Disk- och spoldesinfektorer Del 1: Allmänna krav, termer, definitioner och provningsmetoder (ISO :2006)

Size: px

Start display at page:

Download "Disk- och spoldesinfektorer Del 1: Allmänna krav, termer, definitioner och provningsmetoder (ISO :2006)"

Florence Owen
5 years ago
Views:

1 SVENSK STANDARD SS-EN ISO :2009 Fastställd/Approved: Publicerad/Published: Utgåva/Edition: 2 Språk/Language: engelska/english ICS: ; Disk- och spoldesinfektorer Del 1: Allmänna krav, termer, definitioner och provningsmetoder (ISO :2006) Washer-disinfectors Part 1: General requirements, terms and definitions and tests (ISO :2006) SWEDISH STANDARDS INSTITUTE

2 Hitta rätt produkt och ett leveranssätt som passar dig Standarder Genom att följa gällande standard både e ektiviserar och säkrar du ditt arbete. Många standarder ingår dessutom ofta i paket. Tjänster Abonnemang är tjänsten där vi uppdaterar dig med aktuella standarder när förändringar sker på dem du valt att abonnera på. På så sätt är du säker på att du alltid arbetar efter rätt utgåva. e-nav är vår online-tjänst som ger dig och dina kollegor tillgång till standarder ni valt att abonnera på dygnet runt. Med e-nav kan samma standard användas av era personer samtidigt. Leveranssätt Du väljer hur du vill ha dina standarder levererade. Vi kan erbjuda dig dem på papper och som pdf. Andra produkter Vi har böcker som underlättar arbetet att följa en standard. Med våra böcker får du ökad förståelse för hur standarder ska följas och vilka fördelar den ger dig i ditt arbete. Vi tar fram många egna publikationer och fungerar även som återförsäljare. Det gör att du hos oss kan hitta över 500 unika titlar. Vi har även tekniska rapporter, speci kationer och workshop agreement. Matriser är en översikt på standarder och handböcker som bör läsas tillsammans. De nns på sis.se och ger dig en bra bild över hur olika produkter hör ihop. Standardiseringsprojekt Du kan påverka innehållet i framtida standarder genom att delta i någon av SIS ca 400 Tekniska Kommittéer. 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 gäller som svensk standard. Detta dokument innehåller den officiella engelska versionen av EN ISO :2009. Denna standard ersätter SS-EN ISO :2006, utgåva 1. 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 :2006, edition 1. Copyright/Upphovsrätten till denna produkt tillhör SIS, Swedish Standards Institute, Stockholm, Sverige. Användningen av denna produkt regleras av slutanvändarlicensen som åter 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 sakinnehållet i standarden lämnas av SIS, Swedish Standards Institute, telefon Standarder kan beställas hos SIS Förlag AB som även lämnar allmänna upplysningar om svensk och utländsk standard. Information about the content of the standard is available from the Swedish Standards Institute (SIS), tel Standards may be ordered from SIS Förlag AB, who can also provide general information about Swedish and foreign standards. SIS Förlag AB, SE Stockholm, Sweden. Tel: Fax: sis.sales@sis.se Internet:

5 EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM EN ISO June 2009 ICS Supersedes EN ISO :2006 English Version Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO :2006) Laveurs désinfecteurs - Partie 1: Exigences générales, termes et définitions et essais (ISO :2006) Reinigungs-Desinfektionsgeräte - Teil 1: Allgemeine Anforderungen, Begriffe und Prüfverfahren (ISO :2006) This European Standard was approved by CEN on 16 May 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: 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

6 SS-EN ISO :2009 (E) Provläsningsexemplar / Preview ISO :2006(E) Contents Page Foreword... v Introduction... vi 1 Scope Normative references Terms and definitions Performance requirements General Cleaning Disinfection Rinsing Drying Process chemicals Mechanical and process requirements Materials, design and manufacture/construction Safety Calorifiers and tanks Loading and unloading doors and their controls Pipework and fittings Spray systems Dosing systems Load temperature protection Process temperature control limits Switches, gauges and indicating devices Process verification Instrumentation and controls Temperature indicating systems Pressure indicating systems Timing equipment Operating cycle indicating equipment Recording instruments (if fitted) Control systems Override of automatic control Microprocessor control systems Access to software Fault indication systems Water supply Venting and drainage systems Drainage Air filters installed within the WD Load handling and supports for use within the WD Trolleys Environment Testing for conformity General Test equipment Tests on doors, interlocks and fault indications Tests on water quality and water volume Tests on pipework Tests on instrumentation fitted to the WD iii ISO 2006 All rights reserved iii

7 ISO :2006(E) Provläsningsexemplar / Preview SS-EN ISO :2009 (E) 6.7 Tests on load carriers Thermometric tests Chemical dosing tests Tests of cleaning efficacy Tests of air quality Load dryness test Automatic control test Documentation Information to be supplied by the manufacturer General Before delivery of the WD and for installation At delivery of the WD Marking, labelling and packaging Marking and labelling Packaging Information to be requested from the purchaser by the supplier of the WD Annex A (informative) Test programme Annex B (informative) A 0 concept Comparative lethality of moist heat processes Annex C (normative) Test methods for the detection and assessment of residual proteinaceous contamination Annex D (normative) Microbiological recovery medium for estimation of bacterial contamination of water Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC...69 Bibliography...74 iv ISO 2006 All rights reserved iv

