BS-EN-ISO-17510-2-2003.pdf

BRITISH STANDARD BS EN ISO 17510-2:2003 Sleep apnoea breathing therapy Part 2: Masks and application accessories The European Standard EN ISO 17510-2:2003 has the status of a British Standard ICS 11.040.10 ? Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:03:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 17510-2:2003 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 7 February 2003 © BSI 7 February 2003 ISBN 0 580 41202 4 National foreword This British Standard is the official English language version of EN ISO 17510-2:2003. It is identical with ISO 17510-2:2003. The UK participation in its preparation was entrusted to Technical Committee CH/121/3, Lung ventillators 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 ISO title page, pages 2 to 12, 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 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:03:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM EN ISO 17510-2 January 2003 ICS 11.040.10 English version Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2003) Thérapie de l'apnée du sommeil - Partie 2: Masques et accessoires thérapeutiques (ISO 17510-2:2003) Schlafapnoe-Atemtherapie - Teil 2: Masken und Anwendungszubehör (ISO 17510-2:2003) This European Standard was approved by CEN on 9 September 2002. 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 © 2003 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 17510-2:2003 E Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:03:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 17510-2:2003 (E) 2 Contents page Foreword3 1Scope 4 2Normative references 4 3Terms and definitions5 4Information to be supplied by the manufacturer5 5Construction requirements.6 5.1Face mask connectors6 5.2Compatibility 6 5.3Re-breathing.7 6Methods of test 7 6.1Test to determine the sound pressure level of the gas exhaust port.7 6.1.1Principle7 6.1.2Apparatus .7 6.1.3Procedure .7 6.1.4Expression of results 7 6.2Test to determine the resistance to flow.8 Annex A (informative) Rationale10 Annex ZA (informative) Clauses of this European Standard addressing Essential Requirements or other provisions of EU Directives12 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:03:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 17510-2:2003 (E) 3 Foreword This document (EN ISO 17510-2:2003) has been prepared by Technical Committee CEN /TC 215, “Respiratory and anaesthetic equipment“, the secretariat of which is held by BSI, in collaboration with ISO/TC 121 “Anaesthetic and respiratory equipment“. 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 July 2003, and conflicting national standards shall be withdrawn at the latest by July 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 ISO 17510 covers sleep apnoea breathing therapy products for patients to use in the home. Part 1 applies to the sleep apnoea breathing therapy devices. This part 2 applies to masks, their fixing and to the accessories used to connect a sleep apnoea breathing therapy device to the patient. Annex A is informative. 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, Thu Nov 16 07:03:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 17510-2:2003 (E) 4 1 Scope This part of the European Standard specifies requirements for masks and accessories which are required to connect the patient connection port to a sleep apnoea breathing therapy device and the mask to a patient, and are used for the application of sleep apnoea breathing therapy e.g. nasal masks, gas exhaust ports, connecting element and headgear. This part of EN ISO 17510 does not cover oral appliances. NOTE 1Sleep apnoea breathing therapy devices are covered by EN ISO 17510-1 (see Figure A.1 for typical elements of the two parts of EN ISO 17510). NOTE 2 Annex A contains rationale statements for this Part of EN ISO 17510. 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 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 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 10993 series, Biological evaluation of medical devices. EN ISO 14971, Medical devices - Application of risk management to medical devices (ISO 14971:2000). EN ISO 17510-1:2002, Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy devices (ISO 17510-1:2002). EN 60651, Sound level meters (IEC 60651:1993) EN 60804, Integrating-averaging sound level meters (IEC 60804:2000) IEC/TR 60959, Provisional head and torso simulator for acoustic measurements on air conduction hearing aids. Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:03:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 17510-2:2003 (E) 5 3 Terms and definitions For the purposes of this part of the European Standard, the terms and definitions given in EN ISO 4135:2001, EN ISO 17510-1:2002 and the following apply. 3.1 oral appliance device intended to maintain the oral airway by mechanical means which achieves its purpose independently of a sleep apnoea breathing therapy device 3.2 headgear part that is used to fix the mask in the appropriate position on the patient 3.3 mask part which provides the interface between the patient and the patient connection port or the connecting element NOTE 1According to their application, masks are divided into nasal masks, oral masks or nasal-oral masks. NOTE 2A mask can additionally include specific facilities, e.g. supplementary gas connector, gas exhaust port, monitoring connector, means to minimize re-breathing. 