Sterilisering av medicintekniska produkter - Ångsterilisatorer - Stora

Transcription

1 Sterilisering av medicintekniska produkter - Ångsterilisatorer - Stora autoklaver SIS-remiss Remisstiden utgår: Remissen omfattar: pren 285 Sterilization - Steam sterilizers - Large sterilizers Sterilisering av medicintekniska produkter - Ångsterilisatorer - Stora autoklaver dokument/05. Remisshantering/5.1 Remisser under beredning/2013/ SIS 11025/Remiss11025.doc SIS, Swedish Standards Institute Postadress: STOCKHOLM Telefon: Telefax: Postal address: STOCKHOLM, Sweden Phone: Telefax: SIS is the Swedish member of ISO and CEN Besöksadress: Sankt Paulsgatan 6, Stockholm Organisationsnr: E-post: info@sis.se Office address: Sankt Paulsgatan 6, Stockholm V.A.T. No. SE info@sis.se

2 Sterilisering av medicintekniska produkter - Ångsterilisatorer - Stora autoklaver Ditt svar är viktigt Orientering Det är viktigt att svenska företag, myndigheter och andra organisationer får möjlighet att påverka hur standarderna är utformade. Dina synpunkter på standardförslaget bidrar till att testa riktigheten i den kommande standarden och genom ditt svar ökar också möjligheten att standarden kommer att bli använd och accepterad. SIS eftersträvar att miljöhänsyn tas i standardiseringsarbetet. Vi tar därför gärna emot dina synpunkter även när det gäller dessa frågor. Om du vill påverka innehållet i den kommande standarden ska du använda svarsblanketten som är bifogad. Den europeiska kommittén CEN/TC 102, i vilken Sverige aktivt deltar har utarbetat det förslag till Europastandard som presenteras i denna remiss. Förslaget knyter an till ett EU-direktiv. Det innebär att lagstiftningen inom EU är gemensam på det område som förslaget behandlar. Några svenska särkrav i form av tekniska föreskrifter från myndigheter får inte finnas. Något om förslaget Fastställd Europastandard, som utarbetats på uppdrag av EU-kommissionen, kommer även att fastställas som svensk standard. Den slutgiltiga standarden kan i vissa delar komma att avvika från förslaget beroende på den europeiska remissbehandlingen. Motstridande svensk standard upphävs när Europastandarden fastställs som svensk standard. Det är mycket viktigt att berörda svenska myndigheter besvarar denna remiss och klarlägger om förslaget är förenligt med den svenska lagstiftning som genomfört direktivet. Förslaget finns tillgängligt i engelsk, fransk och tysk språkversion. Här presenteras den engelska versionen. Svaren på denna remiss kommer att utgöra underlag för det svenska yttrandet. Kommentarerna ska vara på engelska. This European Standard specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules. The test loads described in this European Standard are selected to represent the majority of loads (i.e. wrapped goods consisting of metal, rubber and porous materials) for the evaluation of general purpose steam sterilizer for medical devices. However, specific loads (e. g. heavy metal objects or long and/or narrow lumen) will require the use of other test loads. Large steam sterilizers can also be used during the commercial production of medical devices. dokument/05. Remisshantering/5.1 Remisser under beredning/2013/ SIS 11025/Remiss11025.doc SIS, Swedish Standards Institute Postadress: STOCKHOLM Telefon: Telefax: Postal address: STOCKHOLM, Sweden Phone: Telefax: SIS is the Swedish member of ISO and CEN Besöksadress: Sankt Paulsgatan 6, Stockholm Organisationsnr: E-post: info@sis.se Office address: Sankt Paulsgatan 6, Stockholm V.A.T. No. SE info@sis.se

3 This European Standard does not specify requirements for equipment intended to use, contain or be exposed to flammable substances or substances which could cause combustion. This European Standard does not specify requirements for equipment intended to process pathogenic substances or human tissues. This European Standard applies to steam sterilizers designed to accommodate at least one sterilization module or having a chamber volume of at least 60 l. This European Standard does not describe a quality management system for the control of all stages of the manufacture of the sterilizer. NOTE Attention is drawn to the standards for quality management systems e. g. EN ISO Planning and design of sterilizers applying to this European Standard should consider the environmental impact from the product during its life cycle. Environmental aspects are addressed in Annex A. Översättning Svensk kommitté Frågor Beställning Pris Vilka får remissen? Svar på remissen Anvisningar för remissvar Den engelska texten föreslås ges ut som svensk standard utan översättning. Om ni anser att texten bör översättas ber vi er ange detta i ert svar. Samtidigt ber vi er då meddela om ni är beredda att bidra till de extra arbetsinsatser som en översättning skulle kräva. Synpunkter på föreslagen svensk titel tas tacksamt emot. Svaren på denna remiss kommer att behandlas av Sterilisering av medicintekniska produkter, SIS/TK 349, som är svensk referensgrupp för CEN/TC 102 Frågor kring remissen besvaras av Tuula Cammersand, SIS, telefon: , epost: tuula.cammersand@sis.se Förslaget kan beställas från Alexandra Antoni, SIS, telefon: , epost: alexandra.antoni@sis.se Pris för standardförslaget är 400 kronor exkl. moms Remissen har sänts ut till följande: SIS/TK 349, Remissgrupp 349 Besvara remissen genom att returnera bifogade svarsblankett, till tuula.cammersand@sis.se. Se anvisningar. Ett remissvar består av två delar: Svarsblankett (där du röstar ja eller nej till förslaget, eller avstår); Kommentarer. Om remissen innehåller flera standardförslag ska ett svar avges för varje ingående standardförslag. I svarsblanketten finns förberedda svarsalternativ för samtliga standardförslag. Så här fyller du i svarsblanketten "Avstår" om du inte är insatt i förslaget och dess konsekvenser eller om du inte har tid eller möjlighet att sätta dig in i förslaget.

