---
type: "WebPage"
title: "Biological evaluation of medical devices according to ISO 10993-1 in the laboratory"
description: "You wish to carry out a biological evaluation of your medical devices according to ISO 10993-1 Ensure the biocompatibility of your medical devices with ISO 10993-1 Ensuring the biological safety of your medical devices is an essential regulatory requirement.Defining a..."
resource: "https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/biological-evaluation-iso-10993-1/"
tags: ["EN", "pll_69c5005e2f6d8"]
timestamp: "2026-03-30T14:07:56Z"
published: "2026-03-26T10:28:45Z"
language: "en"
author: "Laure Durieux"
---

# Biological evaluation of medical devices according to ISO 10993-1 in the laboratory

## You wish to carry out a biological evaluation of your medical devices according to ISO 10993-1

### Ensure the biocompatibility of your medical devices with ISO 10993-1

Ensuring the biological safety of your [medical devices](https://filab.fr/en/sectors-of-activity/laboratory-analysis-medical-devices.md) is an essential regulatory requirement.
Defining a biological evaluation strategy is a key step in identifying risks related to materials, [released substances](https://filab.fr/en/our-services/our-expertise-services/laboratory-extractable-leachable-testing.md), and patient contact.

ISO 10993-1 provides the framework for this process by defining the overall approach to evaluating the biocompatibility of medical devices. It is based, in particular, on the analysis of biological risks and the selection of appropriate tests according to the nature and use of the device.

At FILAB Laboratory, we support you with partner toxicologists in defining and implementing your biological evaluation strategy, in accordance with the requirements of ISO 10993-1, to demonstrate the [biocompatibility](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing.md) of your medical devices and ensure the integrity of your regulatory dossier.

### Principle of biological assessment according to ISO 10993-1

**ISO 10993-1 does not define a single test**, but rather an approach based on biological risk analysis.

The objective is to **determine which tests are necessary based on several criteria**:

- nature of the materials
- type of contact with the human body
- duration of contact (limited, prolonged, or continuous)
- device characteristics

This analysis then allows for the development of a testing strategy tailored to the medical device.

### Our other analytical services according to ISO 10993

[Determination of sterilization residues using ETO according to ISO 10993-7](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/determination-of-sterilization-residues-by-eto-according-to-iso-10993-7.md)

[Validation of the completeness of an extraction method according to ISO 10993-12](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/laboratory-exhaustiveness-verification-iso-10993-12.md)

[Study of degradation products in your medical devices according to ISO 10993-15](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/study-of-degradation-products-in-your-medical-devices-according-to-iso-10993-15.md)

[Characterization of nanomaterials according to ISO 10993-22](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-nanomaterial/laboratoty-iso-10993-22-nanomaterial-characterization.md)

[Cytotoxicity testing according to ISO 10993-5 in the laboratory](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/cytotoxicity-testing-iso-10993-5.md)

[chemical characterization  according to ISO 10993-18 ](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/laboratory-material-chemical-characterization.md)

[ISO 10993 9 analysis](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/identification-and-quantification-of-degradation-products-according-to-iso-10993-9/)

[Genotoxicity, carcinogenicity, and toxicity testing according to ISO 10993-3](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/genotoxicity-carcinogenicity-toxicity-testing-iso-10993-3.md)

[Toxicological evaluation of leachable substances according to ISO 10993-17](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/toxicological-evaluation-of-leachable-substances-according-to-iso-10993-17.md)

[ISO 10993-13 medical device testing](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/iso-10993-13-medical-devices-characterization.md)

[Characterization of your medical devices according to ISO 10993-19](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/medical-device-characterization-in-a-laboratory-iso-10993-19.md)

[Identification and quantification of degradation products on ceramic medical devices according to ISO 10993-14](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/identification-and-quantification-of-degradation-products-on-ceramic-medical-devices-according-to-iso-10993-14.md)

## The FILAB laboratory performs biological evaluation of your medical devices according to ISO 10993-1

### Why choose FILAB for the biological evaluation of your medical devices according to ISO 10993-1

With the support of a partner laboratory, FILAB assists you in conducting biological evaluation of your medical devices according to ISO 10993-1, in addition to chemical characterization tests (ISO 10993-18).

