Common Standards FAQ

Q: What are ISO and IEC standards for MedTech?

A: ISO (International Organization for Standardization) and IEC (International Electrotechnical Commission) standards are globally recognized frameworks that assist medical device manufacturers in complying with the current State of the Art (SoTA), international best practices, improving patient safety, and meeting legal and industry requirements. ISO standards focus on materials, processes, and testing compliance, while IEC standards centre on product manufacturing and testing, particularly in the electrical and electronic domains.

Q: Why are ISO standards important for manufacturers?

A: ISO standards are crucial for medical device manufacturers as they provide a roadmap on how to produce medical devices that meet the current SoTA, assures safety-performance profile (also known as benefit-risk of a product category) and ensure compliance with regulatory requirements. These standards are widely accepted by regulatory bodies like the US Food and Drug Administration (FDA) and the European Union. Adhering to ISO standards is seen as a benchmark for producing and proving compliance to the SoTA and is considered the gold standard in the industry for regulatory approvals.

Q: What are harmonised standards?

A: Harmonised standards are international standards that have been adopted and recognized by the European Union (EU) to standardize products and laws among member states. These standards are a prerequisite for CE marking, demonstrating adherence to fundamental requirements of general safety and performance (GSPR) required by the European Medical Device Regulations (EU MDR). Harmonised standards are officially declared in the Official Journal of the European Union (OJEU) and are important for market access within the EU.

Q: How do you determine which standards are applicable?

A: The applicability of standards depends on various factors, including device classification, product category, technology deployed, and device features. Manufacturers need to review the classification, features, and intended use of their devices to identify the relevant standards that ensure compliance to performance and safety.

As a starting point, manufacturers need to formulate their clinical development plan (CDP). That will define the intended purpose, intended use, indication, classification, WET checklist, etc to identify applicable standards and match it with the GSPRs to make up the harmonised and common standards applicable for your device in the CDP. This is not mandatory in the CDP, but it is the only document that provides strategic alignment between departments. Specifically for ISO standard selection, it enables alignment between engineering ISO validation testing, clinical trial compliance with ISO 14155:2020 and regulatory requirements that is a strategic best practice. This provides a much needed overview of work required across departments to enable effective project resource planning. This makes the process of conformity far clearer.

Q: What are the most common standards for medical devices and IVDs?

(Harmonised) EN ISO 11737-1:2018: Sterilization of health care products – Microbiological methods.
(Harmonised) EN ISO 11737-2:2019: Sterilization of health care products – Microbiological methods.
EN ISO 13408-6:2021: Aseptic processing of health care products – Part 6: Isolator systems.
(Harmonised) EN ISO 25424:2018: Sterilization of health care products – Low temperature steam and formaldehyde.
(Harmonised) EN ISO 14160:2021: Sterilization of health care products – Liquid chemical sterilising agents for single-use medical devices.
ISO 9001:2015: Quality Management Systems – Requirements.
(Harmonised) ISO 13485: Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes.
ISO 14971: Medical Devices – Application of Risk Management to Medical Devices.
ISO 15223: Medical devices — Symbols to be used with information supplied by the manufacturer.
(Harmonised) ISO 10993: Biological Evaluation of Medical Devices.
(Harmonised) ISO 11135: Sterilization of health-care products — Ethylene oxide.
ISO 11137: Sterilization of health care products — Radiation.
ISO 11607: Packaging for terminally sterilised medical devices.
(Harmonised) IEC 60601: Medical Electrical Equipment.
IEC 62304: Medical Device Software– Software Life Cycle Processes.
(Harmonised) ISO 17664: Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices.
ISO 14001:2015: Environmental management systems.
ISO 50001: Energy management.
ISO 11073: Health Informatics — Device interoperability.
ISO 14155: Clinical investigation of medical devices for human subjects — Good clinical practice.
ISO 15194: In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin.
ISO 16142: Medical devices — Recognized essential principles of safety and performance of medical devices.
ISO 18113: In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling).
ISO 19001: In vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology.
ISO 20417: Medical devices — Information to be supplied by the manufacturer.
ISO 20916: In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice.
ISO 24971: Guidance on the application of ISO 14971.
IEC 62366: Medical devices — Application of usability engineering to medical devices.
IEC 80001: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software.

Q: What is the difference between US and EU requirements?

A: In the US, manufacturers are typically required to adhere to the standard that was in place when the device was approved, and there is no necessity to stay up to date unless there have been design changes.

However, in the EU, manufacturers are required to adhere to the most recent versions of relevant standards as they become available. Compliance with harmonised standards is especially vital for market access in the EU.

Q: Why comply with ISO standards?

A: Adhering to common standards provides a validated roadmap how to produce and test device in the medical industry medical devices and IVDs. If you use an ISO standard it provides a ‘no questions asked’ assurance of meeting the SoTA, and that the product meets the current expectations of quality, safety, and efficacy. These standards not only aid in compliance with regulatory requirements but also contribute to improving patient safety, streamlining processes, and fostering trust and credibility within the industry.

Manufacturers should remain updated with the latest standards to ensure their devices continue to meet the SoTA as this is a moving target due to technology updates and vigilance data (real world safety and performance data on device categories) that inform the ISO requirement revisions.