美国联邦法规第16部分(CPSC16CFR)要求(2

发布日期20110531栏目化药药物评价>>化药质量控制标题FDA人用药品和生物制品包装用容器密封系统指导原则（三）作者高杨部门化药药学二部正文内容按语：美国FDA于1999年5月发布了人用药品和生物制品包装用容器密封系统指导原则（Container Closure Systems for Packaging Human Drugs andBiologics），继而于3年后再次发布了人用药品和生物制品包装用容器密封系统指导原则--问与答（Container Closure Systems for Packaging HumanDrugs and Biologics--Questions and Answers），该指导原则代表了FDA关于人用药品和生物制品包装用容器密封系统的现行观点，对于我国药品注册申请者和药品监管当局都具有很高的借鉴意义。

EMEA直接接触塑料包装材料指导原则的中文版已经于2011年4月在药审中心网站上以电子刊物发表。

此次将FDA 的相关指导原则翻译成中文，供业界参考研究。

本文在翻译过程中得到了百特（中国）投资有限公司的金天明女士和龚明涛博士的大力支持，在此表示诚挚谢意。

尽管译稿经过笔者认真校核，但是由于水平有限，文中错误再所难免，恳请批评指正。

限于电子刊物的篇幅，将该指导原则将分为四篇连续刊出，前三篇为人用药品和生物制品包装用容器密封系统指导原则，最后一篇为人用药品和生物制品包装用容器密封系统指导原则--问与答，本文为第三篇。

Ⅳ.批准后的包装变更对于已批准的申请（NDA，ANDA或BLA），如果容器密封系统发生变更，或者容器密封系统的组件发生变更，或者组件的组成材料发生变更，又或者涉及上述内容的操作发生变更，均须在申请中进行报告。

对于NDA或ANDA，具体的资料要求请见21CFR 314.70（对已批准申请的补充申请和其他变更），对于BLA，请见21CFR 601.12（对已批准申请的变更）。

美国联邦法规第16部分（CPSC 16CFR）要求2007-09-20美国联邦法规与玩具有关的内容如下：1、1303部分：关于含铅油漆和某些含有铅油漆消费品的禁令条款1) 在1303部分，消费品产品安全委员会根据消费品安全条例（CPSA）15U.S.C.2057，2058第8.9章公布，供消费者使用的油漆和类似的涂层材料含铅或铅化合物（以金属铅计）不得超过总的不挥发油漆重量或干漆层重量的0.06%，否则则为危险品，禁止使用。

下列消费品被宣布为禁止使用的危险品。

a) 用于儿童使用的，含有“含铅油漆”的玩具和其它制品；b) 供消费者使用的，含有“含铅油漆”的家俱制品。

2) 本禁令适用于（a）段所述的1978年2月27日后制造的产品，这些产品称为“消费品”，该术语已在SPSA第3（a）（1）中作了定义。

法规包括上文述及的习惯为销售、使用、消费或家庭内外，学校、娱乐场等供消费者观赏的产品和分发的消费品。

摩托车、轮船所用的油漆，不包括在本禁令的范围内，因为它们超出了“消费品”的定义。

除了直接销售给消费者的产品外，本禁令还适用于售后被消费者使用的产品，如用于住宅、学校、医院、公园、运动场、公共建筑或其它消费者可能直接接触油漆表面的区域。

3) 根据（1）发现儿童触及的油漆、涂层含铅量超过0.06%，则有铅中毒的极大的危险。

2、1500部分：对危险物质和危险品管理及执行的法规：2.1 1500.44 鉴别极易燃或易燃固体物质的方法1) 样品制备a) 颗粒、粉未和糊状的样品：把样品放入一个平底的矩形金属舟中，舟的尺寸为152.4mm ×25.4mm，深6.35mm。

b) 硬质或软质固体：测量样品尺寸，用金属环形架，夹子、环或其它装置，将样品固定，使其长轴水平放置，使样品最大表面积自然暴露。

2) 步骤：把制备好的样品置于无气流处，该处能在每次试验后进行通风和清洁。

试验时，样品温度应保持在20℃～30℃之间。

Loong Run Toys Co.,Ltd玩具安全培训资料(供集团内部学习参考用)整理:戴京玉(东莞联弘QA部高级主任)指导:黄汉强先生(东莞联弘QA/QC经理)审阅:吕子豪先生(联志集团品管部董事)日期:2007.10.30备注:本份资料乃尽可能由公开信息中取得,经整理后仅供学习参考用.目录第一章美国玩具安全法律法规---(page 3~15)第二章欧盟对玩具的技术法规、标准及合格评定程序—(page 16-32)第三章加拿大关于玩具、儿童产品的市场准入简介---(page 33-35)第四章日本对玩具的技术法规、标准及市场准入制度--- (page 36~45)第五章中国玩具安全标准概况---(page 46-49)附表:附表1-----------欧盟主要玩具协調標准附表2-----------欧盟玩具产品合格评定程序附表3-----------玩具产品获得CE 标志流程图附表4-----------欧盟常见玩具产品类别适用的技术法规附表5-----------(日本)与玩具有关的电器分类附表6-----------(日本)含有有害物质的家用产品的限制标准概要附表7-----------(美国)玩具主要安全标准附表8--1-------主要玩具出口国(美国/欧盟/日本/加拿大/中国等)重金属限量表附表8--2-------主要玩具出口国(美国/欧盟/日本/加拿大/中国等)重金属限量表附表9-----------國際玩具標準要求簡表附表10---------玩具標準比對簡介第一章:美国玩具安全法律法规一、美国的消费品安全法律法规简介美国联邦制的国家结构形式，导致了美国法律体系的庞杂性，美国有关产品的技术法规分散于美国的联邦法律法规体系之中，既存在于国会制定的成文法——法案(Act)中，也存在于联邦政府各部门制定的条例、要求、规范中。

