GB/T 16886.6-1997
Biological evaluation of medical devices--Part 6: Tests for local effects after implantation (English Version)

Standard No.

GB/T 16886.6-1997

Language

Chinese, Available in English version

Release Date

1997

Published By

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China

Status

Be replaced 2017-04

Replace By

GB/T 16886.6-2015

Latest

GB/T 16886.6-2022

Scope

This standard specifies the test methods for evaluating the local reaction of materials into living tissue at the level of naked eye and microscopic observation. This standard applies to the biological safety evaluation of test materials implanted in a certain part of the living body. Implants are not subjected to mechanical or functional loads. The evaluation of local reaction is based on the tissue reaction caused by the test sample, compared with the tissue reaction caused by the materials used in medical devices that have been clinically confirmed to be acceptable, and a judgment is made. The post-implantation local reaction test method is suitable for evaluating subchronic reactions (short-term, within 12 weeks), or chronic reactions (long-term, more than 12 weeks).

GB/T 16886.6-1997 history

• 2022 GB/T 16886.6-2022 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation
• 2015 GB/T 16886.6-2015 Biological evaluation of medical devices.Part 6:Tests for local effects after implantation
• 1997 GB/T 16886.6-1997 Biological evaluation of medical devices--Part 6: Tests for local effects after implantation

GB/T 16886.6-1997 -All Parts