SIST EN 50103:1998

Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for the active (including active implantable) medical device industry

The guidelines contained in this European Standard are applicable to a QUALITY SYSTEM as specified by EN 29001 and EN 46001 or EN 29002 and EN 46002. This European Standard does not add to, or otherwise change the requirements of those standards, and is not intended to be used directly in the assessment of a SUPPLIER' s QUALITY SYSTEM. The guidelines provide concepts and objectives which should be considered by a SUPPLIER of ACTIVE MEDICAL DEVICES while developing and maintaining his QUALITY SYSTEM. This European Standard: - provides examples of how to meet the requirements, while recognizing that other methods which achieve the same ends are equally acceptable; - gives general advice on how to meet the requirements; - draws attention to aspects of requirements that may not be readily apparent to those unfamiliar with QUALITY SYSTEMS used in the ACTIVE MEDICAL DEVICE industry.

Anleitung f�r die Anwendung von EN 29001 und EN 46001 und von EN 29002 und EN 46002 f�r die aktive (einschlie�lich implantierbare aktive) Medizinprodukte herstellende Industrie

Guide pour l'application des EN 29001 et EN 46001 et des EN 29002 et EN 46002 � l'industrie des dispositifs m�dicaux actifs (comprenant les dispositifs actifs implantables)

Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for the active

General Information

• Status: Withdrawn
• Publication Date: 31-Aug-1998
• Withdrawal Date: 11-Mar-2009
• ICS: 03.120.10 - Quality management and quality assurance
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 27-Feb-2009
• Due Date: 22-Mar-2009
• Completion Date: 12-Mar-2009
• 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
• Mandate: BC/CLC/02-89 - BC/CLC/02-89
• Ref Project: EN 50103:1995 - Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for the active (including active implantable) medical device industry

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 50103:1998
01-september-1998
Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN
46002 for the active
Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002
for the active (including active implantable) medical device industry
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Ta slovenski standard je istoveten z: EN 50103:1995
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN 50103:1998 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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