在美国消费品安全领域，与玩具、化妆晶及儿童用品有关的法案有5个：《消费品安全法案》(Consumer Product Safety Act，CPSA)、《联邦危险品法案》(Federal Hazardous Substances Act，FHSA)、《可燃纺织品法案》(Flammable Fabrics Act，FFA)、《防毒包装法案》(Poison Prevention Packaging Act，PPPA)和《联邦食品、药品和化妆品法案》(Federal Food，Drug and Cosmetic Act，FDCA)。

16 CFR 1610服用纺织品阻燃法规简介近年来，纺织品的阻燃性作为一项重要的安全性指标已经引起了世界各国的高度关注。

很多国家都对纺织品特别是服用纺织品的阻燃性能提出了要求，尤其是美国还制定了服用纺织品阻燃性法规–l6 CFR l610。

该法规的主要内容包括：阻燃性的测试方法、燃烧性能的等级、为服用纺织品设定的技术要求、使用不合适纺织品的警告(燃烧级别为3级的纺织品不适宜作服用纺织品)等内容。

CPSC（美国消费品安全委员会）作为美国政府的独立代理，负责该法规各方面的管理、实施、解释和必要的修订，并对生产商、进口商、发行商、零售商等所有有关部门和人员进行管理、监督和处罚。

我国出口美国的纺织品因阻燃性不合格而被处罚的现象屡见不鲜，这应引起我们的足够重视。

本文对美国l6 CFR l610法规中的服用纺织品阻燃要求进行简要的介绍。

1 测试方法适用范围通过对法规CFR 1610，CFR 1611，CFR 1615，CFR 1616不同的适用范围进行比较和分析，总结本法规的适用范围是：涂层或未涂层材料、胶片和纤维、整理剂或涂层中含有硝基的面料除外，幅宽在2 in以上，用于制作服装的面料。

免除测试的产品：帽子、手套、鞋类、夹层；免除测试的纤维和面料：克重大于2.6 oz/yd2的光面织物；以腈纶、改性腈纶、锦纶、涤纶、羊毛、烯烃类纤维纯纺或相互混纺而成的织物（以上纤维与其他纤维的混纺织物不是免除测试的产品）。

测试原理以织物的燃烧速率进行评判：纺织品按规定的方法与火焰接触一定的时间后，移去火焰，测定织物续燃和阴燃的时间以及织物的损毁长度。

续燃和阴燃的时间越短，损毁长度越低，则织物的阻燃性能越好。

实验步骤1.3.1预实验：根据面料的不同种类选择不同的预实验方法。

光面织物：长度和宽度方向各测试一个样品，然后选择燃烧最快的方向取5个样品；绒面织物：在逆绒的方向测试5个样品。

1.3.2样品准备根据预实验测试的结果在燃烧最快的方向上测试5个样品，尺寸为：2 in.×6 in.，放入试样夹（如果是绒面织物需增加刷试样的过程，目的是使面料表面的绒毛立起），调湿后，水平放置在温度为105℃的烘箱中烘干30 min，然后放入干燥器中冷却15 min～3 h.1.3.3测试1.3.3.1原样测试将实验用45度法燃烧测试仪调整至使用状态，试样和火源的距离为5/16 in.，调整火焰的高度为5/8 in.，将试样从干燥器中取出放入测试箱中，将计时线和重物连接就位，并将试样架向前移至测试位置，并关上测试箱的门。

