ISO 10993-1:2018 Compliance Guidelines Explained
The SN EN ISO 10993-1:2021 standard outlines the biological evaluation of medical devices, emphasizing the importance of risk management in ensuring the safety and effectiveness of these products. Published by the International Organization for Standardization (ISO), this standard applies to various medical devices to ensure they meet biological safety criteria.
SN EN ISO 10993-1:2021
Biologische Beurteilung von Medizinprodukten - Teil 1: Beurteilung und Prüfungen im Rahmen eines Risikomanagementsystems (ISO 10993-1:2018, einschliesslich korrigierte Fassung 2018-10)
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)
This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of medical devices based on the nature and duration of their contact with the body; — the evaluation of existing relevant data from all sources; — the identification of gaps in the available data set on the basis of a risk analysis; — the identification of additional data sets necessary to analyse the biological safety of the medical device; — the assessment of the biological safety of the medical device. This document applies to evaluation of materials and medical devices that are expected to have direct or indirect contact with: — the patient´s body during intended use; — the user´s body, if the medical device is intended for protection (e.g., surgical gloves, masks and others). This document is applicable to biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices. This document also gives guidelines for the assessment of biological hazards arising from: — risks, such as changes to the medical device over time, as a part of the overall biological safety assessment; — breakage of a medical device or medical device component which exposes body tissue to new or novel materials. Other parts of ISO 10993 cover specific aspects of biological assessments and related tests. Device-specific or product standards address mechanical testing. This document excludes hazards related to bacteria, moulds, yeasts, viruses, transmissible spongiform encephalopathy (TSE) agents and other pathogens.
Purpose and objectives
The primary objective of SN EN ISO 10993-1:2021 is to provide a structured framework for the biological evaluation of medical devices within a risk management process. This standard aims to ensure that medical devices are safe for their intended use by identifying potential biological risks and evaluating them systematically. It emphasizes a comprehensive approach to assessing biocompatibility, taking into account factors such as device materials, intended use, and duration of contact with the body. The standard also seeks to promote international harmonization in the evaluation of medical devices, facilitating global trade and patient safety.
Scope: who must comply
The SN EN ISO 10993-1:2021 standard applies to manufacturers of all types of medical devices, including active, implantable, and non-implantable devices. It is essential for organizations within the healthcare technology sector, such as medical device manufacturers, regulatory bodies, and testing laboratories, to comply with these guidelines to ensure the safety of their products. Compliance is particularly critical for companies developing devices that come into direct contact with human tissues or fluids, as these products pose higher biological risks. By adhering to the ISO 10993-1:2018 compliance guidelines, companies can effectively manage risks associated with biocompatibility and enhance their product safety profiles.
How SN EN ISO 10993-1:2021 relates to other standards
SN EN ISO 10993-1:2021 is part of a broader set of standards related to the biological evaluation of medical devices. Key related standards include:
- ISO 10993-5: Focuses on in vitro cytotoxicity testing, providing methods to assess the effects of materials on cell cultures.
- ISO 10993-10: Addresses the testing of irritation and skin sensitization, essential for devices that contact skin or mucous membranes.
- ISO 14971: Provides a framework for risk management in medical devices, complementing the biological evaluation processes outlined in ISO 10993-1.
Revision history and current status
The SN EN ISO 10993-1 standard is published by the International Organization for Standardization (ISO), with its current revision dating back to 2021. This revision introduced updates to the risk management process and clarified the biological evaluation pathways for different types of medical devices. Key changes involved enhanced guidelines for assessing data from various sources and streamlined approaches for identifying data gaps through comprehensive risk analyses. These improvements aim to support manufacturers in navigating the complexities of biological safety assessments effectively.