587689_CERT (USP Class VI certificate)

乌干达PVOC认证详情今天把乌干达PVOC认证的详细认证指南和步骤一步一步写的很详细一点，因为各个发证机构的审核要求差别很大，如果不了解这些机构的规则，就无法规避一些风险，导致出口商很被动。

因此，最好在乌干达做PVOC认证。

例如，一个客户生产自行车，有一批自行车要运到乌干达。

起初，他们在杭州找到一家代理公司，说可以办。

客户立即组织生产了一批自行车，然后将信息发送给杭州的代理商，要求其在乌干达申请PVOC认证。

杭州的代理机构将该信息发送给乌干达发证机构BV,以申请PVOC认证。

结果这个BV机构不接受客户的检测报告，因为客户的检测报告是EN14766标准做的，而BV只能接受ISO4210标准做的检测报告。

根本没有商量的余地。

我请了一家自行车实验室用ISO4210标准做了整个测试，费用至少3万。

顾客是愚蠢的。

后来客户找到我们，问我们有没有办法。

根据客户目前情况的信息，我们无能为力，因为现在自行车标准已经更新了。

IS04210-2014 是强制性要求，其他标准真的不能接受。

但是，在我们与客户沟通的过程中，我们发现这个问题还是可以解决的。

就是他说这个标准的检测报告他哥们的厂子做过，但是检测项目不全，只做了部分检测。

我们让他借这份检测报告，然后让客户把产品标签上的产品型号改一下,和检测报告一致。

就这样，我们又找了一家发证机构申请，最后一切顺利。

领证通关。

因为有些机构, 不像BV那么苛刻, 必须要有整个项目的检测报告。

所以从这些事情可以看出，不专业的代理会浪费客户很多钱。

如果真的做检测，光是检测费就上万。

后来按照我们的应急措施，终于解决了问题，没有花检测报告的钱。

幸好客户找到了我们。

不然这三万块的检测费肯定花光了。

COS证书简介由于有着众多的⼈⼝及发达的经济，欧洲是世界上巨⼤的药品消耗地区，同时也是向外输出药物制剂的最⼤地区。

与美国⼀样，出于对⾃⾝资源和环保的考虑，决⼤多数欧洲国家严格控制原料药的⽣产规模。

欧洲制药⼯业发达⽽且历史悠久，集中了很多世界主要跨国制药企业，成为世界上向外输出药品制剂最多的地区。

随着欧洲逐渐⼀体化，欧盟版图不断扩⼤,作为⼀个整体，它正成为世界上最⼤的原料药进⼝市场之⼀，也是我国众多原料药⽣产⼚家的重要⽬标市场。

由于欧洲国家⼀般较⼩，经济市场⼀体化⼀直是⼤势所趋, 进程在不断加速。

早在1964年，欧盟就成⽴了统⼀的公共卫⽣委员会（Public Health Committee）和欧洲药典委员会(Committee of European Pharmacopoeia)，颁布了在所有成员国内都具有法律效⼒的欧洲药典。

欧洲药典委员会也由最初的⼋个成员国发展到现在三⼗⼀个成员国，包括：奥地利、⽐利时、波⿊、克罗地亚、塞浦路斯、捷克共和国、丹麦、芬兰、法国、德国、希腊、匈⽛利、冰岛、爱尔兰、意⼤利、卢森堡、荷兰、挪威、葡萄⽛、斯洛伐克共和国、斯洛⽂尼亚、西班⽛、瑞典、瑞⼠、前南斯拉夫联盟、⼟⽿其、英国等，基本上涵盖了欧洲的主要国家。

在公共卫⽣委员会和欧洲药典委员会的协调和规范下，近⼏年欧洲的医药管理体制和法规发⽣了明显的变化。

对成员国以外的医药产品进⼊成员国市场的管制政策也做出了相应的调整。

1995年阿姆斯特丹条约（Treaty of Amsterdam）⽣效以后，欧盟成⽴了专门的药物评审机构--欧洲药物评审局（EMEA，European Agency for the Evaluation of Medicinal Product）。

