GB/T 16886.18-2011: Biological evaluation of medical devices -- Part 18: Chemical characterization of materials

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Scope

This part of GB/T 16886 describes the qualitative and quantitative framework for material identification and its chemical composition. The chemical characterization information obtained can be obtained.
Used for some important applications, such as.
--- As part of the overall biosafety evaluation of medical devices (ISO 10993-1 and ISO 14971).
--- By measuring the level of leachables in medical devices to assess compliance with the allowable limits for the substance based on health risk assessment
Quantity (ISO 10993-17).
--- Determine the equivalence of the proposed material and the clinically established material.
--- Determine the equivalence of the final device and the prototype device, and check the relevance of the prototype device data used to support the final device evaluation.
--- Screening for new materials for the intended clinical application of medical devices.
This part of GB/T 16886 does not cover the qualitative and quantitative determination of degradation products. See ISO 10993-9 for details on this.
ISO 10993-13, ISO 10993-14 and ISO 10993-15.
The GB/T 16886 standard applies to materials or instruments that come into direct or indirect contact with the human body. (See ISO 4993-1.2003, 4.2.1)
This part of GB/T 16886 is intended to be applied to material suppliers and medical device manufacturers for biosafety evaluation.

Basic Data

Standard ID	GB/T 16886.18-2011 (GB/T16886.18-2011)
Description (Translated English)	Biological evaluation of medical devices -- Part 18: Chemical characterization of materials
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.040.01
Word Count Estimation	19,199
Date of Issue	2011-12-30
Date of Implementation	2012-05-01
Quoted Standard	ISO 10993-1-2003; ISO 10993-17; YY/T 0316-2008
Adopted Standard	ISO 10993-18-2005, 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 applies to material suppliers and manufacturers of medical devices for biological safety evaluation application.