GB/T 16886.11-2011: Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity

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Scope

This part of GB/T 16886 specifies the requirements for evaluating the potential adverse systemic reactions of medical device materials and gives the test
Step guide.

Basic Data

Standard ID	GB/T 16886.11-2011 (GB/T16886.11-2011)
Description (Translated English)	Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.040.01
Word Count Estimation	29,250
Date of Issue	2011-12-30
Date of Implementation	2012-05-01
Older Standard (superseded by this standard)	GB/T 16886.11-1997
Quoted Standard	ISO 10993-1; ISO 10993-2; ISO 10993-12
Adopted Standard	ISO 10993-11-2006, 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 evaluation of medical device materials lead to potentially adverse systemic reactions requirements and test procedures are given guidelines.