美国玩具安全标准与规定CPSC美国消费者产品安全委员会CPSC是联邦政府机构,负责制定消费者产品的安全规范.针对玩具和儿童用品,CPSC颁布了一系列有关安全要求的法律条文.条文规定,凡是生产上述产品的厂家都需按要求进行必要的测试,证明其产品符合CPSC相关的规定.没有通过测试的产品严禁出售,在美国销售此类产品属于违法行为.所有玩具和儿童用品包括8岁以下的儿童设计的产品都要符合CFR中标题16的标准.标准如下：没有通过测试的产品严禁出售,在美国销售此类产品属于违法行为.如禁售产品在装运准备入关,则CPSC美国海关扣压货物或禁止该货物入关.如果进品商仍在销售以前的没有通过测试的产品,则要求进口商停止销售.如果玩具具有严重的造成意外事故的危险,或经CPSC判定为不符合安全规定的玩具,则要求进口商从零售商和顾客中收回这些玩具.ASTM F963除了CPSC规定外,一个含义更为广泛的安全标准,标准消费者安全规范：玩具安全,ASTM F963最初在1986年建立.最新的版本ASTM F963在1996年11月10日通过.本标准的目的是建立一个全国认准的玩具安全要求,以使玩具在正常使用和合理可预见的滥用时发生的事故降低到最少.本标准不排队家长在选择适合儿童年龄的玩具时应尽的责任,或儿童接触同一类玩具时家长的监督责任.除了与玩具安全有关,本标准不涉及产品的性能与质量.除了CPSC规定中正常使用和滥用测试的标准规定外,ASTM F963还包括以下的附加安全规定：—弹射玩具—钉和紧固件—金属丝或杆件—绳和橡皮筋—包装薄膜—轮、轮胎和轴—折叠装置和铰链—机械装置的孔间隙和可触及性—稳定性和超载要求—封闭的空间—模拟的保护装置—挤压玩具—出牙器和出牙玩具—代连接在童床或游戏围栏上的玩具—玩具柜—电池驱动玩具—学前玩偶—球物理性能方面的安全规定：1、包装薄膜弹性塑料薄膜和弹性塑料膜—薄膜额定厚度必须为毫米以上；—实际厚度不得少于毫米.2、玩具上的绳和橡皮筋绳—一根细长的、柔软的材料,包括单纤维丝,纺织和搓捻的绳,粗绳,塑料纺织袋,丝带,及那些通常被称谓线的纤维状材料.供18个月以下的儿童使用的玩具不包括拖拉玩具上含有或系有绳或橡皮筋,在松弛状态和承受51B的重荷时测量,其最大长度必须小于12英寸.如果绳/橡皮筋盘或多段绳/橡皮筋或缠结或形成环状而与玩具的任何部位连接,包括在绳/橡皮筋末端的珠子或其它附着件,在51B的重力作用下,环的周长必须小于14英寸.本标准适用于滥用试验前后.3、学前玩偶被定义为头端是圆的、球形或半球形,颈是细的,而跟颈相连的是一个无任何附属结构的简单圆柱形：总长度不超过英寸.不能穿过附加测试器内径是的空腔.4、球被定义为由纤维束,毛线束,或线束粘在一起的,并且中间被牢固的绑或固定,外形成刷状,形成圆球形或半圆球形的由填充材料制成的小物体.5、脉冲在距玩具表面25厘米的任何位置测量时,玩具不能产生瞬间声级超过138分贝的脉冲噪音.电池驱动玩具的基本要求在ASTM F963-96a中总共有十一条来说明使用电池驱动玩具时潜在的危险如遇热过度,渗漏和爆炸等.1、包装电池盖或电池盖附近要标有永久性清晰易懂的电池极性和电压标志.2、最高可允许额定电压任何二个可接触电接点之间的最高可允许直流额定电压约为24V.3、防止一次性电池的充电这适用于电池可以放错和充电器可以对装有一次性电池的玩具充电的情况.4、电池的可触及性对于供3岁以下的儿童使用的玩具,在滥用测试或前或后,所有电池在不使用工具和情况下,都不能可触及.5、小电池的可触及性所有玩具中的电池如果能完全进入小零件测试筒,在滥用测试或前或后,所有电池在不使用工具和情况下,都不能可触及.6、不同电池的分开使用在任何单一的电路内不能将不同型号或容量的电池混用.7、表面温度测试在正常使用期间和合理可预见滥用后,电池表面温度不得超过71度,包括安装马达的情况下.8、短路测试在正常使用期间和合理可预见滥用后,不得出现可影响温度测试的短路现象.9、电短路接触除了在终羰的接触表面外,电气电路不能与电池的任何部分形成电接触.10、密封产品假使电池产生的气体量足以形成燃烧危险,密封产品的设计必须使电池产生的气体被吸收或泄出.11、操作说明使用一只以上电池的玩具需注明：1新、旧电池不可混用；2碱性电池、普通电池和充电电池不可混用.毒性1、重金属测试油漆和类似的表面涂层材料中重金属含量标准要符合最新的欧洲标准和规定.细节请参照附录IV.2、铅、镉测试用来或可能盛放食品的玩具的部件,如陶瓷茶具必须符合FDCA中402a2c和FDA产品合格方针导则中的有关要求.3、聚氯乙烯中的邻苯二甲酸二脂测试橡皮奶嘴、拔浪鼓和出牙器等PVC原料产品中含量不得超过固体物质含量的3%.4、亚硝铵含量测试橡皮奶嘴要求进行亚硝铵含量测试.5、填充材料的清洁度测试填充玩具的松散填充料不能有来自昆虫、鸟、啮齿类动物或其它动物寄生虫侵扰的不良材料,也不能有在良好操作规范中可能产生的污物,如碎片和金属屑.确定不良材料的测试方法见“法定分析化学家协会的法定分析方法”的第16章.另外,无论是天然还是合成的纤维填充材料都应满足“宾夕法尼亚洲填充玩具的容许量规定”的相关要求.6、微生物测试在ASTM中,清洁度包括另一个含义.尤其要注意含有液体、凝胶等玩具化妆品和玩具,因为他们为细菌生长提供了一个良好的环境.可注水的玩具要做所有的大肠茵测试.含有液体、凝胶和粉末等的玩具化妆品和玩具要求做微生限量测试USP〈62〉和抗微生物防腐剂的有效性测试USP〈51〉.安全标识要求某些玩具,以及在某些情况下它们的包装,要求加上安全标识来表明潜在的危险和使用说明.下列产品和玩具的包装必须按照规定的格式和措辞.—童床和游戏围栏玩具—活动玩具—滚轴滑冰鞋和玩具滑析—模拟的保护装置格式是：1、安全标记要全部大写并集中在第一行；2、警告标记可以在左侧或中间；3、“危险”或其它字样应继续写下去.而且,信号词“小心”或“警告”的所有字母都必须为高度不小于1/8英寸的大写字母.有关危险的声明和其它规定的声明必须用大写或小写字母,其中大写字母的高度不得小于1/16英寸.用在包装上的这类标识必须标在包装的一个主要展示面上,并且与它们出现在其上的背景成鲜明对比.所有的安全标识必须显眼和易读,必须与其它说明或图案明显分开.例如：系在童床和游戏围栏上的活动玩具在通过热印、丝网印刷,或类似的染色过程,将安全标识印到玩具本身上时,在滥用试验前或后,标签依然清晰易读.当安全标识以粘贴方式贴到玩具上时,该标签必须牢固地粘贴在玩具上,标签的任何边缘都不能翘起.在经过滥用试验前或后,标签依然清晰易读.美国小零件危险警告标签规定美国总统克林顿在1994年6月16日就已签发了儿童安全保护法案H.R965.消费者安全委员会于1995年2月27日颁布了修正案,并且于1995年8月28日最终生效,以对在美国生产或进入美国的产品作出规定.1995年8月28日后,制造商还有六个月时间以使他们的产品符合该规定.此法案包括：（a ） 如小球为三岁以下的儿童使用时,该球直径小于或等于”,则禁止出售. （b ） 在某些儿童使用的玩具、游戏机上的窒息危险警告标语应包括：1小物体至少三岁但小于六岁儿童使用的玩具和游戏机,若该玩具或游戏机 中包含小物体,则应有发下的警告声明：警告：窒息危险——小物体不适用于三岁以下儿童使用.2汽球,标识应写明：8岁以下 的儿童产生窒息危险,需成年人监护.将未充气的气球远离儿童.破裂的气球立即丢弃.3小球三岁或以上儿童使用的小球,标识应写明：窒息危险——此玩具是小球,不适用于三岁以下儿童使用. 岁儿童使用并含有小球的玩具或游戏机,标识 应写明：3岁以下儿童使用4弹子三岁或以上儿童使用的弹子,标识应写明：窒息危险——此玩具是弹子,不适用于三岁以下儿童使用. 岁儿童使用并含有弹子的玩具或游戏机,标识 应写明： 警告：窒息危险——玩具含有弹子 不适用于3岁以下儿童使用（c ） 以上标签要用英语写而且要清晰易读在以下地方： —在产品包装的主要展示面；—任何说明材料如说明书等要随附该产品；—如果该产品出售时无包装,在集装箱或售货机上,当出售产品时,警告标签则必须要被展示. （d ） 如果产品没有以上的规定标签,则被认为是冒牌的危险产品. （e ） 字符类型随主要展示面而定：。

