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Norm
ISO 10993-4:2002
Issue date: 2002 10 22
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
ISO 10993-4:2002 provides general requirements for evaluating the interactions of medical devices with blood.
It describes
a classification of medical and dental devices ...
Read more
Withdrawn
: 2017 04 12
Publisher:
International Organization for Standardization
Format:
Digital | 34 Pages
Language:
English
Currently valid:
ICS
ISO 10993-4:2002 provides general requirements for evaluating the interactions of medical devices with blood.
It describes
- 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,
- the fundamental principles governing the evaluation of the interaction of devices with blood,
- 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. ISO 10993-4:2002 describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device.
ISO 10993-4:2017
2017 04 12
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
Norm
ISO 10993-4:2002
2002 10 22
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
Norm
↖
ISO 10993-4:1992
1992 12 30
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
Norm
Norm
ISO 10993-4:2017
Issue date :
2017 04 12
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood