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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 044 Date of Entry 07/26/2016 
FR Recognition Number 2-238
Standard
ANSI AAMI BE83:2006/(R)2011
Biological evaluation of medical devices - Part 18: Chemical characterization of materials
Scope/Abstract
This part of ISO 10993 describes a framework for the identification of a material and the identification and quantification of its chemical constituents. The chemical characterization information generated can be used for a range of important applications, for example:
--As part of an assessment of the overall biological safety of a medical device (ISO 10993-1 and 14971).
--Measurement of the level of a leachable substance in a medical device in order to allow the assessment of compliance with the allowable limit derived for that substance from health based risk assessment (ISO 10993-17).
--Judging equivalence of a proposed material to a clinically established material.
--Judging equivalence of a final device to a prototype device.
--Screening of potential new materials for suitability in a medical device for a proposed clinical application.
This part of ISO 10993 does not address the identification or quantification of degradation products, which is covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15. The ISO 10993 series of standards is applicable when the material or device comes into contact with the body directly or indirectly (see 4.2.1 of ISO 10993-1:2003).
This part of ISO 10993 is intended for suppliers of materials and manufacturers of medical devices, when carrying out a biological safety assessment.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Clause 1.0. the 3rd and 4th bullets
Clause 5.0, Paragraph 1 and Items a and b
Clause 5.0, Paragraph 4, Fourth Sentence: phrase (simulated extraction)
Clause 5.0, Paragraph 5, the first sentence: "The extent of chemical characterization required should reflect the nature and duration of the clinical exposure and shall be determined by the toxicological risk assessor based on the data necessary to evaluate the biological safety of the device"
Clause 6.2, First Paragraph, the Last Sentence: "The level of qualitative data provided/required shall reflect the category of medical device in terms of degree of invasiveness and clinical exposure duration as well as the nature of the materials and shall be justified"
Clause 6.2, Second Paragraph, the Second Sentence "The use of a standardized material, e.g. ISO 5832-1, in its intended use is considered to meet this requirement"
Clause 7.1 Second Paragraph, the Second Sentence "As noted in 6.2 the extent of characterization required is determined by the invasiveness and duration of clinical exposure in the intended use".
Table 2, Row 1, Quantitative FTIR.
Clause 7.3, Table 3, Footnote b, the Second Sentence: "When product analysis is already available, it is generally not necessary to repeat the analysis of those elements already reported"
Annex A (informative), Clause A.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 1.0 the 3rd and 4 th bullets are in conflict with an existing final published guidance, see section III of the guidance listed below.
Clause 5.0 paragraph 1 and items a, b are in conflict with an existing final published guidance, see section III of the guidance listed below.
Clause 5.0, paragraph 4, fourth sentence : phrase (simulated extraction) are in conflict with an existing final published guidance, see section V. A. of the guidance listed below.
Clause 5.0 paragraph 5, the first sentence; 6.2, first paragraph, the last sentence; and 7.1 second paragraph , the second sentence; and Annex A, Clause A.1 are in conflict with an existing final published guidance, see section VII of the guidance listed below.
Clause 6.2 , second paragraph, the second sentencere is in conflict with an existing final published guidance, see section III C bullet 4 of the guidance listed below.
Table 2, Row 1, Quantitative FTIR are in conflict with an existing final published guidance, see section VI G of the guidance listed below.
Clause 7.3 Table 3, Footnote b, the second sentence is in conflict with an existing final published guidance, see section III C bullet 4 of the guidance listed below.
Annex A (informative), Clause A.1 are in conflict with an existing final published guidance, see section VI G of the guidance listed below.
Transition Period
FDA recognition of ANSI/AAMI BE83:2006/(R)2011 [Rec# 2-238] will be superseded by recognition of ISO 10993-18 Second edition 2020-01 [Rec# 2-276]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 2-238] until July 10, 2022. After this transition period, declarations of conformity to [Rec# 2-238] 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 June 2016.
FDA Technical Contacts
 Irada Isayeva
  FDA/OC/CDRH/OSEL/DBCMS/
  301-796-2618
  Irada.Isayeva@fda.hhs.gov
 Jiwen Zheng
  FDA/OC/CDRH/OSEL/DBCMS/
  301-796-3352
  jiwen.zheng@fda.hhs.gov
Standards Development Organizations
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
ANSI American National Standards Institute https://www.ansi.org/
FDA Specialty Task Group (STG)
Biocompatibility
*These are provided as examples and others may be applicable.
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