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GB/T 16886.7-2015 English PDF (GBT16886.7-2015)

GB/T 16886.7-2015 English PDF (GBT16886.7-2015)

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GB/T 16886.7-2015: Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals

GB/T 16886.7-2015
Biological evaluation of medical devices - Part 7. Ethylene oxide sterilization residuals ICS 11.100
C30
National Standards of People's Republic of China
Replace GB/T 16886.7-2001
Medical device biology evaluation
Part 7. Ethylene oxide sterilization residues
Released on December 10,.2015
2017-01-01 implementation
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China China National Standardization Administration issued
Foreword
GB/T 16886 "Biology Evaluation of Medical Devices" is divided into the following sections. --- 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 delayed type hypersensitivity test;
--- Part 11. Systemic toxicity test;
---Part 12. Sample preparation and reference samples;
--- Part 13. Qualitative and quantitative determination of polymer degradation products; --- 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 limitable amount of leachables;
---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 part 7 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 16886.7-2001 "Biology Evaluation of Medical Devices Part 7. Ethylene Oxide Sterilization Residues", and Compared with GB/T 16886.7-2001, the main technical contents are changed as follows. --- Modified the introduction;
--- Revised 4.1 overview;
--- Revised 4.3 Allowable Limits. Added overview; modified ethylene oxide (EO) and 2-chloroethanol (ECH) allowable limits; added Surface contact devices and implants can withstand exposure limits and modify the average daily contact dose of special devices EO and ECH; --- Modified 4.4.3 product sampling;
--- Modified 4.4.6 product leaching;
--- Modified Appendix A gas chromatographic evaluation;
--- Modified Appendix B for the determination of EO and ECH by gas chromatography. extraction of EO and ECH standard solutions, instruments, reagents and products The content is integrated into Appendix J and Appendix K; the precision, linearity, method detection limit and quantitative limit are determined; Table B.2 Recommended gas chromatographic conditions;
--- Added Appendix C application GB/T 16886 series standard This part determines the process of EO and ECH residues in medical devices Diagram and guide;
--- Revised the original Appendix D (now Appendix E) to determine the leaching conditions of EO residues; --- Revised the original Appendix E (now Appendix F) Description. The title of the appendix was changed to "Description of the provisions of this part of GB/T 16886"; EO And the ECH allowable limit determination is integrated into Appendix G and Appendix H respectively; and supplemented and improved; --- Increased the determination of Appendix G EO Residue Limits;
--- Added the determination of the allowable limit of Appendix H ECH;
--- Increased the determination of the allowable limit of Appendix I EG; --- Added preparation of Appendix J EO and ECH standards;
--- Added the test method for Appendix K Ethylene Oxide.
This section uses the translation method equivalent to ISO 10993-7.2008 "Medical Evaluation of Medical Devices Part 7. Residues of Cyclohexyl Ester Sterilization". The documents of our country that have a consistent correspondence with the international documents referenced in this part are as follows. GB/T 16886.1-2001 Biological evaluation of medical devices - Part 1. Evaluation and testing (ISO 10993-1..1997, 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 16886.10-2005 Biological evaluation of medical devices - Part 10. Stimulation and delayed hypersensitivity test (ISO 10993-10.2002, IDT)
GB/T 16886.12-2005 Biological evaluation of medical devices - Part 12. Sample preparation and reference samples (ISO 10993-12.2002, IDT) GB/T 16886.17-2005 Biological evaluation of medical devices - Part 17. Establishment of limits for leaching materials (ISO 10993-17.2002, IDT) This part is proposed by the State Food and Drug Administration.
This part is under the jurisdiction of the National Technical Committee for Standardization of Medical Device Biology Evaluation (SAC/TC248). This section drafted by. State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center. The main drafters of this section. Luo Hongyu, Shi Yanping, Pan Huaxian, Sun Guangyu, Liu Lili, Shen Yong, Xu Kai. The previous versions of the standards replaced by this section are.
