| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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066
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Date of Entry 05/25/2026
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FR Recognition Number
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2-313
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| Standard | |
ISO 10993-1 Sixth edition 2025-11
Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process
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Scope/AbstractThis 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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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
Phrase "consumer products or" in clause 6.5.11.3
Clause 6.9 Biological risk estimation
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
NOTE 1: ISO TC194 WG1 experts are developing technical reports on the application of ISO 10993-1:2025, covering topics such as intermittent contact, bioaccumulation, reasonably foreseeable misuse, and application throughout the medical device life cycle. We encourage you to contact the review offices about implementing related clauses before you begin biological evaluation of your medical devices.
NOTE 2: The additional genotoxicity evaluation requirements specified in Tables 2, 3, and 4, and Clause 6.5.7 of ISO 10993-1:2025 may not align with Table A.1 in Attachment A of the guidance listed below (reference 1) for all prolonged contact devices. We encourage you to contact the review offices to discuss implementation of these requirements before you begin biological evaluation of your medical devices.
This standard is recognized in part because:
Phrase "consumer products" in clause 6.5.11.3 is in conflict with an existing published final guidance, see Attachment G of the guidance listed below (reference 1). Not all materials in consumer products are included in Attachment G of the guidance listed below.
Clause 6.9 Biological risk estimation is in conflict with another FDA-recognized standard, see clauses 5.5, 6, and 7 of ISO 14971:2019 listed below (reference 2). |
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Transition Period
| FDA recognition of ISO 10993-1 Fifth edition 2018-08 [Rec# 2-258] will be superseded by recognition of ISO 10993-1 Sixth edition 2025-11 [Rec# 2-313]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 2-258] until July 1, 2029. After this transition period, declarations of conformity to [Rec# 2-258] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| 21 CFR Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies |
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Relevant FDA Guidance and/or Supportive Publications*
1. Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices--Part 1: Evaluation and testing within a risk management process", Issued September 2023.
2. ISO 14971 Third Edition 2019-12 Medical devices - Application of risk management to medical devices
3. ISO/TR 24971 Second edition 2020-06 Medical devices - Guidance on the application of ISO 14971
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
