ISO INTERNATIONAL STANDARD. Sleep apnoea breathing therapy Part 2: Masks and application accessories

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1 INTERNATIONAL STANDARD ISO First edition Sleep apnoea breathing therapy Part 2: Masks and application accessories Thérapie de l'apnée du sommeil Partie 2: Masques et accessoires thérapeutiques Reference number ISO :2003(E) ISO 2003

2 PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. ISO 2003 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel Fax copyright@iso.org Web Published in Switzerland ii ISO 2003 All rights reserved

3 Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO was prepared by the European Committee for Standardization (CEN) in collaboration with Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 3, Lung ventilators and related equipment, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement). Throughout the text of this document, read "...this European Standard..." to mean "...this International Standard...". ISO consists of the following parts, under the general title Sleep apnoea breathing therapy: Part 1: Sleep apnoea breathing therapy devices Part 2: Masks and application accessories For the purposes of this part of ISO 17510, the CEN annex regarding fulfilment of European Council Directives has been removed. Annex ZZ provides a list of corresponding International and European Standards for which equivalents are not given in the text. ISO 2003 All rights reserved iii

4 Contents Foreword... v 1 Scope Normative references Terms and definitions Information to be supplied by the manufacturer Construction requirements Face mask connectors Compatibility Re-breathing Methods of test Test to determine the sound pressure level of the gas exhaust port Principle Apparatus Procedure Expression of results Test to determine the resistance to flow...5 Annex A (informative) Rationale...7 Annex ZZ (normative) Corresponding International and European Standards for which equivalents are not given in the text...9 page iv ISO 2003 All rights reserved

5 Foreword This document (EN ISO :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 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). EN ISO 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. ISO 2003 All rights reserved v

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7 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 does not cover oral appliances. NOTE 1 Sleep apnoea breathing therapy devices are covered by EN ISO (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 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 , Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets. EN , Anaesthetic and respiratory equipment - Conical connectors - Part 2: Screw-threaded weight-bearing connectors (ISO :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 series, Biological evaluation of medical devices. EN ISO 14971, Medical devices - Application of risk management to medical devices (ISO 14971:2000). EN ISO :2002, Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy devices (ISO :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. ISO 2003 All rights reserved 1

8 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 :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 1 According to their application, masks are divided into nasal masks, oral masks or nasal-oral masks. NOTE 2 A 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 NOTE A 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: 4.1 if 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; 4.2 the intended purpose of the mask and application accessories; 4.3 the pressure-flow curve of any gas exhaust port throughout the working pressure range (see A.3); 4.4 the working pressure range of the mask and/or the connecting element; 4.5 the sound pressure level of any gas exhaust port measured according to 6.1 (see A.4); 4.6 if appropriate, the symbol STERILE in accordance with EN 980 and the method of sterilization; 4.7 if appropriate, the symbol LOT in accordance with EN 980 or serial number; 4.8 if appropriate, an indication of the date by which the mask and application accessories can be used safely, expressed as the year and month; 4.9 if appropriate, an indication that the mask and application accessories are not for re-use; 2 ISO 2003 All rights reserved

9 4.10 if 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; 4.11 any special storage and/or handling conditions; 4.12 any special operating instructions; 4.13 any 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; 4.14 if the packaging contains more than one component, information necessary for correct assembly of the components; 4.15 if 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; 4.16 instructions necessary in the event of damage to the sterile packaging and, if appropriate, details of appropriate methods of re-sterilisation; 4.17 information 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; 4.18 a warning statement to the effect that any occlusion of any gas exhaust port should be prevented; 4.19 instructions for the correct disposal of the mask and application accessories; 4.20 a 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 (cmh 2 0) (see A.6); 4.22 information relating to the means provided to minimize the risk of re-breathing (see 5.3). 5 Construction requirements 5.1 Face mask connectors Face mask connectors, if conical, shall be 15 mm or 22 mm size connectors conforming to EN or EN Non-conical connectors shall not engage with conical connectors conforming to EN or EN unless they comply with the engagement, disengagement and leakage requirements of EN or Compatibility 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 series. ISO 2003 All rights reserved 3

10 A risk analysis shall be performed in accordance with EN ISO Re-breathing Means shall be provided to minimize the risk of re-breathing during normal use and single fault condition. NOTE The 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 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 Apparatus Sound pressure measuring device, in accordance with EN and EN type Dummy head, in accordance with IEC/TR Procedure For a face mask with integral exhaust port, fit the mask to the dummy head ( ) 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 Connect a breathing tube and ensure that no leakage occurs By appropriate measures, acoustically isolate the tubing systems in such a manner that the noise caused or conducted by the tubing system does not affect the sound level measurement at the gas exhaust port Apply a constant gas pressure of 1 kpa to the appropriate inlet port Position the microphone etc. for measurement according to IEC/TR and corresponding to the person's left and right ears At each position of the microphone determine the time average sound pressure level L eq (i.e. the energy averaged A-frequency weighted and F-time weighted sound pressure level) for the noise level during use and the background noise. Duration of each measurement is at least 10 s The measurement shall be in accordance with accuracy class 2 according to EN ISO 3744, in particular the environmental conditions apply with: K 2 2 db and the difference between the measured noise level and the environmental noise level shall be L 6 db and K 1 1,3 db The measurement shall be in accordance with provisions specified in EN ISO i.e. acoustic environment, measuring devices, mounting and operation etc Expression of results Express the sound levels L eq measured according to EN ISO 3744, at the left-hand and right-hand measuring positions, free of the influence of the external noise as well as the measuring environment. 4 ISO 2003 All rights reserved

