Biological evaluation of absorbable medical devices -- Part 1: Guidance for absorbable implants

Standard Number YY/T 1775.1-2021
Organization Standardization Administration of China
Level National
Category Guide | Practice
Status
  • MAR 2021 Published
ABSTRACT

This part of YY/T 1775 specifies general guidelines for biological evaluation of absorbable implants to support the development of absorbable implants.
Safety evaluation.
This section applies to the guidance for the evaluation of absorbable implants based on the GB/T 16886 risk assessment process.
Note. The absorbable implant is expected to be degradable by design, so the degradation products will be released to the patient. This is because this type of product and other products are not expected to be absorbed by the patient's body.
Of medical devices have fundamentally different characteristics.