| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
050
|
Date of Entry 09/17/2018
|
|
FR Recognition Number
|
2-255
|
| Standard | (Included in ASCA) |
ISO 10993-11 Third edition 2017-09
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity |
|
Identical AdoptionANSI AAMI ISO 10993-11: 2017
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity |
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Scope/Abstract| This document specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions. |
|
| Extent of Recognition
|
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. |
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ASCA Notes
The following test methods are included in the ASCA pilot program:
Acute Systemic Toxicity;
Material-Mediated Pyrogenicity, in conjunction with USP <151> (recognition number: 2-272). |
|
Public Law, CFR Citation(s) and Procode(s)*
| 21 CFR Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies |
|
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.
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
|
| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
