Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
This standard is developed in accordance with the rules given in GB/T 1.1-2009.
Attention is drawn to the possibility that some of the elements of this standard may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This standard was proposed by the National Medical Products Administration of People’s Republic of China.
This standard is under the jurisdiction of the National Technical Committee on Dental Materials, Instruments & Equipments of Standardization Administration of China (SAC/TC 99).
General technical requirements for dental collagen membrane
1 Scope
This standard specifies the terms and definitions, classification, requirements and test methods for dental collagen membrane.
This standard is applicable to the membrane materials with collagen as the main component for repairing soft and hard oral tissue defects caused by various reasons, which plays a role of guiding, isolating, repairing, fixing, reducing tension and replacing.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 528-2009 Rubber, vulcanized or thermoplastic — Determination of tensile stress-strain properties
GB/T 1040.3-2006 Plastics — Determination of tensile properties — Part 3: Test conditions for films and sheets
GB 5009.6-2016 National food safety standard — Determination of fat in foods
GB/T 6682-2008 Water for analytical laboratory use — Specification and test methods
GB/ T 14233.1-2008 Test methods for infusion, transfusion, injection equipments for medical use — Part 1: Chemical analysis methods
GB/T 14233.2-2005 Test methods for infusion, transfusion, injection equipment for medical use — Part 2: Biological test methods
GB/T 16886.1 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
GB/T 16886.3 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.4 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
GB/T 16886.5 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
GB/T 16886.6 Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
GB/T 16886.7 Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
GB/T 16886.10 Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
GB/T 16886.11 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
GB/T 16886.12 Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
GB/T 16886.20 Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
YY/T 0127.2 Biological evaluation of medical devices used in dentistry — Part 2: Test method — Acute systemic toxicity: intravenous path
YY/T 0127.4 Biological evaluation of medical devices used in dentistry — Part 2: Test method — Bone implant test
YY/T 0127.8 Biological evaluation of dental materials — Part 2: Biological evaluation test method of dental materials — Subcutancous implant test
YY/T 0127.10 Biological evaluation of medical devices used in dentistry — Part 2: Test method — Salmonella typhimurium reverse mutation assay (Ames mutagenicity test)
YY/T 0268 Dentistry — Biological evaluation of medical devices used in dentistry — Part 1: Evaluation and test
YY/T 0606.25-2014 Tissue engineered medical product — Part 25: Quantification of remnant DNA in biological materials utilizing animal tissues and their derivatives: Fluorescence method
YY 0954-2015 Nonactive surgical implants — Type I collagen implants — Specific requirements
YY/T 1511-2017 Collagen sponge
Pharmacopoeia of the People's Republic of China (2020)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
dental collagen membrane
dental membrane material with collagen as the main component, generally including purified collagen membrane, recombinant collagen membrane and acellular matrix membrane (purified collagen membrane: membranous product prepared by physical or chemical crosslinking of collagen extracted from animal tissues; recombinant collagen membrane: membranous product prepared by physical or chemical crosslinking of collagen prepared by genetic engineering technology; acellular matrix membrane: membrane with the extracellular matrix as the main component that is obtained by removing the cellular components of tissues/organs by chemical and/or physical methods, while retaining its organizational structure)
3.2
patch utilizing animal tissues and their derivatives animal derived materials
materials containing animal derived materials (animal tissues and their derivatives), all or part of which are made of animal tissues, and materials made of animal tissue derivatives or substances naturally obtained from animal bodies through special processing, which can be used for filling, repairing, barrier and anti-adhesion of defective tissues
3.3
type I collagen
collagen composed of two α1 peptide chains and one α2 peptide chain, whose structure has triple helix characteristics, in which, arranged into bundles regularly, five collagen molecules aggregate to form collagen fibrils, and multiple collagen fibrils are connected end-to-end and head-to-tail according to rules to form type I collagen fibers with different thicknesses
3.4
additives
natural or synthetic substances which are added in medical devices during the production, processing or storage, and expected to achieve a special purpose in the final products, e.g., crosslinking agents, modifiers, protectants, antibacterial agents, inorganic minerals, etc.
