Please select and order
€171.12
excl. VAT
Add to cart
Norm
ÖNORM EN ISO 10993-10
Issue date: 2014 10 15
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2013)
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Withdrawn: 2023 07 15
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 80 Pages
Language:
German
| English
| Download GER/ENG
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 skin sensitization.
This part of ISO 10993 includes:
a) pretest considerations for irritation, including in silico and in vitro methods for dermal exposure;
b) details of in vivo (irritation and sensitization) test procedures;
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. In Annex B several special irritation tests are described for application of medical devices in areas other than skin.
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
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...
Norm
Norm
Issue date :
2006 07 06
Biological evaluation of medical devices — Part 2: Animal welfare requirements
Norm
Issue date :
2009 11 30
Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
Norm
Issue date :
2012 06 29
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
Norm
Issue date :
2010 06 04
Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
Norm
Issue date :
2001 11 22
Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
Norm
Issue date :
2000 11 30
Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys (Corrected version 2001-03)
Norm
Issue date :
2005 06 30
Biological evaluation of medical devices — Part 18: Chemical characterization of materials
Norm
Issue date :
2009 10 13
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
Norm
Issue date :
2006 07 06
Biological evaluation of medical devices — Part 2: Animal welfare requirements
Norm
Issue date :
2019 11 26
Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
Norm
Issue date :
2010 06 04
Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
Norm
Issue date :
2001 11 22
Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
Norm
Issue date :
2019 11 26
Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys
Norm
Issue date :
2020 01 13
Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process
Norm
Issue date :
2003 02 26
Clinical investigation of medical devices for human subjects — Part 1: General requirements
Norm
Issue date :
2003 05 16
Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans
Norm
Issue date :
2023 07 15
Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
Norm
Issue date :
2010 07 27
Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
