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Norm
ÖNORM EN ISO 10993-4
Issue date: 2009 08 15
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006)
This part of ISO 10993 provides general requirements for evaluating the interactions of medical devices with blood.
It describes
a) a classification of medical and dent...
Withdrawn: 2017 11 01
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 47 Pages
Language:
German
| English
| Download GER/ENG
Currently valid:
Optionally co-design standards:
ICS
This part of ISO 10993 provides general requirements for evaluating the interactions of medical devices with blood.
It describes
a) a classification of medical and dental devices that are intended for use in contact with blood, based on the
intended use and duration of contact as defined in ISO 10993-1,
b) the fundamental principles governing the evaluation of the interaction of devices with blood,
c) the rationale for structured selection of tests according to specific categories, together with the principles and
scientific basis of these tests.
Detailed requirements for testing cannot be specified because of limitations in the knowledge and precision of tests
for interactions of devices with blood. This part of ISO 10993 describes biological evaluation in general terms and
may not necessarily provide sufficient guidance for test methods for a specific device.
ÖNORM EN ISO 10993-4
2018 01 01
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (I...
Norm
ÖNORM EN ISO 10993-4
2017 11 01
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (I...
Norm
ÖNORM EN ISO 10993-4
2009 08 15
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (I...
Norm
↖
ÖNORM EN ISO 10993-4
2006 12 01
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (I...
Norm
ÖNORM EN ISO 10993-4
2003 04 01
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (I...
Norm
ÖNORM EN 30993-4
1994 05 01
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (I...
Norm
Norm
Issue date :
1997 12 11
Biological evaluation of medical devices — Part 1: Evaluation and testing
Norm
Issue date :
1992 12 30
Biological evaluation of medical devices — Part 2: Animal welfare requirements
Norm
Issue date :
2017 11 01
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
Norm
Issue date :
2002 10 22
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood