BS-EN-13544-1-2001.pdf

BRITISH STANDARD BS EN 13544-1:2001 Incorporating Amendment No. 1 Respiratory therapy equipment Part 1: Nebulizing systems and their components The European Standard EN 13544-1:2001, with the incorporation of amendment A1:2004, has the status of a British Standard ICS 11.040.10 ? Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:56:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 13544-1:2001 This British Standard, having been prepared under the direction of the Health and Environment Sector Policy and Strategy Committee, was published under the authority of the Standards Policy and Strategy Committee on 18 October 2001 © BSI 26 July 2004 ISBN 0 580 38211 7 National foreword This British Standard is the official English language version of EN 13544-1:2001, including amendment A1:2004. It supersedes BS 7711-3:1994 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/46, Lung ventilators and related equipment, which has the responsibility to: 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 found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or British Standards Online. 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 does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible 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 of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 43 and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments 1526526 July 2004Annex DD deleted Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:56:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM EN 13544-1 August 2001 + A1 June 2004 ICS 11.040.10 English version Respiratory therapy equipment Part 1: Nebulizing systems and their components (including amendment A1:2004) Matériel respiratoire thérapeutique Partie 1: Systèmes de nébulisation et leurs composants (inclut lamendement A1:2004) Atemtherapiegeräte Teil 1: Verneblersysteme und deren Bauteile (enthält Änderung A1:2004) This European Standard was approved by CEN on 29 June 2001; amendment A1 was approved by CEN on 22 April 2004. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which 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 Management Centre or to any CEN member. This European Standard 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 Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels © 2004 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13544-1:2001 + A1:2004 E Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:56:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13544-1:2001 (E) 2 Contents page Foreword5 Introduction 6 Section one - General.7 1 R) Scope.7 2 Normative references7 3 Terms and definitions8 4 General requirements and general requirements for test9 5 Classification 10 6 Identification, marking and documents10 7 Power input.13 Section two - Environmental conditions14 8 Basic safety categories.14 9 Removable protective means14 10 Environmental conditions14 11 Not used.14 12 Not used.14 Section three - Protection against electric shock hazards.15 13 General.15 14 Requirements related to classification.15 15 Limitation of voltage and/or energy.15 16 Enclosures and protective covers .15 17 Separation15 18 Protective earthing, functional earthing and potential equalization15 19 R) Continuous leakage currents and patient auxiliary currents15 20 Dielectric strength.15 Section four - Protection against mechanical hazards 16 21 Mechanical strength16 22 Moving parts.16 23 Surfaces, corners and edges16 24 Stability in normal use.16 25 Expelled parts.16 26 Vibration and noise.16 27 Pneumatic and hydraulic power16 Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:56:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13544-1:2001 (E) 3 28 Suspended masses16 Section five - Protection against hazards from unwanted or excessive radiation17 29 X-radiation17 30 Alpha, beta, gamma, neutron radiation and other particle radiation 17 31 Microwave radiation17 32 Light radiation (including lasers) .17 33 Infra-red radiation .17 34 Ultra-violet radiation17 35 Acoustical energy (including ultra-sonics).17 36 Electromagnetic compatibility17 Section six - Protection against hazards of ignition of flammable anaesthetic mixtures18 37 R) Locations and basic requirements18 38 R) Marking, accompanying documents.18 39 R) Common requirements for category AP and category APG equipment18 40 R) Requirements and tests for Category AP equipment, parts and components thereof.18 41 R) Requirements and tests for Category APG equipment, parts and components thereof18 Section seven - Protection against excessive temperatures and other safety hazards.19 42 Excessive temperatures19 43 R) Fire prevention.19 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection19 45 Pressure vessels and parts subject to pressure19 46 Human errors20 47 Electrostatic charges 20 48 Biocompatibility.20 49 Interruption of the power supply20 Section eight - Accuracy of operating data and protection against hazardous output .21 50 Accuracy of operating data.21 51 Protection against hazardous output.21 Section nine - Abnormal operation and fault conditions; environmental tests .22 52 Abnormal operation and fault conditions.22 53 Environmental tests22 Section ten - Constructional requirements23 54 R) General23 55 Enclosures and covers23 56 Components and general assembly23 57 Mains parts, components and layout.24 58 Protective earthing - Terminals and connections.24 59 Construction and layout24 Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:56:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13544-1:2001 (E) 4 Annex A A (informative) Rationale.26 Annex B B (informative) Diameters of the particles depositable fraction29 Annex C C (normative) Test methods for the aerosol output rate, the aerosol output and for particle sizing 30 Annex DD (deleted)30 Annex EE (informative) Mass balance checks on cascade impactor tests.39 Annex ZA (informative) Clauses of this European Standard addressing Essential Requirements or other provisions of EU Directives.40 Bibliography .43 Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:56:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13544-1:2001 (E) 5 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 publication of an identical text or by endorsement, at the latest by February 2002, and conflicting national standards shall be withdrawn at the latest by February 2002. 