UNE-EN ISO 10993-4:2017
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
Hardcopy , PDF
Spanish, Castilian, English
15-11-2017
24-01-2018
This part of ISO 10993 specifies general requirements for evaluating the interactions of medical devices with blood.It describesa)a classification of medical 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.
| Committee |
CTN 111
|
| DocumentType |
Standard
|
| Pages |
98
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Superseded
|
| Standards | Relationship |
| EN ISO 10993-4:2017 | Identical |
| ISO 10993-4:2017 | Identical |
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