BS-EN-13328-2-2002.pdf
BRITISH STANDARD BS EN 13328-2:2002 Incorporating Corrigendum No. 1 and Amendment No. 1 Breathing system filters for anaesthetic and respiratory use Part 2: Non-filtration aspects The European Standard EN 13328-2:2002, with the incorporation of amendment A1:2003 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 13328-2:2002 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 27 November 2002 © BSI 4 February 2004 ISBN 0 580 40853 1 National foreword This British Standard is the official English language version of EN 13328-2:2002, including amendment A1:2003. The UK participation in its preparation was entrusted to Technical Committee CH/45, Tracheal tubes 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 of 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 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 of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 8, an inside back cover 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 14268 Corrigendum No. 1 18 December 2002Correction to title 149464 February 2004New definition 3.6 and additional list item k) to Clause 8 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 13328-2 November 2002 + A1 December 2003 ICS 11.040.10 English version Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects (includes amendment A1:2003) Filtres pour systèmes respiratoires utilisés en anesthésie et soins respiratoires - Partie 2: Propriétés autres que la filtration (inclut lamendement A1:2003) Filter für Atemsysteme zur Anwendung bei Anästhesie und Beatmung - Teil 2: Aspekte, die nicht die Filtration betreffen (enthält Änderung A1:2003) This European Standard was approved by CEN on 8 August 2002, and amendment A1 was approved by CEN on 21 November 2003. 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, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, 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 © 2002 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13328-2:2002 + A1:2003 E Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:56:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13328-2:2002 (E) 2 Contents page Foreword3 1 Scope 4 2 Normative references4 3 Terms and definitions .4 4 BSF port connectors .5 4.1 Breathing system and patient connection ports5 4.2 Accessory ports.5 5 Test methods5 5.1 Ambient conditions of test .5 5.2 Measurement of pressure drop5 5.3 Test method for gas leakage5 6 Requirements for BSFs supplied sterile .6 6.1 Sterility assurance.6 6.2 Packaging of BSFs supplied sterile.6 7 Marking.6 7.1 Use of symbols 6 7.2 Marking of BSF.6 7.3 Marking of package .6 7.4 BSF intended for single use .6 8 Information to be provided by the manufacturer .7 Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of EU Directives8 Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:56:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13328-2:2002 (E) 3 Foreword This document (EN 13328-2:2002) 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 May 2003, and conflicting national standards shall be withdrawn at the latest by May 2003. 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. EN 13328 consists of the following parts under the general title Breathing system filters for anaesthetic and respiratory use : Part 1 : Salt test method to assess filtration performance Part 2 : Non-filtration aspects 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, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Foreword to amendment A1 This document (EN 13328-2:2002/A1:2003) 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 13328-2:2002 shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by June 2004, and conflicting national standards shall be withdrawn at the latest by June 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, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, 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 13328-2:2002 (E) 4 1 Scope This Part of this European Standard specifies requirements for non-filtration aspects of breathing system filters (BSFs) intended for the filtration of respired gases in humans when used with a breathing system. It addresses connection ports, leakage, resistance to flow, packaging, marking and information supplied. It is not intended for other types of filter e.g. those designed to protect vacuum sources or gas sample lines, to filter compressed gases, to protect test equipment used for physiological respiratory measurements. 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). EN 556-1, Sterilization of medical devices Requirements for medical devices to be designated “STERILE” Part 1: Requirements for terminally sterilized medical devices EN 868-1, Packaging materials and systems for medical devices which are to be sterilized Part 1: General requirements and test methods EN 980, Graphical symbols for use in the labelling of 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) EN 13328-1:2001, Breathing system filters for anaesthetic and respiratory use Part 1 : Salt test method to assess filtration performance EN 60601-1, Medical electrical equipment Part 1: General requirements for safety EN ISO 9360-1, Anaesthetic and respiratory equipment Heat and moisture exchangers (HMEs) for humidifying respired gases in humans Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000) 3 Terms and definitions For the purposes of this European Standard, the following terms and definitions apply. 