GB/T 16886.18-2022 Biological evaluation of medical devices—Part 18: Chemical characterization of medical device materials within a risk management process (English Version)
GB/T 16886.18-2022 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process
1 Scope
This document specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation and control of biological risks from material constituents, using a generally stepwise approach to the chemical characterization which can include one or more of the following:
- the identification of its materials of construction (medical device configuration);
- the characterization of the materials of construction via the identification and quantification of their chemical constituents (material composition);
- the characterization of the medical device for chemical substances that were introduced during manufacturing (e.g. mould release agents, process contaminants, sterilization residues);
- the estimation (using laboratory extraction conditions) of the potential of the medical device, or its materials of construction, to release chemical substances under clinical use conditions (extractables);
- the measurement of chemical substances released from a medical device under its clinical conditions of use (leachables).
This document can also be used for chemical characterization (e.g. the identification and/or
quantification) of degradation products. Information on other aspects of degradation assessment are covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15.
The GB/T (Z) 16886 series is applicable when the material or medical device has direct or indirect body contact (see ISO 10993-1 for categorization by nature of body contact).
This document is intended for suppliers of materials and manufacturers of medical devices, to support a biological evaluation.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
...
....
3 Terms and definitions
For the purposes of this document, the definitions in ISO 10993-1 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
- ISO Online browsing platform: available from https://www.iso.org/obp;
- IEC Electropedia: available from http://www.electropedia.org/.
3.1
accelerated extraction
extraction whose duration is shorter than the duration of clinical use but whose conditions do not result in a chemical change to the substances being extracted
Note: See also Annex D.
3.2
analytical evaluation threshold; AET
threshold below which the analyst need not identify or quantify leachables or extractables or report them for potential toxicological assessment
Note: See Annex E.
3.3
analytically expedient
situation where an extraction vehicle can be directly evaluated with generally available analytical methods with the sensitivity and selectivity necessary to achieve a designated reporting threshold such as the AET
3.4
analytical screening method
method whose purpose is to discover, identify and semi-quantitatively estimate the concentration of all relevant analytes in a test sample above an established reporting threshold (such as the AET)
3.5
analytical targeting method
method whose purpose is to quantify, with an appropriately high degree of accuracy and precision, specified analytes in a specified test sample over a specified concentration range
3.6
chemical characterization
process of obtaining chemical information, accomplished either by information gathering or by information generation, for example, by literature review or chemical testing
3.7
chemical information
qualitative and quantitative, if applicable, knowledge related to the configuration, composition and production of the medical device and/or its materials of construction, thereby establishing the identities and amounts of constituents present in the materials and device
Note 1: See also 5.2.1, 5.2.2, 5.2.3, and Annex B.
Note 2: Chemical information can be used to establish the hypothetical worst-case release of chemicals from a medical device, predicated on the circumstance that all chemicals present in the device are released from the device under its clinical conditions of use.
3.8
clinically established
medical device, component, or material of construction which has been used extensively for specified and established clinical uses for which biocompatibility has been established
3.9
component
item which forms one part of a medical device, but is not itself a medical device
3.10
constituent
chemical that is present in a finished medical device or its materials of construction
Note: Constituents may be intentionally present (e.g. an additive such as an antioxidant) or unintentionally present (e.g. an impurity or degradant).
3.11
convertor
person or company who converts or fabricates a basic raw material into a semi-finished product (e.g. a former of lengths of rod, tubing, or plastic components)
3.12
digestion
process of completely solubilizing a medical device, one or more of its components or one or more of its materials of construction by breaking it down into its fundamental structural units, including its elemental constituents or monomeric units
3.13
dissolution
process of completely solubilizing a medical device, one or more of its components or one or more of its materials of construction, generally preserving the molecular structures of its constituents
3.14
exaggerated extraction
extraction that is intended to result in a greater number or amount of chemical constituents being released as compared to the amount generated under the clinical conditions of use
Note: It is important to ensure that the exaggerated extraction does not result in a chemical change of the material or the substances being extracted.
