EN 556:1994 + A1:1998

Sterilization of medical devices - Requirements for terminally-sterilized medical devices to be labelled "Sterile"

Migrated from Progress Sheet (TC Comment) (2000-07-10): CEN/CS will isusue a full new version of the standard, thus incorporatiing the ++ amendment as EN 556:1994 + A1:1998 (ZM, 971105; see text of the resolution). ++ The Amendment will be sent to FV immediately.

Sterilisation von Medizinprodukten - Anforderungen für in der Endverpackung zu sterilisierende Medizinprodukte, die als "Steril" gekennzeichnet werden

Stérilisation des dispositifs médicaux - Exigences pour les dispositifs médicaux ayant subi une stérilisation terminale étiquetés "Stérile"

Sterilizacija medicinskih pripomočkov - Zahteve za končno sterilizirane medicinske pripomočke, ki morajo biti označeni kot "sterilni"

General Information

• Status: Withdrawn
• Publication Date: 18-Aug-1998
• Withdrawal Date: 02-Oct-2001
• 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: 03-Oct-2001
• Completion Date: 03-Oct-2001
• 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 556:2000 - Sterilization of medical devices - Requirements for terminally-sterilized medical devices to be labelled "Sterile"

Relations

• Replaced By: 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)

SLOVENSKI STANDARD
SIST EN 556:2000
01-januar-2000
6WHULOL]DFLMDPHGLFLQVNLKSULSRPRþNRY=DKWHYH]DNRQþQRVWHULOL]LUDQH
PHGLFLQVNHSULSRPRþNHNLPRUDMRELWLR]QDþHQLNRWVWHULOQL
Sterilization of medical devices - Requirements for terminally-sterilized medical devices
to be labelled "Sterile"
Sterilisation von Medizinprodukten - Anforderungen für in der Endverpackung zu
sterilisierende Medizinprodukte, die als "Steril" gekennzeichnet werden
Stérilisation des dispositifs médicaux - Exigences pour les dispositifs médicaux ayant
subi une stérilisation terminale étiquetés "Stérile"
Ta slovenski standard je istoveten z: EN 556:1994 + A1:1998
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN 556:2000 en
200
...