EN 1422:1997
(Main)Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
This European standard specifies the minimum performance requirements and test methods of two types of sterilizers employing ethylene oxide gas as the sterilant, either as a pure gas or in admixture with other gases (whether supplied ready mixed or mixed at the point of use) in a temporarily sealed chamber. These sterilizers are intended to be used for medical, dental, pharmaceutical, veterinary and industrial or related purposes.
Sterilisatoren für medizinische Zwecke - Ethylenoxid-Sterilisatoren - Anforderungen und Prüfverfahren
Diese Europäische Norm legt Mindestleistungsanforderungen und Prüfverfahren an zwei Typen von Sterilisatoren fest, die Ethylenoxid, entweder als reines Gas oder als Gas im Gemisch mit anderen Gasen, als Sterilisiermittel verwenden (dabei kann das Gemisch in fertigem Zustand geliefert oder erst am Einsatzort hergestellt werden). Diese Sterilisatoren dienen zum Einsatz in der Allgemeinen-, Zahn- oder Tiermedizin, in der Pharmazie, der Industrie oder zu anderen verwandten Zwecken.
Stérilisateurs à usage médical - Stérilisateurs à l'oxyde d'éthylène - Exigences et méthodes d'essai
La présente norme européenne spécifie les exigences minimales de fonctionnement et les méthodes d'essai applicables à deux types de stérilisateurs employant de l'oxyde d'éthylène comme agent stérilisant, soit sous forme de gaz pur, soit mélangé à d'autres gaz (que l'agent stérilisant soit déjà mélangé lorsqu'il est livré ou qu'il soit mélangé sur place avant utilisation) dans une chambre hermétiquement close de façon temporaire. Ces stérilisateurs sont destinés à être utilisés à des fins médicales, dentaires, pharmaceutiques, vétérinaires et industrielles ou à des fins connexes.
Sterilizatorji za uporabo v medicini - Sterilizatorji z etilenoksidom - Zahteve in preskusne metode
General Information
- Status
- Withdrawn
- Publication Date
- 16-Sep-1997
- Withdrawal Date
- 12-May-2009
- Technical Committee
- CEN/TC 102 - Sterilizers for medical purposes
- Drafting Committee
- CEN/TC 102/WG 6 - Gas sterilizers
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 13-May-2009
- Completion Date
- 13-May-2009
- Directive
- 93/42/EEC - Medical devices
Relations
- Effective Date
- 18-Jan-2023
- Effective Date
- 22-Dec-2008
- Effective Date
- 22-Dec-2008
- Effective Date
- 22-Dec-2008
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Frequently Asked Questions
EN 1422:1997 is a standard published by the European Committee for Standardization (CEN). Its full title is "Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods". This standard covers: This European standard specifies the minimum performance requirements and test methods of two types of sterilizers employing ethylene oxide gas as the sterilant, either as a pure gas or in admixture with other gases (whether supplied ready mixed or mixed at the point of use) in a temporarily sealed chamber. These sterilizers are intended to be used for medical, dental, pharmaceutical, veterinary and industrial or related purposes.
This European standard specifies the minimum performance requirements and test methods of two types of sterilizers employing ethylene oxide gas as the sterilant, either as a pure gas or in admixture with other gases (whether supplied ready mixed or mixed at the point of use) in a temporarily sealed chamber. These sterilizers are intended to be used for medical, dental, pharmaceutical, veterinary and industrial or related purposes.
EN 1422:1997 is classified under the following ICS (International Classification for Standards) categories: 11.080 - Sterilization and disinfection. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 1422:1997 has the following relationships with other standards: It is inter standard links to EN 1422:1997+A1:2009, EN 1422:1997/prA1, EN 1422:1997/AC:2002, EN 1422:2014. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 1422:1997 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN 1422:1997 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
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 a usage médical - Stérilisateurs a l'oxyde d'éthylene - 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 1422:1997SIST EN 1422:2000en01-januar-2000SIST EN 1422:2000SLOVENSKI
STANDARD
SIST EN 1422:200
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