3.15
exhaustive extraction
multi-step extraction conducted until the amount of material extracted in a subsequent extraction step is less than 10 % by gravimetric analysis (or achieved by other means) of that determined in the initial extraction step
3.16
extractable
substance that is released from a medical device or material of construction when the medical device or material is extracted using laboratory extraction conditions and vehicles
3.17
extraction power
ability of an extraction vehicle to extract (or leach) substances from a medical device, component or material of construction
Foreword I
Introduction IV
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 Characterization procedure
5.1 General
5.2 Establish medical device configuration and material composition
5.2.1 General
5.2.2 Information gathering
5.2.3 Information generation
5.3 Assess material/chemical equivalence to a clinically established material or medical device
5.4 Assess the hypothetical worst-case chemical release based on total exposure to the medical device’s chemical constituents
5.4.1 Establish the hypothetical worst-case chemical release
5.4.2 Assess the hypothetical worst-case chemical release
5.5 Establish an analytical evaluation threshold
5.6 Estimate the chemical release; perform extraction study
5.7 Assess the estimated chemical release (extractables profile)
5.8 Determine the actual chemical release; perform leachables study
5.9 Assess the actual chemical release (leachables profile)
5.10 Exiting the chemical characterization process
6 Chemical characterization parameters and methods
6.1 General
6.2 Material composition
6.3 Extractables and leachables
6.4 Structural composition or configuration
6.5 Analytical methods
7 Reporting of the chemical characterization data
Annex A (informative) General principles of chemical characterization
Annex B (informative) Information sources for chemical characterization
Annex C (informative) Principles for establishing biological equivalence
Annex D (informative) Principles of sample extraction
Annex E (informative) Calculation and application of the analytical evaluation threshold (AET)
Annex F (informative) Qualification of analytical methods used for extractables/leachables
Annex G (informative) Reporting details for analytical methods and chemical data
Bibliography
Standard
GB/T 16886.18-2022 Biological evaluation of medical devices—Part 18: Chemical characterization of medical device materials within a risk management process (English Version)
Standard No.
GB/T 16886.18-2022
Status
valid
Language
English
File Format
PDF
Word Count
9500 words
Price(USD)
285.0
Implemented on
2024-1-1
Delivery
via email in 1 business day
Detail of GB/T 16886.18-2022
Standard No.
GB/T 16886.18-2022
English Name
Biological evaluation of medical devices—Part 18: Chemical characterization of medical device materials within a risk management process
GB/T 16886.18-2022 Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process
1 Scope
This document specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation and control of biological risks from material constituents, using a generally stepwise approach to the chemical characterization which can include one or more of the following:
- the identification of its materials of construction (medical device configuration);
- the characterization of the materials of construction via the identification and quantification of their chemical constituents (material composition);
- the characterization of the medical device for chemical substances that were introduced during manufacturing (e.g. mould release agents, process contaminants, sterilization residues);
- the estimation (using laboratory extraction conditions) of the potential of the medical device, or its materials of construction, to release chemical substances under clinical use conditions (extractables);
- the measurement of chemical substances released from a medical device under its clinical conditions of use (leachables).
This document can also be used for chemical characterization (e.g. the identification and/or
quantification) of degradation products. Information on other aspects of degradation assessment are covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15.
The GB/T (Z) 16886 series is applicable when the material or medical device has direct or indirect body contact (see ISO 10993-1 for categorization by nature of body contact).
This document is intended for suppliers of materials and manufacturers of medical devices, to support a biological evaluation.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
...
....
3 Terms and definitions
For the purposes of this document, the definitions in ISO 10993-1 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
- ISO Online browsing platform: available from https://www.iso.org/obp;
- IEC Electropedia: available from http://www.electropedia.org/.
3.1
accelerated extraction
extraction whose duration is shorter than the duration of clinical use but whose conditions do not result in a chemical change to the substances being extracted
Note: See also Annex D.
3.2
analytical evaluation threshold; AET
threshold below which the analyst need not identify or quantify leachables or extractables or report them for potential toxicological assessment
Note: See Annex E.
