YY/T 0127.15-2018Biological evaluation of medical devices used in dentistry - Part 15: Subacute and subchronic systemic toxicity test:oral route (English PDF)

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".

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.

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

4 Terms and definitions

The following terms and definitions as defined in ISO 10993-11 apply to this document.