im体育APP provides biocompatibility analysis and toxicology 服务 as per ISO 18562 for breathing 气体 pathway devices. We work closely with customers to help identify all necessary testing and compliance requirements to support global device approval from relevant regulatory bodies.
什么是ISO 18562测试?
The ISO 18562 series of standards outlines the general principles for the testing required for the evaluation of breathing 气体 pathways of medical devices.
We support with ISO 18562 compliance across four parts, as shown below. 我们的 laboratories utilize 最先进的设备 such as thermal desorption 气体 chromatography mass spectrometry (GC-MS)，直接进样GC-MS; Inductively coupled plasma mass spectrometry (ICP-MS). to help you achieve global market access.
The key benefits of ISO 18562 testing
- 法规遵从性
- 加强病人安全
- 风险管理
- 全球市场准入
- 质量保证
- 综合分析
- 技术专长和见解
- 有效的审批途径
- 定制测试解决方案
加强病人安全
Enhanced patient 安全ty of breathing 气体 pathway devices involves identifying and mitigating potential hazards like sensitization, 刺激, 毒性, 致癌性, 诱变, 和基因毒性, thereby 安全guarding patient health. This is achieved through a comprehensive risk management framework that offers a structured approach to evaluating and managing risks associated with these devices, ultimately enhancing their 安全ty and reliability.
另外, quality assurance measures play a vital role by ensuring the integrity 和质量 of these medical devices through rigorous testing methodologies and adherence to Good Laboratory Practice (GLP) quality systems, further bolstering patient 安全ty.
利用我们的技术专长
我们的 technical expertise in ISO 18562 testing involves the utilization of industry-leading equipment and highly skilled personnel to conduct thorough analyses. We strictly adhere to ISO 18562 standards to ensure that you have absolute trust in the reliability of our analysis.
我们的 comprehensive analysis covers a wide range of device biocompatibility aspects, such as 可吸入颗粒物 emissions, volatile organic compounds (VOCs), 冷凝物中的可溶物, allowing for a holistic evaluation of product 安全ty. We offer customized solutions through close collaborating to understand your specific testing and compliance needs, tailoring our approach to ensure regulatory requirements are met effectively. 另外, we provide transparent documentation of testing procedures and results to enable stakeholders to evaluate the biocompatibility of the tested product.
ISO 18562-1: Evaluation and testing within a risk management process
A flow diagram of the risk management process is available in our free to 下载 whitepaper titled: ISO 18562 Biocompatibility Evaluation of Breathing Gas Pathways
ISO 18562-2: 测试 for emissions of 可吸入颗粒物
The standard describes testing methodology and acceptance criteria for the quantitation of particles ranging from 0.直径2 μm ~ 10 μm. The acceptable levels of 可吸入颗粒物 generated by respiratory medical devices are based on worldwide published health data.
ISO 18562-3: 测试 for emissions of VOCs
The potential contamination of the 气体 stream in a respiratory medical device due to the presence of VOCs presents a significant risk in terms of patient 安全ty. These compounds often cause 刺激 to the eyes, nose and throat and can have toxic, 致癌, mutagenic and / or genotoxic effects on humans.
ISO 18562-4: 测试 for leachables in condensate
The final part of the standard is only applicable where a medical device has the potential to form a condensate during clinical use.
A simulated use extraction study of the device is performed and any potential inorganic or organic leachables are characterised using a combination of Inductively Coupled Plasma (ICP) and Gas 色谱法-Mass Spectrometry (GC-MS) techniques.
We support your regulatory compliance journey
im体育APP supports your regulatory approval journey through ISO 18562 testing, leveraging a worldwide network of medical device testing laboratories specializing in assessing breathing 气体 pathways for respiratory and ventilation devices and accessories. 我们的 expertise ensures that your medical devices meet the regulatory standards set by organizations like the U.S. FDA and EU MDR, thereby expediting the approval process and minimizing delays to market.
We provide guidance and assistance in navigating the regulatory landscape, helping companies streamline approval procedures. 我们的 comprehensive ISO 18562 studies assess hazards associated with breathing 气体 pathway devices, 包括可浸冷凝物, 可吸入颗粒物, Volatile Organic Compounds (VOCs), ensuring product biocompatibility for medical use and facilitating global market access.
为什么选择im体育APP?
With one of the largest and most experienced Extractables and 可滤取的 testing 世界实践, in addition to unparalleled experience testing a breadth of products that extend from pharmaceuticals, 生物制剂, 和设备, 到消费产品等等, as your regulatory and scientific partner, im体育APP will help you to navigate the most efficient path to regulatory approval.
im体育APP材料技术 分析测试服务 conducts all studies with the highest degree of scientific integrity, under our Quality Management 系统. 我们的 analytical laboratories feature the latest 最先进的设备 that we operate in compliance with Good Laboratory Practice (GLP) quality systems.
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, 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.
看今天Download our ISO 18562 biocompatibility evaluation white paper for free
Learn more about the importance of biocompatibility studies in the R&D stages of medical product development.
We delve into the four parts of ISO 18562 and how effective studies help support product compliance and reduce delays to market.
本白皮书由 迈克·鲁上校 Market 发展 Manager for Extractables & 生命科学的可浸出物 曼彻斯特.
下载Read our blog post in response to the FDA class 1 recall of 2 million medical devices
ISO需求 18562医疗设备测试 has accelerated as the result of class 1 medical device recall (MDR).
The recall involves various types of mechanical ventilators, including bi-level airway pressure (BiPAP) and, continuous positive airway pressure (CPAP).
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欢迎来到曼彻斯特im体育APP
我们的 曼彻斯特实验室 is home to over 50 life science experts dedicated to helping our clients ensure patient 安全ty.
We bring cutting-edge extractable & 可滤取的技术, 最先进的设备, knowledge of regulatory standards to provide high quality analytical data to help you make key decisions on your product.
Your global partner from discovery to market
还在研究? Here are a handful of our many 服务 to help achieve regulatory approval quickly and efficiently.
Extractables and 可滤取的 Studies
我们的 extractables and leachables studies offer tailored solutions that ensure patient 安全ty and compliance with industry standards.
Pharmaceutical and Biopharmaceutical Unknown Identification and Impurity 测试
我们的 experts work closely with customers at every stage of the product lifecycle to identify unwanted compounds and ensure products are pure, 安全, 和质量.
Troubleshooting and Updating Analytical Methods
im体育APP provides troubleshooting and updating analytical methods 服务 to help you achieve more consistent product quality, 更高效的制造, 降低成本，节省资金.
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, 药品容器, enabling you to ensure the quality and 安全ty of your product.
强迫退化研究
元件的强制退化, stress testing 服务 per ICH Q1A guidelines assess the stability of drug substances or drug products with effects on purity, 效力, 病人的安全.
Pharmaceutical Stability Storage and 测试
im体育APP offers advanced pharmaceutical stability testing and ICH storage 服务 to ensure the maintenance of product quality, 安全ty and efficiency throughout the shelf life.
im体育APPal Impurity 测试 and Analysis
im体育APP’s trace metal laboratories provide expert elemental impurities testing and analysis in compliance with USP and ICH Q3D guidelines to ensure the 安全ty of drugs and drug products.
CMC产品开发服务
我们的 CMC product development 服务 include formulation development, parenteral and topical product development, 微生物检测服务, 和咨询公司.