BS-EN-13544-1-2007.pdf

BRITISH STANDARD BS EN 13544-1:2007 Respiratory therapy equipment Part 1: Nebulizing systems and their components The European Standard EN 13544-1:2007 has the status of a British Standard ICS 11.040.10 ? Licensed Copy: London South Bank University, London South Bank University, Fri Jun 01 01:33:13 GMT+00:00 2007, Uncontrolled Copy, (c) BSI BS EN 13544-1:2007 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 May 2007 © BSI 2007 ISBN 978 0 580 50791 5 National foreword This British Standard was published by BSI. It is the UK implementation of EN 13544-1:2007. It supersedes BS EN 13544-1:2001 which is withdrawn. The UK participation in its preparation was entrusted by Technical Committee CH/121, Anaesthetic and respiratory equipment, to Subcommittee CH/121/3, Lung ventilators and related equipment. A list 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 legal obligations. Amendments issued since publication Amd. No. DateComments Licensed Copy: London South Bank University, London South Bank University, Fri Jun 01 01:33:13 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM EN 13544-1 April 2007 ICS 11.040.10Supersedes EN 13544-1:2001 English Version Respiratory therapy equipment - Part 1: Nebulizing systems and their components Matériel respiratoire thérapeutique - Partie 1: Systèmes de nébulisation et leurs composants Atemtherapiegeräte - Teil 1: Verneblersysteme und deren Bauteile This European Standard was approved by CEN on 22 March 2007. 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 CEN 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 CEN Management Centre has the same status as the official versions. CEN members are the national standards 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 Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR 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 13544-1:2007: E Licensed Copy: London South Bank University, London South Bank University, Fri Jun 01 01:33:13 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EN 13544-1:2007 (E) 2 Contents Page Foreword5 Introduction.6 1 R) Scope .7 2 Normative references7 3 Terms and definitions .9 4 General requirements and general requirements for test.10 4.1 Modifications to Clause 3 of EN 60601-1:1990 .10 4.2 Clause 4 of EN 60601-1:199010 4.3 Alternative type-test methods11 5 Classification11 6 Identification, marking and documents.11 6.1 Marking on the outside of equipment or equipment parts11 6.3 Marking of controls and instruments 12 6.4 Symbols12 6.8.2 Instructions for use .12 6.8.3 Technical description14 7 Power input 14 8 Basic safety categories.14 9 Removable protective means.14 10 Environmental conditions.15 11 Not used15 12 Not used15 13 General15 14 Requirements related to classification15 15 Limitation of voltage and/or energy.15 16 Enclosures and protective covers.15 17 Separation 15 18 Protective earthing, functional earthing and potential equalization15 19 Continuous leakage currents and patient auxiliary currents15 20 Dielectric strength .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 noise16 27 Pneumatic and hydraulic power.17 Licensed Copy: London South Bank University, London South Bank University, Fri Jun 01 01:33:13 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EN 13544-1:2007 (E) 3 28 Suspended masses.17 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 radiation17 34 Ultra-violet radiation17 35 Acoustical energy (including ultra-sonics).17 36 Electromagnetic compatibility .18 37 R Locations and basic requirements 18 38 R Marking, accompanying documents18 39 R Common requirements for category AP and category APG equipment18 40 R Requirements and tests for Category AP equipment, parts and components thereof18 41 R Requirements and tests for Category APG equipment, parts and components thereof .18 42 Excessive temperatures .18 43 R) Fire prevention18 44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection 19 45 Pressure vessels and parts subject to pressure .19 46 Human errors.19 47 Electrostatic charges19 48 Biocompatibility.20 49 Interruption of the power supply .20 50 Accuracy of operating data20 51 Protection against hazardous output20 52 Abnormal operation and fault conditions.21 53 Environmental tests21 54 General .21 55 Enclosures and covers.21 56 Components and general assembly21 57 Mains parts, components and layout23 58 Protective earthing - Terminals and connections23 59 Construction and layout.23 Annex A A (informative) Rationale 24 Annex B B (informative) Diameters of the particles depositable fraction.27 Annex C C (normative) Test methods for the aerosol output rate, the aerosol output and for particle sizing.28 CC.1 Method of test for the aerosol output rate28 CC.1.1 Test conditions28 CC.1.2 R) Principle of test.28 CC.1.3 Test equipment28 Licensed Copy: London South Bank University, London South Bank University, Fri Jun 01 01:33:13 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EN 13544-1:2007 (E) 4 Annex D D (normative) Mass balance checks on cascade impactor tests36 DD.1 Aerosol output rate and aerosol output tests: .36 DD.2 Particle sizing test .36 Annex E E (informative) Environmental aspects37 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42 EEC on medical devices .39 Bibliography41 Licensed Copy: London South Bank University, London South Bank University, Fri Jun 01 01:33:13 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EN 13544-1:2007 (E) 5 Foreword This document (EN 13544-1:2007) 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 October 2007, and conflicting national standards shall be withdrawn at the latest by October 2007. This document supersedes EN 13544-1:2001. 