标准编号:	YY/T 1794-2021
中文名称:	口腔胶原膜通用技术要求
英文名称:	General technical requirements for dental collagen membrane
中标分类:	C33    口腔科器械、设备与材料
行业分类:	YY    医药行业标准
ICS分类:	11.060.10 11.060.10    牙科材料 11.060.10
发布机构:	国家药品监督管理局
发布日期:	2021-03-10
实施日期:	2022-4-1
标准状态:	valid
翻译语言:	英文
文件格式:	PDF
中文字符数:	11000 字
翻译价格(元):	770.0
交付时间:	付款后 1 个工作日

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

口腔胶原膜通用技术要求 1 范围 本标准规定了口腔胶原膜材料的术语和定义、分类、要求及试验方法。 本标准适用于修复各种原因引起的口腔软、硬组织缺损，起到引导、隔离、修补、固定、减张、替代等作用的以胶原蛋白为主要成分的膜材料。 2 规范性引用文件 下列文件对于本文件的应用是必不可少的。凡是注日期的引用文件，仅注日期的版本适用于本文件。凡是不注日期的引用文件，其最新版本(包括所有的修改单)适用于本文件。 GB／T 528—2009 硫化橡胶或热塑性橡胶 拉伸应力应变性能的测定 GB／T 1040.3—2006 塑料 拉伸性能的测定 第3部分：薄膜和薄片的试验条件 GB 5009.6—2016 食品安全国家标准 食品中脂肪的测定 GB／T 6682—2008 分析实验室用水规格和试验方法 GB／T 14233.1—2008 医用输液、输血、注射器具检验方法 第1部分：化学分析方法 GB／T 14233.2—2005 医用输液、输血、注射器具检验方法 第2部分：生物学试验方法 GB／T 16886.1 医疗器械生物学评价 第1部分：风险管理过程中的评价与试验 GB／T 16886.3 医疗器械生物学评价 第3部分：遗传毒性、致癌性和生殖毒性试验 GB／T 16886.4 医疗器械生物学评价 第4部分：与血液相互作用试验选择 GB／T 16886.5 医疗器械生物学评价 第5部分：体外细胞毒性试验 GB／T 16886.6 医疗器械生物学评价 第6部分：植入后局部反应试验 GB／T 16886.7 医疗器械生物学评价 第7部分：环氧乙烷灭菌残留量 GB／T 16886.10 医疗器械生物学评价 第10部分：刺激与皮肤致敏试验 GB／T 16886.11 医疗器械生物学评价 第11部分：全身毒性试验 GB／T 16886.12 医疗器械生物学评价 第12部分：样品制备与参照材料 GB／T 16886.20 医疗器械生物学评价 第20部分：医疗器械免疫毒理学试验原则和方法 YY／T 0127.2 口腔医疗器械生物学评价 第2单元：试验方法 急性全身毒性试验：静脉途径 YY／T 0127.4 口腔医疗器械生物学评价 第2单元：试验方法 骨埋植试验 YY／T 0127.8 口腔材料生物学评价 第2单元：口腔材料生物试验方法 皮下植入试验 YY／T 0127.10 口腔医疗器械生物学评价 第2单元：试验方法 鼠伤寒沙门氏杆菌回复突变试验(Ames试验) YY／T 0268 牙科学 口腔医疗器械生物学评价 第1单元：评价与试验 YY／T 0606.25—2014 组织工程医疗产品 第25部分：动物源性生物材料DNA残留量测定法：荧光染色法 YY 0954—2015 无源外科植入物 Ⅰ型胶原蛋白植入剂 YY／T 1511—2017 胶原蛋白海绵 中华人民共和国药典(2020年版) 3 术语和定义 下列术语和定义适用于本文件。 3.1 口腔胶原膜 dental collagen membrane 以胶原蛋白为主要成分的口腔膜材料，一般包括纯化胶原膜、重组胶原膜和脱细胞基质膜。纯化胶原膜是指利用动物组织提取的胶原蛋白经过物理或化学交联制备而成的膜状产品；重组胶原膜是指利用基因工程技术制备的胶原蛋白经过物理或化学交联制备而成的膜状产品；脱细胞基质膜主要是采用化学和／或物理等方法去除组织／器官的细胞成分，同时保留其组织构架而得到的以细胞外基质为主要成分的膜。 3.2 动物源性材料 patch utilizing animal tissues and their derivatives animal derived materials 含有动物来源的材料(动物组织及其衍生物)，全部或部分采用动物组织制成的，及采用动物组织衍生物或由动物体自然获取的物质经特定工艺处理而制成的材料，可用于缺损组织的填充、修复、屏障、防粘连等。 3.3 Ⅰ型胶原 type Ⅰ collagen 由2条α1肽链和1条α2肽链组成，结构具有三螺旋特点；按规则排列成束，以5个胶原分子聚集而形成胶原原纤维；多个胶原原纤维按规则以端端、首尾错位连接形成粗细不等的Ⅰ型胶原纤维。 3.4 添加物 additives 医疗器械在生产、加工或贮存过程中，添加其中期望在最终产品中达到某种特殊目的的物质，可以是天然或合成的物质。例如：交联剂、改性剂、保护剂、抗菌剂、无机矿物质等。 