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)

INB

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.

Publikation: 2021-04-0155 SeitenICS: 11.100.20

This document outlines the SN EN ISO 10993-1:2021 standard, which addresses the biological evaluation of medical devices, focusing on evaluation and testing within a risk management process. It applies to all medical devices expected to contact the body, either directly or indirectly, ensuring their biological safety during intended use.

What SN EN ISO 10993-1:2021 covers

The SN EN ISO 10993-1:2021 standard provides a framework for evaluating the biological safety of medical devices within a risk management process. It establishes key principles governing the evaluation, categorization of devices based on their contact with the body, and the assessment of relevant data regarding their biological safety. The standard extends to all types of medical devices, including both active and non-active devices, as well as implantable and non-implantable devices. However, it explicitly excludes hazards related to pathogens such as bacteria, viruses, and other infectious agents. This comprehensive approach ensures that medical devices are evaluated for their potential biological risks, contributing to safer healthcare technology.

Who needs to comply with SN EN ISO 10993-1:2021

Compliance with SN EN ISO 10993-1:2021 is crucial for manufacturers of medical devices, which range from large multinational corporations to small startups within the healthcare technology industry. Regulatory bodies, quality assurance professionals, and product safety experts must also adhere to this standard to ensure the safety and efficacy of medical devices marketed globally. Roles such as regulatory affairs specialists, compliance officers, and R&D teams play vital parts in the implementation process, making this standard relevant across various positions in the medical device supply chain.

Key requirements

• General Principles: Establishes overarching principles that govern the biological evaluation process.
• Classification of Devices: Outlines how to categorize medical devices based on their contact with the body, influencing the evaluation process.
• Data Evaluation: Requires the analysis of existing data on the biological safety of materials and devices from numerous sources.
• Risk Analysis: Mandates identifying data gaps through comprehensive risk analysis to determine additional data needs.
• Biological Safety Assessment: Provides guidelines for assessing the biological safety of the medical device to ensure compliance with safety standards.

These requirements are typically audited through a combination of documentation reviews and on-site inspections to ensure adherence to the standard.

How to implement SN EN ISO 10993-1:2021

Implementing SN EN ISO 10993-1:2021 involves several key steps. First, organizations should conduct a gap analysis to identify areas needing improvement in their current biological evaluation processes. This is followed by thorough documentation of practices and protocols that comply with the standard. Training sessions should be organized to ensure that all stakeholders understand their roles in the evaluation process. Afterward, an internal audit should be performed to assess compliance and effectiveness. Finally, a certification audit can be conducted by an external body to validate adherence to the standard, ensuring that the organization meets the required benchmarks for biological safety evaluation.

Related standards

• ISO 10993-2: Focuses on animal welfare requirements and the use of animals in biological evaluation testing.
• ISO 10993-3: Addresses the tests for genotoxicity, carcinogenicity, and reproductive toxicity.
• ISO 10993-5: Specifies testing for in vitro cytotoxicity, critical for assessing biological response at the cellular level.
• ISO 10993-7: Deals with the ethylene oxide sterilization of medical devices, impacting their biological safety.
• ISO 13485: Sets requirements for quality management systems in medical device manufacturing, ensuring compliance with various standards, including biological evaluation.

Why SN EN ISO 10993-1:2021 matters

Adhering to SN EN ISO 10993-1:2021 provides significant business advantages, including enhanced market access, improved customer trust, and compliance with legal regulations. By ensuring the biological safety of medical devices, manufacturers can gain a competitive edge in the healthcare technology sector. This standard not only protects patients and users but also fosters innovation in medical device development. For further training and purchasing options, explore the links below.