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GB/T 16886.4-2003 (GB/T16886.4-2003)

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GB/T 16886.4-2003
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.01
C 30
GB/T 16886.4-2003 / ISO 10993-4.2002
Biological evaluation of medical devices - Part 4.
Selection of tests for interactions with blood
(ISO 10993-4.2002, IDT)
ISSUED ON. MARCH 05, 2003
IMPLEMENTED ON. AUGUST 01, 2003
Issued by. General Administration of Quality Supervision, Inspection and
Quarantine
Table of Contents
Foreword ... 3 
Introduction ... 5 
1 Scope ... 6 
2 Normative references ... 6 
3 Terms and definitions ... 6 
4 Abbreviated terms ... 8 
5 Types of device in contact with blood (as classified in GB/T 16886.1/ISO
10993-1) ... 9 
6 Characterization of blood interactions ... 11 
Annex A (informative) Preclinical evaluation of cardiovascular devices and
prostheses ... 21 
Annex B (informative) Laboratory tests - Principles, scientific basis and
interpretation ... 27 
Annex C (informative) Evaluation of haemolytic properties of medical devices
and their components ... 35 
Bibliography ... 45 
Foreword
This Part of GB/T 16886 identically adopts ISO 10993-4.2002 “Biological
evaluation of medical devices - Part 4. Selection of tests for interactions with
blood”.
The name of GB/T 16886 is “Biological evaluation of medical devices”,
consisting of the following parts.
- Part 1. Evaluation and testing within a risk management process;
- Part 2. Animal welfare requirements;
- Part 3. Tests for genotoxicity carcinogenicity and reproductive toxicity;
- Part 4. Selection of tests for interactions with blood;
- Part 5. Tests for in vitro cytotoxicity;
- Part 6. Tests for local effects after implantation;
- Part 7. Ethylene oxide sterilization residuals;
- Part 8. Selection and limitation of reference materials for biological tests;
- Part 9. Framework for identification and quantification of potential
degradation products;
- Part 10. Tests for irritation and sensitization;
- Part 11. Tests for systemic toxicity;
- Part 12. Sample preparation and reference materials;
- Part 13. Identification and quantification of degradation products from
polymeric medical devices;
- Part 14. Identification and quantification of degradation products from
ceramics;
- Part 15. Identification and quantification of degradation products from
metals and alloys;
- Part 16. Toxicokinetic study design for degradation products and leachables;
- Part 17. Establishment of allowable limits for leachable substances;
- Part 18. Chemical characterization of materials.
The biological tests in other aspects shall have standards of other parts.
Annex A, Annex B and Annex C of this Part are informative.
This Part was proposed by China Food and Drug Administration.
This Part shall be under the jurisdiction of National Technical Committee on
Medical Equipment Biology Evaluation of Standardization Administration of
China.
The drafting organizations of this Part. Jinan Medical Device Quality
Supervision and Inspection Center of China Food and Drug Administration,
Tianjin Medical Biomaterials Testing and Research Center.
Main drafters of this Part. You Shaohua, Shi Hongdao, Wu Ping, Liu Xin.
Biological evaluation of medical devices - Part 4.
Selection of tests for interactions with blood
1 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.
2 Normative references
The provisions in following documents become the provisions of this Part of
GB/T 16886 through reference in this Standard. For dated references, the
subsequent amendments (excluding corrigendum) or revisions do not apply to
this Part, however, parties who reach an agreement based on this Part are
encouraged to study if the latest versions of these documents are applicable.
For undated references, the latest edition of the referenced document applies.
GB/T 16886.1-2001, Biological evaluation of medical devices -- Part 1.
Evaluation and testing (idt ISO 10993-1.1997)
GB/T 16886.2-2000, Biological evaluation of medical devices -- Part 2.
Animal welfare requirements (idt ISO 10993-2.1992)
3 Terms and definitions
For the purposes of this document, the terms and definitions defined in GB/T
......
 
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.