EMEA将制剂药品上市的核准（Marketing Authorization）程序分成两种，即"集中申请"和"互认申请"。

In its origin, USP <88> was developed as a series of tests packaged together in various iterations to become what is known as a Class Test. These classifications range from Class I through Class VI and as the classification increases, so does the number of extraction vehicles and number of tests required. These individual tests include intracutaneous irritation, acute systemic toxicity and implantation and the four possible vehicles used are USP 0.9% Saline for Injection, Vegetable Oil (cottonseed or sesame seed), Ethanol and Polyethylene Glycol 400. At its inception, a Class VI would be performed to label a plastic product with the VI-70 to indicate it had passed a class test with extracts at 70 degrees. USP <88> was originally written to consider plastics, but it has expanded over the years to be applied to many other material types. A Class VI tested material can be sold to medical device companies with a certain level of comfort about material safety. Medical device and drug companies many times put into their spec sheets that a material or individual component in their final device designs or manufacturing lines must be Class VI material. Then the final finished product is ISO 10993 tested for biocompatibility if applicable. Material vendors though many times sell their resins, tubing, filters etc. to many different end users although they may custom formulate materials also.This variety of end users may have different internal quality standards and some may simply require a USP <88> Class VI to be performed while others may want ISO 10993 testing. While it’s a boon for the biocompatibility labs to first perform a USP <88> Class I-VI and then later ISO 10993 tests when different end users request it, it’s an obvious burden on the material vendors. It is possible to combine the requirements of the two testing guidances into a single test that could support a wider range of end user requirements. ISO 10993 contains within it an equivalent test for each of the USP Class VI individual components, but all details are not the same. What the USP/ISO Class VI could do is to take the worst case conditions for the intracutaneous irritation and acute systemic toxicity tests from each version of the tests and then have two separate implant tests performed.The table below goes through each of the tests and lists the differences between the two methods.It should be noted, but not to be bogged down in details, that USP <88> also allows for the irritation test to be performed in guinea pigs and the implantation test to be performed in rats. These options are not used in any frequency but are available.In the end, this combined version of the Class VI may allow for material vendors to satisfy most of their client quality requirements. Vendors may still be requested for additional testing of materials such as USP <87>, USP <661>, ISO 10993-10 sensitization, ISO 10993-5 cytotoxicity or ISO 10993-11 pyrogenicity.Now, I know there may be some manufacturers out there wondering if they can submit USP <88> testing in lieu of ISO 10993 testing and the answer is an emphatic no! Also, just because all of the materials used to make a device are USP <88> Class VI certified it does not mean manufacturers are exempt from 10993-1 evaluation. When different material components are combined to form finished products that are then sterilized, there are a lot of chemical interactions going on which can form byproducts. Analytical chemists and sterilization specialists can talk your ear off on this and I promise you’ll learn a few new things after talking with them. Class VI tests are an important tool in your toolbox, but you’ll need all your tools to build your framework, biological evaluation andfinal toxicological risk assessments.Moving forward, there are current discussions about USP <87> and <88> that they become more of a risk based evaluation of raw materials or manufacturing components closer to a ISO 10993-1 approach. A meeting was held at USP regarding this topic and while changes aren’t imminent, they are on the horizon.。

