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GB/T 16886.12-2017 English PDF (GBT16886.12-2017)

GB/T 16886.12-2017 English PDF (GBT16886.12-2017)

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GB/T 16886.12-2017: Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials

GB/T 16886.12-2017
Biological evaluation of medical devices--Part 12. Sample preparation and reference materials ICS 11.100.20
National Standards of People's Republic of China
Replace GB/T 16886.12-2005
(ISO 10993-12..2012, IDT)
Released on.2017-12-29
2018-07-01 implementation
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China China National Standardization Administration issued
GB/T 16886 "Biological Evaluation of Medical Devices" consists of the following components. --- Part 1. Evaluation and testing in the risk management process;
--- Part 2. Animal welfare requirements;
--- Part 3. Genotoxicity, carcinogenicity and reproductive toxicity test; --- Part 4. Test options for interaction with blood;
---Part 5. In vitro cytotoxicity test;
--- Part 6. Post-implantation local reaction test;
---Part 7. Ethylene oxide sterilization residue;
---Part 9. Qualitative and quantitative frameworks for potential degradation products; --- Part 10. Stimulation and skin sensitization test;
--- Part 11. Systemic toxicity test;
--- Part 12. Sample preparation and reference materials;
--- Part 13. Qualitative and quantitative determination of degradation products of polymer medical devices; --- Part 14. Qualitative and quantitative determination of ceramic degradation products; ---Part 15. Qualitative and quantitative determination of metal and alloy degradation products; ---Part 16. Design of toxicokinetics of degradation products and solubles; --- Part 17. The establishment of a leachable allowable limit;
---Part 18. Chemical characterization of materials;
---Part 19. Physical chemistry, morphological and surface characterization of materials; --- Part 20. Principles and methods for immunological toxicology testing of medical devices. This part is the 12th part of GB/T 16886.
This part is drafted in accordance with the rules given in GB/T 1.1-2009. This part replaces GB/T 16886.12-2005 "Biological evaluation of medical devices Part 12. Sample preparation and reference samples". versus The main technical changes compared with GB/T 16886.12-2005 are as follows. --- Amend the standard name to "Medical Device Biological Evaluation Part 12. Sample Preparation and Reference Materials"; --- Added the terms "limit leaching", "leachables" and "leachables"; (see Chapter 3); --- Added general requirements (see Chapter 4);
--- Revised the extraction conditions and methods (see 10.3, 10.3 of the.2009 edition); --- Revised the relevant content of the test sample extraction principle (see Appendix C, Appendix C of the.2009 edition); --- Increased limit leaching for the biological evaluation of polymeric materials (see Appendix D). This section uses the translation method equivalent to ISO 10993-12.2012 "Medical Device Biological Evaluation Part 12. Sample Preparation and Reference According to the material.
The documents of our country that have a consistent correspondence with the international documents referenced in this part are as follows. GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management (ISO 10993-1.2009, IDT)
GB/T 16886.2-2011 Biological evaluation of medical devices - Part 2. Animal welfare requirements (ISO 10993-2..2006, IDT) GB/T 16886.3-2008 Biological evaluation of medical devices - Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3.2003, IDT)
GB/T 16886.4-2003 Biological evaluation of medical devices - Part 4. Selection of test for interaction with blood (ISO 10993-4. 2002, IDT)
GB/T 16886.5-2017 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity test (ISO 10993-5.2009, IDT)
GB/T 16886.6-1997 Biological evaluation of medical devices - Part 6. Post-implantation partial response test (ISO 10993-6. 1994, IDT)
GB/T 16886.7-2001 Biological evaluation of medical devices - Part 7. Resin residues from ethylene oxide (ISO 10993-7. 1995, IDT)
GB/T 16886.9-2017 Biological evaluation of medical devices - Part 9. Qualitative and quantitative framework for potential degradation products (ISO 10993-9.2009, IDT)
GB/T 16886.10-2017 Medical Device Biology Evaluation Part 10. Stimulation and delayed type hypersensitivity test (ISO 10993-10.2010, IDT)
GB/T 16886.11-2011 Biological evaluation of medical devices - Part 11. Systemic toxicity test (ISO 10993-11.2006, IDT)
2012, IDT)
GB/T 16886.13-2017 Biological evaluation of medical devices - Part 13. Qualification and determination of degradation products of polymer medical devices Quantity (ISO 10993-13.2010, IDT)
GB/T 16886.14-2003 Biological evaluation of medical devices - Part 14. Qualification and quantification of ceramic degradation products (ISO 10993-14.2001, IDT)
GB/T 16886.15-2003 Biological evaluation of medical devices - Part 15. Qualification and quantification of degradation products of metals and alloys (ISO 10993-15.2000, IDT)
GB/T 16886.16-2013 Biological evaluation of medical devices - Part 16. Toxic kinetics of degradation products and solubles Design (ISO 10993-16.2010, IDT)
GB/T 16886.17-2005 Biological evaluation of medical devices - Part 17. Establishment of leaching allowances (ISO 10993- 17.2002, IDT)
GB/T 16886.18-2011 Biological evaluation of medical devices - Part 18. Chemical characterization of materials (ISO 10993-18.2005) GB/T 16886.19-2011 Biological evaluation of medical devices - Part 19. Physical chemistry, morphological and surface properties Expropriation (ISO 10993-19.2006)
YY/T 0316-2008 Medical Device Risk Management for Medical Devices (ISO 14971.2007, IDT) Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents. This part is proposed by the State Food and Drug Administration.
