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YY/T 0127.15-2018: Biological evaluation of medical devices used in dentistry--Part 15: Subacute and subchronic systemic toxicity test: oral route
Status: Valid YY/T 0127.15: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0127.15-2018 | English | 299 |
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Biological evaluation of medical devices used in dentistry--Part 15: Subacute and subchronic systemic toxicity test: oral route
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YY/T 0127.15-2018
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| YY/T 0127.15-2009 | English | 639 |
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Biological evaluation of medical devices used in dentistry. Part 2: Test method. Subacute and subchronic systemic toxicity test: oral route
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YY/T 0127.15-2009
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Basic data | Standard ID | YY/T 0127.15-2018 (YY/T0127.15-2018) | | Description (Translated English) | Biological evaluation of medical devices used in dentistry--Part 15: Subacute and subchronic systemic toxicity test: oral route | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C33 | | Word Count Estimation | 15,164 | | Date of Issue | 2018-04-11 | | Date of Implementation | 2019-05-01 | | Older Standard (superseded by this standard) | YY/T 0127.15-2009 | | Regulation (derived from) | China Drug Administration Announcement No. 4 of 2018 | | Issuing agency(ies) | State Drug Administration | YY/T 0127.15-2018: Biological evaluation of medical devices used in dentistry--Part 15: Subacute and subchronic systemic toxicity test: oral route
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(Biological evaluation of oral medical devices Part 15. Subacute and subchronic systemic toxicity tests. Oral routes)
ICS 11.060.10
C33
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 0127.15-2009
Biological evaluation of oral medical devices
Part 15. Subacute and subchronic systemic toxicity tests.
Oral route
Part 15. Subacuteandsubchronicsystemictoxicitytest.oralroute
Published on.2018-04-11
2019-05-01 implementation
State Drug Administration issued
Foreword
YY/T 0127 is the standard for specific biological test methods for oral medical devices and is divided into the following sections.
---YY/T 0127.1 "Body test of oral material biological test method";
---YY/T 0127.2 "Biology Evaluation of Oral Medical Devices Part 2. Test Methods Acute Systemic Toxicity Test. Vein
way";
---YY/T 0127.3 "Biology evaluation of oral medical devices - Part 3. Application test in root canals";
---YY/T 0127.4 "Biology Evaluation of Oral Medical Devices, Unit 2. Test Method Bone Implantation Test";
---YY/T 0127.5 "Biological evaluation of oral medical devices - Part 5. Inhalation toxicity test";
---YY/T 0127.6 "Biology evaluation of oral materials, Unit 2. Dominant lethal test of biological methods of oral materials";
---YY/T 0127.7 "Biology evaluation of oral medical devices Part 7. Application of dental pulp dentin";
---YY/T 0127.8 "Biology Evaluation of Oral Materials, Unit 2. Subcutaneous Implantation Test of Biological Materials for Dental Materials";
---YY/T 0127.9" Biological Evaluation of Oral Medical Devices Part 2. Test Methods Cytotoxicity Test. Agar Diffusion Method
And filter diffusion method";
---YY/T 0127.10" Biological evaluation of oral medical devices, Unit 2. Test method Salmonella typhimurium
Variable test (Ames test);
---YY/T 0127.11 "Biology evaluation of oral medical devices Part 11. Covering marrow test";
---YY/T 0127.12 "Diagnostic Oral Medical Device Biological Evaluation Unit 2. Test Method Micronucleus Test";
---YY/T 0127.13 "Biology evaluation of oral medical devices Part 13. Oral mucosal irritation test";
---YY/T 0127.14 "Biological evaluation of oral medical devices, Unit 2. Test methods for acute oral systemic toxicity test";
---YY/T 0127.15" Biological evaluation of oral medical devices - Part 15. Subacute and subchronic systemic toxicity test. Oral
way";
---YY/T 0127.16" Biological evaluation of oral medical devices Part 2. Test methods In vitro chromosomes of mammalian cells
Distortion test
---YY/T 0127.17 "Biology evaluation of oral medical devices - Part 17. Mutation of mouse lymphoma cells (TK)
test";
---YY/T 0127.18 "Biology evaluation of oral medical devices - Part 18. Dentin barrier cytotoxicity test";
This part is part 15 of YY/T 0127.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This part replaces YY/T 0127.15-2009 "Biology Evaluation of Oral Medical Devices Part 2. Test Methods Subacute and
Subchronic systemic toxicity test. oral route.