4 "Tillstyrker utan kommentarer" om du anser att förslaget kan godtas som standard utan förändringar. "Tillstyrker med kommentarer" om du anser att förslaget kan godtas som standard, fast med de förändringar du angivit i dina kommentarer. "Avstyrker med motivering" om du anser att förslaget innehåller felaktigheter eller är olämpligt att godta som standard. Du ska ange en motivering till avstyrkandet och skälen ska vara av allvarligare karaktär. Ange om du/ni har erfarenhet inom den föreslagna standardens tillämpningsområde och om du/ni haft möjlighet att pröva förslagets tillämpning i er verksamhet. Kom gärna med synpunkter på den föreslagna svenska titeln Om du vill lämna kommentarer Så här fyller du i blanketten för kommentarer Fyll i medföljande blankett för kommentarer enligt anvisningarna nedan, Om standardförslaget är på engelska ska kommentarerna vara på engelska. Detta för att säkerställa en korrekt användning av fackuttryck. För att skapa en ny tabellrad ställer du markören i sista tabellcellen och trycker tab. ID Lämna blankt eller ange en kortform av er identitet som svarslämnare (t.ex. initialer, eller förkortning av företags-/organisationsnamn) Clause No./Subclause No./Annex (e.g. 3.1) För varje kommentar ges en referens till relevant avsnitt i standardförslaget. Paragraph/Figure/Table/Note (e.g. Table 1) Om möjligt preciseras relevant stycke, figurnr, tabellnr, not, eller dylikt i standardförslaget. Type of comment Varje kommentar kategoriseras med någon av förkortningarna te, ed, ge med följande innebörd: te: teknisk kommentar ed: redaktionell kommentar (editorial) ge: generell kommentar Comment (justification for change) Föreslagna ändringar motiveras/förklaras kortfattat. Proposed change För te- och ed-kommentarer ges entydiga förslag till ersättningstext, tillägg eller strykning, gärna enligt följande exempel:

5 Change shall to should. Add the text see enclosure. Remove the text see enclosure.

6 Template for comments and secretariat observations Date: pren 285 SIS-remiss Signatur 1 Line number Clause/ Subclause Paragraph/ Figure/ Table/ Type of comment 2 Comments Proposed change Observations of the secretariat Svar från: 1 Ange din signatur 2 Type of comment: ge = general te = technical ed = editorial ISO/IEC electronic balloting commenting template/version page 1 of 1

7 SVARSBLANKETT SIS-remiss (1) e-post: SIS Remissvar Tuula Cammersand STOCKHOLM SIS/TK 349, Sterilisering av medicintekniska produkter Svar på SIS-remiss avseende pren 285 Senaste svarsdatum Uppgifter om svarslämnaren Företag/Organisation/Myndighet Enskild person Företag/Organisation/Myndighet Handläggare (namn, telefon) Datum Remissvar Avstår Tillstyrker utan kommentarer Tillstyrker med kommentarer Avstyrker med motivering Har erfarenhet inom det område förslaget täcker Har tillämpat förslaget Ej berörd Kommentarer till föreslagen svensk titel SIS, Swedish Standards Institute SIS is the Swedish member of ISO and CEN Postadress: STOCKHOLM Besöksadress: Sankt Paulsgatan 6, Stockholm Organisationsnr: Telefon: Telefax: E-post: Postal address: STOCKHOLM, Sweden Office address: Sankt Paulsgatan 6, Stockholm V.A.T. No. SE Phone: Telefax: info@sis.se

8 EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM DRAFT pren 285 May 2013 ICS Will supersede EN 285:2006+A2:2009 English Version Sterilization - Steam sterilizers - Large sterilizers Stérilisation - Stérilisateurs à la vapeur d'eau - Grands stérilisateurs Sterilisation - Dampf-Sterilisatoren - Groß-Sterilisatoren This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee CEN/TC 102. If this draft becomes a European Standard, 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. This draft European Standard was established by CEN 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-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to provide supporting documentation. Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and shall not be referred to as a European Standard. EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. pren 285:2013: E