4 Classification
Dental collagen membrane materials may be classified as follows: crosslinked membrane and non-crosslinked membrane according to whether they are crosslinked or not; allogeneic and xenogeneic according to the source; dermal matrix membrane, pericardium and small intestinal submucosa membrane according to the origin; acellular matrix membrane, purified collagen membrane and recombinant collagen membrane according to the process; guided tissue regeneration (GTR) membrane, guided bone tissue regeneration membrane, gingival mucosa and other soft tissue repair regeneration membranes according to the intended use.
5 Requirements
5.1 Physical and mechanical properties
5.1.1 Appearance
It shall meet the requirements of the manufacturer.
5.1.2 Dimensions
It shall meet the requirements of the manufacturer.
5.1.3 Structural characteristics
The manufacturer shall describe the structural characteristics of dental collagen membrane (such as pore size, pore size distribution, porosity), and define its test methods. The structural characteristics of the product shall meet the requirements of the manufacturer.
5.1.4 Thermal denaturation (if applicable)
The temperature of thermal denaturation shall meet the requirements of the manufacturer.
5.1.5 Water absorbability
The liquid absorbability shall meet the requirements of the manufacturer.
5.1.6 Tensile strength
The tensile strength shall not be less than the value specified by the manufacturer.
5.1.7 Elongation at break
The elongation at break shall not be less than the value specified by the manufacturer.
Note: This item is not applicable to the dental collagen membrane used by non-suture method.
5.1.8 Tear force
The tear force shall not be less than the value specified by the manufacturer.
Note: This item is not applicable to the dental collagen membrane used by non-suture method.
5.2 Chemical properties
5.2.1 pH value
The pH value shall meet the requirements of the manufacturer.
5.2.2 Total content of heavy metal (calculated in Pb)
The total content of heavy metal shall not be greater than 10 mg/kg.
5.2.3 Trace elements
Cadmium (Cd), chromium (Cr), copper (Cu), lead (Pb), molybdenum (Mo), iron (Fe), nickel (Ni), arsenic (As), mercury (Hg) and other elements introduced in the process shall be less than the manufacturer's limits.
5.2.4 Ethylene oxide residuals
According to GB/T 16886.7, the manufacturer shall set the limit of ethylene oxide residuals based on the duration of contact between the product and human body.
Note: This item is applicable to the collagen membrane sterilized by ethylene oxide.
5.2.5 Composition
5.2.5.1 Total protein content: It shall meet the requirements of the manufacturer.
5.2.5.2 Hydroxyproline content: It shall meet the requirements of the manufacturer.
5.2.5.3 Collagen identification: If applicable, it shall meet the requirements of the manufacturer.
Note: This item is applicable to the purified collagen membrane and recombinant collagen membrane, but not applicable to acellular matrix materials.
5.2.5.4 Foreign protein content: the total content of foreign protein shall not exceed the limit specified by the manufacturer, and the content (mass fraction) of any kind of foreign protein except collagen in the purified and recombined collagen membrane shall be less than 1.0%.
5.2.5.5 Fat content (mass fraction): The fat content of purified and recombinant collagen membranes shall be not more than 1%.
5.2.5.6 DNA residual content: It shall meet the requirements of the manufacturer.
5.2.5.7 Host cell residuals: There shall be no intact nucleus.
5.2.5.8 Residue on ignition (mass fraction): It shall be not more than 1%, if applicable.
5.2.5.9 Additives content: If applicable, establish and specify the allowable limit of additives, and their content shall meet the requirements of the manufacturer.
Note: The identification of additives is not specified in this standard, and the specific properties and efficacy of collagen membrane with additives shall be specified separately by the manufacturer.