---GB/T 16886.7-2001.
introduction
The development, validation and routine control requirements for the ethylene oxide sterilization process for medical devices are given in the international standards established by ISO /TC198. ISO /TC194 has developed a number of international standards that clearly define the biological testing of medical devices, the choice of tests, and the classification of devices. Specific requirements are imposed on the amount of ethylene oxide and other sterilization process residues. Other international standards describe the specific requirements of specific product biology tests. As stated in the introduction to ISO 11135-1.2007, when determining the suitability of ethylene oxide (EO) for sterilization of medical devices, it is important that Ensure that EO, 2-chloroethanol (ECH) and ethylene glycol (EG) levels are present in patients with minimal risk to normal use. therefore, It is important to consider the use of alternative materials and sterilization processes during the design and development of the product. EO is thought to lead to a series of students The physical response, including the stimulation, organ damage, mutagenicity and carcinogenicity to humans and animals, and the development of ISO 10993-7 The reproductive effects of animals have been considered. The adverse effects of ECH and EG are also considered. Actually for most instruments The exposure of EO and ECH is much lower than the maximum specified in ISO 10993-7. In addition, when EO sterilization is selected, even if the provisions of this part of GB/T 16886 are not considered, the contact of EO residues should be reduced. lowest. The requirements in this section are in addition to the biological evaluation and testing requirements for various types of medical devices described in GB/T 16886.1. For EO The acceptability of sterilized instruments is demonstrated in conjunction with biological evaluation and testing requirements as well as EO sterilization process residue limits. When using EO When ECH is present in a medical device for bacteria, the maximum allowable residue of ECH is also clearly defined. This part has taken into account the local effects (such as Stimulate) and integrate into the EO given in 4.3.5.2 and Appendix G, and the tolerable exposure limit of ECH given in 4.3.5.3 and Appendix H Among the quantities (TCL).
Medical device biology evaluation
Part 7. Ethylene oxide sterilization residues
1 Scope
This part of GB/T 16886 specifies EO and 2-chloroethanol (ECH) residues on a single piece of medical device sterilized by ethylene oxide (EO). The allowable limit of retention, the EO and ECH detection steps, and the method of determining whether the device can be shipped. Also provided in the informative appendix Other background information, including guidelines and application flow diagrams in this section. This section does not include EO-sterilized instruments (such as in vitro diagnostic equipment) that are not in contact with the patient. Note. The limit for ethylene glycol (EG) is not specified in this section. 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 10993-1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management (Biologicalevalua- tionofmedicaldevices-Part 1.Evaluationandtestingwithinariskmanagementprocess) ISO 10993-3 Biological evaluation of medical devices - Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity (Biologicale- valuationofmedicaldevices-Part 3.Testsforgenotoxicity,carcinogenicityandreproductivetoxicity) ISO 10993-10 Biological evaluation of medical devices - Part 10. Stimulation and delayed hypersensitivity test (Biologicalevalua- tionofmedicaldevices-Part 10.Testsforirritationanddelayed-typehypersensitivity) ISO 10993-12 Biological evaluation of medical devices - Part 12. Sample preparation and reference samples (Biologicalevaluationof medicaldevices-Part 12. Samplepreparationandreferencematerials)
ISO 10993-17 Biological evaluation of medical devices - Part 17. Establishment of leaching allowances (Biological evaluationofmedicaldevices-Part 17.Establishmentofalowablelimitsforleachablesubstances) 3 Terms and definitions
The following terms and definitions defined by ISO 10993-1 and ISO 10993-17 apply to this document. 3.1
Simulated using leaching simulated-useextraction
Water leaching to simulate product use, by evaluating the level of residue that the patient or user is exposed to in the daily use of the device, Leaching in accordance with the requirements of this part of ISO 10993. 3.2
Limit extraction exhaustiveextraction
Subsequent leaching to the extract is less than the amount of EO or ECH in the first extract, or the dip is measured. There was no significant increase in cumulative residue.
