SIST EN 1422:2014
(Main)Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
EN 1422 specifies the requirements and the relevant tests for automatically controlled sterilizers employing ethylene oxide (EO) gas as the sterilant, either as a pure gas or a mixture with other gases, being used for the sterilization of medical devices and their accessories. This European Standard specifies requirements for ethylene oxide sterilizers (EO-sterilizers) working at super or sub-atmospheric pressure for: - the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices; - the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes. The test loads described in this European Standard are selected to represent a number of loads for the evaluation of the performance of EO sterilizers for medical devices. However, specific loads may require the use of other test loads.
Sterilisatoren für medizinische Zwecke - Ethylenoxid-Sterilisatoren - Anforderungen und Prüfverfahren
Diese Europäische Norm legt die Anforderungen und entsprechenden Prüfverfahren für automatisch gesteuerte Sterilisatoren fest, die EO entweder als reines Gas oder als Gas im Gemisch mit anderen Gasen, als Sterilisiermittel in Einrichtungen des Gesundheitswesens, Unternehmen für Medizinprodukte oder Unternehmen für Sterilisationsdienstleistungen zur Sterilisation von Medizinprodukten und Zubehör verwenden.
Diese Sterilisatoren eignen sich insbesondere für die Sterilisation von wärmeempfindlichen Medizinprodukten.
Diese Europäische Norm legt die Anforderungen an EO Sterilisatoren, die mit Über oder Unterdruck betrieben werden, fest hinsichtlich:
- der Leistungsfähigkeit und der Ausführung von Sterilisatoren, um sicherzustellen, dass sich das Verfahren zur Sterilisation von Medizinprodukten eignet;
- der Einrichtung und Steuerungen dieser Sterilisatoren, die für die Validierung und Lenkung der Anwendung der Sterilisationsverfahren erforderlich sind.
Die in dieser Europäischen Norm beschriebenen Prüfbeladungen werden stellvertretend für eine Anzahl von Beladungen zur Bewertung der Leistungsfähigkeit von EO Sterilisatoren für Medizinprodukte gewählt. Dennoch kann es bei bestimmten Beladungen erforderlich sein, andere Prüfbeladungen zu verwenden.
In der vorliegenden Europäischen Norm werden weder die Prüfungen zur Bestimmung der Wahrscheinlichkeit, dass ein behandeltes Produkt steril ist, noch die vor der Freigabe eines sterilen Produktes notwendigen routinemäßigen Qualitätsprüfungen festgelegt. Diese Themen werden in EN ISO 11135 1 behandelt.
In dieser Europäischen Norm werden keine Anforderungen an die Arbeitssicherheit im Zusammenhang mit der Ausführung und dem Betrieb von Einrichtungen zur EO-Sterilisation festgelegt.
ANMERKUNG Zu weiteren Informationen bezüglich der Sicherheit siehe die Beispiele in den Literaturhinweisen. Es können auch nationale oder regionale Regelungen bestehen.
Anforderungen zur Sicherheit werden in EN 61010 1, EN 61010 2 040 und in der Richtlinie 94/9/EG (ATEX) behandelt und in dieser Europäischen Norm nicht erneut genannt. Auch EN 60204 1 kann eine nützliche Anleitung bieten.
Bei der Planung und Ausführung von EO Sterilisatoren nach dieser Europäischen Norm sollten die vom Produkt während dessen Lebenszyklus ausgehenden Umweltauswirkungen berücksichtigt werden. Umweltgesichtspunkte werden in Anhang G behandelt.
Die vorliegende Europäische Norm ist nicht dazu vorgesehen, bei der Bewertung der Konformität mit EN ISO 11135 1 als eine Prüfliste für die Eignung eines vorhandenen EO Sterilisators zu dienen.
Diese Europäische Norm behandelt nicht die Sterilisation durch EO oder Gemische mit EO, das (die) direkt in einzelne Produktverpackungen eingeleitet wird (werden), weil diese Prozesse nicht gelenkt und validiert werden können.
Die vorliegende Europäischen Norm behandelt nicht die Risikoanalyse, die während der Ausführung eines EO Sterilisators durchzuführen ist. Es ist jedoch bekannt, dass es sich hierbei um einen wesentlichen Schritt bei der Ausführung eines Medizinproduktes handelt (siehe z. B. EN ISO 14971).
