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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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Why you need the latest amendment to BS EN ISO 15223-1 for your medical devices
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Why you need the latest amendment to BS EN ISO 15223-1 for your medical devices

The BS EN ISO 15223-1 standard has been a fundamental tool for medical device manufacturers, ensuring that devices are appropriately labelled and easily understood across global markets. A recently published amendment to this standard brings critical updates that manufacturers must integrate to stay compliant and continue to benefit from the standard's extensive advantages. An overview of BS EN ISO 15223-1 BS EN ISO 15223-1 Medical devices. Symbols to be used with information to be supplied by the manufacturer - General requirements is a widely recognized standard that specifies the symbols used to convey important information related to medical devices. These symbols are crucial for manufacturers, healthcare professionals, and end-users, particularly in regions with specific language requirements. The symbols standardize how information is presented on medical devices, their packaging, and accompanying documentation, making it easier for users to understand essential details regardless of their language or location. This standard is not only about compliance; it’s about enhancing safety, usability, and the efficiency of communication across the global medical device market. Whether used in clinical settings, integrated into regulatory documentation, or applied in quality management systems, the symbols in BS EN ISO 15223-1 support a broad spectrum of industry needs. To discover more about how standards can help facilitate bringing safe and compliant medical devices to the global market, visit our medical devices topic page. Understanding the key changes in the recent amendment The newly published amendment to BS EN ISO 15223-1:2021+A1:2025 introduces two significant changes that manufacturers need to incorporate: Introduction of a defined term for “Authorized Representative”: the amendment adds a new, clearly defined term for an "authorized representative," which is particularly important for manufacturers operating in regions that require the appointment of such representatives. This addition ensures that the term is universally understood and applied consistently across different jurisdictions. Modification of the EC REP symbol: the amendment modifies the existing EC REP symbol, which previously indicated a European Commission representative. The updated symbol is now more generic, making it applicable in any country or region that mandates the use of an authorized representative. This change is particularly beneficial for manufacturers who distribute their products globally, as it simplifies labelling requirements and reduces the need to create region-specific symbols. The importance of adopting the amended standard For manufacturers who have previously purchased and implemented BS EN ISO 15223-1, understanding the significance of this amendment is crucial. The standard is a key component of regulatory compliance, particularly in regions like the European Union, where it aligns with the Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (EU IVDR). By adopting the amended version - BS EN ISO 15223-1:2021+A1:2025 - manufacturers ensure that their labelling practices remain compliant with current regulations, avoiding potential legal and regulatory challenges. Moreover, the amendment reflects a broader global push towards standardization in medical device labelling. As supply chains become increasingly international, the need for symbols that are universally recognized and understood is more important than ever. The recent updates directly address this need, providing symbols that are not only compliant with the latest regulations but also versatile enough to be used across various jurisdictions. What are the benefits of BS EN ISO 15223-1:2021+A1:2025 BS EN ISO 15223-1:2021+A1:2025 offers a multitude of benefits that extend beyond regulatory compliance. Here’s why this standard remains invaluable to the medical device industry: Global standardization: recognized worldwide, these symbols facilitate international regulatory compliance and market access. Enhanced safety and usability: clear symbols reduce errors and enhance patient safety by conveying critical information effectively across languages. Regulatory compliance: aligns with major regulations (EU MDR, IVDR, US FDA), streamlining market entry and approval. Efficiency in communication: overcomes language barriers, reducing costs associated with multiple labels. Quality management integration: supports consistent labelling, aligning with BS EN ISO 13485 for quality compliance. Cost and time savings: standardized symbols lower production costs and streamline packaging design, freeing up label space. Why you need the amended version If you have already invested in BS EN ISO 15223-1, it’s important to recognize that the recent amendment is not just an optional update but a necessary step to ensure ongoing compliance and relevance. BS EN ISO 15223-1:2021+A1:2025 supersedes the original version, meaning that for regulatory declarations of conformity, the updated version is now required. Without this amendment, your products might fall out of compliance with critical regulations, particularly within the European Union. Moreover, the changes introduced in the amendment reflect a broader move towards global standardization and efficiency in communication. By adopting the amended version, you ensure that your products remain competitive and compliant in a rapidly evolving market. Don’t risk non-compliance or outdated practices. Purchase BS EN ISO 15223-1:2021+A1:2025 today and ensure that your medical devices meet the latest regulatory requirements, enhance safety and remain competitive in global markets.Read more
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.
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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