tsca无毒证明表格
关于TSCA（毒性物质控制法）无毒证明表格，通常是指美国环保署（EPA）要求的化学物质注册表（TSCA注册表）的一部分。

根据TSCA，美国EPA要求生产者或进口者向其提交化学物质的相关信息，以评估其对人类健康和环境的潜在风险。

对于化学物质的无毒证明，生产者或进口者需要填写TSCA注册表中的相关部分，并提供相关的测试数据和其他支持材料。

TSCA无毒证明表格通常包括以下内容：
1. 化学物质的标识信息，包括化学名、CAS号等。

2. 化学物质的生产或进口数量等基本信息。

3. 化学物质的用途和暴露情况描述，包括预期的人类暴露途径和环境释放途径等。

4. 化学物质的毒理学数据和风险评估结果，包括对人类健康和环境的潜在影响等。

5. 其他支持材料，如相关的研究报告、测试数据等。

填写TSCA无毒证明表格需要生产者或进口者对其产品进行全面
的评估和测试，并确保提供的信息准确、完整。

此外，根据TSCA的
要求，如果化学物质的使用或暴露可能导致潜在的健康或环境风险，生产者或进口者可能需要提供进一步的信息或进行额外的评估。

总之，TSCA无毒证明表格是美国EPA要求的一项重要文件，涉
及化学物质的注册和评估，对于生产者和进口者来说需要严格遵守
相关规定，确保提供的信息准确、可靠。

usp标准品证书一、USP标准品：USP标准品是美国药典 (USP) 为处方及非处方药物、食品补充剂和其它保健产品制订质量标准而生产出来的参照物和对照品。

USP标准品是美国公认的法定公共标准设定机构生产出来的标准品成为USP标准品。

然而很多人认为具备生产标准品资格的美国公司生产出来的标准品也是USP标准品，这种说法是错误的。

USP标准品价格是很透明的。

由于中美贸易量非常大，中国进入美国市场的药物等化学用品非常多，很多企业为了能保证企业的质量，都选用了USP标准品作为对照品。

这样一来中国市场的USP需求量是很大的。

如何检索USP标准品：1. 进入USP官网，找到“Reference Standards”，点击“Purchase”。

得到下面的页面：2. 点击“Search and buy Reference Standards”3. 在右上角search那里输入需要的标准品名称，就可以出现标准品的名称及规格，点击标准品名称，就会出现标准品的各项信息，如批号、SDS、HS等。

若是我们标准品批次号与当前标准品批次号相同就说明我们的标准品在有效期内。

在这里我们还能知道前些批次的有效使用日期，查看标准品USP证书等。

二、EP标准品EP标准品是欧盟国家药品质量检测的惟一指导标准品，所有药品和药用底物的生产厂家在欧洲范围内推销和使用的过程中，必须遵循EP的质量标准，EP标准品是生产中对产品进行检测是否符合欧盟标准的标准对照物质。

EP是欧洲药典的简称，标准品即标准物品，作为一种衡量标准，用做药物方面，则为含量测定中的标准含量。

生物制品标准物质系指用于生物制品效价、活性或含量测定的或其特性鉴别、检查的生物标准品或生物参考物质。

对照品系指用于鉴别、检查、含量测定和校正检定仪器性能的标准物质。

EP标准品是指以欧洲药典为准则的标准物质对照品。

EP标准品被广泛用在欧洲化工药物生物等生产，是欧洲化工等行业的不可缺少的物品，是欧洲化工行业质量的参考标准。

USP88classVIvsISO10993In its origin, USP <88> was developed as a series of tests packaged together in various iterations to become what is known as a Class Test. These classifications range from Class I through Class VI and as the classification increases, so does the number of extraction vehicles and number of tests required. These individual tests include intracutaneous irritation, acute systemic toxicity and implantation and the four possible vehicles used are USP 0.9% Saline for Injection, Vegetable Oil (cottonseed or sesame seed), Ethanol and Polyethylene Glycol 400. At its inception, a Class VI would be performed to label a plastic product with the VI-70 to indicate it had passed a class test with extracts at 70 degrees. USP <88> was originally written to consider plastics, but it has expanded over the years to be applied to many other material types. A Class VI tested material can be sold to medical device companies with a certain level of comfort about material safety. Medical device and drug companies many times put into their spec sheets that a material or individual component in their final device designs or manufacturing lines must be Class VI material. Then the final finished product is ISO 10993 tested for biocompatibility if applicable. Material vendors though many times sell their resins, tubing, filters etc. to many different end users although they may custom formulate materials also.This variety of end users may have different internal quality standards and some may simply require a USP <88> Class VI to be performed while others may want ISO 10993 testing. While it’s a boon for the biocompatibility labs to first perform a USP <88> Class I-VI and then later ISO 10993 tests when different end users request it, it’s an obvious burden on the material vendors. It is possible to combine the requirements of the two testing guidances into a single test that could support a wider range of end user requirements. ISO 10993 contains within it an equivalent test for each of the USP Class VI individual components, but all details are not the same. What the USP/ISO Class VI could do is to take the worst case conditions for the intracutaneous irritation and acute systemic toxicity tests from each version of the tests and then have two separate implant tests performed.The table below goes through each of the tests and lists the differences between the two methods.It should be noted, but not to be bogged down in details, that USP <88> also allows for the irritation test to be performed in guinea pigs and the implantation test to be performed in rats. These options are not used in any frequency but are available. In the end, this combined version of the Class VI may allow for material vendors to satisfy most of their client quality requirements. Vendors may still be requested for additional testing of materials such as USP <87>, USP <661>, ISO 10993-10 sensitization, ISO 10993-5 cytotoxicity or ISO 10993-11 pyrogenicity.Now, I know there may be some manufacturers out there wondering if they can submit USP <88> testing in lieu of ISO 10993 testing and the answer is an emphatic no! Also, just because all of the materials used to make a device are USP <88> Class VI certified it does not mean manufacturers are exempt from 10993-1 evaluation. When different material components are combined to form finished products that are then sterilized, there are a lot of chemical interactions going on which can form byproducts. Analytical chemists and sterilization specialists can talk your ear off on this and I promise you’ll learn a few new things after talking with them. Class VI tests are an important tool in your toolbox, but you’ll need all your tools to build your framework, biological evaluation andfinal toxicological risk assessments.Moving forward, there are current discussions about USP <87> and <88> that they become more of a risk based evaluation of raw materials or manufacturing components closer to a ISO 10993-1 approach. A meeting was held at USP regarding this topic and while changes aren’t imminent, they are on the horizon.。

