YY/T 0268-2001 English PDF (YY/T0268-2001)

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YY/T 0268-2001: Dentistry--Preclinical evaluation of biocompatibility of medical devices used in dentistry--Part 1: Evaluation and test methods selection
YY/T 0268-2001
YY
PHARMACEUTICAL INDUSTRY STANDARD
C 33
Record No.. 9610-2002
YY/T 0268-2001 / neq ISO 7405.1997
Replacing YY/T 0268-1995
Dentistry - Preclinical Evaluation of Biocompatibility of
Medical Devices Used in Dentistry – Part 1.Evaluation and
Test Methods Selection
ISSUED ON. NOVEMBER 9, 2001
IMPLEMENTED ON. MARCH 1, 2002
Issued by. National Medical Products Administration
Replaced
Table of Contents
Foreword... 3
ISO Foreword... 6
1 Scope... 7
2 Normative References... 7
3 Definitions... 9
4 Classification of Medical Devices Used in Dentistry... 10
5 Biological Evaluation and Test... 11
Appendix A (Prompted) Classification of Partial Dental Material and Biological
Evaluation and Test Options List... 14
Foreword
This Standard inequivalently adopts the International Standardization Organization ISO 7405.
1997 Dentistry - Preclinical Evaluation of Biocompatibility of Medical Devices Used in
Dentistry - Test Methods for Dental Materials, and the specific test methods listed in the ISO
7405.1997 standard are not included in this Standard.
This Standard replaces YY 0268-1995 Biological Evaluation of Dental Materials - Unit 1.
Guideline of Biological Evaluation of Dental Materials; and is changed from a mandatory
standard to a recommended standard.
This Standard does not contain specific test methods. The relevant test methods can be selected
from the corresponding pharmaceutical industry standards, national standards and international
standards. When applying this Standard, it shall be used in conjunction with the ISO 10993
Biological Evaluation of Medical Devices series of standards, and the GB/T 16886 Biological
Evaluation of Medical Devices series of standards.
This Standard includes the classification of oral materials and the selection of biological
evaluation and test items. When recommending test methods, the first principle to consider is
to minimize the use of animals.
This Standard differs from ISO 7405.1997 in the following respects.
--- Standard name
Name of ISO 7405.1997 is Dentistry - Preclinical Evaluation of Biocompatibility of
Medical Devices Used in Dentistry - Test Methods for Dental Materials;
Name of this Standard is Dentistry – Preclinical Evaluation of Biocompatibility of
Medical Devices Used in Dentistry – Part 1.Evaluation and Test Methods Selection.
--- Scope
The scope of ISO 7405.1997 indicates that “it is applicable to preclinical evaluation of
biocompatibility of dental materials intended for human use, including testing of
pharmacological agents necessary to constitute the entire device under test.”
The scope of this Standard indicates that “this Standard specifies the classification of
medical devices used in the dental and the selection of biocompatibility preclinical
evaluation and test items.”
--- Normative References
The pharmaceutical industry standards regarding biological testing methods for dental
materials have been added to this Standard.
--- Specific test method
ISO 7405.1997 also contains some test methods specifically applicable to dental
devices/materials, such as in vitro cytotoxicity test (agar covering method and molecular
filtration method), pulpodentinal test, root canal application test and pulp capping test.
Details of these test methods are not included in this Standard. Since these test methods
have been or are being developed into relevant standards, they can be directly quoted
when applying them.
--- Table 1
Table 1 in ISO 7405.1997 lists the sources of each test method. The source of the test
method has been deleted from Table 1 of this Standard. Add "Note" below Table 1.“See
Appendix A for the biological evaluation of some dental materials and the selection of
test items”.
---Appendix A
Appendix A is added for convenience of use. It is the most basic item that shall be
considered in the biological evaluation and testing of some existing dental materials.
Appendix A, B and C in the ISO 7405.1997 standard have been cancelled. Taking into
account the characteristics of the application site of dental materials, Appendix A will
involve the test of "skin irritation and intradermal reaction", specifically the "dental
mucosal irritation test". This Standard is different from the original YY 0268-1995 in the
following aspects;
--- Classification of dental materials.
