GB/T 16886.17-2005: Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances

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Scope

This Part of GB/T 16886 specifies a method for the determination of allowable
limits for substances leachable from medical devices. It is intended for use in
deriving standards and estimating appropriate limits where standards do not
exist. It describes a systematic process through which identified risks arising
from toxicologically hazardous substances present in medical devices can be
quantified.
This Part is not applicable to devices that have no patient contact (e.g. in vitro
diagnostic devices).
Exposure to a particular chemical substance may arise from sources other than
the device, such as food, water or air. This Part does not address the potential
for exposure from such sources.

Basic Data

Standard ID	GB/T 16886.17-2005 (GB/T16886.17-2005)
Description (Translated English)	Biological evaluation of medical devices. Part 17: Establishment of allowable limits for leachable substances
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.100
Word Count Estimation	26,265
Date of Issue	2005-11-04
Date of Implementation	2006-04-01
Adopted Standard	ISO 10993-17-2002; IDT
Regulation (derived from)	Announcement of Newly Approved National Standards No. 1, 2006 (No. 88 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 leachables allowable limits determination method, its purpose is to get the standard and the use of wood to build your prospective limited edition properly assessed. This is a systematic process of description Ding, through this process, send toxic substances in the therapy equipment to determine the risk of being quantified. This standard does not apply is not in contact with the patient not the instrument from the standard equipment does not involve contact with certain chemicals, such as food, water, air.