750 Part 1-8) IEC 60601-2-19 DIN EN 60601-2-19 (VDE 0750 Part 2-19) Amendments This standard differs from DIN EN ISO 8185:2007-09 as follows: a) Annex ZA (informative) concerning t

7、he relationship between this European Standard and the essential requirements of EU Directive 93/42/EEC on medical devices has been updated on the basis of EU Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directives 90/385/EEC on the approxim

8、ation of the laws of the Member States relating to active implantable medical devices and 93/42/EEC on medical devices and EU Directive 98/8/EC on the placing on the market of biocidal products. Previous editions DIN EN ISO 8185: 1998-02, 2007-09 DIN EN ISO 8185 Corrigendum 1: 2002-11 2 The responsi

9、ble German body involved in its preparation was the Normenausschuss Rettungsdienst und Krankenhaus (Rescue Services and Hospital Standards Committee), Technical Committee NA 053-03-01 AA Ansthesie und Beatmung.DIN EN ISO 8185:2009-07 National Annex NA (informative) Bibliography DIN EN 60601-1 (VDE 0

10、750 Part 1), Medical electrical equipment Part 1: General requirements for safety DIN EN 60601-1-2 (VDE 0750 Part 1-2), Medical electrical equipment Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility Requirements and tests DIN EN 60601-1-6 (VDE 750 Part 1-

11、6), Medical electrical equipment Part 1-6: General requirements for safety Collateral standard: Usability DIN EN 60601-1-8 (VDE 750 Part 1-8), Medical electrical equipment Part 1-8: General requirements for safety Collateral standard: General requirements, tests and guidance for alarm systems in med

12、ical electricalequipment and medical electrical systems DIN EN 60601-2-19 (VDE 0750 Teil 2-19), Medical electrical equipment Part 2: Particular requirements for the safety of baby incubators DIN EN ISO 3744, Acoustics Determination of sound power levels of noise sources using sound pressure Engineer

13、ing method in an essential free field over a reflecting plane DIN EN ISO 4135, Anaesthetic and respiratory equipment Vocabulary DIN EN ISO 5356-1, Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets DIN EN ISO 9360-1, Anaesthetic and respiratory equipment Heat and mois

14、ture exchangers (HMEs) for humidifying respired gases in humans Part 1: HMEs for use with minimum tidal volumes of 250 ml DIN EN ISO 9360-2, Anaesthetic and respiratory equipment Heat and moisture exchangers (HMEs) for humidifying respired gases in humans Part 2: HMEs for use with tracheostomized pa

15、tients having minimum tidal volumes of 250 ml DIN EN ISO 10524-1, Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices 3 DIN EN ISO 8185:2009-07 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NO

16、RM EN ISO 8185 April 2009 ICS 11.040.10 Supersedes EN ISO 8185:2007English Version Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems (ISO 8185:2007) Humidificateurs respiratoires mdicaux Exigences spcifiques des systmes dhumidification respi

17、ratoires (ISO 8185:2007) Anfeuchter fr Respirationsluft fr medizinische Zwecke Besondere Anforderungen an Anfeuchtersysteme fr Respirationsluft (ISO 8185:2007) This European Standard was approved by CEN on 21 March 2009. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which

18、 stipulate the conditions for giving this EuropeanStandard 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 Stan

19、dard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions. CEN members are the national stan

20、dards bodies of Austria, Belgium, 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 King

21、dom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 8185:2009: ECon

22、tents Page Foreword 4 Introduction . 5 1 Scope . 7 2 Normative references . 8 3 Terms and definitions. 8 4 General requirements and general requirements for tests 10 5 Classification. 10 6 Identification, marking and documents 11 7 Power input . 13 8 Basic safety categories 139 Removable protective

23、means 13 10 Environmental conditions 13 11 Not used. 14 12 Not used. 14 13 General. 14 14 Requirements related to classification. 14 15 Limitation of voltage and/or energy 14 16 Enclosures and protective covers 14 17 Separation . 14 18 Protective earthing, functional earthing and potential equalizat

