The International Organisation for Standardisation began its work in 1946, aiming to bring together global experts to create international standards for processes such as manufacturing, quality assurance, product safety, and process management. You do not need to have an understanding of all ISO standards, but there are a few that may be applicable to your research, or to technology you are developing. It is also possible to achieve ISO Certification, your technology can be assessed and approved / certified as being in line with the relevant ISO Standards by auditing or regulatory bodies (see in particular, ISO 13485).
It is recommended to include information on any ISOs you will be adhering to within your SOPs. Unfortunately, access to the full standards is not free, but check with your organisation who may be able to provide access to the guidance. It should also be noted that the below ISOs may be the main ISO for a family of related Standards – Make sure to check for any related sub-ISOs that could be useful for your work.
N.B. All ISO Standards are assessed for revision every five years. It is your responsibility to monitor any changes to relevant ISOs that may affect your product or your work.
Below are some examples of ISOs that might be useful for your work:
Other useful ISOs:
These Standards may not directly relate to your work, but could contain useful information (such as particular Terms & Definitions defined within these Standards):
ISO 20417:2021 Medical Devices – Information to be supplied by the Manufacturer.
ISO 15223-1:2021 Medical Devices – Symbols to be used with information to be supplied by the Manufacturer: General Requirements.
ISO 15223-2:2021 Medical Devices – Symbols to be used with medical device labels, labelling, and information to be supplied: Symbol development, selection, and validation.
ISO 10933-1:2018 Biological Evaluation of Medical Devices – Principles of, and evaluation strategies and processes for medical devices. Includes details on risk assessments for biohazards relating to a medical device.
ISO 14971:2019 Application of Risk Management to Medical Devices – Outlines the definitions of terminology, processes, strategies, and principles of risk management for medical devices.
ISO 3864-1:2011 Graphical Symbols – Safety Colours and Safety Signs – Part 1
ISO 7000 Graphical Symbols for use on equipment – Registered Symbols
ISO/IEC 27017:2015 Information Technology – Security Techniques: Code of practice for information security controls.
ISO/IEC 27005:2022 Information security, Cybersecurity and Privacy Protection – Guidance on managing information security risks. Contains useful general information on identifying and managing risks.
ISO 14644-1:2015 Cleanrooms and associated controlled environments (Part 1 of a multi-part ISO)
- Part 1 – Classification of air cleanliness by particle concentration.
- Part 2 – Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration.
- Part 3 – Test Methods
- Part 4 – Design, construction and start-up.
- Part 5 – Operations
- Part 7 – Separative devices (clean air hoods, glove boxes, isolators, and mini-environments).
- Part 8 – Classification of air cleanliness by chemical concentration
- Part 9 – Classification of surface cleanliness by particle concentration.
- Part 10 - Classification of surface cleanliness by chemical concentration.
ISO 14698 Cleanrooms and associated controlled environments – Biocontamination control
- Part 1 – General Principles and methods
- Part 2 – Evaluation and interpretation of biocontamination data
This is a non-exhaustive list of potentially useful ISOs that it could be valuable to read up on, depending on the nature of both your technological innovation and your planned project.
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