In France, within the medical device sector, FILAB is one of the few laboratories to offer you a comprehensive 5,200 m² analytical facility for physicochemical analyses within the framework of the biological evaluation of your medical devices.

Our human size, our permanent investments and our knowledge of the medical devices sector guarantee to our customers a **reliability of the results**, a **fast treatment** of the requests and a **tailor-made support of their needs**.

### Our other analytical services

[R&D support](https://filab.fr/en/our-services/rd/rd-support/): custom [chemical analysis](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-nitrosamines/laboratory-analysis-biomedicine.md),[material and surface characterization](https://filab.fr/en/our-services/our-analysis-services/laboratory-analysis-composite-material/), [analytical development](https://filab.fr/en/our-services/rd/life-cycle-of-an-analytical-method-in-the-laboratory/analytical-development/)

Process validation: [Cleaning](https://filab.fr/en/our-services/our-expertise-services/laboratory-analyis-standard-iso-19227.md) (ISO 19227), [surface treatment](https://filab.fr/en/our-services/our-analysis-services/laboratory-surface-characterization/laboratory-analysis-expertise-surface-treatment.md)

[Problem solving](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-failures.md): non-conformity,[breakage](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-failures/laboratory-analysis-ruptures.md), adhesion,[corrosion...  ](https://filab.fr/en/our-services/our-expertise-services/laboratory-analysis-deposit-contamination/laboratory-expertise-and-analysis-of-corrosion.md)

## Our FAQ

 To which medical devices does the ISO 10993-1 standard apply?
ISO 10993 applies to a wide range of medical devices:

- implantable devices
- surgical devices
- devices in contact with the skin or mucous membranes
- devices in contact with blood
- materials or components used in medical devices.

 What is the biological evaluation of a medical device?
Biological evaluation involves analyzing the potential risks a medical device may pose to the patient during use. Its aim is to demonstrate that the materials and substances present in the device are biocompatible and safe for the body.

This process is governed by ISO 10993-1, which defines the overall approach to the biological evaluation of medical devices.

 Which medical devices are subject to biological evaluation?
This approach applies to the majority of medical devices, particularly those that come into contact with the human body:

- implantable devices
- evices in contact with the skin or mucous membranes
- devices in contact with blood
  surgical
- instruments
  components or materials used in medical devices

The requirements depend primarily on the type and duration of contact with the body.

 Does biological evaluation include chemical characterization?
Yes. Chemical characterization of materials is an important step in biological evaluation.

It allows, in particular:

- the identification of extractable and leachable substances
- the detection of impurities or manufacturing residues
- the assessment of toxicological risks associated with the identified compounds

This information helps guide the biological testing strategy.

 Is biological evaluation mandatory for placing on the market?
Yes. Biological evaluation is one of the regulatory requirements for placing medical devices on the market, particularly under the European regulation:

Regulation (EU) 2017/745 (MDR)

It demonstrates that the medical device does not present an unacceptable biological risk to the patient.

 When should the biological assessment be carried out?
Biological evaluation can be performed at different stages:

- during the development of a medical device
- during a modification of the material or process
- as part of a regulatory assessment
- during a re-evaluation of an existing device

This approach helps to anticipate risks and ensure safe market access.

 How to get a quote from FILAB?
To obtain a quote, you can contact our team via our contact form, by phone, or by email.

Simply tell us your requirements (type of material, desired analysis, applicable standards, urgency, quantity of samples, etc.). We will then send you a personalized technical and pricing proposal within 24-48 hours.

 What is the typical duration of the analysis?
Turnaround times vary depending on the nature of the analysis and the complexity of the expert assessment project.

However, FILAB is committed to providing fast turnaround times tailored to your industrial constraints and urgent needs.