美国联邦法规 16 CFR 1500.86 列为禁止供儿童使用的玩具和其他物品的豁免原文出处：作者：编辑： [2009-02-25][打印文章] [关闭窗口]§ 1500.86 Exemptions from classification as a banned toy or other bannedarticle for use by children.(a) The term banned hazardous substance as used in section 2(q)(1)(A) of the act (repeated in §1500.3(b)(15)(i)(A)) of the act shall not apply to the following articles:(1) Toy rattles described in §1500.18(a)(1) in which the rigid wires, sharp protrusions, or loose small objects are internal and provided that such rattles are constructed so that they will not break or deform to expose or release the contents either in normal use or when subjected to reasonably foreseeable damage or abuse.(2) Dolls and stuffed animals and other similar toys described in §1500.18(a)(3) in which the components that have the potential for causing laceration, puncture wound injury, or other similar injury are internal, provided such dolls, stuffed animals, and other similar toys are constructed so that they will not break or deform to expose such components either in normal use or when subjected to reasonably foreseeable damage or abuse.(3) [Reserved](4) Any article known as a “baby-bouncer,”“walker-jumper,” or “baby-walker”and any other similar article (referred to in this paragraph as “article(s)”) described in §1500.18(a)(6) provided:(i) The frames are designed and constructed in a manner to prevent injury from any scissoring, shearing, or pinching when the members of the frame or other components rotate about a common axis or fastening point or otherwise move relative to one another; and(ii) Any coil springs which expand when the article is subjected to a force that will extend the spring to its maximum distance so that a space between successive coils is greater than one-eighth inch (0.125 inch) are covered or otherwisedesigned to prevent injuries; and(iii) All holes larger than one-eighth inch (0.125 inch) in diameter and slots, cracks, or hinged components in any portion of the article through which a child could insert, in whole or in part a finger, toe, or any other part of the anatomy are guarded or otherwise designed to prevent injuries; and(iv) The articles are designed and constructed to prevent accidental collapse while in use; and(v) The articles are designed and constructed in a manner that eliminates from any portion of the article the possibility of presenting a mechanical hazard through pinching, bruising, lacerating, crushing, breaking, amputating, or otherwise injuring portions of the human body when in normal use or when subjected to reasonably foreseeable damage or abuse; and(vi) Any article which is introduced into interstate commerce after the effective date of this subparagraph is labeled:(A) With a conspicuous statement of the name and address of the manufacturer, packer, distributor, or seller; and(B) With a code mark on the article itself and on the package containing the article or on the shipping container, in addition to the invoice(s) or shipping document(s), which code mark will permit future identification by the manufacturer of any given model (the manufacturer shall change the model number whenever the article undergoes a significant structural or design modification); and(vii) The manufacturer or importer of the article shall make, keep, and maintain for 3 years records of sale, distribution, and results of inspections and tests conducted in accordance with this subparagraph and shall make such records available at all reasonable hours upon request by any officer or employee of the Consumer Product Safety Commission and shall permit such officer or employee to inspect and copy such records, to make such stock inventories as he deems necessary, and to otherwise check the correctness of such records.(5) Clacker balls described in §1500.18(a)(7) that have been designed,manufactured, assembled, labeled, and tested in accordance with the following requirements, and when tested at the point of production or while in interstate commerce or while held for sale after shipment in interstate commerce do not exceed the failure rate requirements of the table in paragraph (a)(5)(vi) of this section:(i) The toy shall be so designed and fabricated that:(A) Each ball: Weighs less than 50 grams; will not shatter, crack, or chip; is free of cracks, flash (ridges due to imperfect molding), and crazing (tiny surface cracks); and is free of rough or sharp edges around any hole where the cord enters or over any surface with which the cord may make contact. Each ball is free of internal voids (holes, cavities, or air bubbles) if the balls are made of materials other than those materials (such as ABS (acrylonitrile butadiene styrene), nylon, and high-impact polystyrene) that are injection-molded and possess high-impact characteristics.(B) The cord: Is of high tensile strength, synthetic fibers that are braided or woven, having a breaking strength in excess of 445 Newtons (100 pounds); is free of fraying or any other defect that might tend to reduce its strength in use; is not molded in balls made of casting resins which tend to wick up or run up on the outside of the cord; and is affixed to a ball at the center of the horizontal plane of the ball when it is suspended by the cord. Clacker balls where the mass of each ball is less than 12 grams (0.42 oz.) and the distance between the center of the pivot and the center of the ball cannot exceed 180 mm (7.1 inches) may have a minimum cord breaking strength of less than 445 Newtons (100 pounds), as computed by the following formula:Adjusted Cord Breaking Strength in Newtons=0.1382(mb) (Rp), where mb=mass of a single ball in grams andRp=pivot length in mm.(C) When the cord is attached to the ball by means of a knot, the end beneath the knot is chemically fused or otherwise treated to prevent the knot from slipping out or untying in use.(ii) The toy shall be tested at the time of production:(A) By using the sampling procedure described in the table in subdivision (v i) of this subparagraph to determine the number of units to be tested.(B) By subjecting each ball tested to 10 drops of a 2.25 kg (5-pound) steel impact rod or weight (57-mm (21/4-inch) diameter with a flat head) dropped 1220 mm (48 inches) in a vented steel or aluminum tube (60-mm (23/8-inch) inside diameter) when the ball is placed on a steel or cast iron mount. Clacker balls where the mass of each ball is less than 12 grams (0.42 oz.) and the distance between the center of the pivot and the center of the ball cannot exceed 180 mm (7.1 inches) may be tested by dropping the impact weight from a height of less than 1220 mm (48 in.), where the height is computed as follows:Adjusted drop height in mm=179×10−5(mb) (Rp2), where mb=mass of a single ball in grams andRp=pivot length in mm.Any ball showing any chipping, cracking, or shattering shall be counted as a failure within the meaning of the third column of the table in paragraph (a)(5)(vi) of this section.(C) By inspecting each ball tested for smoothness of finish on any surface of the ball which may come in contact with the cord during use. A cotton swab shall be rubbed vigorously over each such surface or area of the ball; if any cotton fibers are removed, the ball shall be counted as a failure within the meaning of the fourth column of the table in subdivision (vi) of this paragraph. The toy shall also be checked to ascertain that there is no visibly perceptible “wicking up” or “running up” of the casting resins on the outside of the cord in the vicinity where the ball is attached.(D) By fully assembling the toy and testing the cord in such a manner as to test both the strength of the cord and the adequacy with which the cord is attached to the ball and any holding device such as a tab or ring included in the assembly.The fully assembled article shall be vertically suspended by one ball and a 445-Newton (100-pound) test applied to the bottom ball. Clacker balls where the mass of each ball is less than 12 grams (0.42 oz.) and the distance betw een the center of the pivot and the center of the ball cannot exceed 180 mm (7.1 inches) may be tested with a force of under 445 Newtons (100 pounds). The test force for these clacker balls shall be the same as the cord breaking strength calculated in §1500.86(a)(5)(i)(B). Any breaking, fraying, or unraveling of the cord or any sign of slipping, loosening, or unfastening shall be counted as a failure within the meaning of the fourth column of the table in paragraph (a)(5)(vi) of this section.(E) By additionally subjecting any ring or other holding device to a 222-Newton (50-pound) test load applied to both cords; the holding device is to be securely fixed horizontally in a suitable clamp in such a manner as to support 50 percent of the area of such holding device and the balls are suspended freely. Clacker balls where the mass of each ball is less than 12 grams (0.42 oz.) and the distance between the center of the pivot and the center of the ball cannot exceed 180 mm (7.1 inches) may have their holding device tested with a force of less than 222 Newtons (50 pounds). The holding device test force for these clacker balls shall be half of the cord breaking strength calculated in §1500.86(a)(5)(i)(B). Any breaking, cracking, or crazing of the ring or other holdi ng device shall be counted as a failure within the meaning of the fourth column of the table in paragraph (a)(5)(vi) of this section.