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SIST

SIST EN 46001:1995

(Main)

Quality systems - Medical devices - Particular requirements for the application of EN 29001

Quality systems - Medical devices - Particular requirements for the application of EN 29001

Qualitätssicherungssysteme - Medizinprodukte - Besondere Anforderungen für die Anwendung von EN 29001

Systemes qualité - Dispositifs médicaux - Exigences particulieres relatives a l'application de l'EN 29001

Quality systems - Medical devices - Particular requirements for the application of EN 29001/Amendment

General Information

Status
Withdrawn
Publication Date
30-Apr-1995
Withdrawal Date
31-Oct-1999
ICS
03.100.70 - Management systems
11.020.01 - Quality and environmental management in health care
Technical Committee
VAZ - Healthcare
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
01-Nov-1999
Due Date
01-Nov-1999
Completion Date
01-Nov-1999
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
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 46001:1993/AC:1994 - Quality systems - Medical devices - Particular requirements for the application of EN 29001

Relations

Replaced By
SIST EN 46001:1999 - Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001
Effective Date
01-Nov-1999

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Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Quality systems - Medical devices - Particular requirements for the application of EN 29001/AmendmentQualitätssicherungssysteme - Medizinprodukte - Besondere Anforderungen für die Anwendung von EN 29001Systemes qualité - Dispositifs médicaux - Exigences particulieres relatives a l'application de l'EN 29001Quality systems - Medical devices - Particular requirements for the application of EN 2900111.040.01Medicinska oprema na splošnoMedical equipment in general03.120.10Vodenje in zagotavljanje kakovostiQuality management and quality assuranceICS:Ta slove
...

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