EN 15424:2007

Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices

1.1   Inclusions
1.1.1   This European Standard specifies requirements for the development, validation and routine control of a Low Temperature Steam and Formaldehyde (LTSF) sterilization process for medical devices.
NOTE   Although the scope of this standard is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment.
1.1.2   This European Standard is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized and the organizations with responsibility for sterilizing medical devices. (See EN ISO 14937:2000, Table E.1)
1.1.3   This European Standard covers sterilization processes which use a mixture of low temperature steam and formaldehyde as sterilant, and which are working below ambient pressure only.
1.2   Exclusions
1.2.1   Sterilization processes validated and controlled in accordance with the requirements of this standard should not be assumed to be effective in inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.
1.2.2   This standard does not specify requirements for designating a medical device as "STERILE". Such requirements are given in EN 556-1.
1.2.3   This standard does not specify a quality management system for the control of all stages of production of medical devices.
NOTE   Attention is drawn to the standards for quality management systems (see EN ISO 13485) that control all stages of production or reprocessing of medical devices including the sterilization process. It is not a requirement of this standard to have a complete quality management system during manufacture or reprocessing, but those elements of such a system that are required are normatively referenced at appro

Sterilisation von Medizinprodukten - Niedertemperatur-Dampf-Formaldehyd - Anforderungen an die Entwicklung, Validierung und Routineüberwachung von Sterilisationsverfahren für Medizinprodukte

Stérilisation des dispositifs médicaux - Vapeur d'eau à basse température et au formaldéhyde - Exigences pour le développement, la validation et le contrôle de routine des procédés de stérilisation

1.1   Inclusions
1.1.1   La présente Norme européenne spécifie les exigences relatives à la mise au point, à la validation et au contrôle de routine d'un procédé de stérilisation à la vapeur et au formaldéhyde à température basse (LTSF) pour les dispositifs médicaux.
NOTE   Bien que le domaine d'application de la présente norme se limite aux dispositifs médicaux, elle spécifie les exigences et fournit un guide qui peut être applicable à d'autres produits et équipements.
1.1.2   La présente Norme européenne est destinée à être appliquée par les personnes chargées de la mise au point des procédés, les fabricants d’équipements de stérilisation, les fabricants de dispositifs médicaux destinés à être stérilisés et les organisations responsables de la stérilisation des dispositifs médicaux (voir EN ISO 14937:2000, Tableau E.1).
1.1.3   La présente Norme européenne couvre les procédés de stérilisation employant un mélange de vapeur et de formaldéhyde à température basse en tant que stérilisant et fonctionnant uniquement en dessous de la pression ambiante.
1.2   Exclusions
1.2.1   Il convient que les procédés de stérilisation validés et contrôlés conformément aux exigences de la présente norme ne soient pas supposés efficaces pour l'inactivation des agents responsables des encéphalopathies spongiformes telles que la tremblante du mouton, l'encéphalopathie spongiforme bovine et la maladie de Creutzfeld-Jacob. Des recommandations spécifiques ont été formulées dans certains pays pour le traitement des matériaux potentiellement contaminés par ces agents.
1.2.2   La présente norme ne spécifie pas d’exigence pour qualifier un dispositif médical de « STERILE ». De telles exigences sont fournies dans l’EN 556-1.
1.2.3   La présente norme ne spécifie pas de système de management de la qualité pour le contrôle de toutes les étapes de production des dispositifs médicaux.

Sterilizacija medicinskih pripomočkov - Para nizke temperature in formaldehid - Zahteve za razvoj, validacijo in rutinsko kontrolo sterilizacijskih postopkov za medicinske pripomočke

General Information

• Status: Withdrawn
• Publication Date: 03-Apr-2007
• Withdrawal Date: 21-Jun-2011
• ICS: 11.080.01 - Sterilization and disinfection in general
• Technical Committee: CEN/TC 204 - Sterilization of medical devices
• Drafting Committee: CEN/TC 204 - Sterilization of medical devices
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 22-Jun-2011
• Completion Date: 22-Jun-2011
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
• Ref Project: SIST EN 15424:2007 - Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices

Relations

• Replaced By: EN ISO 25424:2011 - Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009)
• Effective Date: 14-May-2011

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devicesStérilisation des dispositifs médicaux - Vapeur d'eau a basse température et au formaldéhyde - Exigences pour le développement, la validation et le contrôle de routine des procédés de stérilisationSterilisation von Medizinprodukten - Niedertemperatur-Dampf-Formaldehyd - Anforderungen an die Entwicklung, Validierung und Routineüberwachung von Sterilisationsverfahren für MedizinprodukteTa slovenski standard je istoveten z:EN 15424:2007SIST EN 15424:2007en,fr,de11.080.01Sterilizacija in dezinfekcija na splošnoSterilization and disinfection in generalICS:SLOVENSKI
STANDARDSIST EN 15424:200701-september-2007

EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 15424April 2007ICS 11.080.01 English VersionSterilization of medical devices - Low temperature steam andformaldehyde - Requirements for development, validation androutine control of a sterilization process for medical devicesStérilisation des dispositifs médicaux - Développement,validation et contrôle de routine des procédés destérilisation - Vapeur d'eau à basse température et auformaldéhydeSterilisation von Medizinprodukten - Niedertemperatur-Dampf-Formaldehyd - Anforderungen an die Entwicklung,Validierung und Routineüberwachung vonSterilisationsverfahren für MedizinprodukteThis European Standard was approved by CEN on 17 February 2007.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards 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 translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial 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 STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2007 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 15424:2007: E

Process definition based on inactivation of reference microorganisms and knowledge of bioburden on product items to be sterilized.26

Process definition based on inactivation of reference microorganisms.27 B.1 General.27 B.1.1 Overkill approach.27 B.1.2 Penetration characteristics into medical devices.27 B.2 Test procedure.28 B.2.1 General.28 B.2.2 Biological indicators.28 B.2.3 Test systems.28 B.2.4 Load configuration.28 B.2.5 Testing.28 Annex C (informative)
Guidance on application of this European Standard.30 C.1 Scope.30 C.2 Normative references.30 C.3 Terms and definitions.30 C.4 Quality management system elements.30 C.5 Sterilizing agent characterization.30 C.5.1 Neutralization.30 C.5.2 Studies of microbial inactivation.31 C.6 Process and equipment characterization.31 C.7 Product definition.31 C.7.1 General.31 C.7.2 Design considerations for medical devices intended for sterilization.32 C.7.3 Packaging considerations.32 C.8 Process definition.32 C.8.1 General.32 C.8.2 Influence on product and packaging.33 C.8.3 Determination of process effectiveness.33 C.9 Validation.34 C.9.1 General.34 C.9.2 Install
...