(F) By cutting each ball tested in half and then cutting each half perpendicularly to the first cut into three or more pieces of approximately equal thickness. Each portion is to be inspected before and after cutting, and any ball showing any flash, crack, crazing, or internal voids on such inspection is to be counted as a failure within the meaning of the fourth column of t he table in paragraph (a)(5)(vi) of this section. Balls that are injection-molded and possesshigh-impact characteristics (such as injection-molded balls made of ABS, nylon, or high-impact polystyrene) though exempt from the requirements that there be no internal voids, must be tested to determine the presence of any flash, crack or grazing. A transparent ball shall be subjected to the same requirements except that it may be visually inspected without cutting.(iii) The toy shall be fully assembled for use at time of sale, including the proper attachments of balls, cords, knots, loops, or other holding devices.(iv) The toy shall be labeled:(A) With a conspicuous statement of the name and address of the manufacturer, packer, distributor, or seller.(B) To bear on the toy itself and/or the package containing the toy and/or the shipping container, in addition to the invoice(s) and shipping document(s), a code or mark in a form and manner that will permit future identification of any given batch, lot, or shipment by the manufacturer.(C) To bear a conspicuous warning statement on the main panel of the retail container and display carton and on any accompanying literature: That if cracks develop in a ball or if the cord becomes frayed or loose or unfastened, use of the toy should be discontinued; and if a ring or loop or other holding device is present, the statement “In use, the ring or loop must be placed around the middle finger and the two cords positioned over the forefinger and held securely between the thumb and forefinger,” or words to that effect which will provide adequate instructions and warnings to prevent the holding device from accidentally slipping out of the hand. Such statements shall be printed in sharply contrasting color within a borderline and in letters at least 6 mm (1/4inch) high on the main panel of the container and at least 3 mm (1/8) high on all accompanying literature.(v) The manufacturer of the toy shall make, keep, and maintain for 3 years records of sale, distribution, and results of inspections and tests conducted in accordance with this subparagraph and shall make such records available upon request at all reasonable hours by any officer or employee of the Consumer Product Safety Commission, and shall permit such officer or employee to inspect and copy such records and to make such inventories of stock as he deems necessary and otherwise to check the correctness of such records.(vi) The lot size, sample size, and failure rate for testing clacker balls are as follows:(vii) Applicability of the exemption provided by this paragraph shall be determined through use of the table in paragraph (a)(5)(vi) of this section. A random sample of the number of articles as specified in the second column of the table shall be selected according to the number of articles in a particular batch, shipment, delivery, lot, or retail stock per the first column. A failure rate as shown in either the third or fourth column shall indicate that the entire batch, shipment, delivery, lot, or retail stock has failed and thus is not exempted under this paragraph from classification as a banned hazardous substance.(6) Caps (paper or plastic) described in §1500.18(a)(5), provided:(i) Such articles do not produce peak sound pressure levels greater than 158 decibels when tested in accordance with §1500.47, and provided any such articles producing peak sound pressure levels greater than 138 decibels but not greater than 158 decibels when tested in accordance with §1500.47 shall bear the following statement on the carton and in the accompanying literature in accordance with §1500.121: “WARNING—Do not fire closer than 1 foot to the ear. Do not use indoors.”(ii) Any person who elects to distribute toy caps in accordance with paragraph (a)(6)(i) of this section shall promptly notify the Consumer Product Safety Commission, Bureau of Compliance, Washington, D.C. 20207, of their intention and shall conduct or participate in a program to develop caps that produce a sound pressure level of not more than 138 decibels when tested in accordance with §1500.47.(iii) Any person who elects to distribute caps in accordance with paragraph (a)(6)(i) of this section shall, after notification of his intentions to the Commission in accordance with paragraph (a)(6)(ii) of this section, submit to the Consumer Product Safety Commission, Bureau of Compliance, Washington, DC 20207, a progress report not less frequently than once every 3 months concerni ng the status of his program to develop caps that produce a sound level of not more than 138 decibels when tested in accordance with §1500.47.(7) Dive sticks and similar articles described in §1500.18(a)(19) that come to rest at the bottom of a container of water in a position in which the long axis of the article is greater than 45 degrees from vertical when measured in accordance with the following test method:(i) Test equipment.(A) A container that is filled with tap water to a depth at least 3 inches [76 mm] greater than the longest dimension of the dive stick. The container shall: ( 1) Be sufficiently wide to allow the dive stick to lie along the bottom with its long axis in a horizontal position,( 2) Have clear side walls to permit observation of the dive stick under water, and( 3) Be placed on a level surface and have a flat bottom.(B) A protractor or other suitable angle measurement device that has an indicator for 45 degrees from vertical.(ii) Testing procedure(A) If the dive stick is sold such that the consumer is required to attach an additional component(s) to the dive stick, then the product shall be tested both with and without the attachment(s).(B) From just above the water surface, drop the dive stick into the container.(C) Let the dive stick sink and come to rest at the bottom of the container. If the dive stick is designed so that the weight can be adjusted by adding water or other substance, adjust the weight so that the dive stick sinks and comes torest with its long axis positioned as close to vertical as possible.(D) Align the angle measurement device alongside the dive stick underwater and wait for the dive stick to come to rest if there is any water disturbance. Determine whether the long axis of the dive stick is greater than or less than 45 degrees from vertical.(8) Dive sticks and similar articles described in §1500.18(a)(19) in which the maximum force measured in the following test method is less than 5–lbf [22N]. The test shall be conducted in the ambient environment of the laboratory and not under water.(i) Test equipment.(A) A compression rig that has a force gauge or equivalent device that is calibrated for force measurements within a minimum range of 0 to 5 lbf [0–22 N] and with an accuracy of ±0.1 lbf [±0.44 N] or better. The test rig shall have a system to guide this force application in the vertical direction and shall have a means to adjust the rate of load application.(B) Compression disk—the loading device that is attached to the force gauge shall be a rigid metal disk with a minimum diameter of 1.125 inches [29 mm].(C) Vise or other clamping device.(ii) Testing procedure(A) Position the bottom of the dive stick in the clamping device so that the longest axis of the dive stick is vertical. The bottom end of the dive stick is the end that sinks to the bottom of a pool of water. Secure the bottom of the dive stick in the clamp such that the clamping mechanism covers no more than the bottom1/2inch [13 mm] of the dive stick.(B) Apply a downward force at a rate of 0.05 in/sec (±0.01 in/sec) [1.3 mm.sec ±0.3 mm/sec] at the top of the dive stick with the compression disk positioned so that the plane of the disk contact surface is perpendicular to the long axis of the dive stick.(C) Apply the load for a period of 40 seconds or until the maximum recorded force exceeds 5-lbf [22 N].(D) Record the maximum force that was measured during the test.(b) [Reserved](9) Boston Billow Nursing Pillow and substantially similar nursing pillows that are designed to be used only as a nursing aide for breastfeeding mothers. For example, are tubular in form, C- or crescent-shaped to fit around a nursingmother's waist, round in circumference and filled with granular material. [38 FR 27012, Sept. 27, 1973, as amended at 53 FR 46839, Nov. 18, 1988; 59 FR 9076, 9077, Feb. 25, 1994; 66 FR 13651, Mar. 7, 2001; 68 FR 70140, Dec. 17, 2003;73 FR 77495, Dec. 19, 2008]。

