標準編號:	YY/T 1794-2021
中文名稱:	口腔膠原膜通用技術要求
英文名稱:	General technical requirements for dental collagen membrane
中標分類:	C33    口腔科器械、設備與材料
行業分類:	YY    醫藥行業標準
ICS分類:	11.060.10 11.060.10    牙科材料 11.060.10
發布機構:	國家藥品監督管理局
發布日期:	2021-03-10
實施日期:	2022-4-1
標準狀態:	valid
翻譯語言:	英文
文件格式:	PDF
中文字符數:	11000 字
翻譯價格(元):	770.0
交付時間:	付款后 1 個工作日

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

口腔膠原膜通用技術要求 1 范圍 本標準規定了口腔膠原膜材料的術語和定義、分類、要求及試驗方法。 本標準適用于修復各種原因引起的口腔軟、硬組織缺損，起到引導、隔離、修補、固定、減張、替代等作用的以膠原蛋白為主要成分的膜材料。 2 規范性引用文件 下列文件對于本文件的應用是必不可少的。凡是注日期的引用文件，僅注日期的版本適用于本文件。凡是不注日期的引用文件，其最新版本(包括所有的修改單)適用于本文件。 GB／T 528—2009 硫化橡膠或熱塑性橡膠 拉伸應力應變性能的測定 GB／T 1040.3—2006 塑料 拉伸性能的測定 第3部分：薄膜和薄片的試驗條件 GB 5009.6—2016 食品安全國家標準 食品中脂肪的測定 GB／T 6682—2008 分析實驗室用水規格和試驗方法 GB／T 14233.1—2008 醫用輸液、輸血、注射器具檢驗方法 第1部分：化學分析方法 GB／T 14233.2—2005 醫用輸液、輸血、注射器具檢驗方法 第2部分：生物學試驗方法 GB／T 16886.1 醫療器械生物學評價 第1部分：風險管理過程中的評價與試驗 GB／T 16886.3 醫療器械生物學評價 第3部分：遺傳毒性、致癌性和生殖毒性試驗 GB／T 16886.4 醫療器械生物學評價 第4部分：與血液相互作用試驗選擇 GB／T 16886.5 醫療器械生物學評價 第5部分：體外細胞毒性試驗 GB／T 16886.6 醫療器械生物學評價 第6部分：植入后局部反應試驗 GB／T 16886.7 醫療器械生物學評價 第7部分：環氧乙烷滅菌殘留量 GB／T 16886.10 醫療器械生物學評價 第10部分：刺激與皮膚致敏試驗 GB／T 16886.11 醫療器械生物學評價 第11部分：全身毒性試驗 GB／T 16886.12 醫療器械生物學評價 第12部分：樣品制備與參照材料 GB／T 16886.20 醫療器械生物學評價 第20部分：醫療器械免疫毒理學試驗原則和方法 YY／T 0127.2 口腔醫療器械生物學評價 第2單元：試驗方法 急性全身毒性試驗：靜脈途徑 YY／T 0127.4 口腔醫療器械生物學評價 第2單元：試驗方法 骨埋植試驗 YY／T 0127.8 口腔材料生物學評價 第2單元：口腔材料生物試驗方法 皮下植入試驗 YY／T 0127.10 口腔醫療器械生物學評價 第2單元：試驗方法 鼠傷寒沙門氏桿菌回復突變試驗(Ames試驗) YY／T 0268 牙科學 口腔醫療器械生物學評價 第1單元：評價與試驗 YY／T 0606.25—2014 組織工程醫療產品 第25部分：動物源性生物材料DNA殘留量測定法：熒光染色法 YY 0954—2015 無源外科植入物 Ⅰ型膠原蛋白植入劑 YY／T 1511—2017 膠原蛋白海綿 中華人民共和國藥典(2020年版) 3 術語和定義 下列術語和定義適用于本文件。 3.1 口腔膠原膜 dental collagen membrane 以膠原蛋白為主要成分的口腔膜材料，一般包括純化膠原膜、重組膠原膜和脫細胞基質膜。純化膠原膜是指利用動物組織提取的膠原蛋白經過物理或化學交聯制備而成的膜狀產品；重組膠原膜是指利用基因工程技術制備的膠原蛋白經過物理或化學交聯制備而成的膜狀產品；脫細胞基質膜主要是采用化學和／或物理等方法去除組織／器官的細胞成分，同時保留其組織構架而得到的以細胞外基質為主要成分的膜。 3.2 動物源性材料 patch utilizing animal tissues and their derivatives animal derived materials 含有動物來源的材料(動物組織及其衍生物)，全部或部分采用動物組織制成的，及采用動物組織衍生物或由動物體自然獲取的物質經特定工藝處理而制成的材料，可用于缺損組織的填充、修復、屏障、防粘連等。 3.3 Ⅰ型膠原 type Ⅰ collagen 由2條α1肽鏈和1條α2肽鏈組成，結構具有三螺旋特點；按規則排列成束，以5個膠原分子聚集而形成膠原原纖維；多個膠原原纖維按規則以端端、首尾錯位連接形成粗細不等的Ⅰ型膠原纖維。 3.4 添加物 additives 醫療器械在生產、加工或貯存過程中，添加其中期望在最終產品中達到某種特殊目的的物質，可以是天然或合成的物質。例如：交聯劑、改性劑、保護劑、抗菌劑、無機礦物質等。 