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
5 Requirements
6 Test methods
Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
This standard is developed in accordance with the rules given in GB/T 1.1-2009.
Attention is drawn to the possibility that some of the elements of this standard may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This standard was proposed by the National Medical Products Administration of People’s Republic of China.
This standard is under the jurisdiction of the National Technical Committee on Dental Materials, Instruments & Equipments of Standardization Administration of China (SAC/TC 99).
General technical requirements for dental collagen membrane
1 Scope
This standard specifies the terms and definitions, classification, requirements and test methods for dental collagen membrane.
This standard is applicable to the membrane materials with collagen as the main component for repairing soft and hard oral tissue defects caused by various reasons, which plays a role of guiding, isolating, repairing, fixing, reducing tension and replacing.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 528-2009 Rubber, vulcanized or thermoplastic — Determination of tensile stress-strain properties
GB/T 1040.3-2006 Plastics — Determination of tensile properties — Part 3: Test conditions for films and sheets
GB 5009.6-2016 National food safety standard — Determination of fat in foods
GB/T 6682-2008 Water for analytical laboratory use — Specification and test methods
GB/ T 14233.1-2008 Test methods for infusion, transfusion, injection equipments for medical use — Part 1: Chemical analysis methods
GB/T 14233.2-2005 Test methods for infusion, transfusion, injection equipment for medical use — Part 2: Biological test methods
GB/T 16886.1 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
GB/T 16886.3 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.4 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
GB/T 16886.5 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
GB/T 16886.6 Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
GB/T 16886.7 Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
GB/T 16886.10 Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
GB/T 16886.11 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
GB/T 16886.12 Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
GB/T 16886.20 Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
YY/T 0127.2 Biological evaluation of medical devices used in dentistry — Part 2: Test method — Acute systemic toxicity: intravenous path
YY/T 0127.4 Biological evaluation of medical devices used in dentistry — Part 2: Test method — Bone implant test
YY/T 0127.8 Biological evaluation of dental materials — Part 2: Biological evaluation test method of dental materials — Subcutancous implant test
YY/T 0127.10 Biological evaluation of medical devices used in dentistry — Part 2: Test method — Salmonella typhimurium reverse mutation assay (Ames mutagenicity test)
YY/T 0268 Dentistry — Biological evaluation of medical devices used in dentistry — Part 1: Evaluation and test
YY/T 0606.25-2014 Tissue engineered medical product — Part 25: Quantification of remnant DNA in biological materials utilizing animal tissues and their derivatives: Fluorescence method
YY 0954-2015 Nonactive surgical implants — Type I collagen implants — Specific requirements
YY/T 1511-2017 Collagen sponge
Pharmacopoeia of the People's Republic of China (2020)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
dental collagen membrane
dental membrane material with collagen as the main component, generally including purified collagen membrane, recombinant collagen membrane and acellular matrix membrane (purified collagen membrane: membranous product prepared by physical or chemical crosslinking of collagen extracted from animal tissues; recombinant collagen membrane: membranous product prepared by physical or chemical crosslinking of collagen prepared by genetic engineering technology; acellular matrix membrane: membrane with the extracellular matrix as the main component that is obtained by removing the cellular components of tissues/organs by chemical and/or physical methods, while retaining its organizational structure)
3.2
patch utilizing animal tissues and their derivatives animal derived materials
materials containing animal derived materials (animal tissues and their derivatives), all or part of which are made of animal tissues, and materials made of animal tissue derivatives or substances naturally obtained from animal bodies through special processing, which can be used for filling, repairing, barrier and anti-adhesion of defective tissues
3.3
type I collagen
collagen composed of two α1 peptide chains and one α2 peptide chain, whose structure has triple helix characteristics, in which, arranged into bundles regularly, five collagen molecules aggregate to form collagen fibrils, and multiple collagen fibrils are connected end-to-end and head-to-tail according to rules to form type I collagen fibers with different thicknesses
3.4
additives
natural or synthetic substances which are added in medical devices during the production, processing or storage, and expected to achieve a special purpose in the final products, e.g., crosslinking agents, modifiers, protectants, antibacterial agents, inorganic minerals, etc.