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 informative Annex ZA, which is an integral part of this document. 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. 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Licensed Copy: London South Bank University, London South Bank University, Fri Jun 01 01:33:13 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EN 13544-1:2007 (E) 6 Introduction This European Standard is based on 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 European Standard are given in Annex AA. Such requirements are indicated by the letter 'R' after the clause number. Licensed Copy: London South Bank University, London South Bank University, Fri Jun 01 01:33:13 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EN 13544-1:2007 (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 and membrane devices) or manually-powered nebulizers. NOTE Requirements for nebulizers having also a humidification function are specified in EN ISO 8185:1997 + AC: 2002 “Humidifiers” (see 56.102). This European Standard does not apply to nebulizers precharged with a specific medicinal product (e.g. MDI, DPI). 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 556 (all parts), Sterilization of medical devices Requirements for medical devices to be designated “STERILE” EN 737-1, Medical gas pipeline systems Part 1: Terminal units for compressed medical gases and vacuum ENV 737-6, Medical gas pipeline systems Part 6: Dimensions and allocation of probes for terminal units for compressed medical gases and vacuum EN 739, Low pressure hose assemblies for use with medical gases EN 980, Graphical symbols for use in the labelling of medical devices EN 1041, Information supplied by the manufacturer with medical devices EN 1281-21), Anaesthetic and respiratory equipment Conical connectors Part 2: Screw-threaded weight- bearing connectors (ISO 5356-2:1987 modified) EN 1707, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Lock fittings EN 20594-1, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements (ISO 594-1:1986) EN 60601-1:1990, Medical electrical equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1:1988) 1) Will be superseded by EN ISO 5356-2, which is currently under preparation. Licensed Copy: London South Bank University, London South Bank University, Fri Jun 01 01:33:13 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EN 13544-1:2007 (E) 8 EN 60601-1-2, Medical electrical equipment Part 1-2: General requirements for safety; Collateral Standard: Electromagnetic compatibility Requirements and tests (IEC 60601-1-2:2001) EN 61000-4-2:1995, Electromagnetic compatibility (EMC) Part 4: Testing and measurement techniques Section 2: Electrostatic discharge immunity test Basic EMC publication (IEC 61000-4-2:1995) EN 61672-1, Electroacoustics Sound level meters Part 1: Specifications (IEC 61672-1:2002) EN 61672-2, Electroacoustics Sound level meters Part 2: Pattern evaluation tests (IEC 61672-2:2003) EN ISO 3744, Acoustics Determination of sound power levels of noise sources using sound pressure Engineering method in an essentially free field over a reflecting plane (ISO 3744:1994) EN ISO 4135:2001, Anaesthetic and respiratory equipment Vocabulary (ISO 4135:2001) EN ISO 5356-1, Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets (ISO 5356-1:2004) EN ISO 7396-1, Medical gas pipeline systems Part 1: Pipelines for compressed medical gases and vacuum (ISO 7396-1:2006) EN ISO 8185, Humidifiers for medical use General requirements for humidification systems (ISO 8185:1997) EN ISO 10524-1, Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006) EN ISO 10524-3, Pressure regulators for use with medical gases Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005) EN ISO 11135-1Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007) EN ISO 11137-1, Sterilization of health care products Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006) EN ISO 11137-2, Sterilization of health care products Radiation Part 2: Establishing the sterilization dose (ISO 11137-2:2006) EN ISO 11137-3, Sterilization of health care products Radiation Part 3: Guidance on dosimetric aspects (ISO 11137-3:2006) EN ISO 14971, Medical devices Application of risk management to medical devices (ISO 14971:2000) EN ISO 15001, Anaesthetic and respiratory equipment Compatibility with oxygen (ISO 15001:2003) EN ISO 17665-1, Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006) IEC 60079-4, Electrical apparatus for explosive gas atmospheres Part 4: Method of test for ignition temperature Licensed Copy: London South Bank University, London South Bank University, Fri Jun 01 01:33:13 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EN 13544-1:2007 (E) 9 3 Terms and definitions For the purposes of this document, the terms and definitions given in EN ISO 4135:2001, Clause 2 of EN 60601-1:1990 and the following apply. 2.1.5 R) applied part: Add the following item: