未使用 REACH 法规高关注物质（SVHC） No use of Substances of Very High Concern (SVHC) under REACH Regulation
本产品符合欧盟 REACH 法规（EC 1907／2006）关于高关注物质（SVHC）的规定。 This product complies with the provisions of the EU REACH Regulation (EC 1907/2006) concerning Substances of Very High Concern (SVHC).
欧盟 RoHS 指令（欧盟关于在电子电器类产品中有害物质的限制） EU RoHS Directive (Restriction of Hazardous Substances in electrical and electronic equipment)
本产品符合欧盟 RoHS 指令 2011／65／EU 附录 II 的修正指令（EU）2015／863 关于电子电器类产品中有害物质的限制规定。 This product complies with the restrictions on hazardous substances in electrical and electronic equipment as stipulated by the EU RoHS Directive 2011/65/EU and its amendment (EU) 2015/863, Annex II.
经重金属检测，本产品中下述重金属含量均未达到方法检出限：铅、汞、镉、六价铬。 Heavy metal testing has confirmed that the following heavy metals in this product are all below the method detection limit: lead, mercury, cadmium, and hexavalent chromium.
经检测，本产品中下述多溴联苯（PBB）、多溴二苯醚（PBDE）、邻苯二甲酸酯类均未达到方法检出限：PBB 包括一溴联苯、二溴联苯、三溴联苯、四溴联苯、五溴联苯、六溴联苯、七溴联苯、八溴联苯、九溴联苯、十溴联苯；PBDE包括一溴二苯醚、二溴二苯醚、三溴二苯醚、四溴二苯醚、五溴二苯醚、六溴二苯醚、七溴二苯醚、八溴二苯醚、九溴二苯醚、十溴二苯醚；邻苯二甲酸酯类包括邻苯二甲酸二（2－乙基己基）酯、邻苯二甲酸丁苄酯、邻苯二甲酸二丁酯、邻苯二甲酸二异丁酯。 Testing has confirmed that the following polybrominated biphenyls (PBBs), polybrominated diphenyl ethers (PBDEs), and phthalates in this product are all below the method detection limit: PBBs include monobromobiphenyl, dibromobiphenyl, tribromobiphenyl, tetrabromobiphenyl, pentabromobiphenyl, hexabromobiphenyl, heptabromobiphenyl, octabromobiphenyl, nonabromobiphenyl, and decabromobiphenyl; PBDEs include monobromodiphenyl ether, dibromodiphenyl ether, tribromodiphenyl ether, tetrabromodiphenyl ether, pentabromodiphenyl ether, hexabromodiphenyl ether, heptabromodiphenyl ether, octabromodiphenyl ether, nonabromodiphenyl ether, and decabromodiphenyl ether; phthalates include bis(2-ethylhexyl) phthalate, butyl benzyl phthalate, dibutyl phthalate, and diisobutyl phthalate.
生物相容性 Biocompatibility
本产品符合ISO 10993 医疗器械生物学评价相关规定。 This product complies with the relevant provisions of ISO 10993 for the biological evaluation of medical devices.
测试项包括：ISO 溶血（ISO 10993－4：2017）、ISO L－929细胞MTT洗脱试验 24 小时浸提 \＆ 24 小时测定（ISO 10993－5：2009）、ISO 3 只兔的皮内反应试验（双浸提）（ISO 10993－2：2022）、ISO豚鼠最大剂量致敏试验（双浸提）（ISO 10993－10：2021）、ISO 急性全身毒性试验（双浸提）（ISO 10993－11：2017）、ISO 材料介导的热原试验（生理盐水浸提）（ISO 10993－2：2022）。 Test items include: ISO hemolysis (ISO 10993-4:2017), ISO L-929 cell MTT elution test with 24-hour extraction & 24-hour assay (ISO 10993-5:2009), ISO intracutaneous reactivity test in 3 rabbits (double extraction) (ISO 10993-2:2022), ISO guinea pig maximization sensitization test (double extraction) (ISO 10993-10:2021), ISO acute systemic toxicity test (double extraction) (ISO 10993-11:2017), ISO material-mediated pyrogen test (saline extraction) (ISO 10993-2:2022).
本产品符合 USP Class VI 美国药典第六级生物相容性测试的相关规定。 This product complies with the relevant requirements of USP Class VI biological compatibility testing as per the United States Pharmacopeia.
