YY/T 1576-2017Tissue engineering medical device products—Standard practice for implantation assessment of absorbable/resorbable biomaterials (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

1 Scope

This standard specifies the implantable test program to evaluate the tissue response to absorbable biomaterials.

This standard applies only to clinical use is expected, Absorbable biomaterials with a residence time in bone or soft tissue greater than 30 days and less than 3 years.

Note. Biomaterials absorbed in a shorter period of time may be based on other criteria that specify the time of implantation. For slow degradation, only three years before being absorbed students Materials, should carefully consider the applicability of this standard. Tissue reactions caused by degradable materials are expected to differ from non-degradable absorbent materials. In most cases, Chronic inflammation can be observed during degradation of the biomaterials, but local histology will recover or repair after the material has degraded and absorbed. therefore, Minimal tissue response, often equivalent to "biocompatible," requires longer implant time.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.

Biological evaluation of medical devices - Part 6. Local response test after implantation (ISO 10993-6.:1996). 2007, IDT)

GB/T 16886.11-2011 Biological evaluation of medical devices - Part 11. Systemic toxicity tests (ISO 10993-11:2006, IDT)

3 Summary

It is recommended that small experimental animals, such as mice, rats, hamsters or rabbits, be preferentially selected and will be evaluated under the most stringent conditions The final sample is implanted in its most relevant tissue anatomical site.

Depending on the particular considerations of a particular study, larger experimental animals such as dogs, goats or sheep may be selected for use. Species of experimental animals The selection should also consider the availability of historical data on the biological evaluation of similar medical devices/biomaterials in order to contribute to the fraction of the data available Analysis and comparison.

All animal tests should be carried out in accordance with the relevant regulatory requirements by the nationally approved agency.

4 Meaning and purpose

4.1 This standard as a screening test guide for the evaluation of human implanted in the body and is expected to more than 30 days, 3 years to absorb the degradation of biological materials Local tissue reaction. For the description of this standard, please refer to Appendix A.

4.2 The evaluation of non-absorbable biomaterials local reactions after implantation test should be GB/T 16886.6-2015 requirements. This section In the experimental program and the standard criteria for non-absorbent bio-material test program similar to the analysis of the host reaction should consider biological The degradability of the material and the effect of the degradation products on the inflammatory response of the local tissue and the repair process of the implant site.

4.3 The biomaterials to be tested should be in the form of the final product intended for use, including sterilization. The ratio of material/organism to be The clinical use of the device is relevant. The ratio of material surface area or mass to animal body weight is recommended to be 1, 10, 50 times.