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The aim of medical device standards is to ensure patient safety whilst supporting timely market access to global medical device technology. We strive to set the global standard in thorough, responsive, robust conformity assessments that are recognized and trusted worldwide. We understand the challenges medical device manufacturers face in bringing compliant products to market efficiently and safely, so develop medical device standards to support them.

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How to tackle hazards in AI medical devices using BS AAMI 34971
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How to tackle hazards in AI medical devices using BS AAMI 34971

As AI becomes a more prevalent technology in medical devices it’s become clear that the associated risks need special consideration. This article charts the development history of a new, jointly produced document that answers this emerging need. Artificial intelligence (AI) has a strong role to play in healthcare and medical devices. It can improve clinical outcomes as well as efficiency and healthcare management. That said, it can also bring its own unique risks that can jeopardize patient safety or increase inefficiency. Recognizing the issues, BSI, the US Standards Development Organization and the Association for the Advancement of Medical Instrumentation (AAMI) have worked together to develop guidance on the use of AI as a medical technology. Initially we held a series of joint workshops with stakeholders in the US and UK and two whitepapers were published on the topic. One of the key outcomes from this work was a recommendation to develop “risk management guidance to assist in applying BS EN ISO 14971 to AI as a medical technology”. BS EN ISO 14971: Risk management guidance BS EN ISO 14971 is the established international standard that provides a methodology for assessing and managing the risks associated with medical devices. It’s been recognized by medical device regulators and adopted as a national standard in countries around the world. It has become the global standard used by medical device manufacturers and regulators to govern risk management – so it made sense to use it as the foundation of the new work.    It was then agreed that the new standard on applying BS EN ISO 14971 to medical technology with AI should be jointly developed and published by BSI and AAMI. A BSI drafting panel worked in conjunction with an AAMI drafting panel to agree on a common text for publication by AAMI and BSI. For simplicity purposes, BSI is publishing this joint work as a British Standard in the UK and AAMI is delivering a Technical Information Report (TIR) for the US market. The culmination of this work in the UK is the British Standard now available as BS/AAMI 34971:2023 Application of ISO 14971 to machine learning in artificial intelligence. Guide. Incidentally, the ambition all along has been for this guidance to become the basis of ISO/IEC guidance on risk management of AI as a medical technology in the future – so it’s been written with that in mind. Also it may be the first of a series of jointly developed work items by AAMI and BSI.   What’s in BS/AAMI 34971?  BS/AAMI 34971 provides guidance on applying a BS EN ISO 14971 risk management process to the evaluation of medical technology using artificial intelligence, and in particular, machine-learning. It tackles how hazards already identified in BS EN ISO 14971 could affect the safety and effectiveness of medical technology incorporating machine-learning AI. It also provides examples, suggests strategies for eliminating or mitigating the associated risk and explores additional unique or emergent hazards/hazardous situations. It’s important to state that BS/AAMI 34971 doesn’t modify the risk management process—rather it provides information and guidance to inform the application of BS EN ISO 14971 to AI/ML medical technology. What are the benefits of using BS/AAMI 34971? The benefit of using the standard is that it will help medical AI software developers and medical device manufacturers to identify the particular hazards relating to AI that need to be considered.  This will ultimately make devices more compliant and safer, plus it will help manufacturers to: enter new markets innovate more quickly develop their expertise and efficiency increase market confidence in their devices.  Ensure you are managing the AI risks in your medical devices by adding BS/AAMI 34971 to your collection today. Discover BSI Knowledge Over 100,000 internationally recognized standards are available for simple and flexible access with a BSI Knowledge subscription. Build your own custom collection of standards or opt for access to one of our pre-built modules and keep up to date with any relevant changes to your standards strategy. Request to learn more.Read more
How to plan and conduct a world-class IVD clinical performance study with BS EN ISO 20916
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How to plan and conduct a world-class IVD clinical performance study with BS EN ISO 20916

Would you like to conduct world-class clinical performance studies for IVD devices? To support you, we’ve published BS EN ISO 20916:2024. In the fast-evolving field of in vitro diagnostic (IVD) medical devices, ensuring that clinical performance studies meet international standards is crucial for manufacturers. The publication of BS EN ISO 20916:2024 In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice provides a comprehensive framework for planning, designing, conducting, recording, and reporting these studies. This international standard is now more relevant than ever, especially for those looking to export their products to the European Union (EU). What’s the importance of BS EN ISO 20916 for IVD manufacturers? BS EN ISO 20916 offers significant benefits to IVD manufacturers by helping them: Plan high-quality clinical performance studies: the standard provides detailed guidelines on the necessary steps to ensure that studies are robust and scientifically valid. Conduct rigorous clinical performance studies: by adhering to this standard, manufacturers can ensure their studies are thorough and adhere to recognized industry best practices. Maintain high ethical standards: the standard emphasizes the importance of protecting the rights, safety, and well-being of patients who provide specimens for studies. Produce accurate and reliable data: it ensures that the data generated from studies is trustworthy and can be used to make informed healthcare decisions. At its core, BS EN ISO 20916 is designed to help ensure that IVD medical devices are both safe and effective. This is crucial for maintaining trust in these devices and for protecting patients. Discover how our medical device standards support manufacturers bring safe and reliable products to the market, by visiting our Medical Devices topic page. New amendments: Annex ZA and the EU IVDR One of the key updates in BS EN ISO 20916:2024 is the inclusion of Annex ZA. This new annex clarifies the relationship between the standard and the EU In Vitro Diagnostic Regulation (IVDR) 2017/746. For manufacturers in the UK and elsewhere who aim to commercialize their IVD products in Europe, understanding and complying with the IVDR is essential. Annex ZA helps bridge this gap by mapping the requirements of the standard to the General Safety and Performance Requirements of the EU regulation. Understand the benefits of adopting BS EN ISO 20916 For IVD manufacturers looking to conduct world-class clinical performance studies, BS EN ISO 20916:2024 is an indispensable resource. It provides clear guidelines on every aspect of the study process, from planning and design to reporting and compliance. Some of the other benefits manufacturers might experience from implementing this standard include: Risk mitigation By following this standard, manufacturers can better mitigate risks associated with clinical performance studies. This includes ensuring the safety of subjects and maintaining the integrity of the data collected. Regulatory compliance The standard provides a voluntary means for manufacturers to demonstrate conformity with the essential requirements of the EU IVDR, streamlining market entry and compliance processes. Ethical considerations BS EN ISO 20916:2024 emphasizes high ethical standards, ensuring that patients are treated with respect and that their rights and well-being are protected throughout the study. Reliable and robust results The standard helps ensure that studies produce high-quality, accurate, and reliable data, which is essential for making safe healthcare decisions. To ensure your IVD medical devices meet the highest standards of safety and effectiveness, and to navigate the regulatory landscape with confidence, get your copy of BS EN ISO 20916:2024 today.
BS EN ISO 17665: Discover the best practice for the moist heat sterilization of healthcare products
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BS EN ISO 17665: Discover the best practice for the moist heat sterilization of healthcare products

If you are involved with the sterilization of healthcare products, then you need to know about the publication of BS EN ISO 17665:2024 Sterilization of health care products. Moist heat. Requirements. This newly revised international standard consolidates three previous sterilization standards (BS EN ISO 17665-1:2006, DD CEN ISO/TS 17665-2:2009, and PD ISO/TS 17665-3:2013) into one comprehensive document, providing an all-encompassing guide for the development, validation, and routine control of moist heat sterilization processes. For healthcare manufacturers, adopting this standard early can offer numerous advantages, even before it is harmonized to European regulations. Understanding the requirements of BS EN ISO 17665 BS EN ISO 17665:2024 sets forth stringent requirements and extensive guidance for moist heat sterilization. It aims to ensure that sterilization processes are robust, reproducible, and effective in eliminating microbiological contaminants. This standard encompasses every stage of the sterilization process, including: process and product design and development; validation of the process; routine monitoring; documentation control; management responsibility; resource provisioning; external product control; product traceability; and non-conforming product control. Additionally, the standard includes detailed guidance on modern sterilization principles, microbiological and physical process development, and examples of effective sterilization methods.  To learn more about our suite of healthcare standards, visit our Healthcare topic page. What are the benefits of adopting BS EN ISO 17665? Although BS EN ISO 17665:2024 is not yet harmonized, healthcare product manufacturers should not delay reviewing the requirements and beginning the implementation process.: Ensuring patient safety By aligning with the most up-to-date sterilization practices, manufacturers can ensure that their devices meet the required safety standards, thereby protecting patients from infections and complications. Streamlining operations Consolidating three standards into one simplifies compliance efforts and operational processes. This unified approach can increase efficiency and reduce the complexity associated with adhering to multiple standards. Staying ahead of regulatory changes Familiarizing your team with the latest requirements and innovations in sterilization now will ensure your products are following industry best practices, giving you a marketing advantage. Early adopters will be better prepared to meet regulatory demands without a rushed implementation. Increasing risk management The comprehensive nature of BS EN ISO 17665 aids in identifying potential risks and implementing robust control measures. This proactive approach can mitigate the chances of sterilization failures, ensuring consistent and reliable outcomes. Take the proactive step towards enhancing patient safety, streamlining operations, and preparing for future regulatory requirements. Get your copy of BS EN ISO 17665:2024 today.
Stopping the health hackers: Achieve digital trust in AI medical devices with BS EN ISO/IEC 27002
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Stopping the health hackers: Achieve digital trust in AI medical devices with BS EN ISO/IEC 27002