9 Contents Foreword...4 Introduction Scope Normative references Terms and definitions Mechanical components Process components Instrumentation, indicating and recording devices Control systems Performance requirements Sound power and vibration Rate of pressure change Safety, risk control and usability Packaging and marking Service and local environment Testing Hollow load test Thermometric tests Bowie and Dick test Air leakage test Air detector tests Load dryness test Steam quality test Dynamic sterilizer chamber pressure test Test apparatus, equipment and material Documentation to be supplied with the sterilizer Information to be supplied with the sterilizer Annex A (informative) Environmental aspects Annex B (informative) Steam supply: suggested maximum values of contaminants in feed water and condensate Annex C (informative) Temperature and time tolerances during the small load thermometric test Annex D (informative) Guidance for installation and operational qualification tests to be included in the instructions for use supplied with a sterilizer Annex E (informative) Criteria for identifying sterilizers as the same type Annex F (normative) Test procedures Page 2

10 Annex G (informative) Assessing hazards caused by door movement Annex H (normative) Additional requirements according to machinery function Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices Bibliography

11 Foreword This document (pren 285:2013) has been prepared by Technical Committee CEN/TC 102 Sterilizers for medical purposes, the secretariat of which is held by DIN. This document is currently submitted to the CEN Enquiry. This document will supersede EN 285:2006+A2:2009. 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 93/42/EEC, see informative Annex ZA, which is an integral part of this document. This document does not specify requirements for the validation and routine control of sterilization by moist heat. A European Standard specifying requirements for the validation and routine control of sterilization by moist heat was prepared by CEN/TC 204 "Sterilization of medical devices", see EN ISO The performance requirements specified in this document are not intended for the process to be effective in inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld-Jakob disease. However, some national regulations require the use of modified steam processes as part of a general prion decontamination programme. The standard is a full technical revision of the previous version. The following amendments have been made in comparison with EN 285:2006+A2:2009: scope was modified to differentiate small and large sterilizer by chamber size and to exclude equipment intended to use, contain or be exposed to flammable substances or substances which could cause combustion, and equipment intended to process pathogenic substances or human tissues; normative references and bibliography have been updated; terms and definitions improved, and new definitions added, e.g. "cycle parameter", "fault", "maintenance", "operating cycle stage", "process parameter", "process variable", "services", "sterilizer operator", "sterilization process", "validation"; new subclauses Protection at moving door, 4.5 Loading equipment, 4.6 Transport and 7.3 Software verification and validation added; requirements on sound power and vibration completely redrafted; requirements on safety, risk control and usability (clause 11) completely redrafted including reference to EN ISO 14971; requirements on packaging and marking (clause 12) revised and extended; requirements on service and local environment (clause 13) extended, e.g Lighting added, 13.7 Electromagnetic interference improved; sound power test deleted; 4

12 clauses on documentation to be supplied and information to be supplied by the manufacturer by the manufacturer revised and extended; Annex C on recommended material deleted; normative Annex F on test procedures added; informative Annex G on assessing hazards caused by door movement added; normative Annex H additional requirements according to machinery function added; Annex ZA including Table ZA.1 relationship with the Directive 93/42/EC on Medical Devices and Table ZA.2 relationship on Machinery Directive 2006/42/EC completely revised; editorial revision of whole document. 5

13 Introduction Conformity with the performance requirements for the test specified in this standard establishes a presumption pre-requisite for the definition of process parameters required by EN ISO :2006 for the sterilization of medical devices a sterilizer conforming to this European Standard is intended to process. 6

14 1 Scope This European Standard specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules. The test loads described in this European Standard are selected to represent the majority of loads (i.e. wrapped goods consisting of metal, rubber and porous materials) for the evaluation of general purpose steam sterilizer for medical devices. However, specific loads (e. g. heavy metal objects or long and/or narrow lumen) will require the use of other test loads. Large steam sterilizers can also be used during the commercial production of medical devices. This European Standard does not specify requirements for equipment intended to use, contain or be exposed to flammable substances or substances which could cause combustion. This European Standard does not specify requirements for equipment intended to process pathogenic substances or human tissues. This European Standard applies to steam sterilizers designed to accommodate at least one sterilization module or having a chamber volume of at least 60 l. This European Standard does not describe a quality management system for the control of all stages of the manufacture of the sterilizer. NOTE Attention is drawn to the standards for quality management systems e. g. EN ISO Planning and design of sterilizers applying to this European Standard should consider the environmental impact from the product during its life cycle. Environmental aspects are addressed in Annex A. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 764-1, Pressure equipment Part 1: Terminology Pressure, temperature, volume, nominal size EN 764-7:2002, Pressure equipment Part 7: Safety systems for unfired pressure equipment EN 867-5:2001, Non-biological systems for use in sterilizers Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S EN 1041, Information supplied by the manufacturer of medical devices EN :2009, High efficiency air filters (EPA, HEPA and ULPA) Part 1: Classification, performance testing, marking EN :2005, Stainless steels Part 2: Technical delivery conditions for sheet/plate and strip of corrosion resisting for general purposes EN :2005, Stainless steels Part 3: Technical delivery conditions for semi-finished products, bars, rods, wire, sections and bright products of corrosion resistant steels for general purposes EN (all parts), Shell boilers EN (all parts), Unfired pressure vessels EN :2009+A1:2011+A2:2011+A3:2011, Unfired pressure vessels Part 5: Inspection and testing EN 14222:2003, Stainless steel shell boilers 7

