Skip to main content

ISO 10993 Standard

ISO 10993 is a series of standards created to assess the biocompatibility of medical devices, ranging from dental implants to surgical masks, to manage biological risk.

In reference to these standards, "biocompatibility" is defined as the "ability of a medical device or material to function with an appropriate host response in a specific application".

ISO 10993 consists of several parts, each of which addresses specific aspects related to the biosafety assessment of medical devices.

In total, ISO 10993 is composed of multiple sections covering different aspects of the assessment, such as toxicity testing, sensitization testing, irritation testing and carcinogenic risk assessment, among others.

Each section provides detailed guidelines for assessing the biosafety of medical devices, with the aim of ensuring their safe use in clinical settings.

Objectives

  • To help determine the biocompatibility of medical devices
  • Prevent the use of devices that may harm human health
  • Identify and quantify soluble and insoluble elements that can potentially be released from a medical device.

Importance of biocompatibility assessment

Biocompatibility assessment is essential to ensure the safety of medical devices.

A product that is not biocompatible may cause adverse reactions in the human body, such as inflammation, infection or even rejection of the material.

Therefore, it is essential to carry out extensive testing to assess the biocompatibility of products before they are placed on the market.

Compliance with ISO 10993

Compliance with ISO 10993 can be assessed by certification bodies and testing laboratories specialized in the biosafety assessment of medical devices.

These bodies and laboratories are accredited to carry out tests and assessments in accordance with the requirements set out in the standard, in order to determine whether a medical device complies with the required biosafety standards.

It is important for medical device manufacturers to seek certification and endorsement from these bodies to demonstrate compliance with ISO 10993 and to ensure the safety and effectiveness of their products.

At OSF we use materials for the manufacture of medical device parts for our customers that meet the requirements of ISO 10993, such as, for example, the drainage bottle used in lipomodelling.

If you would like to know more about this topic, please contact us.

Also, follow us on social media to keep up to date with the latest news.