Tagasi

ISO 10993-10:2010

Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization

Üldinfo
Kehtetu alates 16.11.2021
Direktiivid või määrused
puuduvad
Standardi ajalugu
Staatus
Kuupäev
Tüüp
Nimetus
16.11.2021
Põhitekst
27.07.2010
Põhitekst
Põhitekst
ISO 10993-10:2002
Muudatus
ISO 10993-10:2002/Amd 1:2006
ISO 10993-10:2010 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization. ISO 10993-10:2010 includes: pretest considerations for irritation, including in silico and in vitro methods for dermal exposure; details of in vivo (irritation and sensitization) test procedures; key factors for the interpretation of the results. Instructions are given for the preparation of materials specifically in relation to the above tests and several special irritation tests are described for application of medical devices in areas other than skin.
*
*
*
PDF
67,10 € koos KM-ga
Paber
67,10 € koos KM-ga
Standardi monitooring
Teised on ostnud veel
Põhitekst

ISO 10993-5:2009

Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
Uusim versioon Kehtiv alates 20.05.2009
Põhitekst

ISO 10993-1:2018

Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process (Corrected version 2018-10)
Uusim versioon Kehtiv alates 17.08.2018
Põhitekst

ISO 20457:2018

Plastics moulded parts -- Tolerances and acceptance conditions
Uusim versioon Kehtiv alates 28.08.2018
Põhitekst

ISO 15223-1:2016

Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements (Corrected version 2017-03)
Kehtetu alates 06.07.2021