8 SS-EN ISO :2009 (E) Provläsningsexemplar / Preview EN ISO :2009 (E) Foreword The text of ISO :2006 has been prepared by Technical Committee ISO/TC 198 Sterilization of health care products of the International Organization for Standardization (ISO) and has been taken over as EN ISO :2009 by Technical Committee CEN/TC 102 Sterilizers for medical purposes the secretariat of which is held by DIN. 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 December 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 :2006. 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 :2006 has been approved by CEN as a EN ISO :2009 without any modification. v 3

9 ISO :2006(E) Provläsningsexemplar / Preview SS-EN ISO :2009 (E) Introduction This part of ISO is the first of a series of standards specifying the performance of washer-disinfectors and specifies the general requirements for performance applicable to all washer-disinfectors. The requirements given in this part of ISO are applicable to all washer-disinfectors specified in subsequent parts of the ISO series, except insofar as they may be modified or added to by a subsequent part, in which case the requirements of that particular part will apply. Fields of application within the scope of ISO series include laboratory, veterinary, dental and pharmaceutical applications and other specific applications, such as washer-disinfectors for bedsteads and transport carts and the disinfection of crockery and cutlery intended for use with immunologically compromised patients. Washer-disinfectors should be used only for processing the type of loads specified by the manufacturer of the washer-disinfector. In selecting the appropriate washer-disinfector, reference should be made both to this part of ISO and to the relevant subsequent parts of ISO series. It is the user s responsibility to ensure that the choice of type of washer-disinfector, operating cycle or quality of services or process chemicals is appropriate for any particular load. Safety requirements for washer-disinfectors are given in IEC This part of ISO has been prepared on the basis that each individual washer-disinfector will be subject to validation tests (commissioning and performance qualification on first installation) and that in use continued compliance will be established by periodic tests carried out by, or on behalf of, the user. Verification of cleaning efficacy is a key aspect of establishing satisfactory performance of a washerdisinfector. The current state of knowledge has not permitted development of a single test method. As an interim measure reference has been made to test methods which are currently being applied in a number of different countries. The specification for these test methods including their test soils can be found in ISO/TS It remains the intention of the Technical Committee of TC 198 to develop a single test method. In respect of the potential adverse effects on the quality of water intended for human consumption caused by the washer-disinfector: a) it should be noted that, until verifiable European criteria are adopted, existing national regulations concerning the use and/or the characteristics of the washer-disinfector remain in force; b) the ISO series of standards provides no information as to whether the washer-disinfector may be used without restrictions in any of the member states of the EU or EFTA. vi ISO 2006 All rights reserved vi

11 SS-EN ISO :2009 (E) Washer-disinfectors Part 1: General requirements, terms and definitions and tests 1 Scope This part of ISO specifies general performance requirements for washer-disinfectors (WD) and their accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice. It specifies performance requirements for cleaning and disinfection as well as for the accessories which can be required to achieve the necessary performance. The methods and instrumentation required for validation, routine control and monitoring and re-validation, periodically and after essential repairs, are also specified. The requirements for washer-disinfectors intended to process specific loads are specified in subsequent parts of this standard. For washer-disinfectors intended to process loads of two or more different types the requirements of all relevant parts of this standard apply. This part of ISO does not specify requirements intended for machines for use for laundry or general catering purposes. This part of ISO does not include requirements for machines which are intended to sterilize the load, or which are designated as sterilizers, these are specified in other standards e.g. EN 285. The specified performance requirements of this standard may not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies. NOTE If it is considered that prion protein can be present, particular care is needed in the choice of disinfectants and cleaning agents to ensure that the chemicals used do not react with the prion protein in a manner that may inhibit its removal or inactivation. This part of ISO may be used by prospective purchasers and manufacturers as the basis of agreement on the specification of a WD. The test methods for demonstration of compliance with the requirements of this part of ISO may also be employed by users to demonstrate continued compliance of the installed WD throughout its working life. Guidance on a routine test programme is given in Annex A. 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 228-1, Pipe threads where pressure-tight joints are not made on the threads Part 1: Dimensions, tolerances and designation ISO 7000, Graphical symbols for use on equipment Index and synopsis ISO 2006 All rights reserved 1

Skorstenar Krav för metallskorstenar Del 1: Systemskorstenar. Chimneys Requirements for metal chimneys Part 1: System chimney products

SVENSK STANDARD SS-EN 1856-1:2009 Fastställd/Approved: 2009-06-15 Publicerad/Published: 2009-08-18 Utgåva/Edition: 2 Språk/Language: engelska/english ICS: 91.060.40 Skorstenar Krav för metallskorstenar