Stérilisateurs à usage médical - Stérilisateurs à l'oxyde d'éthylène - Exigences et méthodes d'essai
La présente Norme européenne énonce les exigences et essais relatifs aux stérilisateurs à commande automatisée employant de l’oxyde d’éthylène gazeux (OÉ) comme agent stérilisant – soit pur soit mélangé avec d’autres gaz – utilisés dans les centres de soins médicaux, chez les fabricants de dispositifs médicaux ou chez les sous-traitants qui stérilisent des dispositifs médicaux et leurs accessoires.
Ces stérilisateurs servent principalement à la stérilisation de dispositifs médicaux thermosensibles.
La présente Norme européenne spécifie les exigences relatives aux stérilisateurs à l'OÉ fonctionnant au-dessus ou au-dessous de la pression atmosphérique, concernant :
- leur performance et leur conception pour garantir que le procédé permette de stériliser des dispositifs médicaux ;
- l’équipement et les contrôles de ces stérilisateurs nécessaires à la validation et au contrôle de routine des procédés de stérilisation.
Les charges d’essais décrites dans la présente Norme européenne sont choisies pour représenter une palette de charges pour l’évaluation de la performance des stérilisateurs à OÉ pour dispositifs médicaux. Toutefois, des charges spéciales peuvent réclamer l’utilisation d’autres charges d’essai.
La présente Norme européenne ne spécifie pas les essais qui doivent être effectués pour déterminer la probabilité qu’un objet traité soit stérile, ni les essais de contrôle qualité de routine nécessaires avant de mettre sur le marché un objet stérile. Ces questions sont traitées dans l'EN ISO 11135-1.
La présente Norme européenne ne spécifie pas non plus d’exigences relatives à la sécurité du travail liée à la conception et au fonctionnement d’installations de stérilisation à l’OÉ.
NOTE 1 Pour plus de renseignements sur la sécurité, consulter les exemples de la bibliographie. Des réglementations nationales ou régionales peuvent également exister.
Les spécifications relatives à la sécurité sont traitées dans l’EN 61010-1, l’EN 61010-2-040 et la directive 94/9/CE (ATEX) et ne sont donc pas répétées dans la présente Norme européenne. L’EN 60204-1 peut également fournir des indications précieuses.
Il convient que la planification et la conception des produits voulus conformes à la présente Norme européenne tiennent compte de l'impact environnemental du produit pendant son cycle de vie. Les aspects environnementaux sont traités à l'Annexe G.
La présente Norme n'est pas destinée à servir de liste de contrôle pour déterminer l'acceptabilité d'un stérilisateur à l'OÉ existant lors de l'évaluation de sa conformité à l'EN ISO 11135-1.
La présente Norme européenne ne traite pas de la stérilisation par introduction d’OÉ ou de mélange contenant de l’OÉ directement dans des emballages individuels de produit car ces procédés ne peuvent être contrôlés et validés.
La présente Norme européenne ne traite pas non plus de l’analyse de risques à réaliser lors de la conception d’un stérilisateur à OÉ. Il est cependant reconnu qu’il s’agit là d’une étape essentielle de la conception d’un dispositif médical (voir par exemple l’EN ISO 14971).
Sterilizatorji za uporabo v medicini - Sterilizatorji z etilenoksidom - Zahteve in preskusne metode
Standard EN 1422 določa zahteve in ustrezne preskuse za samodejno nadzorovanje sterilizatorjev z etilenoksidom (EO), čistim plinom ali mešanico drugih plinov, ki se uporabljajo za sterilizacijo medicinskih pripomočkov in dodatne opreme. Ta evropski standard določa zahteve za sterilizatorje z etilenoksidom (sterilizatorji EO), ki delujejo v področju nad ali pod atmosferskim tlakom za: – delovanje in načrtovanje sterilizatorjev za sterilizacijo medicinskih pripomočkov; – opremo in kontrolnike teh sterilizatorjev, potrebnih za preverjanje in rutinski nadzor med postopkom sterilizacije. Preskusne obremenitve, opisane v tem evropskem standardu, so izbrane, da predstavljajo število obremenitev za ocenjevanje delovanja sterilizatorjev EO za medicinske pripomočke. Pri določenih obremenitvah je lahko potrebna uporaba drugih preskusnih obremenitev.