U.S. CONSUMER PRODUCT SAFETY COMMISSIONOffice of ComplianceChildren’s Sleepwear Regulations 1, 16 C.F.R. Parts 1615 & 16161This document is a simple summary of the children’s sleepwear requirements and does not replace the requirements published in 16 C.F.R. Parts 1615 & 1616. The summary does not include all of the details included in those requirements. For those details,please refer to the regulation or contact the Office of Compliance at the address below.What is the purpose of the children’s sleepwear flammability standards?To protect children from burns, these rules require that children’s sleepwear must be flame resistant and self-extinguish if a flame from a candle, match, lighter or a similar item causes it to catch fire. The rules cover all children’s sleepwear above size 9 months and up to size 14 and require that(1) the fabric and garments must pass certainflammability tests; or(2) be "tight fitting" as defined by specifieddimensions.Where can I find the requirements for children’s sleepwear?The regulations are published in the Code of Federal Regulations in Title 16, Part 1615 for children’ssleepwear sized above 9 months and up to 6X, and in Title 16, Part 1616 for children’s sleepwear sized 7through 14. The two rules contain basically the same requirements, with the main difference being the sizes of the garments covered by each.What is children’s sleepwear?Children’s sleepwear is any article of clothing, such as a nightgown, pajama, robe or loungewear, that is sized above 9 months and up to size 14 and that is intended to be worn primarily for sleeping or activities related to sleeping.To determine whether a garment is sleepwear, the Commission considers:1. The nature of the garment and its suitability forsleeping or activities related to sleeping;2. How the garment is promoted and distributed; and3. The likelihood that the garment will be used bychildren primarily for sleeping or activities related to sleeping in a substantial number of cases.Underwear and diapers are not children’s sleepwear.A garment sized nine months or smaller intended for use by infants is not required to meet the standard if:(1) It is a one-piece garment and is not longer than 25¾ inches, or it is a two-piece garment and has no piece longer than 15 ¾ inches; and(2) It has a label stating in months the age of thechildren for whom it is intended.Even though these types of garments are exempt from the requirements of this rule, they must still meet the flammability requirements for clothing textiles, 16C.F.R. 1610 and vinyl plastic film, 16 C.F.R. 1611.How do I test sleepwear to make sure that it complies with the flammability standards?Because of the detail in the regulation, we have only provided a general overview of the sampling and testing requirements. For more detailed information about the test equipment and procedure, sampling garments or fabric, selecting specimens, and other requirements, please refer to the regulation or contact the Office of Compliance.The general test uses a sample of five 3½ inch by 10-inch specimens cut from the fabric or garment seams and trim being tested. Each specimen is testedseparately. Place each specimen in a metal holder and suspend each holder vertically in the test cabinet.Apply the gas flame to the bottom edge of thespecimen for 3 seconds. Measure the char length of each specimen.Testing for flammability involves selecting and testing a specified number of samples of three different items – fabric, prototype seams and trim, and production garment seams. Fabric (or garments) must be tested as produced (or after one laundering) and after 50 launderings.Depending on the results of testing, an item may be accepted, rejected, or require additional sampling and testing. In general, a sample of five specimens cannot have an average char length greater than 7.0 inches or have more than a specified number of individual 10-inch char lengths.Fabric: Finished fabric that is ready to be made into sleepwear must be grouped into Fabric Production Units (FPUs) and tested before you use the fabric to make prototype garments. An FPU may be up to 5,000 linear yards of the fabric. You may include different colors or print patterns of the same fabric in the same FPU if they exhibit similar burn characteristics. Test one sample of five specimens from each end of each FPU (two samples per FPU).The FPU is accepted or rejected based upon the fabric sampling plan criteria. If 15 consecutive FPUs of a fabric are accepted, the number of linear yards of fabric in the FPU may be increased. If an FPU is rejected, subsequent FPUs must be tested with a third sample of five specimens taken from the middle of the FPU.Garment prototypes: Before you actually produce garments that will be sold, you must test prototypes of each garment design characteristic. This testing helps to ensure that you have designed a garment that will comply with the standards when it is mass-produced. Seam types and trim that will actually be used in the garments must be tested. Most sleeve and neckline bindings/rib cuffs do not have to be tested. Test three samples, five specimens each, of the longest seam type, three samples of each different seam type 10 inches or longer, and three samples of each type of trim.Prototype seams and trims are accepted or rejected based upon the prototype sampling plan criteria. Production garments: Finished garments produced for sale must be grouped into Garment Production Units (GPUs) and tested. One GPU may include up to 500 dozen garments. A GPU may include garments with different trim and fasteners, as long as the other characteristics of the garments (e.g. fabric, thread, and seam construction), are identical, except for size, color, and print pattern.From randomly selected garments, test three samples, five specimens each, from the longest type of seam.GPUs are accepted or rejected based upon the production garment sampling plan.What if sleepwear fails the flammability tests? Rejected units may not be retested, used, or promoted for use in children’s sleepwear. Rejected units can be destroyed, exported (only with CPSC approval), or reworked to improve their flammability resistance. You must retest reworked units according to the FPU and GPU testing procedure. Such units must comply with the flammability requirements before the fabric or garments are introduced into commerce as children’s sleepwear.How do I make tight-fitting sleepwear?Tight-fitting sleepwear garments must(1)not exceed the maximum dimensions specified inthe regulations for the chest, waist, seat, upperarm, thigh, wrist, or ankle;(2)have no fabric ornament or trim, such as lace orribbon, which extends more than ¼ inch from thepoint at which it is attached to the garment;(3)have sleeves that taper from the shoulders to theends of the sleeves(4)have pant legs that taper from the thighs to theends of the pant legs;(5)if they are 1-piece, taper from the chest down tothe waist and from the seat up to the waist;(6)if they are 2-piece,(a)have an upper piece that tapers from the chestto the bottom of the piece,(b)if the upper piece has fastenings, have thelowest fastening located within 6 inches of thebottom of the piece, and(c)have a lower piece that tapers from the seat tothe top of the piece;(7)bear a permanent label stating size of garment.(8)bear a hang tag alerting buyers that the garmentsare not flame-resistant and should be worn snugfitting because loose-fitting garments are morelikely to catch fire(9)comply with all of the flammability requirementsfor clothing textiles and vinyl plastic film.Figure 3 - Text of HangtagWhat are the marketing responsibilities of retailers, distributors and wholesalers who sell children’s sleepwear?Retailers, distributors and wholesalers of children’s sleepwear (including infant sleepwear (sized 9 months and under) and tight fitting sleepwear) should(1)not advertise, promote, or sell as children’ssleepwear, any garment which another party hasindicated does not meet the requirements of thechildren’s sleepwear flammability standards and/or are not intended or suitable for use as sleepwear;(2)place or advertise fabrics and garments covered bythe children’s sleepwear standards in differentparts of a department, store, catalog, or web site,from those in which fabrics and garments whichmay resemble but are not children’s sleepwear are sold or marketed;(3)use store display signs, and/or catalog or web sitenotations that point out the difference betweendifferent types of fabrics and garments, forexample, by indicating which are sleepwear items and which are not; and(4)avoid advertising or promoting garments or fabricsthat do not comply with the children’s sleepwearstandards in a manner that may cause consumers to view those items as children’s sleepwear or asbeing suitable for making such sleepwear.Are there any requirements for labeling and keeping records?Yes, for sleepwear garments that meet the flammability performance requirements there are additional requirements. Please refer to the regulation for more detailed information. In general:(1)each article of children's sleepwear must have apermanent label with instructions on how to takecare of the garment to protect it from chemicals or other treatments that can reduce its flameresistance;(2)children's sleepwear must have a permanent labelwith a unit identification (number, letter, date, orcombination thereof) so manufacturers can trackthe garment's associated fabric and garmentproduction lots in the event of a recall;(3)manufacturers and importers must maintain writtenrecords as specified in the regulations.Are there any other requirements for children’s sleepwear?Yes. The Federal Trade Commission (FTC) has labeling laws that apply to clothing. Contact the FTC at for more information. In addition, even though functional attachments to clothing, such as buttons and zipper pulls, are exempt from the “Small Parts” regulation, we recommend that you voluntarily test such attachments on garments up to and including size 2 to ensure that those children cannot choke, aspirate, or swallow those attachments. (See the “use and abuse” tests described at 16 C.F.R.§§ 1500.50 through 1500.52, and the small parts requirements at 16 C.F.R. Part 1501.)Where can I find additional information?You can obtain the Standards for the Flammability of Children’s Sleepwear, 16 C.F.R. Parts 1615 & 1616, from the CPSC web site at: . For more information on the requirements for children’s sleepwear contact the Consumer Product Safety Commission, Office of Compliance, Washington, D.C. 20207, telephone: (301) 504-7913, e-mail:sect15@.。