This part is under the jurisdiction of the National Medical Device Biology Evaluation Standardization Technical Committee (TC428). This section drafted by. State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center. The main drafters of this section. Hou Li, Sun Likui, Liu Chenghu.
The previous versions of the standards replaced by this section are.
---GB/T 16886.12-2005.
This part of GB/T 16886 specifies guidelines for the preparation of sample preparation methods and reference materials for the biological evaluation of medical devices. sample The preparation method should take into account the biological evaluation method and the material to be evaluated. Each biological test method requires the selection of materials and extraction Solvents and conditions.
This section is based on current national and international norms, procedures and standards and will be reviewed and revised periodically. Medical device biology evaluation
Part 12. Sample preparation and reference materials
1 Scope
This part of GB/T 16886 specifies that medical devices are tested in accordance with the biological systems specified in other parts of GB/T 16886. The sample preparation and reference material selection requirements to be followed are given, and a program guide is given. This section specifically proposes.
---Test sample selection;
--- Select a representative part from the device;
---Test sample preparation;
---Test control;
---Selection and requirements for reference materials;
--- Preparation of extract.
This section does not apply to living cells, but can be applied to materials or instrument components in a combination product containing living cells. 2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this article. Pieces. For undated references, the latest edition (including all amendments) applies to this document. ISO 10993 (all parts) Biological evaluation of medical devices (Biologicalevaluationofmedicaldevices) ISO 14971 Medical Device Risk Management for Medical Devices (Medicaldevices-Applicationofriskman- Agementtomedicaldevices)
3 Terms and definitions
The following terms and definitions apply to this document.
Accelerated extraction acceleratedextraction
Use of a device that shortens the time that the material is leached into the medium, but does not cause chemical changes in the extracted material. Leaching of leachable or leachable material in the feed.
Example. Conditions for accelerated leaching include increasing temperature, agitation, changing the leaching medium, and the like. 3.2
Blank blank
Leaching medium without test material. During the leaching, the same container as the test sample was placed and the same leaching conditions were employed. Note. The purpose of the blank is to evaluate the possible interference effects of the leaching vessel, the leaching medium and the leaching process. 3.3
Standard sample certifiedreferencematerial; CRM
A reference material with a certificate whose one or more characteristic values are determined by a traceability procedure that is traceable to accurate reproduction. Indicates the unit of measurement for this characteristic value, and each characteristic value of the certificate is accompanied by the uncertainty of the given confidence level. [ISO Guide 30.1992, Definition 2.2]
Strict extraction exaggeratedextraction
Any leaching that is expected to result in a release of chemical components greater than the amount released under simulated conditions of use. Note. Ensuring that the rigorous leaching does not result in chemical changes in the material. 3.5
Limit extraction exhaustiveextraction
Subsequent extraction of the leachable material into the leachate is less than the 10% detectable amount of the first leach solution. Note. It is impossible to completely recover the residual amount, so use the definition of the above limit extraction method. See also Appendix C. 3.6
Experimental control
Substances with appropriate reaction characteristics, often used in specific test systems to evaluate whether the reaction of the test system is reproducible and suitable Suitability.
Extract extract
A liquid obtained by leaching from a test sample or a control sample.
Extractables extractables
Release of a medical device or material with a solvent and/or leaching at least the same or more stringent conditions as expected The substance released.
Indicates that a material has the same structure or composition and that it is associated with a biological endpoint, continues to produce or does not produce a particular organism Learn the properties of the reaction.
Note. Regardless of the batch of material being leached from the test sample, if the biological response of a reference material to a particular test falls within the test specified by the test Within the certainty range, it can be considered to have uniformity.
Leachable leachables
A substance that can be released during clinical use of a medical device or material. 3.11
Negative control negativecontrol
A fully characterized material and/or substance. When the material and/or substance is tested by a specified procedure, the test procedure is verified It is desirable to have a reproducible, appropriate negative, non-reactive or minimal response in the test system. Note. In practice, the negative control is the reference material but may include a blank, leaching medium/solvent. 3.12
Positive control
A fully characterized material and/or substance. The test procedure is confirmed when the material and/or substance is evaluated by a specified test method. It is suitable to obtain a reproducible, appropriate positive or reactive response in the test system. 3.13
Reference material referencematerial; RM
One or more characteristic values that are sufficiently reproducible and have been determined to be useful for calibrating instruments, evaluating measurement methods, or assigning values to materials material.
Note 1. Rewrite ISO Guide 30.1992, definition 2.1.
Note 2. The reference material in this part of GB/T 16886 refers to a fully characterized material or substance. When tested according to the prescribed procedure, the test procedure can be confirmed Suitability and a reproducible, expected response. This reaction can be either a negative reaction or a positive reaction. 3.14
Simulated using leaching simulated-useextraction
The leaching in accordance with the requirements of this part of GB/T 16886 is evaluated by the patient or user during the routine use of a certain device. Leaching of a simulated product used to leach material levels.
