GB/T 16886.10-2005: Biological evaluation of medical devices -- Part 10: Tests for irritation and sensitization

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Scope

This Part of GB/T 16886 describes the procedure for the assessment of medical
devices and their constituent materials with regard to their potential to produce irritation
and delayed-type hypersensitivity.
This Part of GB/T 16886 includes
a) pretest considerations,
b) details of the test procedures, and
c) key factors for the interpretation of the results.
Instructions are given in annex A for the preparation of materials specifically in relation
to the above tests.
Supplementary tests which are required specifically for devices used intradermally in
the ocular, oral, rectal, penile and vaginal areas are given in annex B.

Basic Data

Standard ID	GB/T 16886.10-2005 (GB/T16886.10-2005)
Description (Translated English)	Biological evaluation of medical devices. Part 10: Tests for irritation and sensitization
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.040
Word Count Estimation	46,436
Date of Issue	2005-03-23
Date of Implementation	2005-12-01
Older Standard (superseded by this standard)	GB/T 16886.10-2000
Quoted Standard	GB/T 16886.1; GB/T 16886.2; GB/T 16886.9; GB/T 16886.12; GB/T 16886.13; GB/T 16886.14; GB/T 16886.15; ISO 10993-18; ISO 14155-1-2002; ISO 14155 - 2-2003
Adopted Standard	ISO 10993-10-2002; IDT
Regulation (derived from)	Announcement of Newly Approved National Standards No. 6, 2005 (No. 80 overall)
Issuing agency(ies)	General Administration of Quality Supervision, Inspection and Quarantine of the People Republic of China, China National Standardization Administration Committee
Summary	This standard specifies: Medical devices and their constituent materials of potential irritation and delayed-type hypersensitivity evaluation steps.