11 Note These values correspond to the operating noise at the patient's ears and are expressed in db(a). 6.2 Test to determine the resistance to flow A flow generator, a flow control and a flow measuring device are set up in series (see Figure 1) The outlet of the measuring device is considered the patient connection port. Place a pressure measuring device at the patient connection port. Connect the mask and/or components of any connecting element to the patient connection port. Set the flow to 50 l/min and 100 l/min respectively and record the generated pressure at the patient connection port. Any inaccuracy of the pressure measurement shall be added to the results recorded and the sum shall be stated as required in NOTE Any opening other than the opening to apply the gas flow to the patient should be sealed during the measurement of the pressure at the patient connection port. ISO 2003 All rights reserved 5

12 5 Key Flow generator 2 Flow control 3 Flow measuring device 4 Patient connection port with connection to the pressure measuring device 5 Mask and/or components of any connecting element 6 Direction of flow Figure 1 Test apparatus to determine the resistance to flow 6 ISO 2003 All rights reserved

13 Annex A (informative) Rationale A.1 This annex provides a concise rationale for the important requirements of this European Standard and is intended for those who are familiar with the subject of this European Standard but who have not participated in its development. An understanding of the reasons for the main requirements is considered to be essential for its proper application. Furthermore, as clinical practice and technology change, it is believed that a rationale for the present requirements will facilitate any revision of this European Standard necessitated by those developments. A.2 Figure A.1 is meant to ensure comprehension of the entire sleep apnoea breathing system in general as well as the definitions specified in this part of EN ISO Key 1 Headgear 2 Mask 3 Connecting element (optional) 4 Patient connection port 5 Breathing tube 6 Gas output port connector 7 Sleep apnoea breathing therapy device (see EN ISO ) 8 Scope of EN ISO Scope of EN ISO Figure A.1 Typical example of sequence of elements of the two parts of EN ISO ISO 2003 All rights reserved 7

14 A.3 The pressure-flow-curve of the gas exhaust port is a piece of information to enable the user to assess the risk of re-breathing. Furthermore, it is of major importance in relation to pressure control throughout the entire sleep apnoea breathing therapy system. A.4 Information about the sound power level is state-of-the-art, since no parameter other than this one provides an accurate specification of the noise emission of a source, without influence from the environmental conditions and the distance to the source of emission. Nevertheless, this standard requires information about the sound pressure level, as this parameter presently constitutes a reference parameter that provides more practical information. A.5 If parts and/or materials are made of natural latex and may have contact with the patient, the packaging should include a warning that this product may cause allergic reactions. A.6 The number of medically successfully treated obstructive apnoea incidents depends very much on the stability of the CPAP. Sleep apnoea breathing devices usually control the pressure at the patient connection port i.e. not at the outlet of the application accessories e.g. the mask. Sleep apnoea breathing therapy devices are usually combined with masks and application accessories of different manufacturers. Whereas most devices are pressure-adjustable at the patient connection port, all connected accessories and masks are outside the area where pressure is controlled. Therefore these masks have direct impact on the pressure received by the patient. The resistance of masks and accessories connected to sleep apnoea breathing therapy devices depends on respiratory flow. High peak flows in particular can cause a substantial pressure drop between the patient connection port and the patient s airway. As a consequence, the patient does not receive the required therapeutic pressure, the probability of apnoea is increased and the therapeutic objective is not achieved. In addition the high flow resistance adversely affects the pressure control performance of the device and therefore also the therapeutic quality. In the case of bi-level positive airway pressure devices this can result in a decreased quality of the switching process between the two pressure levels. This also reduces the acceptance of the therapy by the patient. The proposed requirements and the test method stated serve to provide guidance to users and clinicians when selecting an appropriate device, masks, accessories and the combination thereof, and to ensure compatibility of the masks and accessories with sleep apnoea breathing therapy devices. 8 ISO 2003 All rights reserved

15 Annex ZZ (normative) Corresponding International and European Standards for which equivalents are not given in the text At the time of publication of this part of ISO 17510, the edition of the following document was valid. Members of ISO and IEC maintain registers of currently valid International Standards. EN 980 ISO 15223, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied ISO 2003 All rights reserved 9

16 ICS Price based on 9 pages ISO 2003 All rights reserved

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