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CEN

EN 552:1994/A1:1999

(Amendment)

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

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Withdrawn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
18-May-1999
Withdrawal Date
14-Apr-2006
ICS
11.080 - Sterilization and disinfection
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
15-Apr-2006
Completion Date
15-Apr-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
SIST EN 552:2000/A1:2000 - Sterilization of medical devices - Validation and routine control of sterilization by irradiation

Relations

Replaced By
EN ISO 11137-3:2006 - Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects (ISO 11137-3:2006)
Effective Date
22-Dec-2008
Replaced By
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
22-Dec-2008
Replaced By
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
EN 552:1994 - Sterilization of medical devices - Validation and routine control of sterilization by irradiation
Effective Date
22-Dec-2008

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EN 552:2000/A1:2000EN 552:2000/A1:2000
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EN 552:2000/A1:2000
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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 552:2000/A1:2000
01-januar-2000
6WHULOL]DFLMDPHGLFLQVNLKSULSRPRþNRY9DOLGDFLMDLQUHGQLQDG]RUVWHULOL]DFLMH]
REVHYDQMHP
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
...

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