GB/T 16886.4-2003: Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood

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Scope

This Part of GB/T 16886 provides general requirements for evaluating the
interactions of medical devices with blood. It describes
a) a classification of medical and dental devices that are intended for use in
contact with blood, based on the intended use and duration of contact as
defined in GB/T 16886.1/ISO 10993-1;
b) the fundamental principles governing the evaluation of the interaction of
devices with blood;
c) the rationale for structured selection of tests according to specific
categories, together with the principles and scientific basis of these tests.
Detailed requirements for testing cannot be specified because of limitations in
the knowledge and precision of tests for interactions of devices with blood. This
Part of GB/T 16886 describes biological evaluation in general terms and may
not necessarily provide sufficient guidance for test methods for a specific device.

Basic Data

Standard ID	GB/T 16886.4-2003 (GB/T16886.4-2003)
Description (Translated English)	Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.040.01
Word Count Estimation	32,317
Date of Issue	3/5/2003
Date of Implementation	8/1/2003
Adopted Standard	ISO 10993-4-2002, IDT
Issuing agency(ies)	General Administration of Quality Supervision, Inspection and Quarantine of the People Republic of China
Summary	This Standard specifies the evaluation of medical devices for interactions with blood General requirements. GB/T 16886 of This Standard specifies a) in accordance with the purpose and the top of the contact time GB/T 16886. 1/ISO 10993-1 requirements for contact with blood of medical and dental instruments are classified, b) equipment basic evaluation principles for interactions with blood. c) Depending on the device classification. Binding assays and the scientific basis of its primitive monument selection principles given trial.