4 分类 口腔胶原膜材料按是否交联可分为交联膜和非交联膜；按来源分为同种异体、异种等；按来源部位分为真皮基质膜、心包膜、小肠黏膜下层膜等；按工艺分为脱细胞基质膜、纯化胶原膜、重组胶原膜等；按照预期用途分为引导组织再生膜、引导骨组织再生膜、牙龈黏膜等软组织修补再生膜等。 5 要求 5.1 物理机械性能 5.1.1 外观 应符合制造商的规定。 5.1.2 尺寸 应符合制造商的规定。 5.1.3 结构特性 制造商应对口腔胶原膜的结构特性(如：孔径大小、孔径分布、孔隙率等)进行描述，并明确其测试方法。产品的结构特性应符合制造商规定。 5.1.4 热变性(如适用) 热变性温度应符合制造商规定。 5.1.5 吸水性 液体吸收性应符合制造商规定。 5.1.6 拉伸强度 拉伸强度应不小于制造商规定。 5.1.7 断裂伸长率 断裂伸长率应不小于制造商规定。 注：以非缝合方式使用的口腔胶原膜不适用此项。 5.1.8 撕裂力 撕裂力应不小于制造商规定。 注：以非缝合方式使用的口腔胶原膜不适用此项。 5.2 化学性能 5.2.1 酸碱度 pH值应符合制造商规定。 5.2.2 重金属总量(以铅Pb计) 应不大于10 mg／kg。 5.2.3 微量元素 镉(Cd)、铬(Cr)、铜(Cu)、铅(Pb)、钼(Mo)、铁(Fe)、镍(Ni)、砷(As)、汞(Hg)及工艺环节中引入的其他元素应小于制造商限量值。 5.2.4 环氧乙烷残留量 经环氧乙烷灭菌的口腔胶原膜，依照GB／T 16886.7的规定，制造商应根据产品与人体的接触时间制定环氧乙烷残留量限值。 注：此项目适用于经环氧乙烷灭菌的胶原膜。 5.2.5 成分 5.2.5.1 总蛋白含量：应符合制造商规定。 5.2.5.2 羟脯氨酸含量：应符合制造商规定。 5.2.5.3 胶原鉴定：如适用，应符合制造商规定。 注：此项目适用于纯化胶原膜和重组胶原膜，不适用于脱细胞基质类材料。 5.2.5.4 杂蛋白含量：杂蛋白总量应不大于制造商规定限量值，纯化和重组胶原膜除胶原蛋白外的任意—种杂蛋白含量(质量分数)均＜1.0％。 5.2.5.5 脂肪含量(质量分数)：纯化和重组胶原膜应不大于1％。 5.2.5.6 DNA残留量含量：应符合制造商规定。 5.2.5.7 宿主细胞残留量：应无完整细胞核。 5.2.5.8 炽灼残渣(质量分数)：如适用，应不大于1％。 5.2.5.9 添加物含量：如适用，建立并规定添加物许可限量，其含量应符合制造商规定。 注：本标准未规定对添加物的识别，添加添加物的胶原膜特有的性能及功效由制造商另行规定。 5.2.6 助剂残留 根据生产过程中使用的助剂种类，应规定相应加工助剂的残留量并符合制造商规定。 5.3 生物要求 5.3.1 无菌 产品应无菌。 5.3.2 细菌内毒素 应小于20 EU／包装。 5.3.3 生物学评价 按照YY／T 0268及GB／T 16886.1的原则并结合产品特性进行生物学评价。 注：免疫原性控制方面，建议制造商根据GB／T 16886.20、YY／T 1465系列标准及产品特性制定其产品中引起免疫反应物质的定性和定量控制要求。 6 试验方法 6.1 物理机械性能 6.1.1 外观 取样品5片，在光线充足的地方目测，应符合5.1.1的规定。 6.1.2 尺寸 采用通用量具测量(精确至0.1 mm)，应符合5.1.2的规定。 6.1.3 结构特征 根据制造商规定的方法进行观察和测量，应符合5.1.3的规定。 6.1.4 热变性 称取2 mg～10 mg样品，置于差示扫描量热仪(DSC)样品池进行测量，温度扫描区间为25℃～200℃，升温速率为(1℃～10℃)／min，取峰值作为热变性温度，应符合5.1.4的规定。 6.1.5 吸水性 取质量约为0.1 g的试样，精密称量(精确至0.001 g)，记为m1。将试样浸入盛有37℃±2℃蒸馏水的烧杯中，完全浸润，吸水饱和后。用镊子夹住样品一角从水中取出，持镊子将样品在水面上悬垂1 min，沥去多余水分，再次称量，记为m2，按照式(1)计算吸水量。随机抽取试样5份，以平均值报告饱和吸水倍数，结果应符合5.1.5的规定。 A=(m2-m1)／m1 (1) 式中： A——试样吸水倍数； m2——试样浸水后的质量，单位为克(g)； m1——试样浸水前的质量，单位为克(g)。 6.1.6 拉伸强度 按GB／T 528—2009中2型试样或GB／T 1040.3—2006规定的方法进行试验，应符合5.1.6的规定。 6.1.7 断裂伸长率 按GB／T 528—2009中2型试样或GB／T 1040.3—2006规定的方法进行试验，应符合5.1.7的规定。 注：以非缝合方式使用的胶原膜不适用此项。 6.1.8 撕裂力 将样品裁成长条形状(10 mm×25 mm)(见图1)，在离短边边缘3 mm处用4-0号缝合线穿过样品，对折缝合线，在距离穿孔处约5 cm处将缝合线打结，防止缝合线脱落。在符合GB／T 6682—2008的3级水中吸水饱和后。将样品未穿线一端和缝合线一端分别固定在力学试验机上，拉伸速度100 mm／min，直至样品被撕裂，取拉伸负荷的最大值为本产品撕裂力。最终结果取5片产品撕裂力的平均值，应符合5.1.8的规定。