SIST EN 552:2000/A1:2000

Sterilization of medical devices - Validation and routine control of sterilization by irradiation

Migrated from Progress Sheet (TC Comment) (2000-07-10): UAP of 4 months (TC Res 3/1998) (CC/980317)

Sterilisation von Medizinprodukten - Validierung und Routineüberwachung für die Sterilisation mit Strahlen

Stérilisation de dispositifs médicaux - Validation et contrôle de routine pour la stérilisation par irradiation

Sterilizacija medicinskih pripomočkov - Validacija in redni nadzor sterilizacije z obsevanjem

General Information

• Status: Withdrawn
• Publication Date: 31-Dec-1999
• Withdrawal Date: 30-Jun-2006
• ICS: 11.080.01 - Sterilization and disinfection in general
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 01-Jul-2006
• Due Date: 01-Jul-2006
• Completion Date: 01-Jul-2006
• 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: EN 552:1994/A1:1999 - Sterilization of medical devices - Validation and routine control of sterilization by irradiation

Relations

• Replaced By: SIST EN ISO 11137-3:2006 - Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects (ISO 11137-3:2006)
• Effective Date: 01-Jul-2006
• Replaced By: SIST EN ISO 11137-1:2006 - Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006)
• Effective Date: 01-Jul-2006
• Replaced By: SIST EN ISO 11137-2:2006 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006)
• Effective Date: 22-Dec-2008
• Amends: SIST EN 552:2000 - Sterilization of medical devices - Validation and routine control of sterilization by irradiation
• Effective Date: 22-Dec-2008
• Replaced By: SIST EN ISO 11137-2:2007 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01)
• Effective Date: 01-Sep-2007

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 552:2000/A1:2000
01-januar-2000
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Sterilization of medical devices - Validation and routine control of sterilization by
irradiation
Sterilisation von Medizinprodukten - Validierung und Routineüberwachung für die
Sterilisation mit Strahlen
Stérilisation de dispositifs médicaux - Validation et contrôle de routine pour la stérilisation
par irradiation
Ta slovenski standard je istoveten z: EN 552:1994/A1:1999
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in g
...