BS EN ISO 10993-1:2025

Biological evaluation of medical devices Requirements and general principles for the evaluation of biological safety within a risk management process

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Standard number:	BS EN ISO 10993-1:2025
Pages:	62
Released:	2026-01-09
ISBN:	978 0 539 21011 8
Status:	Standard

BS EN ISO 10993-1:2025 - Comprehensive Guide to Biological Evaluation of Medical Devices

In the ever-evolving world of medical technology, ensuring the safety and efficacy of medical devices is paramount. The BS EN ISO 10993-1:2025 standard is an essential resource for professionals in the medical device industry, providing a robust framework for the biological evaluation of medical devices. This standard is a cornerstone in the risk management process, offering detailed requirements and general principles to ensure biological safety.

Key Features of BS EN ISO 10993-1:2025

Standard Number: BS EN ISO 10993-1:2025
Pages: 62
Release Date: January 9, 2026
ISBN: 978 0 539 21011 8
Status: Standard

Why Choose BS EN ISO 10993-1:2025?

The BS EN ISO 10993-1:2025 standard is meticulously designed to guide manufacturers and regulatory bodies through the complex landscape of biological safety evaluation. Here are some compelling reasons why this standard is indispensable:

Comprehensive Coverage

Spanning 62 pages, this standard provides an exhaustive overview of the requirements and principles necessary for evaluating the biological safety of medical devices. It covers a wide range of topics, ensuring that all aspects of biological evaluation are addressed.

Up-to-Date Guidelines

Released on January 9, 2026, the BS EN ISO 10993-1:2025 standard reflects the latest advancements and regulatory expectations in the field of medical device safety. It incorporates the most recent scientific findings and industry best practices, ensuring that your evaluations are based on the most current information available.

Risk Management Integration

One of the standout features of this standard is its integration with risk management processes. It provides a structured approach to identifying and mitigating potential biological risks associated with medical devices, helping manufacturers to ensure compliance and enhance patient safety.

Global Recognition

As part of the ISO 10993 series, this standard is recognized and respected worldwide. It aligns with international regulatory requirements, making it an essential tool for companies looking to market their medical devices globally.

Who Should Use This Standard?

The BS EN ISO 10993-1:2025 standard is designed for a wide range of stakeholders in the medical device industry, including:

Manufacturers: Ensure that your products meet the highest standards of biological safety and comply with regulatory requirements.
Regulatory Bodies: Use this standard as a benchmark for evaluating the biological safety of medical devices submitted for approval.
Quality Assurance Professionals: Integrate the principles of this standard into your quality management systems to enhance product safety and reliability.
Research and Development Teams: Leverage the guidelines to design and develop safer, more effective medical devices.

Enhance Your Compliance and Safety Standards

Incorporating the BS EN ISO 10993-1:2025 standard into your processes is a proactive step towards ensuring the biological safety of your medical devices. By adhering to this standard, you not only comply with regulatory requirements but also demonstrate your commitment to patient safety and product excellence.

Conclusion

The BS EN ISO 10993-1:2025 standard is an invaluable resource for anyone involved in the design, manufacture, or regulation of medical devices. Its comprehensive guidelines and integration with risk management processes make it an essential tool for ensuring the biological safety of medical devices. Stay ahead of the curve and ensure your products meet the highest standards of safety and efficacy with this indispensable standard.

For more information on how the BS EN ISO 10993-1:2025 standard can benefit your organization, explore the detailed guidelines and principles it offers. Equip your team with the knowledge and tools necessary to excel in the competitive medical device industry.

DESCRIPTION

BS EN ISO 10993-1:2025

This standard BS EN ISO 10993-1:2025 Biological evaluation of medical devices is classified in these ICS categories:

11.100.20 Biological evaluation of medical devices
11.100 Laboratory medicine

This document specifies the requirements and general principles governing the biological evaluation of medical devices within a risk management process according to ISO 14971. This document applies to the biological evaluation of medical devices that have direct contact or indirect contact with either: — a patient's body during intended use or reasonably foreseeable misuse; or — the body of other users who are not patients, if the medical device is intended for personal protection (e.g. medical gloves, surgical masks). Biological evaluation assesses the biological safety of the medical device by considering the biological risks associated with: — constituents of a medical device; and — tissue-device interactions (including physical effects). The biological evaluation specified in this document can address the biological safety of the medical device, considering the life cycle from design and development through initial use of the finished medical device to final decommissioning or withdrawal from use. The biological evaluation considers both the biological safety of the finished device in first use, and the significance of any changes to the medical device which can occur throughout the life cycle. However, the evaluation of risks related to environmental impacts of decommissioning of medical devices are not within the scope of this document. This document does not mandate re-testing of medical devices that are already on the market and have established and acceptable safety profiles (see 6.6.2). This document can be useful to support clinical or usability evaluations of medical devices. For example, a biological evaluation is a pre-requisite for conducting a clinical trial. This means that principles outlined in this document can be applied to the evaluation of prototype or development stage devices, as well as to finished medical devices. Other parts of the ISO 10993 series cover specific aspects of biological evaluation, such as chemical characterization, biological testing, sample preparation, animal welfare and toxicological risk assessment. For some types of medical devices, specific requirements from other standards (outside the ISO 10993 series) can be considered with a justification for the approach taken if there are differences between the requirements of the ISO 10993 series and those provided in other standards. For example, the ISO 18562 series provides specific requirements for biological evaluation of breathing gas pathway medical devices and ISO 7405 provides specific requirements for biological evaluation of dental devices. The evaluation of risks related to infectious agents [e.g. bacteria, moulds, yeasts, viruses, transmissible spongiform encephalopathy (TSE) agents] is not within the scope of this document. NOTE 1 The evaluation of bacterial endotoxins is addressed by ISO 11737-3. NOTE 2 The evaluation of risks related to viruses, TSE agents and other pathogens originating from materials of animal origin is addressed by the ISO 22442 series.

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