美国FDA《联邦规章典集》(CFR)第21篇目录中文版.doc

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美国FDA《联邦规章典集》（CFR）第21篇目录中文版发布时间：2010-5-11 13:44:12 发布方：奥咨达医疗器械咨询美国《联邦规章典集》（CFR）第21篇“食品与药品”总目概述：美国《联邦规章典集》（Code of Federal Regulations，CFR）第21篇“食品与药品”（Title 21―Food and Drugs）共有9卷（Volume）、3章（Chapter）、1499部（Parts）。其中：第1―8卷第1章第1―1299部，为健康与人类服务部食品与药品管理局（Food and Drug Administration，Department of Health and Human Services）的规章；第9卷第2章第1300―1399部，为司法部毒品强制执行局（Drug Enforcement Administration，Department of Justice）的规章；第9卷第3章第1400―1499部，为毒品控制政策办公室（Office of National Drug Control Policy）的规章。第21篇“食品与药品”（Title 21―Food and Drugs）的概况卷（Volume）章（Chapter）部（Parts）规制机关（Regulatory Entity） 1 Ⅰ 1-99 健康与人类服务部食品与药品管理局（FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES） 2 100-169 3 170-199 4 200-299 5 300-499 6 500-599 7 600-799 8 800-1299 9 Ⅱ 1300-1399 司法部毒品强制执行局（Drug Enforcement Administration，Department of Justice） Ⅲ 1400-1499 毒品控制政策办公室（Office of National Drug Control Policy）第21篇“食品与药品”（Title 21―Food and Drugs）的章、部目录部(Part) 中译文原英文第Ⅰ章―健康与人类服务部食品与药品管理局（CHAPTER Ⅰ―FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES）第A分章―总则（SUBCHAPTER A―GENERAL） 1 一般强制执行规章 GENERAL ENFORCEMENT REGULATIONS 2 一般行政规则与决定 GENERAL ADMINISTRATIVE RULINGS AND DECISIONS 3 产品管辖权 PRODUCT JURISDICTION 5 组织 ORGANIZATION 7 强制执行政策 ENFORCEMENT POLICY 10 行政规范与程序 ADMINISTRATIVE PRACTICES AND PROCEDURES 11 电子化记录；电子化签名 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES 12 正式证据的公众听证 FORMAL EVIDENTIARY PUBLIC HEARING 13 在公众质询委员会前的公众听证 PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY 14 在公众咨询委员会前的公众听证 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE 15 在FDA局长前的公众听证 PUBLIC HEARING BEFORE THE COMMISSIONER 16 在FDA前的规制性听证 REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION 17 行政罚款听证 CIVIL MONEY PENALTIES HEARINGS 19 行为标准与利益冲突 STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST 20 公共信息 PUBLIC INFORMATION 21 隐私保护 PROTECTION OF PRIVACY 25 环境影响考虑 ENVIRONMENTAL IMPACT CONSIDERATIONS 26 药品良好制造规范报告、医疗器械质量体系核查报告以及某些医疗器械产品评价报告的互认：美国与欧共体 MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY 50 人类受试者的保护 PROTECTION OF HUMAN SUBJECTS 54 临床试验者的财务公开 FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS 56 机构审查委员会 INSTITUTIONAL REVIEW BOARDS 58 对非临床实验室研究的良好实验室规范 GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES 60 专利期恢复 PATENT TERM RESTORATION 70 色素添加剂 COLOR ADDITIVES 71 色素添加剂申请 COLOR ADDITIVE PETITIONS 73 免除认证的色素添加剂的列表 LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION 74 适用认证的色素添加剂的列表 LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION 80 色素添加剂认证 COLOR ADDITIVE CERTIFICATION 81 用于食品、药品和化妆品的临时性色素添加剂的一般规范和一般限制 GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS 82 经认证的临时性列表的色素和规范的列表 LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS 83-98 [预留的] [Reserved] 99 已上市的药品、生物制品和器械的未经批准的/新的用途的信息的发布 DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES 第B分章―用于人类消费的食品（SUBCHAPTER B―FOOD FOR HUMAN CONSUMPTION） 100 总则 GENERAL 101 食品标识 FOOD LABELING 102 非标准化食品的普通的或者通常的名称 COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS 104 食品的营养质量指南 NUTRITIONAL QUALITY GUIDELINES FOR FOODS 105 特殊膳食用途的食品 FOODS FOR SPECIAL DIETARY USE 106 婴儿配方母乳替代食品质量控制程序 INFANT FORMULA QUALITY CONTROL PROCEDURES 107 婴儿配方母乳替代食品 INFANT FORMULA 108 紧急许可控制 EMERGENCY PERMIT CONTROL 109 在人类食品与食品-包装材料中的不可避免的污染物 UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL 110 