General Information
Relations
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Sterilizatorji za uporabo v medicini - Sterilizatorji z etilenoksidom - Zahteve in preskusne metodeSterilisatoren für medizinische Zwecke - Ethylenoxid-Sterilisatoren - Anforderungen und PrüfverfahrenStérilisateurs à usage médical - Stérilisateurs à l'oxyde d'éthylène - Exigences et méthodes d'essaiSterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods11.080.10Sterilizacijska opremaSterilizing equipmentICS:Ta slovenski standard je istoveten z:EN 1422:2014SIST EN 1422:2014en,fr,de01-oktober-2014SIST EN 1422:2014SLOVENSKI
STANDARDSIST EN 1422:2000+A1:20091DGRPHãþD
SIST EN 1422:2014
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 1422
May 2014 ICS 11.080.10 Supersedes EN 1422:1997+A1:2009English Version
Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
Stérilisateurs à usage médical - Stérilisateurs à l'oxyde d'éthylène - Exigences et méthodes d'essai
Sterilisatoren für medizinische Zwecke - Ethylenoxid-Sterilisatoren - Anforderungen und Prüfverfahren This European Standard was approved by CEN on 17 April 2014.
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-CENELEC 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-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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1422:2014 ESIST EN 1422:2014
EN 1422:2014 (E) 2
Contents Page Foreword . 4 Introduction . 5 1 Scope . 6 2 Normative references . 6 3 Terms and definitions . 7 4 Technical requirements . 12 4.1 General . 12 4.1.1 Risk control and usability . 12 4.1.2 Materials . 13 4.2 Sterilizer chamber . 13 4.2.1 Chamber size . 13 4.2.2 Doors, closures and interlocks of the sterilizer chamber . 13 4.2.3 Test connections . 14 4.3 Design and construction . 15 4.3.1 General . 15 4.3.2 EO vaporizers . 15 4.3.3 Pipework and fittings . 15 4.3.4 Evacuation system. 15 4.3.5 Control valves . 16 4.3.6 Thermal insulation . 16 4.3.7 Electrical and mechanical safety . 16 4.3.8 Air or inert gas filter . 16 4.3.9 Emission control . 16 4.3.10 Framework and panelling . 17 4.3.11 Loading equipment . 17 4.3.12 Transport . 17 4.4 Indicating, measuring, and recording instruments . 17 4.4.1 General . 17 4.4.2 Temperature sensor. 18 4.4.3 Temperature indicating instruments. 18 4.4.4 Pressure sensors . 19 4.4.5 Timers and time indicating instruments . 19 4.4.6 Sterilizing cycle counter . 19 4.4.7 Relative humidity (RH) sensors . 19 4.4.8 Ethylene Oxide (EO) concentration-measurement . 19 4.4.9 Recording instruments . 20 4.4.10 Indicating instruments . 21 5 Process control . 22 5.1 General . 22 5.2 Software verification and validation . 23 5.3 Sterilization cycle and automatic control . 23 5.3.1 Automatic control . 23 5.3.2 Sterilization cycle . 24 5.4 Override of automatic control . 27 5.5 Fault . 27 6 Performance requirements . 28 SIST EN 1422:2014
EN 1422:2014 (E) 3
6.1 Sterilizing performance . 28 6.1.1 Loading configuration . 28 6.1.2 Physical parameters . 28 6.1.3 Microbiological efficacy . 28 6.2 EO removal (flushing) . 29 6.3 Aeration . 29 7 Sound power . 29 8 Packaging, marking and labelling . 29 9 Information to be supplied by the manufacturer . 30 10 Service and local environment . 32 10.1 General . 32 10.2 Electricity . 33 10.3 Sterilant . 33 10.4 Circulation systems . 33 10.5 Steam . 33 10.6 Water . 34 10.7 Air and inert gasses . 34 10.8 Drainage and discharges . 34 10.9 Ventilation and environment . 34 10.10 Lighting . 34 Annex A (normative) Test instrumentation . 35 Annex B (normative) Leak test cycle . 36 Annex C (normative) Sterilizer chamber profile testing. 37 C.1 Sterilizer chamber internal surfaces . 37 C.2 Empty sterilizer chamber . 37 Annex D (normative) Microbiological test for EO sterilizers . 38 D.1 General . 38 D.2 Test equipment. 38 D.3 Procedure . 39 D.4 Interpretation of results . 40 Annex E (informative) Environmental aspects . 41 E.1 Environmental aspects regarding the life cycle of EO sterilizers . 41 E.2 EO (brief description) . 41 E.3 Environmental impact . 41 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices . 44 Bibliography . 48
SIST EN 1422:2014
EN 1422:2014 (E) 4
Foreword This document (EN 1422:2014) has been prepared 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 November 2014 and conflicting national standards shall be withdrawn at the latest by May 2017. 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 1422:1997+A1:2009. 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. For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. Annexes A, B, C and D are normative and form part of this European Standard. Annexes E and ZA are for information only. The standard is a full technical revision of the previous version. The following amendments have been made in comparison with EN 1422:1997+A1:2009: — new specification of the scope of the standard, e.g. explicit exclusion of sterilizers which employ the injection of EO or mixtures containing EO directly into packages or into a flexible chamber and removal of different types A and B of EO-sterilizers ; — normative references have been updated; — layout of the standard brought in line with the standard for LTSF-sterilization (EN 14180); — the additional requirements from the machinery directive, introduced by the revision of the medical devices directive 2007/47/EC have been addressed (see revised Annex ZA), i.e. update of technical requirements and Tables ZA.1 and ZA.2; — requirements have been rephrased to be performance requirements instead of design requirements; — addition of an environmental checklist; —