3.3
analytically expedient
situation where an extraction vehicle can be directly evaluated with generally available analytical methods with the sensitivity and selectivity necessary to achieve a designated reporting threshold such as the AET
3.4
analytical screening method
method whose purpose is to discover, identify and semi-quantitatively estimate the concentration of all relevant analytes in a test sample above an established reporting threshold (such as the AET)
3.5
analytical targeting method
method whose purpose is to quantify, with an appropriately high degree of accuracy and precision, specified analytes in a specified test sample over a specified concentration range
3.6
chemical characterization
process of obtaining chemical information, accomplished either by information gathering or by information generation, for example, by literature review or chemical testing
3.7
chemical information
qualitative and quantitative, if applicable, knowledge related to the configuration, composition and production of the medical device and/or its materials of construction, thereby establishing the identities and amounts of constituents present in the materials and device
Note 1: See also 5.2.1, 5.2.2, 5.2.3, and Annex B.
Note 2: Chemical information can be used to establish the hypothetical worst-case release of chemicals from a medical device, predicated on the circumstance that all chemicals present in the device are released from the device under its clinical conditions of use.
3.8
clinically established
medical device, component, or material of construction which has been used extensively for specified and established clinical uses for which biocompatibility has been established
3.9
component
item which forms one part of a medical device, but is not itself a medical device
3.10
constituent
chemical that is present in a finished medical device or its materials of construction
Note: Constituents may be intentionally present (e.g. an additive such as an antioxidant) or unintentionally present (e.g. an impurity or degradant).
3.11
convertor
person or company who converts or fabricates a basic raw material into a semi-finished product (e.g. a former of lengths of rod, tubing, or plastic components)
3.12
digestion
process of completely solubilizing a medical device, one or more of its components or one or more of its materials of construction by breaking it down into its fundamental structural units, including its elemental constituents or monomeric units
3.13
dissolution
process of completely solubilizing a medical device, one or more of its components or one or more of its materials of construction, generally preserving the molecular structures of its constituents
3.14
exaggerated extraction
extraction that is intended to result in a greater number or amount of chemical constituents being released as compared to the amount generated under the clinical conditions of use
Note: It is important to ensure that the exaggerated extraction does not result in a chemical change of the material or the substances being extracted.
3.15
exhaustive extraction
multi-step extraction conducted until the amount of material extracted in a subsequent extraction step is less than 10 % by gravimetric analysis (or achieved by other means) of that determined in the initial extraction step
3.16
extractable
substance that is released from a medical device or material of construction when the medical device or material is extracted using laboratory extraction conditions and vehicles
3.17
extraction power
ability of an extraction vehicle to extract (or leach) substances from a medical device, component or material of construction
Contents of GB/T 16886.18-2022
Foreword I
Introduction IV
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 Characterization procedure
5.1 General
5.2 Establish medical device configuration and material composition
5.2.1 General
5.2.2 Information gathering
5.2.3 Information generation
5.3 Assess material/chemical equivalence to a clinically established material or medical device
5.4 Assess the hypothetical worst-case chemical release based on total exposure to the medical device’s chemical constituents
5.4.1 Establish the hypothetical worst-case chemical release
5.4.2 Assess the hypothetical worst-case chemical release
5.5 Establish an analytical evaluation threshold
5.6 Estimate the chemical release; perform extraction study
5.7 Assess the estimated chemical release (extractables profile)
5.8 Determine the actual chemical release; perform leachables study
5.9 Assess the actual chemical release (leachables profile)
5.10 Exiting the chemical characterization process
6 Chemical characterization parameters and methods
6.1 General
6.2 Material composition
6.3 Extractables and leachables
6.4 Structural composition or configuration
6.5 Analytical methods
7 Reporting of the chemical characterization data
Annex A (informative) General principles of chemical characterization
Annex B (informative) Information sources for chemical characterization
Annex C (informative) Principles for establishing biological equivalence
Annex D (informative) Principles of sample extraction
Annex E (informative) Calculation and application of the analytical evaluation threshold (AET)
Annex F (informative) Qualification of analytical methods used for extractables/leachables
Annex G (informative) Reporting details for analytical methods and chemical data
Bibliography