在制造、包装或者保存人类食品中的现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD 113 装在密封容器中的热加工低酸食品 THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS 114 酸化食品 ACIDIFIED FOODS 115 带壳蛋 SHELL EGGS 119 存在显著或者不合理风险的膳食补充剂 DIETARY SUPPLEMENTS THAT PRESENT A SIGNIFICANT OR UNREASONABLE RISK 120 危害分析与关键控制点（HACCP）体系 HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS 123 鱼与渔业产品 FISH AND FISHERY PRODUCTS 129 饮用水加工与装瓶 PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER 130 食品标准：总则 FOOD STANDARDS: GENERAL 131 乳与奶油 MILK AND CREAM 133 乳酪与相关乳酪产品 CHEESES AND RELATED CHEESE PRODUCTS 135 冷冻点心 FROZEN DESSERTS 136 烘焙产品 BAKERY PRODUCTS 137 谷物粉与相关产品 CEREAL FLOURS AND RELATED PRODUCTS 139 通心粉与面条产品 MACARONI AND NOODLE PRODUCTS 145 罐装水果 CANNED FRUITS 146 罐装水果汁 CANNED FRUIT JUICES 150 水果黄油、果冻、防腐剂以及相关产品 FRUIT BUTTERS, JELLIES, PRESERVES, AND RELATED PRODUCTS 152 水果馅饼 FRUIT PIES 155 罐装蔬菜 CANNED VEGETABLES 156 蔬菜汁 VEGETABLE JUICES 158 冷冻蔬菜 FROZEN VEGETABLES 160 蛋与蛋制品 EGGS AND EGG PRODUCTS 161 鱼与有壳的水生动物 FISH AND SHELLFISH 163 可可制品 CACAO PRODUCTS 164 树坚果与花生制品 TREE NUT AND PEANUT PRODUCTS 165 饮料 BEVERAGES 166 人造黄油 MARGARINE 168 增甜剂与餐桌糖浆 SWEETENERS AND TABLE SIRUPS 169 食品敷料与调味料 FOOD DRESSINGS AND FLAVORINGS 170 食品添加剂 FOOD ADDITIVES 171 食品添加剂申请 FOOD ADDITIVE PETITIONS 172 允许直接加入用于人类消费食品的食品添加剂 FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION 173 在用于人类消费的食品中允许的次直接的食品添加剂 SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION 174 间接食品添加剂：总则 INDIRECT FOOD ADDITIVES: GENERAL 175 间接食品添加剂：胶粘剂与涂层的组分 INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS 176 间接食品添加剂：纸与纸板组分 INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS 177 间接食品添加剂：聚合体 INDIRECT FOOD ADDITIVES: POLYMERS 178 间接食品添加剂：辅剂、生产助剂和消毒剂 INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS 179 在食品生产、加工和处理中的辐照 IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF FOOD 180 在额外试验期间临时在食品或者在与食品接触中被允许的食品添加剂 FOOD ADDITIVES PERMITTED IN FOOD OR IN CONTACT WITH FOOD ON AN INTERIM BASIS PENDING ADDITIONAL STUDY 181 先前核准的食品配料 PRIOR-SANCTIONED FOOD INGREDIENTS 182 一般认为安全的物质 SUBSTANCES GENERALLY RECOGNIZED AS SAFE 184 被确认为一般认为安全的直接食品物质 DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE 186 被确认为一般认为安全的间接食品物质 INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE 189 禁止用于人类食品的物质 SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD 190 膳食补充剂 DIETARY SUPPLEMENTS 191-199 [预留的] [Reserved] 第C分章―药品：总则（SUBCHAPTER C―DRUGS: GENERAL） 200 总则 GENERAL 201 标识 LABELING 202 处方药广告 PRESCRIPTION DRUG ADVERTISING 203 处方药销售 PRESCRIPTION DRUG MARKETING 205 对批发处方药销售商颁发州执照的指南 GUIDELINES FOR STATE LICENSING OF WHOLESALE PRESCRIPTION DRUG DISTRIBUTORS 206 人用固体口服剂型药品的印码 IMPRINTING OF SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR HUMAN USE 207 药品生产者的登记与商业销售的药品的列表 REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN COMMERCIAL DISTRIBUTION 208 处方药的药物治疗指导 MEDICATION GUIDES FOR PRESCRIPTION DRUG PRODUCTS 210 制造、加工、包装或者保存药品的现行良好制造规范；总则 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL 211 对完成的药品的现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS 216 药房配药 PHARMACY COMPOUNDING 225 对含药饲料的现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS 226 对A型含药物品的现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES 250 对特殊人用药品的特殊要求 SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS 290 管制的药品 CONTROLLED DRUGS 299 药品；正式名称与已确定的名称 DRUGS; OFFICIAL NAMES AND ESTABLISHED NAMES 第D分章―人用药品（SUBCHAPTER D―DRUGS FOR HUMAN USE） 300 总则 GENERAL 310 新药 NEW DRUGS 312 试验用新药申请 INVESTIGATIONAL NEW DRUG APPLICATION 314 为FDA批准上市新药的申请 APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG 315 诊断用放射性药品 DIAGNOSTIC RADIOPHARMACEUTICALS 316 罕见病药 ORPHAN DRUGS 320 生物利用度与生物等效性要求 BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS 328 含有酒精的预期用于口部摄入的非处方药品 OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL 330 一般认为安全与有效以及不错误标识的非处方人用药品 OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED 331 用于非处方的人类使用的抗酸产品 ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE 332 用于非处方的人类使用的抗胃肠气胀产品 ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE 333 用于非处方的人类使用的局部抗菌药品 TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE 335 用于非处方的人类使用的止泻药品 ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE 336 用于非处方的人类使用的止吐药品 ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE 338 用于非处方的人类使用的帮助夜间睡眠的药品 NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE 340 用于非处方的人类使用的兴奋药品 STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE 341 用于非处方的人类使用的感冒、咳嗽、过敏症药、支气管扩张以及平喘药品 COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE 343 用于非处方的人类使用的内服的止痛、退热以及抗风湿药品 INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE 344 用于非处方的人类使用的局部的耳部药品 TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE 346 用于非处方的人类使用的肛肠药品 ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE 347 用于非处方的人类使用的皮肤保护药品 SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE 348 用于非处方的人类使用的外部的止痛药品 EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE 349 用于非处方的人类使用的眼科药品 OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE 350 用于非处方的人类使用的止汗药品 ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE 352 用于非处方的人类使用的遮光药品 SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY] 355 用于非处方的人类使用的防龋药品 ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE 357 用于非处方的人类使用的其他内服药品 MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE 358 用于非处方的人类使用的其他外用药品 MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE 361 一般认为安全与有效以及不错误标识的处方人用药品：用于研究的药品 PRESCRIPTION DRUGS FOR HUMAN USE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED: DRUGS USED IN RESEARCH 369 在用于非处方销售的药品与器械上关于警告的解释性声明 INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE 370-499 [预留的] [Reserved] 第E分章―动物药品、饮料和相关产品（SUBCHAPTER E―ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS） 500 总则 GENERAL 501 动物食品标识 ANIMAL FOOD LABELING 502 非标准化的动物食品的普通的或通常的名称 COMMON OR USUAL NAMES FOR NONSTANDARDIZED ANIMAL FOODS 509 在动物食品与食品-包装材料中的不可避免的污染物 UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL 510 新动物药 NEW ANIMAL DRUGS 511 作为试验用途的新动物药 NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE 514 新动物药申请 NEW ANIMAL DRUG APPLICATIONS 515 含药饲料厂执照 MEDICATED FEED MILL LICENSE 520 口服剂型的新动物药 ORAL DOSAGE FORM NEW ANIMAL DRUGS 522 植入或者注射剂型的新动物药 IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 524 眼科和局部剂型的新动物药 OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS 526 乳房内的剂型 INTRAMAMMARY DOSAGE FORMS 529 某些其他剂型的新动物药 CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS 530 在动物中的特别标签药品使用 EXTRALABEL DRUG USE IN ANIMALS 556 在食品中新动物药残留的容许量 TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD 558 用于动物饲料的新动物药 NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 564 [预留的] [Reserved] 570 食品添加剂 FOOD ADDITIVES 571 食品添加剂申请 FOOD ADDITIVE PETITIONS 573 在动物饲料与饮用水中允许的食品添加剂 FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS 579 在动物饲料和宠物食品的生产、加工和处理中的辐照 