EN 556-1:2001/AC:2006

Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices

TC - Modification to 4.1 and Bibliography

Sterilisation von Medizinprodukten - Anforderungen an Medizinprodukte, die als 'STERIL' gekennzeichnet werden - Teil 1: Anforderungen an Medizinprodukte, die in der Endpackung sterilisiert wurden

Stérilisation des dispositifs médicaux - Exigences relatives aux dispositifs médicaux en vue d'obtenir l'étiquetage STERILE - Partie 1: Exigences relatives aux dispositifs médicaux stérilisés au stade terminal

Sterilizacija medicinskih pripomočkov – Zahteve za medicinske pripomočke, ki morajo biti označeni s "STERILNO" – 1. del: Zahteve za končno sterilizirane medicinske pripomočke

General Information

• Status: Published
• Publication Date: 19-Sep-2006
• ICS: 11.080.01 - Sterilization and disinfection in general
• Technical Committee: CEN/TC 204 - Sterilization of medical devices
• Drafting Committee: CEN/TC 204/WG 6 - Microbiological quality of processed medical devices
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 20-Sep-2006
• Completion Date: 20-Sep-2006
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic 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 556-1:2002/AC:2006 - Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices

Relations

• Corrects: EN 556-1:2001 - Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
• Effective Date: 22-Dec-2008

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devicesULOL]LUDQHStérilisation des dispositifs médicaux - Exigences relatives aux dispositifs médicaux en vue d'obtenir l'étiquetage STERILE - Partie 1: Exigences relatives aux dispositifs médicaux stérilisés au stade terminalSterilisation von Medizinprodukten - Anforderungen an Medizinprodukte, die als 'STERIL' gekennzeichnet werden - Teil 1: Anforderungen an Medizinprodukte, die in der Endpackung sterilisiert wurdenTa slovenski standard je istoveten z:EN 556-1:2001/AC:2006SIST EN 556-1:2002/AC:2006en,de11.080.01Sterilizacija in dezinfekcija na splošnoSterilization and disinfection in generalICS:SLOVENSKI
STANDARDSIST EN 556-1:2002/AC:200601-december-2006







EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 556-1:2001/ACSeptember 2006Septembre 2006September 2006ICS 11.080.01English versionVersion FrançaiseDeutsche FassungSterilization of medical devices - Requirements for medical devices to bedesignated 'STERILE' - Part 1: Requirements for terminally sterilizedmedical devicesStérilisation des dispositifs médicaux -Exigences relatives aux dispositifsmédicaux en vue d'obtenir l'étiquetageSTERILE - Partie 1: Exigences relativesaux dispositifs médicaux stérilisés au stadeterminalSterilisation von Medizinprodukten -Anforderungen an Medizinprodukte, die als'STERIL' gekennzeichnet werden - Teil 1:Anforderungen an Medizinprodukte, die inder Endpackung sterilisiert wurdenThis corrigendum becomes effective on 20 September 2006 for incorporation in the three officiallanguage versions of the EN.Ce corrigendum prendra effet le 20 septembre 2006 pour incorporation dans le
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