24、ion . 14 19 Continuous leakage currents and patient auxiliary currents. 14 20 Dielectric strength 15 21 Mechanical strength . 15 22 Moving parts 15 23 Surface, corners and edges. 15 24 Stability in normal use 15 25 Expelled parts . 15 26 Vibration and noise. 15 27 Pneumatic and hydraulic power 15 28

25、 Suspended masses 15 29 X-Radiation 16 30 Alpha, beta, gamma, neutron radiation and other particle radiation 16 31 Microwave radiation . 16 32 Light radiation (including lasers) 16 33 Infra-red radiation . 16 34 Ultraviolet energy 16 35 Acoustical energy (including ultrasonics) . 16 2DIN EN ISO 8185

26、:2009-07 EN ISO 8185:2009 (E) 36 Electromagnetic compatibility. 17 37 Locations and basic requirements 17 38 Marking, accompanying documents. 17 39 Common requirements for category AP and category APG equipment . 17 40 Requirements and tests for category AP equipment, parts and components thereof 17

27、 41 Requirements and tests for category APG equipment, parts and components thereof . 17 42 Excessive temperatures . 17 43 * Fire prevention 18 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection 18 45 Pressure vessels and parts subject to pressure

28、. 19 46 Human error. 19 47 Electrostatic charges 19 48 Biocompatibility 19 49 Interruption of power supply . 19 50 Accuracy of operating data 20 51 * Protection against hazardous output . 20 52 Abnormal operation and fault conditions. 21 53 Environmental tests 22 54 General . 22 55 Enclosure and cov

29、ers. 22 56 Components and general assembly . 22 57 Mains parts, components and layout 23 58 Protective earthing Terminals and connections . 23 59 Construction and layout. 24 101 * Humidification system output . 24 102 Liquid container 24 103 Alarm systems. 24 Annex AA (informative) Rationale. 26 Ann

30、ex BB (normative) * Determination of the accuracy of the displayed temperature 33 Annex CC (informative) Specific enthalpy calculations . 35 Annex DD (normative) Temperature sensors and mating ports 41 Annex EE (normative) * Determination of humidification system output 42 Annex FF (normative) * Sta

31、ndard temperature sensor. 45 Annex GG (informative) Environmental aspects. 47 Annex HH (informative) Reference to the essential principals of safety and performance 50 Annex II (informative) Terminology Index of defined terms 52 Bibliography . 54 3DIN EN ISO 8185:2009-07 EN ISO 8185:2009 (E) Annex Z

32、A (Informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC 56Foreword The text of ISO 8185:2007 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” of the International Organization for Standardization

33、(ISO) and has been taken over as EN ISO 8185:2009 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 publication of an identical text or by endorsement,

34、at the latest by October 2009, and conflicting national standards shall be withdrawn at the latest by March 2010. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any

35、 or all such patent rights. This document supersedes EN ISO 8185:2007. 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 EC Directive. For relationship with EC Directive, see informa

36、tive 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, Finland,

37、France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 8185:2007 has been approved by CEN as a EN ISO 81

38、85:2009 without any modification. 4DIN EN ISO 8185:2009-07 EN ISO 8185:2009 (E) 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 Standard is the basic st

39、andard 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 associated Collateral Standards

40、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 apply to specific equipmen

41、t 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, the following draftin

42、g 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 words. “Replacement” mea

43、ns 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” means that existing te

44、xt 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 and figures are number

45、ed 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 and examples: smaller r

46、oman 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 Annex AA is indicated by

47、an asterisk (*). 5DIN EN ISO 8185:2009-07 EN ISO 8185:2009 (E) Humidifiers are used to raise the water content of gases delivered to patients. Gases available for medical use do not contain sufficient moisture and can damage or irritate the respiratory tract or desiccate secretions of patients whose

48、 upper airways have been bypassed. Reduction of the relative humidity at the patient connection port can cause desiccation of tracheo-bronchial secretions in the tracheal or tracheostomy tube, and consequently may cause narrowing or even obstruction of the airway 19. Heat can be employed to increase

49、 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 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 manufacturers have used the sam