GB/T 16886.19-2011 Replaced National standards

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

Publish Date: 2011-12-30 Implement Date: 2012-05-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 16886.19-2011

Standard Type: National standards

Standard Status: Replaced

is_force_gb: no

CCS Name: Medical devices

ICS Name: Integrated medical equipment

Publish Date: 2011-12-30

Implement Date: 2012-05-01

Pages: 16 pages

Scope

This part of GB/T 16886 provides various parameters and test methods for the determination and evaluation of physical-chemical, morphological, and surface characteristics (PMT) of finished medical device materials. This assessment is limited to performance related to biological evaluation and the intended use of medical devices (clinical applications and usage time), 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, as this content is specified in Parts 9, 13, 14, and 15 of GB/T 16886. The chemical characterization of materials is described in GB/T 16886.18.
The GB/T 16886 standard is not applicable to medical devices and materials that do not come into direct or indirect contact with the human body (see ISO 109931).

Development Information

Word Count: 26 Thousand words Pages: 16 pages

Same series standard

GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.2-2011 Biological evaluation of medical devices—Part 2:Animal welfare requirements GB/T 16886.11-2011 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity GB/T 16886.18-2011 Biological evaluation of medical devices—Part 18:Chemical characterization of materials

Superseded by the following standards

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

Referenced Standards

ISO 10993-1 ISO 10993-18

Adopt standards

ISO/TS 10993-19:2006

Related Standards

GB/T 16886.11-1997 Replaced

GB/T 16886.11-1997 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity

Publish Date: 1997-06-26

GB/T 16886.3-1997 Replaced

GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity

Publish Date: 1997-06-26

GB/T 16886.6-1997 Replaced

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

Publish Date: 1997-06-26

GB/T 16886.1-2001 Replaced

GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing

Publish Date: 2001-09-24

GB/T 16886.13-2001 Replaced

GB/T 16886.13-2001 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices

Publish Date: 2001-09-24

GB/T 16886.7-2001 Replaced

GB/T 16886.7-2001 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals

Publish Date: 2001-09-24