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

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Scope

This part of GB/T 16886 gives the physical, chemical, morphological and surface properties (PMT) judgments for finished medical device materials.
Various parameters and test methods with evaluation. This assessment is limited to biological evaluation and the intended use of medical devices (clinical applications and
Time-related performance, even if such performance coincides with clinical effectiveness. This part of GB/T 16886 does not describe the characterization of degradation products
Or quantitative determination, this part has been specified in Part 9, Part 13, Part 14, and Part 15 of GB/T 16886,
Chemical characterization of the material can be found in GB/T 16886.18.
The GB/T 16886 standard does not apply to medical devices and materials that are not in direct or indirect contact with the human body (see ISO 10993-1).

Basic Data

Standard ID	GB/T 16886.19-2011 (GB/T16886.19-2011)
Description (Translated English)	Biological evaluation of medical devices -- Part 19: Physio-chemical, morphological and topographical characterization of materials
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.040.01
Word Count Estimation	18,174
Date of Issue	2011-12-30
Date of Implementation	2012-05-01
Quoted Standard	ISO 10993-1; ISO 10993-18
Adopted Standard	ISOTS 10993-19-2006, IDT
Regulation (derived from)	Announcement of Newly Approved National Standards No. 22 of 2011
Issuing agency(ies)	General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Summary	This standard specifies the physical and chemical materials, finished medical devices, morphology and surface characteristics (PMT) determination and evaluation of the various parameters and test methods. This assessment is limited to medical devices and biological evaluation and intended use (clinical applications and the use of time) related to performance, even if such performance and clinical validity coincide. GB/T 16886 does not describe this part of the characterization of degradation products or quantitative determination of this part in GB/T 16886 Section 9, Part 13, Part 14 and Part 15 requirements, materials chemistry characterization see GB/T 16886. 18. GB/T 16886 standard does not apply to any direct or indirect contact with the human body for medical devices and materials (see ISO 10993-1).