15 EN :1993, Thermocouples Part 2: tolerances (IEC : A1:1989) EN 60751:2008, Industrial platinum resistance thermometers and platinum temperature sensors (IEC 60751:2008) EN :2010, Safety requirements for electrical equipment for measurement, control and laboratory use Part 1: General requirements (IEC :2010) EN :2005, Safety requirements for electrical equipment for measurement, control and laboratory use Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials (IEC :2005) EN :2006, Electrical equipment for measurement, control and laboratory use EMC requirements Part 1: General requirements (IEC :2005) EN ISO 228-1:2003, Pipe threads where pressure-tight joints are not made on the threads Part 1: Dimensions, tolerances and designation (ISO 228-1:2000) EN ISO 3746:2010, Acoustics Determination of sound power levels of noise sources using sound pressure Survey method using an enveloping measurement surface over a reflecting plane (ISO 3746:2010) EN ISO 4017:2011, Hexagon head screws Product grades A and B (ISO 4017:2011) EN ISO 4871, Acoustics Declaration and verification of noise emission values of machinery and equipment (ISO 4871) EN ISO 10012, Measurement management systems Requirements for measurement processes and measuring equipment (ISO 10012) EN ISO , Sterilization of health care products Chemical indicators Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO ) EN ISO 12100:2010, Safety of machinery General principles for design Risk assessment and risk reduction (ISO 12100:2010) EN ISO 14971:2012, Medical devices Application of risk management to medical devices (ISO 14971:2007, Corrected version ) EN ISO , Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements (ISO ) 3 Terms and definitions For the purposes of this document, the terms and definitions given in EN and the following apply. NOTE Other definitions relevant to moist heat sterilization are given in EN ISO :2006, clause access device means used to permit access to restricted parts of the equipment Note 1 to entry: This can be by dedicated key, code or tool. 3.2 air removal removal of air from the sterilizer chamber and sterilizer load to facilitate steam penetration 8

16 3.3 automatic controller programmed device that, in response to cycle parameters, operates the sterilizer sequentially through the operating cycle(s) 3.4 calibration set of operations that establish, under specified conditions, the relationship between values of a quantity indicated by a measuring instrument or measuring system, or values represented by a material measure or a reference material, and the corresponding values realized by standards [SOURCE: ISO/TS 11139:2005, definition 2.4] 3.5 chamber depth depth of the sterilizer chamber which is available for the sterilizer load 3.6 chamber height height of the sterilizer chamber which is available for the sterilizer load 3.7 chamber width width of the sterilizer chamber which is available for the sterilizer load 3.8 cycle complete indication that the operating cycle has been completed according to programme and that the sterilized load is ready for removal from the sterilizer chamber 3.9 cycle parameter physical value including its tolerances used for control, monitoring, indication and recording of the operating cycle 3.10 double ended sterilizer sterilizer in which there is a door at each end of the sterilizer chamber 3.11 endpoint point of the observed change as defined by the manufacturer occurring after the indicator has been exposed to specified stated values [SOURCE: EN ISO :2009, definition 3.3] 3.12 environment surroundings in which an organization operates, including air, water, land, natural resources, flora, fauna, humans, and their interrelation Note 1 to entry: Surroundings in this context extend from within an organism to the global system. [SOURCE: EN ISO 14050:2010, definition 3.1] 9

17 3.13 equilibration time period which elapses between the attainment of the sterilization temperature at the reference measurement point and the attainment of the sterilization temperature at all points within the load [SOURCE: EN ISO :2006, definition 3.13, modified; replaced "reference measuring point" by "reference measurement point" and left out "sterilization" before load] Note 1 to entry: standard. For the purpose of EN 285 the term "sterilization load" applies to the test loads specified in this 3.14 fault <sterilization process> one or more of the process parameters lying outside of its/their specified tolerance(s) [SOURCE: ISO/TS 11139:2005, definition 2.19, modified: <sterilization process> has been added] 3.15 holding time period for which the temperatures at the reference measurement point and at all points within the load are continuously within the sterilization temperature band Note 1 to entry: The holding time follows immediately after the equilibration time. The extent of the holding time is related to the sterilization temperature installation qualification IQ process of obtaining and documenting evidence that equipment has been provided and installed in accordance with its specification [SOURCE: ISO/TS 11139:2005, definition 2.22] 3.17 loading door door in a double ended sterilizer through which the load is put into the sterilizer chamber 3.18 maintenance combination of all technical and associated administrative actions intended to retain an item at/or restore it to a state in which it can perform its specified function [SOURCE: EN ISO :2006, definition 3.22, modified: "required" replaced by "specified"] 3.19 medical device instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of or compensation for an injury, investigation, replacement, modification or support of the anatomy or of a physiological process, supporting or sustaining life, control of conception 10