3.1 breathing system filter device intended to reduce transmission of particulates including micro-organisms in breathing systems NOTE Referred to in this European Standard as BSF ; (plural BSFs). 3.2 BSF breathing system port port of the BSF that connects to the breathing system 3.3 BSF patient connection port port of the BSF intended for connection to devices such as a tracheal or tracheostomy tube connector or a face mask Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:56:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13328-2:2002 (E) 5 3.4 BSF accessory port port of the BSF intended for connection to an accessory device for purposes such as gas sampling, monitoring and pressure measurement 3.5 BSF internal volume volume contained within the BSF when unpressurized, minus the volume of all solid elements within the BSF and the volume inside all female connectors. 3.6 pressure drop difference between the pressure measured in the gas stream flowing into a BSF and the pressure measured in the gas stream flowing out of the BSF at a constant gas flowrate through the BSF 4 BSF port connectors 4.1 Breathing system and patient connection ports The connectors at the breathing system port and the patient connection port shall comply with EN 1281-1. 4.2 Accessory ports If the BSF incorporates any accessory ports, those ports shall not accept 15 mm or 22 mm conical connectors that comply with EN 1281-1 or EN 1281-2 and shall be provided with a means of closure of the ports. NOTE See clause 8 j). 5 Test methods 5.1 Ambient conditions of test Refer to EN 13328-1:2001, 3.2. 5.2 Measurement of pressure drop The measurement of pressure drop shall be determined in accordance with EN ISO 9360-1, using the flow(s) given in table 1. The conditioning procedure in Annex A of EN 13328-1:2001 shall be used. Table 1 Flow for measurement of pressure drop BSF intended use Flow l·min-1 paediatric 15 adult 30 5.3 Test method for gas leakage The BSF shall be tested for gas leakage as specified in EN ISO 9360-1. The conditioning procedure in Annex A of EN 13328-1:2001 shall be used. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:56:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13328-2:2002 (E) 6 6 Requirements for BSFs supplied sterile 6.1 Sterility assurance BSFs supplied and marked as STERILE shall satisfy the requirements of EN 556-1 6.2 Packaging of BSFs supplied sterile The pack shall serve as an effective barrier to the penetration of micro-organisms and particulate material, in accordance with the relevant sections of EN 868-1. 7 Marking 7.1 Use of symbols Some of the requirements of 7.3 and 7.4 can be met by use of appropriate symbols as given in EN 980. 7.2 Marking of BSF BSF shall be marked with the following: a) the direction of orientation towards the patient in the case of orientation-sensitive BSF; b) the letters APG (in accordance with EN 60601-1) if the manufacturer states that the BSF is safe for use with flammable anaesthetics. 7.3 Marking of package The package shall be marked with the following: a) the name and/or trademark of the manufacturer and/or supplier; b) the intended use of the BSF; c) the word STERILE , if appropriate; d) storage instructions; e) Lot number or batch code; f) use-by date, if the BSF is sensitive to storage or has a limited shelf-life. 7.4 BSF intended for single use For BSF intended for single use, either the BSF or the package shall be marked with the words single use or the equivalent. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:56:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13328-2:2002 (E) 7 8 Information to be provided by the manufacturer The following information shall be provided by the manufacturer: a) instructions for use; b) the recommended range of tidal volumes and/or flow rates; c) the pressure drops as measured in accordance with 5.1 and 5.2; d) the internal volume of the BSF in millilitres; e) the gas leakage, in millilitres per minute, measured as specified in 5.3; f) if applicable, a warning of the hazards associated with the use of the BSF with any types of inhalants during inhalation therapy, anaesthetic gases and vapours, and humidifiers and nebulizers; g) if the BSF or parts thereof are reusable, instructions for maintenance and details of cleaning, disinfection and sterilization; h) recommended maximum time of use before either disposal or cleaning; i) instructions for safe disposal after use; j) if the BSF is fitted with one or more Luer connectors, a warning highlighting the potential for inappropriate connection to other devices that can result in a patient hazard. k) penetration value, pre- and post-conditioning, as determined by EN 13328-1. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:56:55 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13328-2:2002 (E) 8 Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of EU Directives This European Standard has been prepared under a mandate give
