Respirationsbehandling av s mnapn Del 1: Respirationsutrustning f r behandling av s mnapn (ISO :2007)

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1 SVENSK STANDARD SS-EN ISO :2009 Fastst lld/approved: Publicerad/Published: Utg va/edition: 3 Spr k/language: engelska/english ICS: Respirationsbehandling av s mnapn Del 1: Respirationsutrustning f r behandling av s mnapn (ISO :2007) Sleep apnoea breathing therapy Part 1: Sleep apnoea breathing therapy equipment (ISO :2007) SWEDISH STANDARDS INSTITUTE

2 Hitta r tt produkt och ett leveranss tt som passar dig Standarder Genom att f lja g llande standard b de e ektiviserar och s krar du ditt arbete. M nga standarder ing r dessutom ofta i paket. Tj nster Abonnemang r tj nsten d r vi uppdaterar dig med aktuella standarder n r f r ndringar sker p dem du valt att abonnera p. P s s tt r du s ker p att du alltid arbetar efter r tt utg va. e-nav r v r online-tj nst som ger dig och dina kollegor tillg ng till standarder ni valt att abonnera p dygnet runt. Med e-nav kan samma standard anv ndas av era personer samtidigt. Leveranss tt Du v ljer hur du vill ha dina standarder levererade. Vi kan erbjuda dig dem p papper och som pdf. Andra produkter Vi har b cker som underl ttar arbetet att f lja en standard. Med v ra b cker f r du kad f rst else f r hur standarder ska f ljas och vilka f rdelar den ger dig i ditt arbete. Vi tar fram m nga egna publikationer och fungerar ven som terf rs ljare. Det g r att du hos oss kan hitta ver 500 unika titlar. Vi har ven tekniska rapporter, speci kationer och workshop agreement. Matriser r en versikt p standarder och handb cker som b r l sas tillsammans. De nns p sis.se och ger dig en bra bild ver hur olika produkter h r ihop. Standardiseringsprojekt Du kan p verka inneh llet i framtida standarder genom att delta i n gon av SIS ca 400 Tekniska Kommitt er. Find the right product and the type of delivery that suits you Standards By complying with current standards, you can make your work more e cient and ensure reliability. Also, several of the standards are often supplied in packages. Services Subscription is the service that keeps you up to date with current standards when changes occur in the ones you have chosen to subscribe to. is ensures that you are always working with the right edition. e-nav is our online service that gives you and your colleagues access to the standards you subscribe to 24 hours a day. With e-nav, the same standards can be used by several people at once. Type of delivery You choose how you want your standards delivered. We can supply them both on paper and as PDF les. Other products We have books that facilitate standards compliance. ey make it easier to understand how compliance works and how this bene ts you in your operation. We produce many publications of our own, and also act as retailers. is means that we have more than 500 unique titles for you to choose from. We also have technical reports, speci cations and workshop agreements. Matrices, listed at sis.se, provide an overview of which publications belong together. Standardisation project You can in uence the content of future standards by taking part in one or other of SIS s 400 or so Technical Committees.

3 Europastandarden EN ISO :2009 g ller som svensk standard. Detta dokument inneh ller den officiella engelska versionen av EN ISO :2009. Denna standard ers tter SS-EN ISO :2007, utg va 2. The European Standard EN ISO :2009 has the status of a Swedish Standard. This document contains the official English version of EN ISO :2009. This standard supersedes the Swedish Standard SS-EN ISO :2007, edition 2. Copyright/Upphovsr tten till denna produkt tillh r SIS, Swedish Standards Institute, Stockholm, Sverige. Anv ndningen av denna produkt regleras av slutanv ndarlicensen som ter nns i denna produkt, se standardens sista sidor. Copyright SIS, Swedish Standards Institute, Stockholm, Sweden. All rights reserved. The use of this product is governed by!the end-user licence for this product. You will nd the licence in the end of this document. Upplysningar om sakinneh llet i standarden l mnas av SIS, Swedish Standards Institute, telefon Standarder kan best llas hos SIS F rlag AB som ven l mnar allm nna upplysningar om svensk och utl ndsk standard. Information about the content of the standard is available from the Swedish Standards Institute (SIS), tel Standards may be ordered from SIS F rlag AB, who can also provide general information about Swedish and foreign standards. SIS F rlag AB, SE Stockholm, Sweden. Tel: Fax: sis.sales@sis.se Internet:

5 EUROPEAN STANDARD NORME EUROP ENNE EUROP ISCHE NORM EN ISO March 2009 ICS Supersedes EN ISO :2007 English Version Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO :2007) Th rapie respiratoire de l'apn e du sommeil - Partie 1: quipement de th rapie respiratoire de l'apn e du sommeil (ISO :2007) Schlafapnoe-Atemtherapie - Teil 1: Schlafapnoe- Atemtherapieger te (ISO :2007) This European Standard was approved by CEN on 24 February 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 COMIT EUROP EN DE NORMALISATION EUROP ISCHES KOMITEE F R NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO :2009: E

7 SS-EN ISO :2009 (E) ISO :2007(E) Contents Page Foreword... v Introduction... vi 1 * Scope Normative references Terms and definitions Requirements Classification and designation Marking, labelling and packaging Power input Basic safety categories Removable protective means Environmental conditions Not used Not used General Requirements related to classification Limitation of voltage and/or energy Enclosures and protective covers Separation Protective earthing, functional earthing and potential equalization Continuous leakage currents and patient auxiliary currents Dielectric strength Mechanical strength Moving parts Surfaces, corners and edges Stability in normal use Expelled parts * Vibration and noise Pneumatic and hydraulic power Suspended masses X-radiation Alpha, beta, gamma, neutron radiation and other particle radiation Microwave radiation Light radiation (including lasers) Infra-red radiation ISO 2007 All rights reserved iii