18 disinfection of medical devices, providing information for medical purposes by means of in vitro examination of specimens derived from the human body, and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means [SOURCE: EN ISO 13485:2012, definition 3.7] 3.20 non-condensable gas air and other gas which will not liquefy under the conditions of saturated steam processes [SOURCE: EN ISO :2006, definition 3.27] 3.21 operating cycle number of operating cycle stages carried out sequentially 3.22 operating cycle stage part of the operating cycle with a specified function related to the process EXAMPLE Air removal stage, plateau period, drying stage and final air admission stage operational qualification OQ process of obtaining and documenting evidence that installed equipment operates within predetermined limits when used in accordance with its operational procedures [SOURCE: ISO/TS 11139:2005, definition 2.27] 3.24 plateau period equilibration time plus the holding time 3.25 pressure vessel vessel comprising the sterilizer chamber, jacket (if fitted), door(s) and components that are in permanent connection with the sterilizer chamber 3.26 process parameter specified value for a process variable Note 1 to entry: The specification for a sterilization process includes the process parameters and their tolerances. [SOURCE: ISO/TS 11139:2005, definition 2.34] 3.27 process variable condition within a sterilization process, changes in which alter microbicidal effectiveness EXAMPLE Time, temperature, pressure, concentration, humidity, wavelength. [SOURCE: ISO/TS 11139:2005, definition 2.35] 11

19 3.28 reference measurement point point where the temperature sensor used for the operating cycle control is located 3.29 reference standard standard, generally having the highest metrological quality available at a given location or in a given organization, from which measurements made there are derived [SOURCE: VIM:1993, definition 6.6] 3.30 risk assessment overall process comprising a risk analysis and a risk evaluation [SOURCE: EN ISO 14971:2012, definition 2.18] 3.31 risk control process through which decisions are reached and protective measures are implemented for reducing risks to, or maintaining risks within, specified levels [SOURCE: EN ISO 14971: 2012, definition 2.19] 3.32 saturated steam water vapour in a state of equilibrium between its liquid phase and its gas phase [SOURCE: EN ISO :2006, definition 3.44, modified: "condensation and evaporation" replaced by "its liquid phase and its gas phase"] 3.33 services supplies from an external source, needed for the function of equipment EXAMPLE Electricity, water, compressed air, drainage. [SOURCE: ISO/TS 11139:2005, definition 2.41] 3.34 sterile condition of a medical device that is free from viable microorganisms [EN 556-1:2001, definition 3.4] 3.35 sterilization validated process used to render a product free from viable microorganisms Note 1 to entry: For "free from viable microorganisms" see EN [SOURCE: ISO/TS 11139:2005, definition 2.47; modified: note deleted and Note 1 to entry has been added] 3.36 sterilization load defined quantity of items that are to be, or that have been, sterilized together 12

20 3.37 sterilization module rectangular parallelepiped of dimensions 300 mm (height) 600 mm (length) 300 mm (width) 3.38 sterilization process series of actions or operations needed to achieve the specified requirements for sterility Note 1 to entry: This series of actions includes pre-treatment of product (if necessary), exposure to the sterilizing agent under defined conditions and any necessary post treatment. The sterilization process does not include any cleaning, disinfection or packaging operations that precede sterilization. [SOURCE: ISO/TS 11139:2005, definition 2.49] 3.39 sterilization temperature minimum temperature on which the evaluation of the sterilization efficacy is based 3.40 sterilization temperature band temperature range the minimum of which is the sterilization temperature Note 1 to entry: These temperatures are usually stated in whole degrees Celsius sterilizer apparatus designed to deliver an operating cycle for the purpose of sterilization 3.42 sterilizer chamber part of the sterilizer which receives the sterilization load [SOURCE: EN ISO : 2006, definition 3.56] 3.43 sterilizer door lid or similar device provided as a means of closing and sealing the sterilizer chamber 3.44 sterilizer operator person operating equipment for its intended purpose 3.45 type test series of checks and tests for a particular design of sterilizer 3.46 unloading door door in a double ended sterilizer through which the load is removed from the sterilizer chamber 3.47 usable space space inside the sterilizer chamber which is not restricted by fixed parts and which is available to accept the sterilization load 13

21 3.48 validation <software> confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use are fulfilled [SOURCE: EN :2010, definition ; modified: <software> added] 3.49 validation <sterilization> documented procedure for obtaining, recording and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications [SOURCE: ISO/TS 11139:2005, definition 2.55; modified: <sterilization> added] 3.50 verification confirmation by examination and provision of objective evidence that the requirements have been fulfilled [SOURCE: EN :2010, definition ] 3.51 works test series of tests performed prior to delivery to demonstrate compliance of each apparatus with its specification [SOURCE: EN ISO :2009, definition 3.64, modified: washer-disinfector removed and apparatus added.] 4 Mechanical components 4.1 Dimensions The chamber volume shall be at least 60 l or the usable space within the sterilizer chamber shall accommodate one or more sterilization modules. 4.2 Materials Materials in contact with steam shall: resist attack from steam and condensate; not cause deterioration of the quality of the steam; not release any substances known to be toxic in such quantities that could create a health or environmental hazard. NOTE 1 Guidance on steam contaminants is given in Table B.2. NOTE 2 Because of the different types of sterilizers and the large number of uses, it is not possible to specify detailed requirements for materials for specific applications. 14

