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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Withdrawn: 2003 11 01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

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

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

Expand

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)

Norm

ISO 13485:1996

Issue date : 1996 12 26

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

ÖVE/ÖNORM EN ISO 13485

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