Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

Link To Website
Standard Number GB/T 16886.1-2022
Organization Standardization Administration of China China
Level National
Category Management System
Status
  • APR 2022 Published
ABSTRACT

This document specifies.

- the general principles governing the biological evaluation of medical devices within a risk management process;

- the general categorization of medical devices based on the nature and duration of their contact with the body;

- the evaluation of existing relevant data from all sources.

Other parts of GB/T 16886 cover specific aspects of biological assessments and related tests. Device-specific or product standards address mechanical testing.