22 4.3 Pressure vessel General The pressure vessel shall comply with EN (all parts) The sterilizer door seal shall be a replaceable component. It shall be possible to inspect and clean the surface of the sterilizer door seal which comes into contact with the sealing faces without the need to dismantle the sterilizer door assembly. NOTE Personnel protective equipment can be needed if the adjacent surface is hot Systems shall be provided to permit the removal of persons or objects entrapped by the moving sterilizer door before the pressure, force and temperature specified in EN :2010, and 10.1 are exceeded. NOTE This can be achieved, e.g. by reversing the direction of the sterilizer door movement After closing the sterilizer door, it shall be possible to open it before an operating cycle has been started It shall not be possible to open a sterilizer door(s) during a cycle Double ended sterilizers Except for maintenance purposes it shall not be possible for more than one sterilizer door to be open at one time It shall not be possible to open the unloading door until a cycle complete indication is obtained It shall not be possible to open the unloading door if a Bowie and Dick cycle or an air leakage test has been carried out (see and ) The control used to start the operating cycle shall be located at the loading side of the sterilizer Test connections The connections as required by and shall be provided. The test connection for pressure test and temperature test as shown in Figure 1 and Figure 2 may be provided as a combined detachable adapter A test connection in accordance with Figure 1 shall be fitted to the sterilizer chamber or in a pipe which is in direct connection with the sterilizer chamber providing it causes no adverse effect on the measurement of the pressure in the sterilizer chamber. The test connection which is used for the connection of a test instrument shall be provided with a cap, marked PT (pressure test) and sealed with either an O-ringseal or a flat seal. 15

23 Dimensions in millimetres Key a Pipe thread ISO 228-G 1/2 A Figure 1 Connection for test instruments A straight connecting sleeve, in accordance with Figure 2, shall be provided at a point of easy access in order to pass flexible cords to the temperature sensors. Dimensions in millimetres Key a Pipe thread ISO 228-G 1/2 A Figure 2 Connection sleeve for thermo elements The connecting sleeve with its O-ring-seal or flat seal shall be closed with a cap, and a temperature proof and mechanically resistant soft packing. The cap shall be marked with the letters TT (temperature test) Test tee(s) and valve cock(s) with sealing plug(s) shall be fitted to permit connection of reference instruments for the calibration of all pressure instruments, connected to the sterilizer chamber and jacket (see and 6.1.4) Insulating material Except where insulation would interfere with the function and operation of the sterilizer, external surfaces of the pressure vessel shall be insulated to reduce heat transmission to the environment [see 25.2 g) and h)] 16

24 4.4 Framework and panelling Where sides of the sterilizer are visible to the sterilizer operator when the sterilizer door(s) is/are closed, they shall be enclosed with panelling. The panelling shall be corrosion-resistant to cleaning agents and local environmental conditions. Removal or opening of panel used as a physical barrier to provide protection (guard) shall require the use of an access device The panelling of the sterilizer shall allow access for maintenance work. Such panelling shall be demountable or the dimensions of any personal access shall be not less than 500 mm wide and not less than mm high, and the access shall not be obstructed. Fixings for these panels shall remain attached to either the panels or to the body of the sterilizer when panels are removed. If the pressure equipment is housed in a frame, this frame shall not promote corrosion of the equipment. The access for maintenance shall be positioned so that it will not compromise the safety of persons and the integrity of sterilized products The panelling shall be designed to provide a continuous contact with the surfaces of the building in which it is installed when these surfaces are within the tolerances given in Tables 1 and 2. Sterilizers designed for incorporation into existing buildings, or purpose built rooms shall provide a continuous joint with adjacent surfaces when these are within the limits given in Tables 1 and 2. Table 1 Tolerances for the aperture into which the sterilizer is installed Dimension m Horizontal plane Tolerance mm Vertical plane up to 3 ± 12 ± 16 above 3 to 6 ± 16 ± 16 above 6 to 15 ± 24 ± 20 above 15 to 30 ± 24 ± 20 above 30 ± 30 ± 30 17

25 Table 2 Deviation from vertical and horizontal flatness and alignment Distance between checkpoints m Finished surfaces of walls and ceilings Deviation mm Finished floor (bearing surface) 0, Loading equipment If required for ergonomic reasons, loading equipment shall be available as a separate accessory to the sterilizer. NOTE Loading equipment is not specified in this standard. 4.6 Transport Where the weight, size or shape of the sterilizer or its various component parts prevents them from being moved by hand, the sterilizer, or each component part must either be fitted with attachments for lifting gear, or be designed so that it can be fitted with such attachments, or be shaped in such a way that standard lifting gear can easily be attached. The sterilizer and it s components (if applicable) shall be packed for transportation and storage in a way that, when handled or transported, all parts of the sterilizer shall remain in their position and orientation so that the sterilizer remains stable and no moving part can cause a hazard. 5 Process components 5.1 Pipework and fittings Pipe joints and fittings shall be both pressure-tight and vacuum-tight Except where this will interfere with the function of the sterilizer the pipework for steam or water at a temperature greater than 60 C shall be thermally insulated to reduce heat transmission to the environment [see also 25.2 g) and h)]. To reduce the formation of condensation cold water pipework should be insulated Means shall be provided to prevent the ingress of particulates of a size and quantity which could affect the performance of a sterilizer. Strainers of a relevant pore size may be used. 18

