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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 044 Date of Entry 07/26/2016 
FR Recognition Number 2-237
ISO  10993-17 First edition 2002-12-01
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
Identical Adoption
ANSI AAMI ISO 10993-17:2002/(R)2012
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
This part of ISO 10993 specifies a method for the determination of allowable limits for substances leachable from medical devices. It is intended for use in deriving standards and estimating appropriate limits where standards do not exist. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified.

This part of ISO 10993 is not applicable to devices that have no patient contact (e.g. in vitro diagnostic devices).

Exposure to a particular chemical substance may arise from sources other than the device, such as food, water or air. This part of ISO 10993 does not address the potential for exposure from such sources.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Clause 6.2.1
Clause 6.3.2 b) 2) and Equation 6
Clause 6.3.3 and Equation 7
Clause 7.1 b) Paragraph 2, Sentences: "Economic feasibility refers to the ability to meet the tolerable exposure without making provision of the device an unsound economic proposition. Cost and availability implications should be considered in the selection of allowable limits to the extent that these impact upon the preservation, promotion or improvement of human health."
Clause 7.2, Words, either and or economically
Annex C, Clause C.2.1
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.
This standard is recognized in part because:
Clause 6.2.1 is in conflict with an existing published final guidance, see VI G. (pdf p. 43/68) of the guidance listed below.
Clause 6.3.2 b)2) and Annex C Clause C2.1 contains a test method that is in conflict with publish literature for extractables/leachables. See references listed below.
Clause 6.3.3 and Equation 7 contains a test method that is in conflict with published literature. See references below.
Clause 7.1 b) and 7.2 are in conflict with another recognized standard (ISO 14971 clause 6.2)
Transition Period
FDA recognition of ISO 10993-17 First edition 2002-12-01 [Rec# 2-237] will be superseded by recognition of ISO 10993-17 Second edition 2023-09 [Rec# 2-303]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 2-237] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 2-237] will not be accepted.
Relevant FDA Guidance and/or Supportive Publications*
ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials.

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.

Reynier, A., Dole, P., Feigenbaum, A. (1999). Prediction of worst case migration: presentation of a rigorous methodology. Food Additives & Contaminants, Vol 16 (4), pp137-152.

Helmroth, E., Dekker, M., Hankemeier, T. (2002). Influence of solvent absorption on the migration of Irganox 1076 from LDPE. Food Additives & Contaminants, Vol 19 (2), pp176-183.

Goddard, M.J., Murdock, D.J., Krewski, D. (1995). Temporal aspects of risk characterization. Inhalation Toxicology, Vol 7, pp 1005-1018.

Murdock, D.J., Krewski, D., and Wargo, J. (1992) Cancer Risk Assessment with Intermittent Exposure. Risk Analysis, Vol 12, pp 569-577.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Jennifer Goode
 Alan Hood
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.