Annex B has been thoroughly revised and Annex D has been deleted. 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, 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 the United Kingdom. SIST EN 1422:2014
EN 1422:2014 (E) 5
Introduction Ethylene oxide (EO) sterilizers employing EO gas as the sterilant, either as a pure gas or in admixture with other gases, are primarily used for the sterilization of heat labile material or product. The EO-sterilizer specified in this European standard can be used for medical, dental, pharmaceutical veterinary and industrial or related purposes. The tests described in this European Standard are reference tests intended for use in demonstrating conformity with the performance requirements specified in this European Standard. They can be used in type tests, works tests, in validation and re-validation tests, or in periodic and routine tests carried out by the user. Validation and routine control of sterilization processes are essential to ensure their efficacy. This European Standard does not cover validation and routine control of EO processes (see prEN ISO 11135:2012). EO is a highly reactive chemical which can present a toxic, flammable or explosive hazard if incorrectly handled (see Annex E). 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. Planning and design of products complying with this standard should consider not only technical issues but also the environmental impact from the product during its life-cycle. Environmental aspects are addressed in Annex E of this standard. By performing tests concurrently and/or in a logical sequence, the total number of tests carried out and waste arising from such tests, is reduced. As a result the burden on the environment can be reduced (see also Annex E). SIST EN 1422:2014
EN 1422:2014 (E) 6
1 Scope This European Standard specifies the requirements and the relevant tests for automatically controlled sterilizers employing ethylene oxide (EO) gas as the sterilant, either as a pure gas or a mixture with other gases, being used for the sterilization of medical devices and their accessories. This European Standard specifies requirements for ethylene oxide sterilizers (EO-sterilizers) working at super or sub-atmospheric pressure for: — the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices; — the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes. The test loads described in this European Standard are selected to represent a number of loads for the evaluation of the performance of EO sterilizers for medical devices. However, specific loads may require the use of other test loads. This European Standard does not specify those tests which are necessary to determine the probability of a processed product being sterile, nor the routine quality control tests required prior to release of sterile product. These topics are addressed in prEN ISO 11135:2012. This European Standard does not specify requirements for occupational safety associated with the design and operation of EO sterilization facilities. NOTE 1 For further information on safety, see examples in the Bibliography. National or regional regulations can exist. This European Standard does not cover sterilizers which employ the injection of EO or mixtures containing EO directly into packages or into a flexible chamber. NOTE 2 See EN ISO 14937. This European Standard is not intended as a checklist for suitability of an existing EO sterilizer when assessing compliance with prEN ISO 11135:2012. This standard is not intended to be applied retrospectively. This European Standard does not cover analytical methods for determining levels of residual EO and/or its reaction products. NOTE 3 For further information see ISO 10993-7. 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 764-7, Pressure equipment - Part 7: Safety systems for unfired pressure equipment EN 868-4, Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods EN 868–5, Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods SIST EN 1422:2014
EN 1422:2014 (E) 7