Intertek Testing Services Ltd., Shanghai3/F, No.2 Building, Shanghai Comalong Ind. Park, No.889 Yishan Rd., Shanghai 200233, China 上海天祥质量技术服务有限公司中国上海宜山路889号齐来工业城2号楼3层 邮政编码 200233Tel: +86 21 61206565 Fax: +86 21 6495 9813Recommended size of Samplefor US CPSC 16 CFR PART 1615/1616 美国儿童睡衣可燃性标准1615/1616取样测试范围 取样说明 送测样品数量 测试项目 1 面料测试 每5000码为1个FPU，PFU编号由客户提供 每个PFU头码取2码×幅宽，尾码取2码×幅宽；如加严取样，则取头中尾各2码（客户需留相同样品量供CPSC抽查，下同）原样测试＋(水洗50次测试/若做过阻燃处理，一定要做洗后测试)2 样板服装的缝线测试 确定在成衣构造中最长的缝线和其他长度达到10in 或以上的缝线； 30块试样 3.5*10英寸 原样测试，不做洗后测试3 样板服装的装饰物测试 装饰物包括缎带、蕾丝、刺绣。

不包括：最长的方向的尺寸小于2in的装饰物；功能性的物品，如拉链、纽扣或弹力的带子 30块试样 3.5*10英寸 原样测试，不做洗后测试4 量产服装的成品接缝测试 1个GPU＝500×12＝6000件（500打） 从每一个GPU中，随意地抽取9件衣服(小号)或者6见衣服（大号）原样测试，不做洗后测试注意： 1. 16 CFR Part 1615：9个月～6岁童装；16 CFR Part 1616：7～14岁童装；2. 阻燃处理后的织物一定要做水洗后测试；首个FPU必须做洗后测试。

