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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number054 Date of Entry 07/06/2020
FR Recognition Number 2-275
Standard
ISO 10993-7 Second edition 2008-10-15
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including: Technical
Corrigendum 1 (2009), AMENDMENT 1: Applicability of allowable limits for neonates and infants (2020)]
Scope/Abstract
ISO 10993-7:2008 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH)
in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for
determining compliance so that devices may be released. Additional background, including guidance and a
flowchart showing how the standard is applied are also included in informative annexes.
EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by ISO
10993-7:2008.
Extent of Recognition
Complete standard
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.
Transition Period
FDA recognition of ISO 10993-7 Second edition 2008-10-15 [Including: Technical Corrigendum 1 (2009)] [Rec#
14-408] will be superseded by recognition of ISO 10993-7 Second edition 2008-10-15 [Including: Technical
Corrigendum 1 (2009), Amendment 1 (2020)] [Rec# 2-275]. FDA will accept declarations of conformity, in
support of premarket submissions, to [Rec# 14-408] until July 10, 2022. After this transition period, declarations
of conformity to [Rec# 14-408] will not be accepted.
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and Food and Drug Administration Staff: Submission and Review of Sterility Information
in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, Issued January 2016.
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 June 2016.
FDA Technical Contacts
Anne D. Lucas Alan Hood
FDA/OC/CDRH/OSEL/DBCMS/ FDA/OC/CDRH/OSEL/DBCMS/
301-796-0283 301-796-0313
Anne.Lucas@fda.hhs.gov Alan.Hood@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/22
FDA Specialty Task Groups (STG)
Biocompatibility (primary)
Sterility
*These are provided as examples and others may be applicable.
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