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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)

Withdrawn : 2003 11 01
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 13 Pages
Language:
German
Currently valid:
ÖVE/ÖNORM EN ISO 13485:2022 02 01
Optionally co-design standards:
Committee 179: Medical technology
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
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
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
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
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
Historie aufklappen
Norm
ISO 13485:1996
Issue date : 1996 12 26
Quality systems — Medical devices — Particular requirements for the application of ISO 9001
Norm
ÖNORM EN ISO 9001
Issue date : 2008 12 01
Quality management systems - Requirements (ISO 9001:2008)
Norm
ISO 8402:1994
Issue date : 1994 03 24
Quality management and quality assurance — Vocabulary
Norm
ISO 9001:1994
Issue date : 1994 06 30
Quality systems — Model for quality assurance in design, development, production, installation and servicing
Norm
ISO 11137:1995
Issue date : 1995 03 09
Sterilization of health care products — Requirements for validation and routine control — Radiation sterilization
Norm
ÖNORM EN ISO 13485
Issue date : 2003 11 01
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)