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ISO 10993 Biocompatibility Parts Reference Table

ISO 10993 is a series, not one document, and teams often cannot remember which part covers cytotoxicity, sensitization or chemical characterization. This reference lists each part with its subject and the situation in which it normally matters.

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Part	Subject	Group	When it matters
ISO 10993-1	Evaluation and testing within a risk management process	Framework	Starting point: defines the biological evaluation process and how to categorize contact
ISO 10993-2	Animal welfare requirements	Framework	Whenever animal studies are considered or commissioned
ISO 10993-3	Tests for genotoxicity, carcinogenicity and reproductive toxicity	Toxicity endpoint	Long-term or implanted contact, or when chemical data raises concern
ISO 10993-4	Selection of tests for interactions with blood	Toxicity endpoint	Devices contacting circulating blood
ISO 10993-5	Tests for in vitro cytotoxicity	Toxicity endpoint	Almost every body-contact device as a baseline endpoint
ISO 10993-6	Tests for local effects after implantation	Toxicity endpoint	Implants and devices with tissue or bone contact
ISO 10993-7	Ethylene oxide sterilization residuals	Sterilization residuals	Any device sterilized with ethylene oxide
ISO 10993-9	Framework for identification and quantification of potential degradation products	Degradation	Devices expected to degrade or corrode in the body
ISO 10993-10	Tests for skin sensitization	Toxicity endpoint	Skin, mucosal and tissue contact devices
ISO 10993-11	Tests for systemic toxicity	Toxicity endpoint	Where leachables could reach the body systemically
ISO 10993-12	Sample preparation and reference materials	Method support	Preparing extracts for any test, choosing extraction conditions
ISO 10993-13	Identification and quantification of degradation products from polymeric medical devices	Degradation	Absorbable or degradable polymers
ISO 10993-14	Identification and quantification of degradation products from ceramics	Degradation	Ceramic implants and coatings
ISO 10993-15	Identification and quantification of degradation products from metals and alloys	Degradation	Metallic implants, corrosion and ion release
ISO 10993-16	Toxicokinetic study design for degradation products and leachables	Degradation	When absorption and distribution data are needed for risk assessment
ISO 10993-17	Establishment of allowable limits for leachable substances	Chemical	Toxicological risk assessment of extractables and leachables
ISO 10993-18	Chemical characterization of medical device materials within a risk management process	Chemical	Material characterization to support or reduce biological testing
ISO 10993-19	Physico-chemical, morphological and topographical characterization of materials	Chemical	Surface and bulk property characterization
ISO 10993-20	Principles and methods for immunotoxicology testing of medical devices	Toxicity endpoint	Where immunotoxicity is a specific concern
ISO/TS 10993-22	Guidance on nanomaterials	Chemical	Devices containing or releasing nanomaterials
ISO 10993-23	Tests for irritation	Toxicity endpoint	Irritation assessment, including in vitro approaches

Which endpoints are required for your device depends on the nature and duration of body contact, your risk assessment and the regulator's expectations. This table lists what each part covers, it does not decide your test plan. Check current editions and any FDA guidance on the use of ISO 10993-1.

Optional review of your biological evaluation workflow

We can look at how material and supplier changes reach your biological evaluation review.

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How to use it

Search by endpoint word (such as sensitization or blood), by part number or by group. Use the When it matters column to confirm that a part is relevant before you buy it or specify a test. Export the list to Excel and add columns for your device, the decision (test, justify, not applicable) and the report reference to form the skeleton of a biological evaluation plan.

Search by endpoint or part number
Group column separates endpoints from method support
Export and add your own decision and report columns

The logic behind the series

Part 1 puts biological evaluation inside the risk management process. Devices are categorized by the nature of body contact and its duration, and that categorization guides which biological effects to consider. Many effects can now be addressed with chemical characterization (Part 18) and toxicological risk assessment (Part 17) rather than by animal testing, which is why those parts are widely used in modern plans.

Worked example

A single-use polymer surgical instrument that touches tissue briefly and is sterilized with ethylene oxide would normally start from Part 1 for categorization, use Part 12 for extract preparation, include Part 5 for cytotoxicity, Part 10 for sensitization and Part 23 for irritation as justified, and address EO residuals under Part 7. Material chemistry data from Part 18 can support the case for omitting other tests.

Common mistakes

Typical problems are testing every endpoint by habit without a rationale, citing superseded editions, changing a material or supplier without reassessing the evaluation, and forgetting that sterilization residuals and aging can change the biological profile. Treat the biological evaluation as a living part of the risk file and link it to design change control.

Frequently Asked Questions

Which ISO 10993 parts do I need for every device?

There is no fixed list. Part 1 is the starting point and the endpoints you address depend on body contact category, duration and your risk assessment. Cytotoxicity is the endpoint most commonly considered for devices that touch the body.

Why are some parts missing?

Some numbers were withdrawn or are not part of the series. Part 8 was withdrawn, and not every number has been published. Always check the current catalogue of the issuing body for the full list.

Can chemical characterization replace biological testing?

In some cases it can reduce or justify omitting tests, provided the characterization and toxicological risk assessment are adequate and the regulator accepts the rationale. It is a decision documented in the evaluation, not an automatic substitution.

Does FDA accept the same endpoints as EU MDR?

Both reference ISO 10993-1, but FDA publishes its own guidance on its use and may expect specific endpoints or presentations. Review current FDA guidance and your notified body expectations for your device.

If supplier material changes are not triggering your biological evaluation review, Netray can talk through connecting ERP material and supplier change records to your change control.

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