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 EU Directive(s). For relationship with EU Directive(s), see informative annex ZA, which is an integral part of this standard. This European Standard applies to respiratory therapy equipment and has been prepared in three parts. This Part addresses nebulizing systems; Parts 2 and 3 address respectively tubing and connectors, and air entrainment devices. Annex CC is normative and forms part of this European Standard. Annexes AA, BB, DD, EE and ZA are for information only. According to the CEN/CENELEC 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, Switzerland and the United Kingdom. Foreword to amendment A1 This document (EN 13544-1:2001/A1:2004) has been prepared by Technical Committee CEN/TC 215 Respiratory and anaesthetic equipment, the Secretariat of which is held by BSI. This amendment to the European Standard EN 13544-1:2001 shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by December 2004, and conflicting national standards shall be withdrawn at the latest by December 2004. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:56:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13544-1:2001 (E) 6 Introduction This European Standard is based on European Standard EN 60601-1:1990. In EN 60601-1:1990, this type of European Standard is referred to as a “Particular Standard”. As stated in 1.3 of EN 60601-1:1990, the requirements of this European Standard take precedence over those of EN 60601-1:1990. Clauses, subclauses, tables and figures additional to those in EN 60601-1:1990 are numbered beginning at '101'. Additional annexes are lettered beginning at 'AA' except for annex 'ZA'. Additional items in lettered lists are lettered beginning 'aa)'. Rationales for some of the requirements of this standard are given in annex AA. Such requirements are indicated by the letter 'R' after the clause number. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:56:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13544-1:2001 (E) 7 Section one - General 1 R) Scope The scope given in clause 1 of EN 60601-1:1990 applies except that 1.1 is replaced by the following: 1.1 This European Standard specifies requirements for nebulizing systems used for the delivery of drugs in an aerosol form to humans through the respiratory system. This European Standard includes gas-powered nebulizers which may be derived from e.g. compressors, pipeline systems, cylinders etc., or electrically-powered nebulizers (e.g. ultrasonic) or manually-powered nebulizers. NOTE Requirements for nebulizers having also a humidification function are specified in EN ISO 8185 “Humidifiers”. This European Standard does not include nebulizers precharged with a specific medicinal product and not for universal application. 2 Normative references This 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 publications 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 (including amendments). Appendix L of EN 60601-1:1990 applies with the following additions : EN 550, Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization. EN 552, Sterilization of medical devices - Validation and routine control of sterilization by irradiation. EN 554, Sterilization of medical devices - Validation and routine control of sterilization by moist heat. EN 556:1994+A1:1998, Sterilization of medical devices - Requirements for medical devices to be labelled “Sterile”. EN 737-3, Medical gas pipeline systems - Part 3: Pipelines for compressed medical gases and vacuum. EN 738-1, Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices. EN 980, Graphical symbols for use in the labelling of medical devices. EN 1041, Information supplied by the manufacturer with medical devices. EN 1281-1, Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets. EN 1281-2, Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors (ISO 5356-2:1987 modified). Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:56:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13544-1:2001 (E) 8 EN ISO 4135:1995, Anaesthesiology - Vocabulary (ISO 4135:1995). EN ISO 8185, Humidifiers for medical use General requirements for humidification systems (ISO 8185:1997). EN 60601-1:1990, Medical electrical equipment - Part 1: General requirements for safety (IEC 60601-1:1988). EN 60601-1-2, Medical electrical equipment - Part 1: General requirements for safety - Collateral Standard: Electromagnetic compatibility - Requirements and tests (IEC 60601-1-2:1993). IEC 60079-4, Electrical apparatus for explosive gas atmospheres - Part 4: Method of test for ignition temperature. IEC 60651, Sound level meters; amendment 1. IEC 61000-4-2, Electromagnetic compatibility (EMC) Part 4: Testing and measurement techniques Section 2: Electrostatic discharge immunity test - Basic EMC publication. ISO 3744, Acoustics - Determination of sound power levels of noise sources using sound pressure - Engineering method in an essentially free field over a reflecting plane1). European Pharmacopoeia, Monograph on preparatio