IRRADIATION IN THE PRODUCTION, PROCESSING, AND HANDLING OF ANIMAL FEED AND PET FOOD 582 一般认为安全的物质 SUBSTANCES GENERALLY RECOGNIZED AS SAFE 584 在动物饲料与饮用水中被确认为一般认为安全的食品物质 FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE IN FEED AND DRINKING WATER OF ANIMALS 589 禁止用于动物食品或者饲料的物质 SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED 590-599 [预留的] [Reserved] 第F分章―生物制品（SUBCHAPTER F―BIOLOGICS） 600 生物制品：总则 BIOLOGICAL PRODUCTS: GENERAL 601 颁发执照 LICENSING 606 对血液与血液组分的现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS 607 对人类血液与血液制品的制造者的机构登记与产品列表 ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS 610 普通生物制品标准 GENERAL BIOLOGICAL PRODUCTS STANDARDS 630 对血液、血液组分和血液衍生物的一般要求 GENERAL REQUIREMENTS FOR BLOOD, BLOOD COMPONENTS, AND BLOOD DERIVATIVES 640 对人类血液和血液制品的附加标准 ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS 660 对用于实验室检测的诊断物质的附加标准 ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS 680 对其他产品的附加标准 ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS 第G分章―化妆品（SUBCHAPTER G―COSMETICS） 700 总则 GENERAL 701 化妆品标识 COSMETIC LABELING 710 化妆品机构的自愿登记 VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS 720 化妆品配料构成声明的自愿存档 VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS 740 化妆品警告声明 COSMETIC PRODUCT WARNING STATEMENTS 741-799 [预留的] [Reserved] 第H分章―医疗器械（SUBCHAPTER H―MEDICAL DEVICES） 800 总则 GENERAL 801 标识 LABELING 803 医疗器械报告 MEDICAL DEVICE REPORTING 806 医疗器械；改正与移动的报告 MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS 807 对器械的制造者与首次进口者的机构登记与器械列表 ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES 808 对州和地方医疗器械要求的联邦优先权的豁免 EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS 809 人用体外诊断产品 IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE 810 医疗器械召回权 MEDICAL DEVICE RECALL AUTHORITY 812 试验用器械豁免 INVESTIGATIONAL DEVICE EXEMPTIONS 813 [预留的] [Reserved] 814 医疗器械的上市前批准 PREMARKET APPROVAL OF MEDICAL DEVICES 820 质量体系规章 QUALITY SYSTEM REGULATION 821 医疗器械跟踪要求 MEDICAL DEVICE TRACKING REQUIREMENTS 822 上市后监视 POSTMARKET SURVEILLANCE 860 医疗器械分类程序 MEDICAL DEVICE CLASSIFICATION PROCEDURES 861 性能标准制定程序 PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT 862 临床化学与临床毒理学器械 CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES 864 血液学与病理学器械 HEMATOLOGY AND PATHOLOGY DEVICES 866 免疫学与微生物学器械 IMMUNOLOGY AND MICROBIOLOGY DEVICES 868 麻醉学器械 ANESTHESIOLOGY DEVICES 870 心血管器械 CARDIOVASCULAR DEVICES 872 牙科器械 DENTAL DEVICES 874 耳、鼻和咽器械 EAR, NOSE, AND THROAT DEVICES 876 胃肠病学-泌尿学器械 GASTROENTEROLOGY-UROLOGY DEVICES 878 普通与整形外科器械 GENERAL AND PLASTIC SURGERY DEVICES 880 普通医院与个人使用器械 GENERAL HOSPITAL AND PERSONAL USE DEVICES 882 神经学器械 NEUROLOGICAL DEVICES 884 产科与妇科学器械 OBSTETRICAL AND GYNECOLOGICAL DEVICES 886 眼科器械 OPHTHALMIC DEVICES 888 矫形外科器械 ORTHOPEDIC DEVICES 890 内科学器械 PHYSICAL MEDICINE DEVICES 892 放射学器械 RADIOLOGY DEVICES 895 禁止的器械 BANNED DEVICES 898 电极铅线与患者电缆的性能标准 PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES 第I分章―乳房造影质量标准法（SUBCHAPTER I―MAMMOGRAPHY QUALITY STANDARDS ACT） 900 乳房造影法 MAMMOGRAPHY 第J分章―放射学的健康（SUBCHAPTER J―RADIOLOGICAL HEALTH） 1000 总则 GENERAL 1002 记录与报告 RECORDS AND REPORTS 1003 缺陷与未能守法的通报 NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY 1004 电子产品的回购、修理或者置换 REPURCHASE, REPAIRS, OR REPLACEMENT OF ELECTRONIC PRODUCTS 1005 电子产品的进口 IMPORTATION OF ELECTRONIC PRODUCTS 1010 电子产品的性能标准：总则 PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL 1020 电离辐射发生

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