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Norm

ÖNORM EN 46001

Issue date: 1996 12 01

Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001

Withdrawn: 2004 02 01
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 14 Pages
Language:
German | English
Currently valid:
ÖVE/ÖNORM EN ISO 13485:2022 02 01
Optionally co-design standards:
Committee 129: Quality Management Systems and Business Excellence
ICS
03.120.10
11.040.01
Topics
Healthcare, Medical equipment, Medical equipment in general
Services & management, Company organization and management. Quality, Quality management and quality assurance
Norm timeline
Normative References
ÖVE/ÖNORM EN ISO 13485
2022 02 01
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)...
Norm
ÖVE/ÖNORM EN ISO 13485
2022 02 01
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)...
Norm
ÖVE/ÖNORM EN ISO 13485
2017 08 01
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)...
Norm
ÖVE/ÖNORM EN ISO 13485
2017 08 01
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)...
Norm
ÖVE/ÖNORM EN ISO 13485
2016 07 01
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)...
Norm
ÖVE/ÖNORM EN ISO 13485
2016 07 01
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)...
Norm
ÖNORM EN ISO 13485
2012 11 01
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 ...
Norm
ÖNORM EN ISO 13485
2012 11 01
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 ...
Norm
ÖNORM EN ISO 13485
2010 02 15
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 ...
Norm
ÖNORM EN ISO 13485
2010 02 15
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 ...
Norm
ÖNORM EN ISO 13485
2007 11 01
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)...
Norm
ÖNORM EN ISO 13485
2007 11 01
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)...
Norm
ÖNORM EN ISO 13485
2003 11 01
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)...
Norm
ÖNORM EN ISO 13485
2003 11 01
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)...
Norm
ÖVE/ÖNORM EN ISO 13485
2001 04 01
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001 (revi...
Norm
ÖNORM EN 46001
1996 12 01
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001
Norm
↖
ÖNORM EN 46001
1994 02 01
Quality systems - Medical devices - Particular requirements for the application of EN 29001
Norm
Expand
Norm
ÖNORM EN ISO 13485
Issue date : 2003 11 01
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
Norm
ÖVE/ÖNORM EN ISO 13485
Issue date : 2001 04 01
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001 (revision of EN 46001:1996) (identical to ISO 13485:1996)

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