GB/T 16886.19-2011
Biological evaluation of medical devices.Part 19: Physico-chemical,morphological and topographical characterization of materials (English Version)

Standard No.

GB/T 16886.19-2011

Language

Chinese, Available in English version

Release Date

2011

Published By

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

Status

Be replaced 2024-01

Replace By

GB/T 16886.19-2022

Latest

GB/T 16886.19-2022

Scope

This part of GB/T 16886 gives various parameters and test methods applicable to the determination and evaluation of physical chemistry, morphology and surface properties (PMT) of finished medical device materials. This assessment is limited to performance related to biological evaluation and intended use of the medical device (clinical application and duration of use), even if such performance coincides with clinical effectiveness. This part of GB/T 16886 does not describe the characterization or quantitative determination of degradation products. This part has been specified in Part 9, Part 13, Part 14 and Part 15 of GB/T 16886. For chemical characterization of materials, see GB /T 16886.18. The GB/T 16886 standard does not apply to medical devices and materials that have no direct or indirect contact with the human body (see ISO 10993-1).

GB/T 16886.19-2011 Referenced Document

• ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*， 2018-08-01 Update

GB/T 16886.19-2011 history

• 2022 GB/T 16886.19-2022 Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials
• 2011 GB/T 16886.19-2011 Biological evaluation of medical devices.Part 19: Physico-chemical,morphological and topographical characterization of materials

GB/T 16886.19-2011 -All Parts