From quality management to sterilization of equipment, discover which standards pave the way for a resilient and high-performing medical devices ecosystem.
1. BS EN ISO 13485:2016+A11:2021 Medical devices. Quality management systems. Requirements for regulatory purposes.
BS EN ISO 13485 gives regulatory requirements for medical device quality management systems.
It provides the basis for ensuring consistent design, development, production, installation, and delivery of products that are safe for their intended purpose. It also harmonizes global requirements and is recognized by regulators in many jurisdictions around the world.
To find out more about which standards are supporting medical device manufacturers, visit our Medical Devices topic page.
2. BS AAMI 34971 Application of ISO 14971 to machine learning in artificial intelligence. Guide.
BS AAMI 34971 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.
The benefit of using this standard is that it will help medical AI software developers and medical device manufacturers to identify the hazards relating to AI that need to be considered.
Considered an essential standard in medical devices, BS EN ISO 14971 is the international standard that helps medical device manufacturers establish, document, and maintain a systematic risk management process across all phases of the lifecycle of a medical device. It is recognized by regulatory authorities in the US, Canada, Europe, and more.
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3. BS EN ISO 15223-1:2021+A1:2025 Medical devices. Symbols to be used with information to be supplied by the manufacturer - General requirements.
It is vital for that the information provided on medical devices is correctly understood by every player in the supply chain.
BS EN ISO 15223-1:2021+A1:2025 is the first part of a series of international standards that specifies which symbols should be used to express information supplied for a medical device - both on their packaging and within accompanying information. Its requirements are applicable to symbols used in a broad spectrum of medical devices that are available globally and need to meet different regulatory requirements.
4. BS EN ISO 11137-2:2015+A1:2023 Sterilization of health care products. Radiation - Establishing the sterilization dose
This international standard is the second in a four-part series on the sterilization of heath care products using radiation. BS EN ISO 11137-2:2015+A1:2023 covers how to establish the minimum sterilization dose. Part 1 covers requirements for development, validation, and routine control of a sterilization process. Part 3 gives guidance on dosimetric aspects. Part 4 gives guidance on control of irradiation processes.
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5. BS EN ISO 10993-1:2020 Biological evaluation of medical devices. Evaluation and testing within a risk management process.
A biological evaluation needs to be done before any medical device can interact with the human body. BS EN ISO 10993-1:2020 helps users plan and conduct such biological evaluations reliably and cost-effectively. It provides a framework for planning and conducting biological evaluations of medical devices. The standard was revised in 2020 to minimize the use of test animals by preferring in vitro models and material characterization.
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6. BS EN ISO 11607-1 Packaging for terminally sterilized medical devices - Requirements for materials, sterile barrier systems and packaging systems.
Maintaining sterility is crucial for patient safety, as contaminated medical devices can lead to infections. BS EN ISO 11607-1 plays a vital role in ensuring that sterilized medical devices arrive at the point of use safely and ready for use. This standard sets out the rules for how packaging for these devices must be made and tested to ensure they remain sterile until the point of use.
The recent updates clarify some requirements and adds new test methods. Discover here.
7. BS EN ISO 11607-2 Packaging for terminally sterilized medical devices - Validation requirements for forming, sealing and assembly processes.
It’s critical that medical devices are sterile up to the point of use. BS EN ISO 11607-2:2020+A1:2023 builds upon BS EN ISO 11607-1 by focusing on the validation requirements for forming, sealing, and assembly processes of sterile packaging for terminally sterilized medical devices.
8. BS EN 556-1 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Part 1. Requirements for terminally sterilized medical devices.
Sterile devices are free of viable microorganisms. The BS EN 556 series of sterilization standards define requirements for designating devices as sterile. Parts 1 and 2 of BS EN 556 provide requirements for terminally sterilized devices and aseptically produced devices respectively.
BS EN 556-1 is the European standard specifying requirements for designating a terminally sterilized medical devices, meaning those subjected to a sterilization process that kills all viable microorganisms (bacteria, fungi, viruses, etc.) on and in the device. It has also been adopted in several countries outside Europe, for example, Australia and China.
9. BS EN 556-2 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Requirements for aseptically processed medical devices.
BS EN 556-2:2015 is a British and European standard that details the requirements for aseptically processed medical devices to be designated as "STERILE". As opposed to BS EN 556-1 which focuses on terminally sterilized devices, this standard focuses on those made under sterile manufacturing conditions (aseptic processing) to achieve sterility throughout the production process.
10. BS EN ISO 11135:2014+A1:2019 Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation, and routine control of a sterilization process for medical devices
BS EN ISO 11135:2014+A1:2019 provides the requirements for ethylene oxide sterilization, a common method for sterilizing medical devices. It specifies parameters for process development, validation, and routine monitoring, ensuring sterility assurance and preventing device-related infections. There current version is under review. Find out more here.
Implementing these standards is paramount for medical devices manufactures committed to delivering high-quality and safe products and services. Join the hundreds of organizations adopting best practices by adding the relevant medical devices standards to your collection today.