Overview

The multi-part series governing biological evaluation (biocompatibility) of medical devices. Part 1, the framework document, was revised in 2025 as its sixth edition, reorganised to align with ISO 14971 and replacing ISO 10993-1:2018.

ISO 10993 is a multi-part series covering the biological evaluation of medical devices — what is commonly called biocompatibility. Part 1 is the framework document: ISO 10993-1:2025, Requirements and general principles for the evaluation of biological safety within a risk management process. It is the sixth edition and replaces ISO 10993-1:2018. The remaining parts specify how individual biological endpoints are assessed.

Part 1 applies to any medical device that comes into direct or indirect contact with the body, including implantable devices, surface-contacting devices, externally communicating devices, and protective items such as gloves and masks. Its central mechanism is categorisation by nature and duration of contact: devices are classified by the type of body contact (surface, externally communicating, implant) and by contact duration (limited, prolonged, long-term), and the categorisation drives which biological endpoints must be addressed.

The 2025 edition was completely reorganised to align with ISO 14971, the medical device risk management standard. Biological evaluation is treated as part of the risk management process rather than as a standalone test programme: the manufacturer identifies biological hazards, evaluates the associated risks using existing data where it exists, and generates new data only where a gap remains. The edition adds guidance on exposure duration, on materials characterisation, and on identification of biological hazards; terminology has been updated, and new annexes explain the rationale for the changes.

A recurring theme across recent revisions of the series is that testing is the last resort, not the first step. The expected sequence is to characterise the materials and the manufacturing process, gather existing data on the materials and any chemical constituents, perform a toxicological risk assessment of identified constituents, and only then conduct biological testing for endpoints that remain unresolved. This is also what reduces unnecessary animal testing, which the series explicitly seeks to minimise.

The other parts of the series cover the endpoints and supporting methods. Among them are animal welfare requirements; genotoxicity, carcinogenicity and reproductive toxicity; interactions with blood; cytotoxicity; local effects after implantation; residuals from sterilisation processes; ethylene oxide sterilisation residuals; irritation and skin sensitisation; systemic toxicity; sample preparation and reference materials; degradation products; toxicological risk assessment of medical device constituents; and chemical characterisation of materials. Individual parts are revised on their own cycles, so the applicable edition for each endpoint must be checked separately — for example, ISO 10993-17:2023 covers toxicological risk assessment of constituents and ISO 10993-4:2017 received Amendment 1 in 2025.

ISO 10993 is not a certifiable standard. There is no biocompatibility certificate. Conformity is demonstrated through a biological evaluation plan and report held in the device's technical documentation, assessed by notified bodies under EU MDR and IVDR and reviewed by regulators such as the FDA during premarket submission. The testing itself is normally performed by laboratories accredited to ISO/IEC 17025 and operating to Good Laboratory Practice; accreditation applies to the laboratory, not to the device manufacturer.

The series interlocks tightly with the rest of the medical device standards set: ISO 14971 supplies the risk management process the 2025 edition is built around, ISO 13485 requires that risk management to be applied throughout product realization, and related standards such as ISO 18562 (biocompatibility of breathing gas pathways) apply the same logic to specific applications.

Purpose

To establish the general principles and requirements for evaluating the biological safety of medical devices within a risk management process, and — through the other parts of the series — to specify the test methods and evaluation approaches for the individual biological endpoints.

Key Benefits

• Provides the internationally accepted framework for demonstrating biological safety of devices
• Categorisation by nature and duration of contact determines the endpoints required
• The 2025 edition integrates biological evaluation directly into ISO 14971 risk management
• Prioritises material characterisation and existing data over new testing
• Reduces unnecessary animal testing through a risk-based evaluation sequence
• Accepted by notified bodies under EU MDR and IVDR and by regulators worldwide
• Covers protective equipment and surface-contacting products as well as implants
• Individual parts give detailed, comparable methods for each biological endpoint

Key Requirements

• Categorise the device by nature of body contact and duration of contact
• Plan the biological evaluation as part of the ISO 14971 risk management process
• Characterise the materials of construction, including processing aids and residuals
• Identify biological hazards arising from the materials, manufacturing process and use
• Gather and evaluate existing data on materials, constituents and equivalent devices
• Perform toxicological risk assessment of identified chemical constituents where applicable
• Determine which biological endpoints remain unaddressed and require testing
• Conduct testing to the relevant parts of the series using appropriately qualified laboratories
• Evaluate residual biological risk and its acceptability within the risk management file
• Consider the effect of manufacturing, sterilisation and ageing on biological safety
• Reassess biological safety when materials, suppliers, processes or sterilisation methods change
• Document the evaluation in a biological evaluation plan and biological evaluation report

Who Needs This Standard?

Medical device and in vitro diagnostic manufacturers whose products contact the body, materials and component suppliers into the sector, contract manufacturers, sterilisation providers, and the regulatory affairs, R&D, materials and toxicology functions that assemble biological evaluation reports. Contract testing laboratories and notified body reviewers use the series as the basis for testing and assessment.

Related Standards