BS EN ISO 10993-10:2013
Biological evaluation of medical devices - Tests for irritation and skin sensitization
Biological evaluation of medical devices - Tests for irritation and skin sensitization
- Статус документа:
- Отменён
- Формат:
- Электронный (PDF)
- Дата публикации:
- 28 февраля 2014 г.
- ICS:
- 11.100.20
- Технический комитет:
- CEN
- SKU:
- BS EN ISO 10993-10:2013
Abstract
1 Scope 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.
Похожие стандарты
Упомянутые в описании и другие стандарты BS
ISO 10993-12:2012
ОтменёнBiological evaluation of medical devices — Part 12: Sample preparation and reference materials
BS ISO 10835:2007
ДействующийDirect reduced iron and hot briquetted iron. Sampling and sample preparation.
1 Scope This International Standard gives a) the underlying theory, b) the basic principles for sampling and preparation of samples , and c) the basic requirements for the design, installation and op…