8 SS-EN ISO :2009 (E) ISO :2007(E) Provläsningsexemplar / Preview 34 Ultra-violet radiation Acoustical energy (including ultra-sonics) Electromagnetic compatibility Locations and basic requirements Marking, accompanying documents Common requirements for Category AP and Category APG equipment Requirements and tests for category AP equipment, parts and components thereof Requirements and tests for category APG equipment, parts and components thereof Excessive temperatures Fire prevention Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection Pressure vessels and parts subject to pressure Human errors Electrostatic charges Biocompatibility Interruption of the power supply Accuracy of operating data Protection against hazardous output Abnormal operation and fault conditions Environmental tests General Enclosures and covers Components and general assembly Mains parts, components and layout Protective earthing Terminals and connections Construction and layout Annex AA (informative) Rationale Annex BB (normative) * Pressure accuracy in normal use test methods Annex CC (normative) Maximum flowrate test method Annex DD (informative) Environmental aspects Annex EE (informative) Reference to the essential principles Annex FF (informative) Terminology Alphabetized index of defined terms Annex ZA (informative)...34 Bibliography iv ISO 2007 All rights reserved

9 SS-EN ISO :2009 (E) EN ISO :2009 (E) Foreword The text of ISO :2007 has been prepared by Technical Committee ISO/TC 121 Anaesthetic and respiratory equipment of the International Organization for Standardization (ISO) and has been taken over as EN ISO :2009 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 September 2009, and conflicting national standards shall be withdrawn at the latest by March Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO :2007. 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 EC Directive. For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document. 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 the United Kingdom. Endorsement notice The text of ISO :2007 has been approved by CEN as a EN ISO :2009 without any modification. 3

10 SS-EN ISO :2009 (E) ISO :2007(E) Provläsningsexemplar / Preview Introduction Sleep apnoea is the clinically significant intermittent absences of normal respiration occurring during sleep. The awareness of the risks associated with sleep apnoea has grown significantly in recent years. As a result, the use of sleep apnoea breathing therapy equipment has become common. This document covers basic safety and essential performance requirements needed to protect patients in the use of this equipment. This document is a Particular Standard based on IEC :1988, including Amendments 1 (1991) and 2 (1995), hereafter referred to as the General Standard. The General Standard is the basic document for the safety of medical electrical equipment used by or under the supervision of qualified personnel in the general medical and patient environment. It also contains certain requirements for reliable operation to ensure safety. The General Standard has associated Collateral Standards and Particular Standards. The Collateral Standards include requirements for specific technologies and/or hazards and apply to all applicable equipment, such as medical electrical systems, EMC, radiation protection in diagnostic X-ray equipment, software, etc. The Particular Standards apply to specific equipment types, such as medical electron accelerators, high frequency surgical equipment, hospital beds, etc. NOTE Definitions of Collateral Standard and Particular Standard can be found in IEC :1988, 1.5 and A.2, respectively. To facilitate the use of this document, the following drafting conventions have been applied. This document uses the same main clause titles and numbering as the General Standard, for ease of crossreferencing of the requirements. The changes to the text of the General Standard, as supplemented by the Collateral Standards, are specified by the use of the following words. Replacement means that the indicated clause or subclause of the General Standard is replaced completely by the text of this document. Addition means that the relevant text of this document is supplementary to the requirements of the General Standard. Amendment means that existing text of the General Standard is modified as indicated by the text of this document. To avoid confusion with any amendments to the General Standard itself, a particular numbering has been employed for elements added by this document: subclauses, tables and figures are numbered starting from 101; additional list items are lettered aa), bb), etc., and additional annexes are lettered AA, BB, etc. Throughout this document, text for which a rationale is provided in Annex AA is indicated by an asterisk (*). vi ISO 2007 All rights reserved

11 INTERNATIONAL STANDARD Provläsningsexemplar / Preview SS-EN ISO :2009 (E) ISO :2007(E) Sleep apnoea breathing therapy Part 1: Sleep apnoea breathing therapy equipment 1 * Scope IEC :1988, Clause 1 applies, except as follows. Amendment (add at the end of the Subclause 1.1): This part of ISO specifies requirements for equipment intended for sleep apnoea breathing therapy for domiciliary use, ships, aircraft and other transport vehicles and for use in healthcare institutions. This part of ISO applies to equipment intended for use with adults and children, and excludes equipment intended for use with neonates. Jet and very high frequency ventilation and oscillation are not considered in this part of ISO This part of ISO does not apply to equipment covered by the scope of the ISO series, including: ISO :2004; ISO :1997; ISO :2002; ISO :2006; ISO :2004. This part of ISO does not apply to equipment covered by the scope of IEC ISO covers sleep apnoea breathing therapy equipment for patient use. ISO applies to masks and accessories used to connect sleep apnoea breathing therapy equipment to the patient. See also Figure AA.1. 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. ISO 32, Gas cylinders Colour coding ISO 3744:1994, Acoustics Determination of sound power levels of noise sources using sound pressure Engineering method in an essentially free field over a reflecting plane ISO 2007 All rights reserved 1

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SVENSK STANDARD SS-EN 316:2009 Fastst lld/approved: 2009-03-11 Publicerad/Published: 2009-04-07 Utg va/edition: 3 Spr k/language: engelska/english ICS: 79.060.20 Tr fiberskivor Typer och beteckningar Wood