3.4 connecting element part connecting the patient connection port and the mask NOTEA connecting element can include specific facilities, e.g. supplementary gas connector, gas exhaust port, monitoring connector, means to minimize re-breathing. 4 Information to be supplied by the manufacturer The label of the packaging and/or the instructions for use shall contain the following information: 4.1if imported into the EU, the name and address of the person responsible or the authorized representative of the manufacturer or the importer established within the EU; 4.2the intended purpose of the mask and application accessories; 4.3the pressure-flow curve of any gas exhaust port throughout the working pressure range (see A.3); 4.4the working pressure range of the mask and/or the connecting element; 4.5the sound pressure level of any gas exhaust port measured according to 6.1 (see A.4); 4.6if appropriate, the symbol STERILE in accordance with EN 980 and the method of sterilization; 4.7if appropriate, the symbol LOT in accordance with EN 980 or serial number; 4.8if appropriate, an indication of the date by which the mask and application accessories can be used safely, expressed as the year and month; 4.9if appropriate, an indication that the mask and application accessories are not for re-use; Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:03:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 17510-2:2003 (E) 6 4.10if re-usable: information necessary for cleaning, disinfection and/or sterilisation, including information about the frequency, methods and agents to be utilized, and number of re-uses of the device; a warning that inappropriate frequency or method or agent can have an adverse effect on the materials used and their performance; 4.11any special storage and/or handling conditions; 4.12any special operating instructions; 4.13any special warnings and/or precautions to be taken (see A.5), including the use of a separate exhalation valve when using a non-valved mask; 4.14if the packaging contains more than one component, information necessary for correct assembly of the components; 4.15if appropriate, a statement to the effect that combinations with other medical devices can alter the performance of the device, e.g. combinations with humidifier for medical use, nebulizer, heat and moisture exchanger (HME), filters, bi-level positive airway pressure device, self-adjusting sleep apnoea breathing therapy device, additional oxygen supply any gas exhaust port; 4.16instructions necessary in the event of damage to the sterile packaging and, if appropriate, details of appropriate methods of re-sterilisation; 4.17information to enable medical staff to brief the patient on any potential contra-indications and any precautions that may need to be taken, particularly in the event of changes in the performance of the device or when external sources of heat are located in the vicinity of the device; 4.18a warning statement to the effect that any occlusion of any gas exhaust port should be prevented; 4.19instructions for the correct disposal of the mask and application accessories; 4.20a warning statement to the effect that electrically conductive breathing tubes should not be used; 4.21 the resistance to flow, at 50 l/min and 100 l/min, of the mask and/or components of any connecting element when measured in accordance with 6.2, expressed as pressure drop in kPa (cmH20) (see A.6); 4.22information relating to the means provided to minimize the risk of re-breathing (see 5.3). 5 Construction requirements 5.1Face mask connectors Face mask connectors, if conical, shall be 15 mm or 22 mm size connectors conforming to EN 1281-1 or EN 1281-2. Non-conical connectors shall not engage with conical connectors conforming to EN 1281-1 or EN 1281-2 unless they comply with the engagement, disengagement and leakage requirements of EN 1281-1 or 1281-2. 5.2Compatibility Parts and/or materials which are intended to be in contact with the patient under normal use conditions shall be tested in accordance with EN ISO 10993 series. Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 16 07:03:13 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 17510-2:2003 (E) 7 A risk analysis shall be performed in accordance with EN ISO 14971. 5.3Re-breathing Means shall be provided to minimize the risk of re-breathing during normal use and single fault condition. NOTEThe design of the mask and application accessories can be such that this requirement is already satisfied and no additional protection is required. 6 Methods of test 6.1 Test to determine the sound pressure level of the gas exhaust port 6.1.1 Principle The noise emission from the gas exhaust port of a mask is measured. This mask is fitted on a dummy head simulating the reception of the operating noise at the patient's ears. 6.1.2 Apparatus 6.1.2.1Sound pressure measuring device, in accordance with EN 60651 and EN 60804 type 1. 6.1.2.2Dummy head, in accordance with IEC/TR 60959. 6.1.3 Procedure 6.1.3.1For a face mask with integral exhaust port, fit the mask to the dummy head (6.1.2.2) as specified by the manufacturer, ensuring a gas-tight seal. For a stand-alone gas exhaust port, position it relative to the dummy head as specified by the manufacturer for normal use, with the outlet port sealed. 6.1.3.2Connect a breathing tube and ensure that no leakage