Biological evaluation of medical devices – Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process
Abstract
This document specifies requirements and general principles governing the biological evaluation of medical devices within a risk management process per ISO 14971. This document applies to the 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, 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 by this document can address the biological safety of the medical device throughout its life cycle from design and development through initial use of the finished medical device to final decommissioning or withdrawal from use. The 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 version of the standard 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 conduct of a clinical trial. This means that principles outlined by this standard can be applied to evaluation of prototype or development stage devices as well as to finished medical devices. Other parts of ISO 10993 cover specific aspects of biological evaluation such as chemical characterisation, biological testing, sample preparations, 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 justification for the approach taken in the event of differences between ISO 10993 requirements and those provided in other standards. For example, the ISO 18562 series of standards 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 Evaluation of risks related to viruses, TSE agents and other pathogens is addressed by the ISO 22442 series, which provide requirements for risk assessments for materials of animal origin.
Begin
2022-02-03
WI
00206092
Planned document number
DIN EN ISO 10993-1
Project number
02703358
Responsible national committee
NA 027-07-12 AA - Biological evaluation of medical devices
Responsible european committee
CEN/TC 206 - Biological and clinical evaluation of medical devices
Responsible international committee
ISO/TC 194/WG 1 - Systematic approach to biological evaluation and terminology