Note. The definition of the above limit leaching is used because complete recovery of the residue is not possible. 4 requirements
4.1 Overview
Note. Information on determining the limit values and other important background information related to the use of this document are given in the informative appendix to this part of ISO 10993. Information and guidelines.
This chapter specifies the maximum allowable residue of EO on a unit product after sterilization of ethylene oxide (EO) in medical devices. Such as ISO 11135- As described in the introduction in.2007, when determining the suitability of EO for medical device sterilization, it is important to ensure EO, 2-chloroethanol (ECH) and The residual level of ethylene glycol (EG) poses the least risk to patients who normally use the product. Moreover, when EO sterilization is selected, even if it is not considered In this section, contact with EO residues should also be minimized. When there is an ECH in a medical device that uses EO sterilization, Specifies the maximum allowable residual amount of ECH. Local effects (such as stimuli) have been considered and integrated into the recommendations given in 4.3.5.2 and Appendix G. EO, and the tolerable contact limit (TCL) of ECH given in 4.3.5.3 and Appendix H. This section does not specify the EG of the device Limited, because the risk assessment data (Appendix I) indicates that the calculated allowable limit level is higher than the possible residual amount in the medical device. however, Acute hemodynamic and hemolysis reactions may occur after rapid intravenous injection of EG hypertonic compounds. Ethylene oxide sterilized Medical devices are not expected to produce hypertonic solutions. The method for determining EO and ECH is given in 4.4. The requirements of this part of ISO 10993 are in addition to the requirements for the biological evaluation and testing of medical devices in ISO 10993-1. For use For EO-sterilized instruments, special attention should be paid to the requirements of ISO 10993-3 and ISO 10993-10. All applicable requirements in ISO 10993-1 The level of EO residue at the time of shipment of various medical devices should be considered. The results of the device biology assessment may require more stringent limits than those specified in 4.3. The limits specified in 4.3 are intended to prevent Set by systemic reaction.
4.2 Device classification
In determining the maximum daily dose of EO and ECH that a medical device is allowed to release to a patient, the device should be classified by contact time. According to 5.3 of ISO 10993-1, the device should belong to one of the following three contact types. a) short-term exposure. equipment that is used, accessed or contacted once, repeatedly or repeatedly within 24 hours; b) long-term exposure. equipment that has been used or contacted for a long time, multiple times or repeatedly within 24 hours and 30 days; c) Prolonged contact. A device that has been used or contacted for more than 30 days, once or repeatedly. If the material or device is part of more than one time classification, more rigorous testing and/or evaluation considerations should be used. For multiple connections The device that is touched should consider the potential cumulative effect and total contact time when deciding which classification the device belongs to. Note. “Multiple use” in this part of ISO 10993 refers to the repeated use of the same device. For example. dialyzer. 4.3 Allowable limit
4.3.1 Overview
For each medical device classified under 4.2, the maximum allowable dose of EO and ECH released to the patient should not exceed the values given below. The limits for long-lasting exposure and long-term exposure to the device are expressed in terms of the maximum average daily dose. Also follow the additional limit of the first 24h contact period And, for permanent contact devices, the additional limit of the first 30 days of contact is to be followed. These limits define the EO and early release to the patient. ECH limited. If there is suitable data available, if multiple instruments containing residues are used at the same time, it should be considered to reduce the limit proportionally, or when When the device is used only for part of the contact period, it should be considered to increase the limit proportionally. These multiple device contacts are given in ISO 10993-17 Factor (CEF) and proportional contact factor (PEF). Appendix G describes the method used to determine the EO allowable limit, which is described in Appendix H. The method of determining the ECH allowable limit, Appendix I describes the basic principle of determining the EG allowable limit. 4.3.2 Permanent contact devices
The average daily dose of EO to the patient should not exceed 0.1 mg/d, in addition to the maximum dose. --- should not exceed 4mg in the first 24h;
--- The first 30d should not exceed 60mg;
--- should not exceed 2.5g in a lifetime.