Form code: TA 251Revision: 2016-12Page 1 of 3TYPE APPROVAL CERTIFICATECertificate No: TAE00001WAThis is to certify:That the Frequency Converterwith type designation(s) S 120 CMIssued toSiemens AGErlangen Bayern , Germanyis found to comply withDNV GL rules for classification – Ships, offshore units, and high speed and light craft DNV GL class programme DNVGL-CP-0395 – Type approval – Semiconductor convertersApplication :Product(s) approved by this certificate is/are accepted for installation on all vessels classed by DNV GL.Issued at Hamburg on 2017-04-05This Certificate is valid until 2022-04-04. DNV GL local station: AugsburgApproval Engineer: Jens Altmann for DNV GLDuy Nam Le Head of SectionThis Certificate is subject to terms and conditions overleaf. Any significant change in design or construction may render this Certificate invalid. The validity date relates to the Type Approval Certificate and not to the approval of equipment/systems installed.Digitally Signed By: Rinkel, MarcoSigning Date: 2017-05-05Location: Hamburg - On behalf ofJob Id: 262.1-021682-1Certificate No: TAE00001WA Product descriptionElectronic control equipmentComponentsElectronic control equipmentApplication/LimitationThis converter modules are destined for the installation in steel cabinets. Marine specific demands have to be considered. Instructions of the installation guide 6SL3097-4AH00-0AP6 have to be observed.The cubicles have to be equipped with anti condensation heating and air inlet filters.Job Id: 262.1-021682-1Certificate No: TAE00001WAComponent characteristics: Temperature class B, Humidity class B, Vibration class A, EMC class A, Degree of protection: IP 20.The EMC measures of the manufacturer have to be observed.This electronic components may be used for the construction of all types of drives including electric propulsion.Type Approval documentationAccording to Siemens Overview chart Drawing No.: A5E407430000A, Project No.: 262.1-021682-1 Tests carried outAccording to Siemens Overview chart Drawing No.: A5E407430000A, Project No.: 262.1-021682-1 Please see Certificate documentation for certificates 1204710HH, 3323506HH, TAE00001BS andTAE00001ESMarking of productIn accordance with Siemens Standard BCHW Appendix 10, Version: V1.5, Released 24.11. 2016 Periodical assessmentThe scope of the periodical assessment is to verify that the conditions stipulated for the Type approval are complied with and that no alterations are made to the product design or choice of materials.The main elements of the assessment are:·Inspection on factory samples, selected at random from the production line (where practicable). ·Results from Production Sample Tests (PST) and Routines (RT) checked (if not available tests according to PST and RT to be carried out).·Review of type approval documentation.·Review of possible change in design, materials and performance.·Ensuring traceability between manufacturer’s product type marking and Type Approval Certificate. Assessment to be performed at 2 and 3,5 years.。

如何快速获得产品国际安全认证
卓云
【期刊名称】《标准科学》
【年(卷),期】2002(000)002
【摘要】产品国际安全认证是产品进入国际市场的必经之路.文章从了解国际标准、国内先作测试、用CB证书和CB测试报告转认证证书、利用互认关系、避免变动认证产品、注意选材、提高效率、信守承诺等8个方面论述了如何能更快更好地
获取产品国际安全认证证书.
【总页数】2页(P19-20)
【作者】卓云
【作者单位】佛山通宝股份有限公司总工办,528000
【正文语种】中文
【中图分类】F7
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