ISO 10993-10:2010 | 合法醫療器材資訊網

2010年10月6日—ISO10993-10:2010describestheprocedurefortheassessmentofmedicaldevicesandtheirconstituentmaterialswithregardtotheirpotential ...

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.

ISO 10993-10:2010 | 合法醫療器材資訊網

2010年10月6日 — ISO 10993-10:2010 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential ... Read More

ISOFDIS 10993-10 | 合法醫療器材資訊網

ISO/FDIS 10993-10. Biological evaluation of medical devices — Part 10: Tests for skin sensitization. General information. Status : Under development. Edition : 4. Read More

ISO 10993-10 | 合法醫療器材資訊網

It is intended to be the basic document for the selection and conduct of tests enabling evaluation of irritation and dermal sensitization responses relevant to safety ... Read More

醫療器材生物相容性試驗(ISO 10993) | 合法醫療器材資訊網

測試物直接或經過萃取後，以貼片吸取萃取液，貼附於大白兔之皮膚表層，觀察是否存有潛在刺激性。參照規範：ISO 10993-10 Tests for irritation and skin ... Read More

法治世界網 | 合法醫療器材資訊網

ISO 10993-10:2010 -醫療設備的生物學評價--第10部分：刺激性與皮膚過敏的測試. Biological evaluation of medical devices -- Part 10: Tests for irritation and skin ... Read More

ISO 10993 | 合法醫療器材資訊網

ISO 2010. INTERNATIONAL. STANDARD. ISO. 10993-10. Third edition. 2010-08-01. Biological evaluation of medical devices —. Part 10: Tests for irritation and ... Read More

醫療器材生物相容性試驗介紹 | 合法醫療器材資訊網

2018年3月12日 — 依據ISO 10993-10. 刺激. • Animal irritation test 皮膚刺激. • Animal intracutaneous (intradermal) reactivity test 皮內刺激. • Special irritation tests. Read More

EN ISO 10993-10 | 合法醫療器材資訊網

EN ISO 10993-10:2013 · Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010) · Biological evaluation of ... Read More

醫材產品生物相容與安全性的考量 | 合法醫療器材資訊網

2017年3月28日 — ISO 10993-3 基因毒性、致癌性、生殖毒性. ISO 10993-4 血液相容性. ISO 10993-5 體外細胞毒性. ISO 10993-6 植入試驗. ISO 10993-10 過敏性、 ... Read More

ISO 10993 | 合法醫療器材資訊網

The ISO 10993 set entails a series of standards for evaluating the biocompatibility of medical devices to manage biological risk. These documents were ... Read More

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