AS ISO 10993.4-2003
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Biological evaluation of medical devices - Selection of tests for interactions with blood
Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users
30-06-2017
English
01-01-2003
Important note : Users cannot be edited or removed once added to your Multi user PDF.Specifies general requirements for evaluating the interactions of medical devices with blood. This Standard 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, the fundamental principles governing the evaluation of the interaction of devices with blood, and the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests.
| Committee |
HE-012
|
| DocumentType |
Standard
|
| ISBN |
0 7337 5368 X
|
| Pages |
34
|
| PublisherName |
Standards Australia
|
| Status |
Withdrawn
|
| Supersedes |
1 ScopeThis part of ISO 10993 provides general requirements for evaluating the interactions of medical devices with blood.It describesa) 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.
| Standards | Relationship |
| ISO 10993-4:2002 | Identical |
First published as AS ISO 10993.4-2002.
Second edition 2003.
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