The average daily dose of ECH to the patient should not exceed 0.4 mg/d, in addition to the maximum dose. --- should not exceed 9mg in the first 24h;
--- The first 30d should not exceed 60mg;
--- should not exceed 10g in a lifetime.
4.3.3 Long-term contact devices
The average daily dose of EO to the patient should not exceed 2 mg/d, in addition to the maximum dose. --- should not exceed 4mg in the first 24h;
--- The first 30d should not exceed 60mg.
The average daily dose of ECH to the patient should not exceed 2 mg/d, in addition to the maximum dose. --- should not exceed 9mg in the first 24h;
--- The first 30d should not exceed 60mg.
4.3.4 Short-term contact devices
The average daily dose of EO to the patient should not exceed 4 mg.
The average daily dose of ECH to patients should not exceed 9 mg.
4.3.5 Surface contact devices and implants can withstand exposure limits 4.3.5.1 Overview
The unit of EO tolerance to exposure (TCL) is micrograms per square centimeter, and the unit of ECH tolerance to contact (TCL) is milligrams. Each square centimeter, square centimeter is the patient-device contact area. Note. The purpose of this clause is to prevent local irritative reactions from EO or ECH released by the device. 4.3.5.2 EO tolerable contact limits
The EO tolerance tolerance for surface contact devices and implants should not exceed 10 μg/cm2, or should be shown as ISO 10993- Very mild irritating response as specified in 10.
4.3.5.3 ECH can withstand exposure limits
The contact tolerance of surface contact devices and implants ECH should not exceed 5 mg/cm2, or should be shown as ISO 10993- Very mild irritating response as specified in 10.
4.3.6 Special circumstances
For multi-instrument systems, the limits for the instruments that each patient is exposed to should be specified. The residual EO of each intraocular lens should not exceed 0.5 μg per day, or should not exceed 1.25 μg per lens. Single artificial crystal The body mass is calculated as 20mg, and other intraocular instruments are calculated according to their masses in proportion to the limit. Due to the level of ECH that produces ophthalmia Four times higher than the corresponding EO level, the acceptable level of ECH for intraocular devices made of chlorine-containing viscoelastic materials may need to be evaluated. For blood cell separators used by patients and blood donors, the maximum allowable dose of EO is 10 mg, and the maximum allowable dose of ECH should not be More than 22mg.
For blood oxygenators and blood separators, the maximum allowable dose of EO to the patient is 60 mg, and the maximum allowable dose of ECH to the patient Should not exceed 45mg.
For instruments used in cardiopulmonary bypass procedures, the maximum allowable limit for EO should be 20 mg and the maximum allowable limit for ECH should be 9 mg. For extracorporeal blood purification equipment, the EO and ECH limits for each device should be 4.6 mg, but may exceed EO lifetime. Dosage.
For surgical orders that are expected to be in contact with intact skin only, the maximum allowable limit for EO is 10 μg/cm2 of tolerable contact limit, ECH A 5 mg/cm2, or surgical list should show a very mild irritating response as specified in ISO 10993-10. Note. Appendix F gives a description of certain instruments whose specified EO limits are inconsistent with general requirements. Appendix C gives a flow chart and guidance for applying this part of ISO 10993 to determine the amount of EO residues in medical devices. 4.4 Determination of EO and ECH residues
4.4.1 Overview
4.4.1.1 Steps
The step of determining compliance with 4.3 includes extracting the residue from the sample, determining the amount of the residue, and measuring the contact surface of the device to And analyze and interpret the data.
Danger. All work performed by the analyst and other personnel preparing the sample, including the use of chemicals and solvents, should be ventilated Carry out the appropriate protective clothing in the closet and review the material safety data before using each chemical. According to occupation Health and safety regulations, health care workers using ethylene oxide sterili...

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