The definition of medical devices in this Standard includes dental devices and dental
materials. Medical devices used in the dentistry are classified according to the nature and
duration of contact with tissue. The classification of dental materials in the original YY
0268-1995 is based on application.
--- Evaluation and test
This Standard follows the basic principles of GB/T 16886.1-2001 - ISO 10993-1.1997
Biological Evaluation of Medical Devices - Part 1.Evaluation and Testing. It
emphasizes that biological evaluation and biological test are two different concepts. The
biological test items listed in Table 1 of this Standard are the framework for biological
evaluation. During application, biological evaluation shall be carried out according to the
items listed in the biological evaluation framework based on the use of the material, the
tissues that may be in contact with the material, and the contact time. However, not all
listed items need to be tested. Therefore, when conducting biological evaluation,
reasonable evaluation procedures must be paid attention to and make full use of existing
information for biological evaluation. Qualitative and quantitative analysis of device
materials shall be carried out as much as possible before biological evaluation to
Dentistry - Preclinical Evaluation of Biocompatibility of
Medical Devices Used in Dentistry – Part 1.Evaluation and
Test Methods Selection
1 Scope
This Standard specifies the classification of medical devices used in the dentistry and
biocompatibility preclinical evaluation and the selection of test items.
2 Normative References
The following standards contain provisions which, through reference in this Standard,
constitute provisions of this Standard. At the time of publication, the editions indicated are valid.
All standards are subject to revision. The parties who are using this Standard shall explore the
possibility of using the latest version of the following standards.
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)
GB/T 16886.3-1997 Biological evaluation of medical devices - Part 3.Tests for genotoxicity,
carcinogenicity and reproductive toxicity (idt ISO 10993-3.1992)
GB/T 16886.5-1997 Biological evaluation of medical devices - Part 5.Tests for cytotoxicity.
in vitro methods (idt ISO 10993-5.1992)
GB/T 16886.6-1997 Biological evaluation of medical devices - Part 6.Tests for local effects
after implantation (idt ISO 10993-6.1994)
GB/T 16886.9-2001 Biological evaluation of medical devices - Part 9.Framework for
identification and quantification of potential degradation products (idt ISO 10993-9.1994)
GB/T 16886.10-2000 Biological evaluation of medical devices - Part 10.Tests for irritation and
sensitization (idt ISO 10993-10.1995)
GB/T 16886.11-1998 Biological evaluation of medical devices--Part 11.Tests for systemic
toxicity (idt ISO 10993-11.1993)
3.5 Negative-control material; reference material
Material or substance which, when tested by the procedure described, demonstrates the
suitability of the procedure to yield a reproducible, appropriate negative, nonreactive or
background response in the test system.
4 Classification of Medical Devices Used in Dentistry
4.1 Classification by nature of contact
For the purposes of this Standard, the classification of medical devices used in dentistry is
derived from GB/T 16886.1 – ISO 10993-1.If a device or material can be placed in more than
one category, the more rigorous testing requirements shall apply. With multiple exposures the
decision into which category a device is placed shall take into account the potential cumulative
effect, bearing in mind the period of time over which these exposures occur.
4.1.1 Noncontact devices
These devices do not contact the patient’s body directly or indirectly, and are not included in
GB/T 16886 - ISO 10993.
4.1.2 Surface-contacting devices
These devices include those that contact the surface of intake or breached skin, the surface of
intact or breached oral mucosa, and those that contact the external surfaces of dental hard tissue,
including enamel, dentine and cementum.
NOTE. Dentine and cementum are considered as surfaces; e.g. after gingival recession.
4.1.3 External communicating devices
These devices include dental devices that penetrate and are in contact with oral mucosa, dental
hard tissues, dental pulp tissue or bone, or any combination of these, and are exposed to the oral
environment.
4.1.4 Implant devices
These devices include dental devices and implants that are partially or fully embedded within
the soft tissue, bone or pulpodentinal tissue or combination of these tissues of the tooth, or any
combination of these, and are not exposed to the oral environment.
4.2 Classification by duration of contact
For the purposes of this Standard, medical devices used in dentistry are classified by duration
of contact as described in GB/T 16886.1 - ISO 10993-1, i.e..