26 5.2 Steam source General A sterilizer can be operated with steam from an external supply, or generated solely for the sterilizer or a group of sterilizers, or generated from within the sterilizer chamber Steam supply from a dedicated steam generator Shell boilers shall comply with EN or applicable parts of EN series The feed water inlet shall be designed to prevent back-syphoning into the feed water system The power requirements and the capacity of the steam generator shall be sufficient to ensure that the steam demand specified for the sterilizer can be met Steam supply from a central source The quality and quantity of the steam to be supplied for use with the sterilizer shall be specified [see 25.2 c)]. NOTE Table B.2 provides guidance on condensate derived from the steam. 5.3 Air filter Where the operating cycle requires the admission of air into the sterilizer chamber after the plateau period, the air shall be admitted through a filter. Air filters should be constructed from material resistant to corrosion and biodegradation. The filter material should be supported in a manner which prevents damage to the filter medium The filter shall comply with class H 14 in accordance with EN :2009, clause 5 or better and the most penetrating particle size shall be 0,3 µm or smaller The filter unit shall be accessible, replaceable and mounted externally to the sterilizer chamber in such a manner that the filter material is kept dry Means shall be provided to prevent the penetration of steam, water and/or condensate from the sterilizer chamber into the filter. 5.4 Vacuum system A vacuum system shall be used for air removal and drying. 6 Instrumentation, indicating and recording devices 6.1 Equipment General All instruments and indicating devices specified in clause 6 shall be located in a position where they can be readily viewed by the sterilizer operator under normal operation of the sterilizer and their function shall be identified Unless otherwise specified instruments and gauges shall be readable by normal or corrected vision from a distance of (1,00 ± 0,15) m and with a minimum external illumination of (215 ± 15) lx. 19

27 Each instrument and gauge shall be located in a manner that ensures that the maximum and minimum values of temperature and humidity specified for the instrument and gauge are not exceeded during normal operation Instruments Sterilizers shall be provided with at least the following instruments: a) sterilizer chamber temperature indicating instrument; b) sterilizer chamber temperature recorder; c) sterilizer chamber pressure indicating instrument; d) sterilizer chamber pressure recorder; e) jacket pressure indicating instrument (if the sterilizer is fitted with a jacket intended to be pressurized); f) steam pressure gauge (if a steam generator is incorporated within the sterilizer panelling). Items b) and d) may be incorporated into a single recording system. The instruments a), c), e) and f) may be incorporated into a system whereby the display of any measurement may be selected by the user. NOTE Safety standards can require additional instruments and indicating devices Indicating devices Sterilizers shall be provided with at least the following indicating devices: a) visual display indicating "sterilizer door(s) locked"; b) visual display indicating "in progress"; c) visual display indicating "cycle complete"; d) visual display indicating "fault" (see 7.2); e) indication of the operating cycle selected; f) operating cycle counter; g) operating cycle stage indication. The operating cycle stage indication may incorporate items a), b) and c) The cycle complete indication shall be cancelled when the sterilizer door opening has been initiated Double ended sterilizer Both ends of the sterilizer shall be provided with at least: a) sterilizer chamber pressure indicating instrument; b) visual display indicating "sterilizer doors locked"; 20

28 c) visual display indicating "in progress"; d) visual display indicating "cycle complete"; e) visual display indicating "fault" (see 7.2). 6.2 Sensors, indicating instruments and time equipment Temperature Temperature sensors Temperature sensors shall be either platinum resistance types complying with Class A of EN 60751:2008, Table 3 or thermocouples complying with one of the tables specified in Tolerance Class 1 of EN :1993, Table 1. NOTE Other sensors of demonstrated equivalence can be used. The temperature sensor shall have a response time τ 90 5 s when tested in water. At least two independent temperature sensors shall be provided. These sensors shall be connected to the sterilizer chamber temperature indicating instrument, temperature recorder and temperature controller as indicated in Figure 3 a) or b). The arrangement illustrated in Figure 3 c) and d) shall not be permitted. 21

29 Sterilizer chamber temperature indicating instrument Key 1 sterilizer chamber Temperature recorder Control and/or monitoring of plateau period by temperature Figure 3 Recommended arrangement of temperature sensors The sensor used for the control of the operating cycle and for the indication and also the sensor used to record the operating cycle shall be located at the point identified as the reference measurement point [see and 25.3 f) 6 th dash] Moveable temperature sensors inside sterilizers Where a moveable temperature sensor and its wiring is located inside the sterilizer chamber, it shall be temperature resistant as well as pressure-tight, vacuum-tight and steam-tight. 22