Note. The confirmation from the analytical laboratory confirms that the simulated use of the leaching is performed under the most challenging conditions for the intended use. Analog product use The method is to consider the tissue to which the device is exposed, the contact temperature and the contact time, assuming the most stringent possible contact classification. 3.15
Stability stability
(Characteristic value) The material is stored under specified conditions and can maintain a specific biological response within specified limits for a specific period of time. Note. Rewrite ISO Guide 30.1992, definition 2.7.
Test sample testsample
Medical devices, components or materials used for biological or chemical testing or evaluation (or representative methods of production and processing in the same way) Sample), or extract or part.
4 General requirements
4.1 As described in ISO 14971, when identifying hazards associated with medical devices and estimating risks, due to changes in processing or processing Hazards caused by inadequate process control should be considered in the design of the test and in the preparation of the sample. Special attention should be paid to residues in the process, Such as trace elements, cleaning and disinfectants.
4.2 A number of different biological test systems are described in ISO 10993. Therefore, reference should be made to the specific criteria of each part to ensure the recommendation. Whether the method is applicable to a particular test system.
4.3 In biological evaluation, a test control should be used to confirm the test procedure and/or to compare the results of the tests between materials. Should be based on biology The test used a negative control, blank and/or positive control suitable for the test. Note. The same type of control can be applied to different tests and can be cross-referenced with other confirmed materials and test methods. Select test control See Appendix A for additional guidance. The use of positive controls in in vivo tests may be affected by animal welfare regulations. 5 Reference Materials (RMs)
5.1 General
Reference materials are established by their respective laboratories. Their chemical, physical and biological characteristics are determined by their respective laboratories. City can be used The goods sold are used as reference materials.
Note 1. See ISO Guide 35.
Materials with high purity, critical characterization, and intended use are often selected as standard samples. Its key chemical, physical and Biological characterization is determined by collaborative calibration of three or more laboratories and then provided to the laboratory by the vendor. Note 2. The user wishes to obtain a reference material or a standard sample supplier promises to supply it for at least 5 years. Otherwise the original RM or CRM should be provided “Public Recipe” is the publication of source materials and detailed processing to ensure uniformity between batches of reference materials. 5.2 Certification of reference materials for biological safety testing
5.2.1 Reference material identification is the process of assigning values (values or magnitudes) to the biological response of a material under specified test conditions to ensure It is reproducible in the laboratory and/or between laboratories. The range of biological reactions associated with this material should pass laboratory tests to make sure.
Note 1. See ISO Guide 34.
5.2.2 The supplier shall certify the reference material. The supplier shall determine the extent to which the material is chemically and physically characterized. Use parameters Each laboratory of the material should identify the biological characterization required for the reference material to identify whether an RM is suitable for a particular test or procedure. Commercially available materials can be used as RM, provided they are certified and certified. 5.2.3 Reference material certification is the process of assigning values (values or magnitudes) to the biological response of a material under the specified test conditions. This over Cheng confirms the test and results of the specific reaction of the material in the form of a certificate. Materials should be determined by interlaboratory testing Biological response.
6 Reference material as a test control application
6.1 Reference materials or standard samples should be used as control materials for biological tests to produce reproducible reactions (ie positive and/or negative). Confirm the suitability of the test procedure. Any material used for this purpose should be characterized in each biological test procedure to confirm the material Applicability of the material to the test. A material that is characterized and certified for use in a reference test method or response (eg, delayed-type hypersensitivity test) It should be used as a reference material for other tests (such as cytotoxicity tests) before being confirmed. Note. The use of reference materials facilitates the comparison of reactions between laboratories and facilitates the reproducibility of test operations in individual laboratories. Evaluation. The reference material used to compare biological reactions preferably has a biological reaction range such as mild, moderate or severe reactions. 6.2 Reference materials used as test controls shall be in accordance with the quality assurance procedures established by the manufacturer and the laboratory. Reference materials and sources, The manufacturer, grade and type should be identified. Reference materials should be prepared in accordance with Chapter 8. 6.3 The reference material shall be used as the test control in the same material class as the test sample, ie polymer, ceramic, metal and colloid. but Yes, purified materials can be used as test controls for mechanically operated test procedures, such as genotoxicity and immune delayed type hypersensitivity reactions. 7 test sample selection
7.1 The test shall be in the final product, a representative sample taken from the final product or a material produced in the same process as the final product. (See ISO 10993-1), or in a suitable leach solution prepared from the above samples or materials. The selection of test samples should be demonstrated. Note. For materials that cure in situ, different test samples may be required, representing both cured and uncured materials. 7.2 When the leachate is required for testing, the same test sample selection procedure is used. 8 Test sample and reference material preparation
8.1 Beware of contamination when disposing of test samples and reference materials. Any residue from the manufacturing process should be considered as an instrument, instrument component or group The components of the piece.
Note. See Appendix B for additional preparati...

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