PRICES include / exclude VAT
Sponsored link
sklademVydáno: 2021-04-09
BS EN ISO 10993-23:2021
Biological evaluation of medical devices Tests for irritation
Format
Availability
Price and currency
Anglicky Secure PDF
Immediate download
407.33 €
You can read the standard for 1 hour. More information in the category: E-reading
Reading the standardfor 1 hour
40.73 €
You can read the standard for 24 hours. More information in the category: E-reading
Reading the standardfor 24 hours
122.20 €
Anglicky Hardcopy
In stock
407.33 €
| Označení normy: | BS EN ISO 10993-23:2021 |
| Počet stran: | 80 |
| Vydáno: | 2021-04-09 |
| ISBN: | 978 0 580 99743 3 |
| Status: | Standard |
DESCRIPTION
BS EN ISO 10993-23:2021
This standard BS EN ISO 10993-23:2021 Biological evaluation of medical devices is classified in these ICS categories:
- 11.100.20 Biological evaluation of medical devices
This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation. The tests are designed to predict and classify the irritation potential of medical devices, materials or their extracts according to ISO 10993-1 and ISO 10993-2.
This document includes:
-
pre-test considerations for irritation, including in silico and in vitro methods for dermal exposure;
-
details of in vitro and in vivo irritation test procedures;
-
key factors for the interpretation of the results.