30 Sterilizer chamber temperature indicating instrument The sterilizer chamber temperature indicating instrument shall: a) be either digital or analogue; b) be graduated in degrees Celsius; c) have a scale which includes the range 50 C to 150 C; d) have an accuracy of ± 1 % or better over the scale range 50 C to 150 C; e) for analogue instruments be graduated in divisions not greater than 2 C; f) for digital instruments have a resolution of 0,1 C or better; g) be adjusted to an accuracy of ± 0,5 C or better at the sterilization temperature; h) have an ambient temperature error compensation not exceeding 0,04 K/K; i) have means to adjust in situ by the use of an access device without dismantling the instrument Pressure The sterilizer chamber pressure indicating instrument shall: a) be either digital or analogue; b) be graduated in kilopascals or bars; c) have a scale which includes the range 0 kpa to 400 kpa or - 1 bar to 3 bar with a zero reading at absolute vacuum or ambient pressure respectively; d) have an accuracy of ± 1,6 % or better over the scale range 0 kpa to 400 kpa (- 1 bar to 3 bar); e) for analogue instruments be graduated in divisions not greater than 20 kpa (0,2 bar); f) for digital instruments have a resolution of 1 kpa (0,01 bar) or better; g) be adjusted to an accuracy of ± 5 kpa (± 0,05 bar) or better at the operating pressure; h) have an ambient temperature error compensation not exceeding 0,04 %/K over the scale range 0 kpa to 400 kpa (- 1 bar to 3 bar); i) have means to adjust in situ by the use of an access device without dismantling the instrument Time indicating equipment If time indicators are fitted they shall: a) be graduated in hours, minutes and seconds as applicable; b) have an error not exceeding 1 %. 23

31 6.3 Records and recorders General The recorder shall be either analogue or digital The recorder shall be independent such that the series of elements of a measuring instrument or measuring system that constitutes the path of the measurement signal from the input (quantity subject to measurement) to the output (the result of the measurement), including value data processing or printed values, are separate from the automatic controller. This does not exclude the transfer of informative data from the automatic controller to the recorder and vice versa, via a combined system for data transfer Records shall include the values for the pressure transition points throughout the operating cycle. The printing of data shall be sufficient to confirm that the cycle parameters have been attained and maintained within the permitted tolerances throughout the operating cycle (see also clause 8). Examples are illustrated in Figure 4 and Table The recorder shall produce a record which shall be readable as defined in when stored in defined conditions for a period of not less than 11 years Records shall be readable when viewed at a distance of (250 ± 25) mm with normal or corrected vision in an illumination of (215 ± 15) lx If times are marked, units shall be either in seconds or minutes or multiples thereof. Time periods up to 5 min shall have an accuracy of ± 2,5 % or better and for periods above 5 min of ± 1 % or better Means shall be provided to adjust the recorder in situ by the use of an access device Recorders producing analogue records Chart speed Recorders producing analogue records shall have a chart speed of not less than 4 mm/min Temperature Temperature recorders producing analogue records shall: a) have a chart graduated in degrees Celsius; b) have a scale which includes the range 50 C to 150 C; c) have an accuracy of ± 1 % or better over the scale range 50 C to 150 C; d) have a chart with graduated divisions not greater than 2 C; e) have a resolution of 1 C or better; f) be adjusted to an accuracy of ± 1 C or better at the sterilization temperature; g) have a sampling rate for each channel of 2,5 s or better. 24

32 Pressure Pressure recorders producing analogue records shall: a) have a chart graduated in kilopascals or bars; b) have a scale which includes the range 0 kpa to 400 kpa or - 1 bar to 3 bar with a zero reading at absolute vacuum or ambient pressure respectively; c) have an accuracy of ± 1,6 % or better over the scale range 0 kpa to 400 kpa (- 1 bar to 3 bar); d) have a chart graduated in divisions not greater than 20 kpa (0,2 bar); e) have a resolution of 5 kpa (0,05 bar) or better; f) be adjusted to an accuracy of ± 5 kpa (± 0,05 bar) or better at the operating pressure; g) have a sampling rate for each channel of 1 s or better Recorders producing digital records Temperature Temperature recorders producing digital records shall: a) have alphanumeric characters; b) have data defined by text; c) have a range which includes 50 C to 150 C; d) have a resolution of 0,1 C or better; e) have an accuracy of ± 1 % or better over the range 50 C to 150 C; f) have a paper width which has a space for a minimum of 15 characters/line; g) have a sampling rate for each channel of 2,5 s or better Pressure Pressure recorders producing digital records shall: a) have alphanumeric characters; b) have data defined by text; c) have a range which includes 0 kpa to 400 kpa (- 1 bar to 3 bar); d) have a resolution of 1 kpa (0,01 bar) or better; e) have an accuracy of ± 1,6 % or better over the range 0 kpa to 400 kpa (- 1 bar to 3 bar); f) have a paper width which has a space for a minimum of 15 characters/line; g) have a sampling rate for each channel of 1 s or better. 25