4 分類 口腔膠原膜材料按是否交聯可分為交聯膜和非交聯膜；按來源分為同種異體、異種等；按來源部位分為真皮基質膜、心包膜、小腸黏膜下層膜等；按工藝分為脫細胞基質膜、純化膠原膜、重組膠原膜等；按照預期用途分為引導組織再生膜、引導骨組織再生膜、牙齦黏膜等軟組織修補再生膜等。 5 要求 5.1 物理機械性能 5.1.1 外觀 應符合制造商的規定。 5.1.2 尺寸 應符合制造商的規定。 5.1.3 結構特性 制造商應對口腔膠原膜的結構特性(如：孔徑大小、孔徑分布、孔隙率等)進行描述，并明確其測試方法。產品的結構特性應符合制造商規定。 5.1.4 熱變性(如適用) 熱變性溫度應符合制造商規定。 5.1.5 吸水性 液體吸收性應符合制造商規定。 5.1.6 拉伸強度 拉伸強度應不小于制造商規定。 5.1.7 斷裂伸長率 斷裂伸長率應不小于制造商規定。 注：以非縫合方式使用的口腔膠原膜不適用此項。 5.1.8 撕裂力 撕裂力應不小于制造商規定。 注：以非縫合方式使用的口腔膠原膜不適用此項。 5.2 化學性能 5.2.1 酸堿度 pH值應符合制造商規定。 5.2.2 重金屬總量(以鉛Pb計) 應不大于10 mg／kg。 5.2.3 微量元素 鎘(Cd)、鉻(Cr)、銅(Cu)、鉛(Pb)、鉬(Mo)、鐵(Fe)、鎳(Ni)、砷(As)、汞(Hg)及工藝環節中引入的其他元素應小于制造商限量值。 5.2.4 環氧乙烷殘留量 經環氧乙烷滅菌的口腔膠原膜，依照GB／T 16886.7的規定，制造商應根據產品與人體的接觸時間制定環氧乙烷殘留量限值。 注：此項目適用于經環氧乙烷滅菌的膠原膜。 5.2.5 成分 5.2.5.1 總蛋白含量：應符合制造商規定。 5.2.5.2 羥脯氨酸含量：應符合制造商規定。 5.2.5.3 膠原鑒定：如適用，應符合制造商規定。 注：此項目適用于純化膠原膜和重組膠原膜，不適用于脫細胞基質類材料。 5.2.5.4 雜蛋白含量：雜蛋白總量應不大于制造商規定限量值，純化和重組膠原膜除膠原蛋白外的任意—種雜蛋白含量(質量分數)均＜1.0％。 5.2.5.5 脂肪含量(質量分數)：純化和重組膠原膜應不大于1％。 5.2.5.6 DNA殘留量含量：應符合制造商規定。 5.2.5.7 宿主細胞殘留量：應無完整細胞核。 5.2.5.8 熾灼殘渣(質量分數)：如適用，應不大于1％。 5.2.5.9 添加物含量：如適用，建立并規定添加物許可限量，其含量應符合制造商規定。 注：本標準未規定對添加物的識別，添加添加物的膠原膜特有的性能及功效由制造商另行規定。 5.2.6 助劑殘留 根據生產過程中使用的助劑種類，應規定相應加工助劑的殘留量并符合制造商規定。 5.3 生物要求 5.3.1 無菌 產品應無菌。 5.3.2 細菌內毒素 應小于20 EU／包裝。 5.3.3 生物學評價 按照YY／T 0268及GB／T 16886.1的原則并結合產品特性進行生物學評價。 注：免疫原性控制方面，建議制造商根據GB／T 16886.20、YY／T 1465系列標準及產品特性制定其產品中引起免疫反應物質的定性和定量控制要求。 6 試驗方法 6.1 物理機械性能 6.1.1 外觀 取樣品5片，在光線充足的地方目測，應符合5.1.1的規定。 6.1.2 尺寸 采用通用量具測量(精確至0.1 mm)，應符合5.1.2的規定。 6.1.3 結構特征 根據制造商規定的方法進行觀察和測量，應符合5.1.3的規定。 6.1.4 熱變性 稱取2 mg～10 mg樣品，置于差示掃描量熱儀(DSC)樣品池進行測量，溫度掃描區間為25℃～200℃，升溫速率為(1℃～10℃)／min，取峰值作為熱變性溫度，應符合5.1.4的規定。 6.1.5 吸水性 取質量約為0.1 g的試樣，精密稱量(精確至0.001 g)，記為m1。將試樣浸入盛有37℃±2℃蒸餾水的燒杯中，完全浸潤，吸水飽和后。用鑷子夾住樣品一角從水中取出，持鑷子將樣品在水面上懸垂1 min，瀝去多余水分，再次稱量，記為m2，按照式(1)計算吸水量。隨機抽取試樣5份，以平均值報告飽和吸水倍數，結果應符合5.1.5的規定。 A=(m2-m1)／m1 (1) 式中： A——試樣吸水倍數； m2——試樣浸水后的質量，單位為克(g)； m1——試樣浸水前的質量，單位為克(g)。 6.1.6 拉伸強度 按GB／T 528—2009中2型試樣或GB／T 1040.3—2006規定的方法進行試驗，應符合5.1.6的規定。 6.1.7 斷裂伸長率 按GB／T 528—2009中2型試樣或GB／T 1040.3—2006規定的方法進行試驗，應符合5.1.7的規定。 注：以非縫合方式使用的膠原膜不適用此項。 6.1.8 撕裂力 將樣品裁成長條形狀(10 mm×25 mm)(見圖1)，在離短邊邊緣3 mm處用4-0號縫合線穿過樣品，對折縫合線，在距離穿孔處約5 cm處將縫合線打結，防止縫合線脫落。在符合GB／T 6682—2008的3級水中吸水飽和后。將樣品未穿線一端和縫合線一端分別固定在力學試驗機上，拉伸速度100 mm／min，直至樣品被撕裂，取拉伸負荷的最大值為本產品撕裂力。最終結果取5片產品撕裂力的平均值，應符合5.1.8的規定。