Extractables and leachables testing of a combination device

Автор: Nelson Labs

Загружено: 2020-11-10

Просмотров: 5107

Описание: Extractables and Leachables testing of combination devices requires a specific study set-up which differentiates from a typical chemical characterization study according to ISO10993-18. In this presentation, we will explain how a chemical characterization study of a combination device should be performed, based on a case study of an insulin device.

Furthermore, we will clarify how to integrate in the study set-up the requirement for Carcinogenic, Mutagenic and Reprotoxic Compounds (CMRs) as specified in section 10.4 in Annex I of the MDR. This requirement is especially important for products falling under article 117.

Finally, drug-device compatibility should not be neglected or forgotten in an overall biocompatibility evaluation.

Не удается загрузить Youtube-плеер. Проверьте блокировку Youtube в вашей сети.
Повторяем попытку...

Extractables and leachables testing of a combination device

Доступные форматы для скачивания:

Скачать видео

Информация по загрузке:

Скачать аудио

Похожие видео

Developing Biocompatibility for Medical Devices - Audrey Turley

Developing Biocompatibility for Medical Devices - Audrey Turley

Chemical Characterization According to Iso10993 18 - Dries Cardoen

Chemical Characterization According to Iso10993 18 - Dries Cardoen

Beyond Hormones: What Else is Driving Perimenopause Symptoms with Dr. Alison DiBarto Goggin

Beyond Hormones: What Else is Driving Perimenopause Symptoms with Dr. Alison DiBarto Goggin

EXTRACTABLES AND LEACHABLES TESTING USING A QUALITY RISK MANAGEMENT APPROACH

EXTRACTABLES AND LEACHABLES TESTING USING A QUALITY RISK MANAGEMENT APPROACH

Lecture on Leachables and Extractables

Lecture on Leachables and Extractables

4 Hours Chopin for Studying, Concentration & Relaxation

4 Hours Chopin for Studying, Concentration & Relaxation

ISO 10993-18 - Introduction to Extractables and Leachables testing for medical devices

ISO 10993-18 - Introduction to Extractables and Leachables testing for medical devices

Updates Coming to ISO 10993 1

Updates Coming to ISO 10993 1

Градиентный спуск, как обучаются нейросети | Глава 2, Глубинное обучение

Градиентный спуск, как обучаются нейросети | Глава 2, Глубинное обучение

Assessing the Safety of Extractables and Leachables for Drug Products: When and How?

Assessing the Safety of Extractables and Leachables for Drug Products: When and How?

Но что такое нейронная сеть? | Глава 1. Глубокое обучение

Но что такое нейронная сеть? | Глава 1. Глубокое обучение

Container Closure Requirements: Preparing for USP 382, 661.1, & 661.2

Container Closure Requirements: Preparing for USP 382, 661.1, & 661.2

Beyond Biocompatibility: 10993-1 & FDA Expectations for Particulate Evaluation in Vascular Devices

Beyond Biocompatibility: 10993-1 & FDA Expectations for Particulate Evaluation in Vascular Devices

Extractable & Leachable Identification in Biopharmaceutical Manufacturing at BioMEDevice 2017

Extractable & Leachable Identification in Biopharmaceutical Manufacturing at BioMEDevice 2017

USP 665 и 1665 Экстрагируемые компоненты для фармацевтического и биофармацевтического производства

USP 665 и 1665 Экстрагируемые компоненты для фармацевтического и биофармацевтического производства

Dr. Ehrenstorfer - Selection and use of isotopic internal standards

Dr. Ehrenstorfer - Selection and use of isotopic internal standards

Calculation of Duration of Exposure & Associated Biological Effects for Biocompatibility Evaluation

Calculation of Duration of Exposure & Associated Biological Effects for Biocompatibility Evaluation

A Dive into Disinfection Validations of Non-critical Devices

A Dive into Disinfection Validations of Non-critical Devices

Essential Principles of Chemical Characterization Applied to Small Volume Parenterals (SVPs)

Essential Principles of Chemical Characterization Applied to Small Volume Parenterals (SVPs)

Комплексный анализ человеческого фактора при тестировании удобства использования медицинских изде...

Комплексный анализ человеческого фактора при тестировании удобства использования медицинских изде...