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ILNAS-EN 46001:1996 Edition 08/1996
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001
  •  
  • 28.5 / copy
  •  
 

Status

Standard - Superseded

Origin

Technical Committee :
CEN/CLC/WG QS : CEN/CENELEC Coordinating working group on quality supplements

Directives

90/385/EEC : Active implantable medical devices
93/42/EEC : Medical devices

Implementation

start of the vote on the project    09/10/1997   date of ratification (dor)    24/10/1995
end of the vote on the project    26/10/1998   date of anouncement (doa)    30/11/1996
start of the vote on the final project    14/10/1999   date of publication (dop)    28/02/1997
end of the vote on the final project      date of withdrawal (dow)    28/02/1997


Publication Official Journal
of the Grand-Duchy of Luxembourg
21/08/1997
Reference

Relations

Evolutions
ILNAS-EN ISO 13485:2000

Relations to older standards
ILNAS-EN 46001:1993/AC:1994
ILNAS-EN 46001:1993

International Classification for Standards (ICS codes) :

03.120.10 : Quality management and quality assurance
11.040.01 : Medical equipment in general

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