4 Classification
Dental collagen membrane materials may be classified as follows: crosslinked membrane and non-crosslinked membrane according to whether they are crosslinked or not; allogeneic and xenogeneic according to the source; dermal matrix membrane, pericardium and small intestinal submucosa membrane according to the origin; acellular matrix membrane, purified collagen membrane and recombinant collagen membrane according to the process; guided tissue regeneration (GTR) membrane, guided bone tissue regeneration membrane, gingival mucosa and other soft tissue repair regeneration membranes according to the intended use.
5 Requirements
5.1 Physical and mechanical properties
5.1.1 Appearance
It shall meet the requirements of the manufacturer.
5.1.2 Dimensions
It shall meet the requirements of the manufacturer.
5.1.3 Structural characteristics
The manufacturer shall describe the structural characteristics of dental collagen membrane (such as pore size, pore size distribution, porosity), and define its test methods. The structural characteristics of the product shall meet the requirements of the manufacturer.
5.1.4 Thermal denaturation (if applicable)
The temperature of thermal denaturation shall meet the requirements of the manufacturer.
5.1.5 Water absorbability
The liquid absorbability shall meet the requirements of the manufacturer.
5.1.6 Tensile strength
The tensile strength shall not be less than the value specified by the manufacturer.
5.1.7 Elongation at break
The elongation at break shall not be less than the value specified by the manufacturer.
Note: This item is not applicable to the dental collagen membrane used by non-suture method.
5.1.8 Tear force
The tear force shall not be less than the value specified by the manufacturer.
Note: This item is not applicable to the dental collagen membrane used by non-suture method.
5.2 Chemical properties
5.2.1 pH value
The pH value shall meet the requirements of the manufacturer.
5.2.2 Total content of heavy metal (calculated in Pb)
The total content of heavy metal shall not be greater than 10 mg/kg.
5.2.3 Trace elements
Cadmium (Cd), chromium (Cr), copper (Cu), lead (Pb), molybdenum (Mo), iron (Fe), nickel (Ni), arsenic (As), mercury (Hg) and other elements introduced in the process shall be less than the manufacturer's limits.
5.2.4 Ethylene oxide residuals
According to GB/T 16886.7, the manufacturer shall set the limit of ethylene oxide residuals based on the duration of contact between the product and human body.
Note: This item is applicable to the collagen membrane sterilized by ethylene oxide.
5.2.5 Composition
5.2.5.1 Total protein content: It shall meet the requirements of the manufacturer.
5.2.5.2 Hydroxyproline content: It shall meet the requirements of the manufacturer.
5.2.5.3 Collagen identification: If applicable, it shall meet the requirements of the manufacturer.
Note: This item is applicable to the purified collagen membrane and recombinant collagen membrane, but not applicable to acellular matrix materials.
5.2.5.4 Foreign protein content: the total content of foreign protein shall not exceed the limit specified by the manufacturer, and the content (mass fraction) of any kind of foreign protein except collagen in the purified and recombined collagen membrane shall be less than 1.0%.
5.2.5.5 Fat content (mass fraction): The fat content of purified and recombinant collagen membranes shall be not more than 1%.
5.2.5.6 DNA residual content: It shall meet the requirements of the manufacturer.
5.2.5.7 Host cell residuals: There shall be no intact nucleus.
5.2.5.8 Residue on ignition (mass fraction): It shall be not more than 1%, if applicable.
5.2.5.9 Additives content: If applicable, establish and specify the allowable limit of additives, and their content shall meet the requirements of the manufacturer.
Note: The identification of additives is not specified in this standard, and the specific properties and efficacy of collagen membrane with additives shall be specified separately by the manufacturer.
Contents of YY/T 1794-2021
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
5 Requirements
6 Test methods