Artificial intelligence (AI) has the potential to rapidly aid progress in the performance of medical devices. Yet, as the technology becomes ever more complex, questions of cybersecurity and trust arise. To ensure the safety of healthcare organizations, providers, and patients, it is more important than ever for manufacturers to implement advanced security controls into their medical devices. AI holds enormous promise for streamlining medical diagnostics, managing patient and clinical data, and contributing to research and development of medical devices. Recent developments have seen AI outperform expert radiologists at spotting breast cancer amongst other diagnostic successes. This has sparked an increase in investment in such technologies that is set to continue to grow significantly in the coming years. While there is significant potential for AI in healthcare, there are also limitations. The primary challenge is how best to secure AI-powered connected medical devices from increasingly frequent and complex cybersecurity risks. Cybersecurity and AI Medical Devices: What’s the risk? Taking greater cybersecurity measures to protect medical devices is more important now than ever. For more than a decade, healthcare has been the largest target for data breaches. Breaches of data in this context can have severe implications, as patients’ lives can be in danger from outdated and unprotected medical devices. For example, a 2019 study from Ben-Gurion University demonstrated how hackers could manipulate CT and MRI results of lung cancer patients – gaining complete control over the number, size, and location of tumours. Both radiologists and AI algorithms were unable to differentiate between the altered and correct scans. In the age of the Internet of Things (IoT), cybersecurity risks also stem from the fact that a multitude of medical devices – including ‘smart’ pacemakers and insulin pumps – are now increasingly connected to the Internet. This makes them extremely vulnerable to attacks. This kind of ‘health hacking’ has the potential to impact patient lives, and can also result in insurance fraud, ransomware attacks and other issues for both patients and healthcare providers. However, there are steps medical device manufacturers can take to protect their devices. Discover how our standards support medical device manufacturers bring compliant products to market efficiently and safely by visiting our ‘Medical Devices Topic Page’. Take control of cybersecurity vulnerabilities with BS EN ISO/IEC 27002 The key to ensuring AI-enabled medical devices are secure lies in taking complete control. Restricting and preventing access to a system is a critical step in protecting systems from cyber risks. A newly revised international cybersecurity standard can help manufacturers to determine and implement the latest security controls to manage the information security risk of their medical devices. BS EN ISO/IEC 27002:2022 Information technology, cybersecurity and privacy protection—Information security controls gives you the latest comprehensive list of internationally recognized information security controls. It helps manufacturers identify the different areas of security risk for their products and implement the appropriate controls to mitigate that risk. In the revision of this standard, the security control guidance was consolidated and modernized to reflect the evolvement of technologies and practices including threat intelligence, information security for use of cloud services, and data leakage prevention. The implementation of the BS EN ISO/IEC 27002 security control guidance enables manufacturers to build effective barriers to entry - such as logins and passwords - to ensure that only those who are authorized to have access can see the data from the device areable to maintain continuous control over their information security, despite the nature of cyberattacks changing. To learn more about the scope of BS EN ISO/IEC 27002, read our article ‘The 4 pillars of control: A modern approach to information security controls’. Digital trust and the benefits of ISO/IEC 27002 As the application of AI medical devices is only set to increase, manufacturers can reap the benefits of demonstrating their commitment to information security. BS EN ISO/IEC 27002 can help medical device manufacturers to: Identify and select controls that are appropriate and proportionate to the risks faced by their AI medical devices Increase the resilience of their medical device information security Show patients and healthcare providers that their information security management is world-class, improving digital trust and possibly the demand for their medical devices Strengthen their risk management and reduce the likelihood of information security breaches By prioritizing digital trust and implementing effective information security controls, manufacturers can drive the future of the use of AI in medical devices and be the transformative force within the sector for the benefit of patients and healthcare providers alike. Achieve digital trust in your AI medical devices by adding BS EN ISO/IEC 27002 to your collection today.

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