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Normas DIN – AENOR
DIN EN 46001:1996-09

DIN EN 46001:1996-09

Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001; German version EN 46001:1996 / Note: A transition period, as set out in DIN EN ISO 13485 (2001-02), exists until 2004-02-01.

Systèmes qualité - Dispositifs médicaux - Exigences particulières relatives à l'application de l'EN ISO 9001; version allemande EN 46001:1996 / Attention: Il existe un délai de transition comme fixé en DIN EN ISO 13485 (2001-02) jusqu'à 2004-02-01.

Qualitätssicherungssysteme - Medizinprodukte - Besondere Anforderungen für die Anwendung von EN ISO 9001; Deutsche Fassung EN 46001:1996 / Achtung: Übergangsfrist, festgelegt durch DIN EN ISO 13485 (2001-02), bis 2004-02-01 beachten.

Fecha Anulación:
2011-02 /Withdrawn
Equivalencias internacionales:

EN 46001 (1996-08)

ISO 13485 (1996-12)

SN EN 46001 (1996)

SN EN 46001 (1997)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 13485:2001-02

Reemplaza a: DIN EN 46001:1993-12

Resumen:
The document specifies, in conjunction with with EN ISO 9001, the quality system requirements for the design/development, production, and where relevant, installation and servicing of medical devices.
Das Dokument legt zusammen mit EN ISO 9001 Anforderungen an das Qualitätssicherungssystem für Design/Entwicklung, Produktions und, wo relevant, Montage und Kundendienst von Medizinprodukten fest.
Keywords:
After-sales services, Applications, Auditing, Conduits, Corrections, Customers, Data, Definitions, Design, Detail specification, Developments, Electrical engineering, Erecting (construction operation), Evaluations, Handling, Inspection, Instruments, International standards, Management systems, Medical devices, Medical equipment, Medical instruments, Medical products, Medical sciences, Methods, Packages, Planning, Preservation, Preventive actions, Process, Production, Quality, Quality assessment systems, Quality assurance, Quality assurance systems, Quality auditing, Quality requirements, Responsibility, Shipping, Specification, Specification (approval), Standards, Steering gear, Surveillance (approval), Testing, Training, Treatment, Use, Verification
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