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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 047 Date of Entry 08/21/2017 
FR Recognition Number 2-248
Standard(Included in ASCA pilot)
ISO 10993-4 Third edition 2017-04
Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
U.S. Identical Adoption
ANSI AAMI ISO 10993-4: 2017
Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
Scope/Abstract
This document specifies general requirements for evaluating the interactions of medical devices with blood.

It describes

a) a classification of medical devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 10993-1,

b) the fundamental principles governing the evaluation of the interaction of devices with blood,

c) the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests.

Detailed requirements for testing cannot be specified because of limitations in the knowledge and precision of tests for evaluating interactions of devices with blood. This document describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device.

The changes in this document do not indicate that testing conducted according to prior versions of this document is invalid. For marketed devices with a history of safe clinical use, additional testing according to this revision is not recommended.
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.
ASCA Notes
The following test methods are included in the ASCA pilot program:
Complement Activation using a U.S. marketed ELISA kit;
Direct and Indirect Hemolysis, in conjunction with ASTM F756-17 (recognition number: 2-250).
Relevant FDA Guidance and/or Supportive Publications*
ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials.

Use of International Standard ISO 10993-1, Biological evaluation of medical devices--Part 1: Evaluation and testing within a risk management process. Guidance for Industry and Food and Drug Administration Staff, Issued on June 16, 2016. Updated September 2020.
FDA Technical Contacts
 Chandramallika (Molly) Ghosh
  FDA/OC/CDRH/OPEQ/OHTV/DHTVB/
  301-796-6496
  molly.ghosh@fda.hhs.gov
 Jennifer Goode
  FDA/OC/CDRH/OPEQ/CSPS/
  301-796-6374
  jennifer.goode@fda.hhs.gov
 Qijin Lu
  FDA/OC/CDRH/OSEL/DAM/
  301-796-2528
  qijin.lu@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Biocompatibility
*These are provided as examples and others may be applicable.
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