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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 047 Date of Entry 08/21/2017 
FR Recognition Number 2-247
Standard
ISO 10993-6 Third edition 2016-12-01
Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
Scope/Abstract
This part of ISO 10993 specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices.

This part of ISO 10993 applies to materials that are

- solid and non-absorbable,

- non-solid, such as porous materials, liquids, gels, pastes, and particulates, and

- degradable and/or absorbable, which may be solid or non-solid.

The test sample is implanted into a site and animal species appropriate for the evaluation of the biological safety of the material. These implantation tests are not intended to evaluate or determine the performance of the test sample in terms of mechanical or functional loading. This part of ISO 10993 can also be applied to medical devices that are intended to be used topically in clinical indications where the surface or lining might have been breached, in order to evaluate local tissue responses.

The local effects are evaluated by a comparison of the tissue response caused by a test sample to that caused by control materials used in medical devices whose clinical acceptability and biocompatibility characteristics have been established. The objective of the test methods is to characterize the history and evolution of the tissue response after implantation of a medical device/biomaterial including final integration or absorption/degradation of the material. In particular for degradable/absorbable materials, the degradation characteristics of the material and the resulting tissue response should be determined.

This part of ISO 10993 does not deal with systemic toxicity, carcinogenicity, teratogenicity or mutagenicity. However, the long-term implantation studies intended for evaluation of local biological effects might provide insight into some of these properties. Systemic toxicity studies conducted by implantation might satisfy the requirements of this part of ISO 10993. When conducting combined studies for evaluating local effects and systemic effects, the requirements of both standards is to be fulfilled.
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.
Relevant FDA Guidance and/or Supportive Publications*
ISO 10993-2:2006 Biological evaluation of medical devices - Part 2: Animal welfare requirements.

ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials.

Guidance for Industry and FDA Staff. General Considerations for Animal Studies for Cardiovascular Devices. Issued on July 29, 2010.

FDA Draft Document (issued on October 14, 2015): General Considerations for Animal studies for Medical Devices, which, when final, will represent the Agency's thinking on this topic.

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 June 2016. Updated September 2020.

FDA Technical Contacts
 Annabelle Crusan
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIB/
  301-796-4926
  Annabelle.Crusan@fda.hhs.gov
 Karen Manhart-Byrnes
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIB/
  301-796-0389
  karen.manhart@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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