The main technical changes in this section and YY/T 0127.15-2009 are as follows.
---Modified standard name;
---Modified the normative reference file, changed "GB/T 16886.12" to "ISO 10993-12" and added "ISO 10993-11"
Medical Device Biology Evaluation Part 11. Systemic Toxicity Test" Standard;
--- Chapter 3 "Purpose" is changed to "Purpose and Principle", adding the content of "test principle", deleting the original part of Chapter 5;
--- Removed the definition of "dose Dose" in terms and definitions, and added the terms and definitions given in ISO 10993-11 to apply
This part;
--- Amend "10 animals per group" to "at least 20 animals in each group (at least 10 in subacute trials)";
--- Amend the "single-dose group test, the test dose is 1000mg/(kg body weight · d)" to the "single-dose group test, the test dose is at least
Is 1000mg/(kg body weight · d)";
--- Amend the "sub-chronic test 5d per week service material" to "sub-chronic test 7d weekly service materials";
--- Revised Appendix A "Common Clinical Symptoms and Observations".
This part is proposed by the State Drug Administration.
This part is under the jurisdiction of the National Technical Committee for Standardization of Dental Materials and Devices (SAC/TC99).
This section drafted by. State Drug Administration, Peking University Medical Device Quality Supervision and Inspection Center, Sichuan Medical Device Biomaterials and
Product Inspection Center, Shanghai Biomaterials Research and Testing Center.
The main drafters of this section. Lin Hong, Han Jianmin, Li Shenglin, Ge Weiyuan, Fu Jia, Liang Jie, Yuan Wei, Sun Wei, Huang Weiwei, Lu Hua.
The previous releases of this section are as follows.
---YY/T 0127.15-2009.
Introduction
There are many types of medical devices. When evaluating the systemic toxicity of medical devices in contact with oral tissues, it should be based on the devices or materials.
The timing of oral tissue contact is specifically selected for subacute or subchronic tests. In most cases, the subacute test was given orally for 28 days.
The subchronic test was 90 days.
Biological evaluation of oral medical devices
Part 15. Subacute and subchronic systemic toxicity tests.
Oral route
1 Scope
This section of YY/T 0127 specifies the subacute and subchronic oral systemic toxicity test methods for oral medical devices.
This section applies to the subacute and subchronic systemic toxicity of the oral route of medical devices for oral contact.
2 Normative references
The following documents are indispensable for the application of this standard. For dated references, only dated versions apply to this standard.
quasi. For undated references, the latest edition (including all amendments) applies to this standard.
ISO 10993-11 Biological evaluation of medical devices - Part 11. Systemic toxicity test (Biologicalevaluationofmedical
devices-Part 11.Testsforsystemictoxicity)
ISO 10993-12 Biological evaluation of medical devices - Part 12. Sample preparation and reference samples (Biologicalevaluationof
medicaldevices-Part 12. Samplepreparationandreferencematerials)
3 Purpose and principle
3.1 Purpose
This test is a repeated oral infusion of an oral medical device or medical device extract in a certain period of time (28d or 90d).
In vivo, its effect on the test animal is determined to determine if it has a potential subacute or subchronic systemic toxicity.
3.2 Test principles
In the process of evaluating the toxicity characteristics of oral medical devices, when the oral toxicity test is repeated, the acute toxicity test can be referred to.
information.
This test provides relevant information for obtaining health hazards caused by repeated oral administration of test samples over a certain period of time. Repeat service
The time of the subacute systemic toxicity test is generally 28d, and the subchronic systemic toxicity test is generally 90d. In order to get as much information as possible
Careful clinical observation of the animals is required.
The toxic reaction of the animal was closely observed daily during the service period, and the animals that were killed during the death or the end of the test were subjected to an autopsy.
Note. The test principles in ISO 10993-11 apply to this document.
4 Terms and definitions
The following terms and definitions as defined in ISO 10993-11 apply to this document.
4.1
No visible harmful effect level noobservedadverseeffectlevel; NOAEL
Under the specified test conditions, no toxic effects associated with the test sample were observed using existing technical means or test indicators.
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