ANSI BE83:2006 pdf download.Biological evaluation of medical devices- -Part 18: Chemical characterization of materials.
Clause 1, fourth bullet
At the end of the sentence delete, 10 check the relevance of data on the latter to be used to support the assessment of the former.”
Subclause 3.6
Change to extraction’
Subclause 3.6
Insert a new first sentence that reads, “the process of treating a material with a solvent to remove soluble substances.”
Subclause 3.6
Move the NOTE to the bottom of 3.6.
Add a new Subclause 3.6.1
Which reads, -exhaustive extraction — extraction until the amount of residues in a subsequent extraction is less than 10% of that detected in the first extraction
Add a new Subclause 3.6.2
Which reads, simulated-use extraction — extraction for evaluating potential risk to the patient or user during routine use of a device, using an extraction method with an appropriate medium that simulates product use
Add a new Subclause 3.6.3
Which reads, extractable — soluble substances removed from a material when treated with a Solvent”
Subclause 3.7
Delete Subclause 3.7 simulated extraction’ however, use the definition for the new subclause 3.6.2
simulated-use extraction.
Add a new Subclause 3.7
That reads, “leachable — chemical removed from a medical device by the action of water or other liquids related to the use of the device”
Example—Additives, sterilant residues, process residues, degradation products, solvents, plasticizers, lubricants, catalysts, stabilizers. anti-oxidants, coloring agents, filters and monomers, among others.
[ISO 10993-7] (ISO 10993-91 [ISO 10993-11] [ISO 10993-16] [ISO 10993-17]”
Table 1
Acid “CE — Capillary electrophoresis”
Add “LC — Liquid chromatography”
Change the footnote to read, Mass spectroscopy is frequently combined with chromatographic techniques such as GC-MS, LC-MS. LC-MS-MS and CE-MS.”
Subclause 6.1
Revise the first sentence to read, “The generation of chemical characterization data is a process linked to risk assessment.”
Subclause 6.1
Revise the second sentence to read, “The chemical characterization requirements and guidance are specified in Subclauses 6.2 to 6.3.”
Subclause 6.1, third paragraph
Add a new first sentence which reads, if the material or device contacts the body directly or indirectly then this standard is applicable (see 4.2.1 of ISO 10993-1:2003).”
Subclause 6.1, third paragraph Change “step” to “stage’.
Subclause 6.1, NOTE 1
Revise NOTE 1 to read, “The risk assessment process referred to in Subclauses 6.2 and 6.3 is outside the scope of this part of ISO 10993 but is mentioned to indicate the important interaction between chemical characterization and risk assessment.”
Subclause 6.1, last paragraph
Delete the last paragraph entirely.
Subclause 6.2
Delete “Step 1” in title.
Subclause 6.2, third paragraph, last sentence
Change “all” to “potential”.
Subclause 6.2
Add a new last paragraph which reads, “Sufficient qualitative information shall be obtained to allow a comparison to determine whether the material is equivalent to that utilized in a device with the same clinical exposure/use and having had the same manufacturing and sterilization processes applied, e.g. established safe use of materials in a product to be used on intact skin.”
Subclause 6.3
Delete entirely.
New Subclause 6.3 (old Subclause 6.4)
Delete “Step 3” in title.
New Subclause 6.3 (old Subclause 6.4)
Add the following two sentences to the end of the first paragraph, “If the quantity of any chemical present remains of toxicological concern, in light of anticipated clinical exposure, as determined by the toxicological risk assessor, the amount of extraction of that chemical shall be measured, by performing, for example, a simulated use extraction. The extraction conditions used shall be documented and justified.”
Add a new last paragraph which reads, “Sufficient quantitative information shall be obtained to permit a risk assessment, when combined with existing toxicological information (see ISO 10993-17 and 4.1 of
ISO 14971:2000).”
Subclause 6.5
Delete entirely.
Subclause 6.6
Delete entirely.
Subclause 7.1
First paragraph. first sentence, revise to read, “Clause 6 of this part of ISO 10993 describes the generation of qualitative and quantitative chemical characterization data for use in the toxicological risk assessment”
Subclause 7.1
Third paragraph, first sentence revise to read. “For Subclauses 6.2 and 6.3, the material scientist and analyst in consultation with the toxicological risk assessor shall determine which parameters are relevant to the assessment of a material or medical device.”
Table 2
Add an X” under “Quantitative” for “Residue on ignition”.
Clause 8
Delete the first sentence of the first paragraph..
Clause 8
Delete item e).
Annex A
Delete Annex A entirely.
Annex A.3.2 (old Annex B.3.2)
Revise the second and third sentences to read, Naming and describing polymers according to these rules does present exact structural features of polymers. However, it does not give any information about additives often contained in the commercially available polymers.’
