GB/T 16886.12-2005 (GB/T 16886.12-2023 Newer Version) PDF English
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GB/T 16886.12-2005: PDF in English (GBT 16886.12-2005) GB/T 16886.12-2005
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.110
C 30
GB/T 16886.12-2005 / ISO 10993-12.2002
Replacing GB/T 16886.12-2000
Biological evaluation of medical devices -
Part 12. Sample preparation and reference materials
(ISO 10993-12.2002, IDT)
ISSUED ON. MARCH 23, 2005
IMPLEMENTED ON. DECEMBER 01, 2005
Issued by.
General Administration of Quality Supervision, Inspection
and Quarantine of the People’s Republic of China;
Standardization Administration of the People’s Republic of
China.
Table of Contents
Foreword ... 3
Introduction ... 5
1 Scope ... 6
2 Normative references ... 6
3 Terms and definitions ... 6
4 Experimental controls ... 9
5 Reference materials ... 10
6 Use of RMs as experimental controls ... 10
7 Test material selection ... 11
8 Test sample and RM preparation ... 11
9 Selection of representative portions from a device ... 12
10 Preparation of extracts of samples ... 12
11 Records ... 16
Annex A (Informative) Experimental controls... 17
Annex B (Informative) General principles and practices of test material
preparation and sample selection ... 19
Annex C (Informative) Principles of test material extraction ... 21
Bibliography ... 24
Foreword
This Part of GB/T 16886 equivalently adopts ISO 10993-12.2002 Biological evaluation of
medical devices - Part 12. Sample preparation and reference materials.
After technical revision, this Part replaces GB/T 16886.12-2000. The main changes are as
follows.
— Add terms “accelerated extraction”, “exaggerated extraction” and “stability of
property values”;
— Change relevant contents and titles of Clause 4, Clause 5, Clause 6 and Clause 7
in 1st Edition;
— Change relevant contents and titles of Annex A, Annex B and Annex C in 1st
Edition.
General title of GB/T 16886 is Biological evaluation of medical devices. It is consisted of
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. Test for in vitro cytotoxicity;
— Part 6. Tests for local effects after implantation;
— Part 7. Ethylene oxide sterilization residuals;
— Part 9. Framework for identification and quantification of potential degradation
products;
— Part 10.Tests for irritation and delayed-type hypersensitivity;
— 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
Introduction
This Part of GB/T 16886 specifies methods of sample preparation and the selection of
reference materials in the biological evaluation of medical devices. Because GB/T 16886
describes many different biological assay systems, the individual parts should be
consulted to ascertain if these recommendations are appropriate for specific test systems.
Sample preparation methods should be appropriate for both the biological evaluation
methods and the materials being evaluated. Each biological test method requires the
selection of materials, extraction solvents and conditions.
This Part of GB/T 16886 is based on existing national and international specifications,
regulations and standards wherever possible. They are periodically reviewed and revised.
Biological evaluation of medical devices -
Part 12. Sample preparation and reference materials
1 Scope
This Part of GB/T 16886 specifies requirements and gives guidance on the procedures to
be followed in the preparation of samples and the selection of reference materials for
medical devices testing in biological systems in accordance with one or more parts of the
GB/T 16886 series.
Specifically, this Part addresses.
— test material selection;
— selection of representative portions from a device;
— test sample preparation;
— experimental controls;
— selection of and requirements for reference materials; and
— preparation of extracts.
The applicability of this Part to absorbable materials, materials that polymerize in situ,
tissue-engineered medical products and materials of biological origin should be carefully
evaluated.
2 Normative references
The articles contained in the following documents have become part of this Part of GB/T
16886 when they are quoted herein. For the dated documents so quoted, all the
modifications (excluding corrigendum) or revisions made thereafter shall not be applicable
to this Standard. For the undated documents so quoted, the latest editions shall be
applicable to this Standard.
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and
testing (GB/T 16886.1-2001, idt ISO 10993-1.1997)
YY/T 0316 Medical devices - Application of risk management to medical devices
(YY/T 0316-2003, idt ISO 14971.2000)
3 Terms and definitions
material with one or more property values that are sufficiently reproducible and well
established to enable use of the material or substance for the calibration of an apparatus,
the assessment of a measurement method, or for the assignment of values to materials
[ISO Guide 30]
NOTE. For the purposes of this Part, a reference material is any well characterized material or substance,
which when tested by the procedure described, demonstrates the suitability of the procedure to yield a
reproducible, predictable response. The response may be negative or positive.
3.11
simulated-use extraction
extraction of a test material or sample with an appropriate medium and under conditions
that simulate product use, for the purpose of evaluating its potential hazard to the patient
or user during its routine clinical use
3.12
stability of property values
ability of a material, when stored under specified conditions, to maintain a specific stated
biological response, within specified limits, for a specific period of time
[ISO Guide 30]
3.13
test material
material, device, device portion, or component thereof subject to biological testing
3.14
test sample
test material or extract subject to biological testing
4 Experimental controls
Experimental controls shall be used in biological evaluations to validate a test procedure
and/or to compare the results between materials. Depending on the biological test,
negative controls, blanks and/or positive controls shall be used as is appropriate to the
test.
NOTE. The same type of control may be applicable to different tests and may allow cross-reference to
other established materials and test methods. Additional guidance on the selection of experimental
controls is given in Annex A. Use of positive controls for in vivo testing may be affected by animal welfare
considered. Tools used for cutting medical devices into representative portions for testing
shall be clean to prevent contamination.
9 Selection of representative portions from a device
9.1 If a device cannot be tested as a whole, each individual material in the final product
shall be represented proportionally in the test sample.
9.1.1 The test sample of devices with surface coatings shall include both coating
material and the substrate.
9.1.2 The test sample shall include a representative portion of the joint and/or seal if
adhesives, radio frequency (RF) seals, or solvent seals are used in the manufacture of a
portion of the device which contacts patients.
9.2 Composite materials shall be tested as finished materials.
9.3 When different materials are present in a single device, the potential for synergies
and interactions shall be considered in the choice of test sample.
9.4 The test sample shall be chosen to maximize the exposure of the test system to the
components of a device that are known to have a potential for a biological response.
10 Preparation of extracts of samples
10.1 General
If extracts of the device are required for a test procedure, the extraction media and
conditions of extraction used shall be appropriate to the nature and use of the final product
and to the purpose of the test, e.g. hazard identification, risk estimation, or risk
assessment. The physicochemical properties of the device materials, leachable
substances, or residues shall be considered when choosing the extraction conditions.
NOTE. For additional guidance on the extraction of samples, see Annex C.
10.2 Containers for extraction
10.2.1 The ext...
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Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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