EN 13445-3, Unfired pressure vessels - Part 3: Design EN 13445-5, Unfired pressure vessels - Part 5: Inspection and testing EN 14222, Stainless steel shell boilers EN 61010–1:2010, Safety requirements for electrical equipment for measurement, control and laboratory use — Part 1: General requirements (IEC 61010-1:2010) EN 61010-2-040:2005, 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 61010-2-040:2005) EN 61326-1:2006, Electrical equipment for measurement, control and laboratory use — EMC requirements — Part 1: General requirements (IEC 61326-1:2005) EN ISO 3746:2010, Acoustics - Determination of sound power levels and sound energy levels of noise sources using sound pressure - Survey method using an enveloping measurement surface over a reflecting plane (ISO 3746:2010) EN ISO 10993-7:2008, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008) prEN ISO 11135:2012, Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2012) EN ISO 11138-1, Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1) EN ISO 11138-2, Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2) EN ISO 11607-1, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1) EN ISO 14971:2012, Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 aeration part of the sterilization process during which ethylene oxide and/or its reaction products desorb from the medical device until predetermined levels are reached Note 1 to entry: This can be performed within the sterilizer and/or in a separate chamber or room. [SOURCE: prEN ISO 11135:2012, 3.1] SIST EN 1422:2014
EN 1422:2014 (E) 8
3.2 air admission stage stage of the cycle beginning with the attainment of the pre-set pressure on the last evacuation of the flushing stage or sterilant removal stage when filtered air is admitted to allow the chamber pressure to equilibrate with ambient pressure [SOURCE: ISO/TS 11139:2006, 2.48] 3.3 automatic controller programmed device that, in response to cycle parameters, operates the sterilizer sequentially through the operating cycle(s) 3.4 biological indicator test system containing viable microorganisms providing a defined resistance to a specified sterilization process [SOURCE: ISO/TS 11139:2006, 2.3] 3.5 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 11139:2006, 2.4] 3.6 conditioning treatment of product within the sterilization cycle, but prior to ethylene oxide admission, to attain a predetermined temperature and relative humidity Note 1 to entry: This part of the sterilization cycle can be carried out either at or above atmospheric pressure or under vacuum. 3.7 controlling regulating variables to specification 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 Note 1 to entry: Upon indication of “cycle complete” a further period of aeration of the processed load can be required. 3.9 ethylene oxide exposure time the period of the sterilization cycle between the end of EO injection and the beginning of EO removal 3.10 fault one or more of the process parameters lying outside of its/their specified tolerance(s) [SOURCE: ISO/TS 11139:2006, 2.19] SIST EN 1422:2014
EN 1422:2014 (E) 9
3.11 flushing stage of the sterilization cycle in which the ethylene oxide is removed from the load and free chamber space of the sterilization chamber Note 1 to entry: Flushing is also known as purging. 3.12 indicating displaying a value, fault or cycle stage 3.13 medical device any 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 —
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, 3.7] 3.14 monitoring checking against specifications 3.15 preconditioning treatment of product, prior to the sterilization cycle, in a room or chamber to attain specified limits for temperature and relative humidity [SOURCE: prEN ISO 11135:2012, 3.25] SIST EN 1422:2014
EN 1422:2014 (E) 10
3.16 process challenge device PCD item designed to constitute a defined resistance to a sterilization process and used to assess performance of the process [SOURCE: ISO/TS 11139:2006, 2.33] Note 1 to entry: The device is so constituted that a physical, biological or chemical indicator can be put in the place which is the most difficult to reach by sterilizing agent(s). Interference of the indicator with the function of the process challenge device is not acceptable. 3.17 process parameter specified value for a process variable [SOURCE: ISO/TS 11139:2006, 2.34] Note 1 to entry: The specification for a sterilization process includes the process parameters and their tolerances. 3.18 process temperature specified chamber temperature for the sterilization cycle 3.19 process variable condition within a sterilization process, changes in which alter microbicidal effectiveness [SOURCE: ISO/TS 11139:2006, 2.35] EXAMPLES Time, temperature, pressure, concentration, humidity. 3.20 recording collecting and storing data Note 1 to entry: Data storing can be realised electronically or by hard copy. 3.21 response time time required for a 90 % change in sensor output when exposed to a step change in the variable being measured 3.22 risk assessment overall process comprising a risk analysis and a risk evaluation [SOURCE: EN ISO 14971:2012, 2.18] 3.23 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, 2.19] SIST EN 1422:2014
EN 1422:2014 (E) 11
3.24 services supplies from an external source, needed for the function of equipment EXAMPLE Electricity, water, compressed air, drainage. [SOURCE: ISO/TS 11139:2006, 2.41] 3.25 sterile free from viable microorgan
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.