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Norm
ÖNORM EN ISO 10993-10
Issue date: 2006 12 01
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002) (consolidated version)
This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent
materials with regard to their potential to produce irritation...
Withdrawn: 2010 01 01
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 65 Pages
Language:
German
| English
Currently valid:
Optionally co-design standards:
ICS
This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent
materials with regard to their potential to produce irritation and delayed-type hypersensitivity.
This part of ISO 10993 includes
a) pretest considerations,
b) details of the test procedures, and
c) key factors for the interpretation of the results.
Instructions are given in annex A for the preparation of materials specifically in relation to the above tests.
Supplementary tests which are required specifically for devices used intradermally in the ocular, oral, rectal, penile
and vaginal areas are given in annex B.
ÖNORM EN ISO 10993-10
2023 07 15
Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)...
Norm
ÖNORM EN ISO 10993-10
2014 10 15
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO...
Norm
ÖNORM EN ISO 10993-10
2010 10 15
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO...
Norm
ÖNORM EN ISO 10993-10
2010 01 01
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensi...
Norm
ÖNORM EN ISO 10993-10
2006 12 01
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensi...
Norm
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ÖNORM EN ISO 10993-10
2003 03 01
Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensi...
Norm
ÖNORM EN ISO 10993-10
1996 07 01
Biological evaluation of medical devices - Part 10: Tests for irritation and sensitization (ISO 1099...
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