ISO 18562 Biocompatibility Evaluation of Breathing Gas Pathways
专职专家
迈克·鲁上校Market 发展 Manager for E&L at im体育APP 生命科学 曼彻斯特. 25+ years of pharmaceutical analysis specialising in trace impurity analysis 和可推断出的 and 可滤取的.
In this white paper we deep-dive into the evaluation of biocompatibility for devices such as ventilators, 呼吸系统, nebulizers and respiratory monitors.
This content was authored by 迈克·鲁上校, Market 发展 Manager for extractables & 浸出研究 曼彻斯特. 迈克 has 25+ years of pharmaceutical analysis experience specializing in trace impurity analysis, 和可推断出的 & 可滤取的.
The paper explains the importance of biocompatibility studies in the R&D stages of product development, and the significance of ISO 18562 as the framework to assess the risks associated with the breathing 气体 pathway products used for within healthcare.
ISO 18562系列
Why download this white paper?
- Learn about the origin of the standard and the medical devices it is relevant to
- Find out about the ISO 18562-1 risk assessment process
- Gain insight into the four parts of ISO 18562
- Understand the value of a trusted testing partner
Complete the form below to download our white paper
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作者简介
As Market 发展 Manager at im体育APP 生命科学 曼彻斯特, 迈克·鲁上校 has over 25+ years of pharmaceutical analysis specialising in trace impurity analysis 和可推断出的 and 可滤取的.
以化学家的身份毕业, 迈克 began his career in the analytical lab of a multinational chemical company, before focusing on NMR and LCMS in the spectroscopy area. Before joining im体育APP in June 2023, 迈克 led an analytical function specializing in extractable and leachable testing, offering expert support globally.
迈克 is dedicated to assisting our clients in bringing forward innovative products that enhance the well-being and comfort of patients.
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观看我们的ISO 18562网络研讨会
观看我们的网络研讨会 for an in-depth overview of ISO 18562 testing, focusing on the bio-compatibility evaluation of breathing 气体 pathway devices. 尼克·莫理 delves into the analytical methodologies essential for supporting this evaluation as per ISO 18562.
Failure to comply can result in costly recalls, 对患者的潜在危害, and damage to a company's reputation and revenue. The webinar addresses these concerns by detailing the testing procedures mandated by ISO 18562 and highlighting real-world examples where inadequate testing led to significant repercussions.
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Here are a handful of our services to help you achieve regulatory approval quickly and efficiently.
ISO 18562 测试: Biocompatibility Analysis
im体育APP provides ISO 18562 biocompatibility analysis for respiratory and ventilation devices to support global device approval.
USP 665, 1665 and BPOG Services
Ensure compliance for single-use systems (SUS). Our testing services provide high-quality results, safeguarding patient safety, fulfilling your regulatory requirements, and expediting time to market.
Excipient Raw Materials and Container 测试
im体育APP has comprehensive capabilities that can be applied to the testing of excipient, 原材料, and pharmaceutical containers, enabling you to ensure the quality and safety of your product.
Extractables and Leachables Studies
Our extractables and 可滤取的 studies offer tailored solutions that ensure patient safety and compliance with industry standards.