EN 556:1994 + A1:1998
(Main + Amendment)Sterilization of medical devices - Requirements for terminally-sterilized medical devices to be labelled "Sterile"
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- Withdrawn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
- 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
- 93/42/EEC - Medical devices
Relations
- Effective Date
- 22-Dec-2008
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
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Frequently Asked Questions
EN 556:1994 + A1:1998 is a amendment published by the European Committee for Standardization (CEN). Its full title is "Sterilization of medical devices - Requirements for terminally-sterilized medical devices to be labelled "Sterile"". This standard covers: 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.
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.
EN 556:1994 + A1:1998 is classified under the following ICS (International Classification for Standards) categories: 11.080 - Sterilization and disinfection. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 556:1994 + A1:1998 has the following relationships with other standards: It is inter standard links to EN 556-1:2001, EN ISO 10651-4:2009, EN 12439:1998. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 556:1994 + A1:1998 is associated with the following European legislation: EU Directives/Regulations: 90/385/EEC, 93/42/EEC, 98/79/EC; Standardization Mandates: M/BC/CEN/89/9. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN 556:1994 + A1:1998 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
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
...
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