---
type: "WebPage"
title: "Study of degradation products in your medical devices according to ISO 10993-15"
description: "As a medical device manufacturer, you want to conduct a degradation products study of your medical devices according to ISO 10993-15 Identification of degradation products The materials used to manufacture medical devices may generate degradation products when exposed to their..."
resource: "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/"
tags: ["EN", "pll_627e2f487cc4d", "Anaïs DECAUX"]
timestamp: "2026-08-25T05:43:26Z"
published: "2022-06-15T14:07:55Z"
language: "en"
author: "bwa"
---

# Study of degradation products in your medical devices according to ISO 10993-15

## As a medical device manufacturer, you want to conduct a degradation products study of your medical devices according to ISO 10993-15

### Identification of degradation products

The materials used to manufacture medical devices may generate degradation products when exposed to their biological environment. The FILAB laboratory conducts degradation products studies of medical devices according to ISO 10993-15. 

In this context, it is important to ensure that their level of tolerability is suitable for the safety of certain medical devices. To achieve this, investigations must be carried out to identify and quantify them.

### What does ISO 10993-15 specify?

The [ISO 10993-15](https://www.iso.org/fr/standard/68937.html) standard sets out the general principles for evaluating and designing degradation studies of materials used in medical devices. “Degradation” here means “decomposition of the material.” It deals exclusively with degradation products from metals and alloys. The FILAB laboratory supports you in conducting degradation products studies of medical devices according to ISO 10993-15.

The method used to evaluate degradation varies according to several factors:

- the nature of the material being studied,
- the medical device,
- its anatomical location

## The FILAB laboratory supports you in conducting your medical device degradation products study according to ISO 10993-15

### Why choose FILAB?

Two complementary standards to ISO 10993-15, specifically covering non-resorbable materials, describe these conditions:

- [ISO 10993-13: Identification and quantification of degradation products from **polymer-based** medical devices](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/iso-10993-13-medical-devices-characterization.md)
- [ISO 10993-14: Identification and quantification of degradation products from **ceramics**](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)

**FILAB is the only laboratory accredited by COFRAC to ISO 17025 for all THREE material degradation tests: metals, polymers and ceramics.  **

### Our medical device testing services

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

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

[Testing laboratory 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)

[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)

[Genotoxicity, carcinogenicity and toxicity tests 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)

[Preparation of samples and reference materials according to ISO 10993-12](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/laboratory-exhaustiveness-verification-iso-10993-12.md)

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

[Biological Evaluation of Medical Devices According to ISO 10993-1](https://filab.fr/en/our-services/our-expertise-services/laboratory-biocompatibility-testing/biological-evaluation-iso-10993-1.md)

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

Our human scale, ongoing investments and knowledge of the medical device sector guarantee our clients **reliable results**, **fast processing** of requests and **tailored support** to meet their needs.