按照AATCC135，60度洗12分钟。

美国玩具安全法律法规中华人民共和国商务部对外贸易司一、美国的消费晶安全法律法规简介美国联邦制的国家结构形式，导致了美国法律体系的庞杂性，美国有关产品的技术法规分散于美国的联邦法律法规体系之中，既存在于国会制定的成文法——法案(Act)中，也存在于联邦政府各部门制定的条例、要求、规范中。

在美国消费品安全领域，与玩具、化妆晶及儿童用品有关的法案有5个：《消费品安全法案》(Consumer Product Safety Act，CPSA)、《联邦危险品法案》(Federal Hazardous Substances Act，FHSA)、《可燃纺织品法案》(Flammable Fabrics Act，FFA)、《防毒包装法案》(Poison Prevention Packaging Act，PPPA)与《联邦食品、药品与化妆品法案》(Federal Food，Drug and Cosmetic Act，FDCA)。

法案对各自辖下产品的安全、环保与对健康影响等方面提出了要求。

针对不一致商品不一致的具体要求，相应的管理部门根据上面法案制定了大量的属于技术法规范畴的具体规范、要求等。

比如针对《消费品安全法案》，消费品安全委员会制定了大量的部门技术法规，集中汇编于《美国联邦法规典集》(Code of Federal Regulations)第16卷部分。

美国技术法规的另一个特点是数量众多，分布广泛。

美国的技术法规要紧收录在《美国法典》(United States Code)或者《美国联邦法规典集》(Code of Federal Regulations)中，比如玩具产品方面的技术法规就分布在16 CFR的1500、1505、1610等几个篇章中。

二、美国的产品安全管理简介联邦政府对涉及公共安全与医疗健康产品的认证工作有统一的管理模式与监督执法。

联邦政府的产品安全管理分由不一致部门负责，如：美国消费者安全委员会(CPSC)管理着管辖多达15 000种用于家庭、体育、娱乐及学校的消费品；食品与药物管理局(FDA)负责医药、生物制品、化妆品等；美国联邦通信委员会(FCC)管制无线电波频率设备；农业部(USDA)管理食用肉类、家禽产品，等。