测试项包括：USP L－929 细胞 MEM 洗脱试验 24 小时浸提 \＆ 48 小时评分（USP41－NF36＜87＞）、USP 急性全身毒性试验（ 4 种浸提， 70^(@)C70^{\circ} \mathrm{C} ）（USP41－NF36＜88＞）、USP 4 只兔的皮内反应试验（ 4 种浸提， 70^(@)C70^{\circ} \mathrm{C} ）（USP41－VF36《88〉）、USP 2 只兔的肌肉植入试验（1周）（USP41－VF36＜88＞）。 Test items include: USP L-929 cell MEM elution test with 24-hour extraction & 48-hour scoring (USP41-NF36 <87>), USP acute systemic toxicity test (4 extractions, 70^(@)C70^{\circ} \mathrm{C} ) (USP41-NF36 <88>), USP intracutaneous reactivity test in 4 rabbits (4 extractions, 70^(@)C70^{\circ} \mathrm{C} ) (USP41-VF36 <88>), USP muscle implantation test in 2 rabbits (1 week) (USP41-VF36 <88>).
美国食品及药物管理局（FDA） U.S. Food and Drug Administration (FDA)
本产品符合美国食品药品监督管理局联邦法规（CFR 177．1520）管制标准。 This product complies with the regulatory standards of the U.S. Food and Drug Administration (CFR 177.1520).
中国食品接触 China Food Contact
本产品符合 GB 4806．7－2023《食品安全国家标准 食品接触用塑料材料及制品通用安全要求》规定的适用于树脂原料的相关要求。 This product meets the relevant requirements for resin materials specified in GB 4806.7-2023 "National Food Safety Standard—General Safety Requirements for Plastic Materials and Articles Intended to Come into Contact with Food."
经符合性测试，本产品感官要求、总迁移量、高锰酸钾消耗量、重金属（以 Pb 计）、芳香族伯胺特 Compliance testing confirms that this product meets the sensory requirements, total migration limits, potassium permanganate consumption, heavy metals (as Pb), and primary aromatic amines.
定迁移量、脱色试验、 5 －亚乙基－2－降冰片烯特定迁移量均满足限值要求。 The specific migration limits for total migration, decolorization test, and 5-ethylidene-2-norbornene all meet the required thresholds.
欧盟（EU）食品接触 EU Food Contact
本产品符合（EU）No 10／2011 委员会关于与食品接触的塑料材料和制品的法规及其修订法规和欧洲议会和理事会关于拟与食品接触的材料和制品的法规（EC）No 1935／2004。 This product complies with Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food, its amendments, and Regulation (EC) No 1935/2004 of the European Parliament and of the Council on materials and articles intended to come into contact with food.
经符合性测试，本产品总迁移量、重金属特定迁移量、初级芳香胺特定迁移量均满足限值要求。 Through compliance testing, this product's total migration, specific migration of heavy metals, and specific migration of primary aromatic amines all meet the required limits.
卤素 halogen
本产品根据 EN 14582：2016《废物的特性 卤素和硫含量 封闭系统中的氧燃烧及其测定方法》要求，不含有氟（F）、氯（Cl）、溴（Br）、碘（I）。 This product complies with EN 14582:2016 "Characterization of waste - Halogen and sulfur content - Oxygen combustion in closed systems and determination methods" and contains no fluorine (F), chlorine (Cl), bromine (Br), or iodine (I).
责任声明：以上信息仅限我司生产／提供产品的合规性承诺，不包括经销商和下游使用者加工使用以及运输过程中引入或反应生成的物质。 Disclaimer: The above information is solely our company's compliance commitment for the products we manufacture/provide, and does not include substances introduced or generated during processing, use by distributors and downstream users, or transportation.
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公司：拓烯科技（裖少州）有限公司 Company: Topolymer Technology (Shaoxing) Co., Ltd
Company Name 1：TopOlefin Technology（Quzhou）Co．，Ltd． Company Name 1: TopOlefin Technology (Quzhou) Co., Ltd.
公司地址：浙江省德州市科鹃路 27 号 Company Address: No. 27 Kejuan Road, Dezhou City, Zhejiang Province
Company Address：No． 2 Đujuan Road，Quzhou City，Zhejiang Province，China Company Address: No. 2 Dujuan Road, Quzhou City, Zhejiang Province, China
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