Supply of Machinery (Safety) Regulations 2008

Supply of Machinery (Safety) Regulations 2008 regulates the placing on the market, and the putting into service, of machinery in the UK. Since 1st January 2021 the Supply of Machinery (Safety) Regulations 2008 became applicable replacing the machinery directive 2006/42/EC which itself superseded the Machinery Directive 98/37/EC. While all are broadly similar, there are significant differences that affect machine builders, those performing final assembly and UKCA marking of machinery, and those placing imported machinery into the market in the UK.

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Main requirements of the regulation:

  • Safety of any powered equipment with moving parts
  • Power can be electrical, pneumatic, hydraulic or other;
  • Requirements for guarding, safety factors for loading, reliability of safety systems, marking and instructions;
  • Extensive requirements for marking and instructions
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There are some exclusions listed in the Regulations:

  • Medical machines in contact with patients
  • Passenger lifts and mine winders
  • Boilers and pressure vessels
  • Means of transport
  • Military equipment

Please refer to the machinery regulations for detailed requirements: Guide-to-machinery-safety-regulations-2008

How we can help

CEM International are an approved body for the Supply of Machinery (Safety) Regulations 2008 and can provide assistance with certification.

Services that we offer as an approved body

CEM can offer services to approve all products defined in Annex IV of the regulations and can help our clients, including manufacturers, importers and exporters, with conformity assessment services, which are necessary for UKCA marking the products. These services include:

Type Examination:

CEM can provide full Type Examination of machinery and issue a certificate confirming that it meets the requirements of the Machinery Regulations. This is a requirement if a machine is listed in Annex IV and is not manufactured in accordance with relevant designated standards. It is also available for other machinery where third party certification is desired. An assembly of machines which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole.

Technical File Lodging:

Where designated standards are applied in full, the Technical File must be lodged with an Approved Body. CEM will acknowledge receipt and provide secure storage for 15 years after the date of last manufacture.

Technical documentation

Upon successful assessment, Supply of Machinery (Safety) Regulations 2008 on Machinery requires a technical documentation as laid out in Annex II. The technical documents must enable the assessment of the conformity of the appliance with the requirements of the Regulations.

Electromagnetic Compatibility Regulations 2016

The Electromagnetic Compatibility Regulations 2016 supersede the EMC Directive 2014/30/EU. The Electromagnetic Compatibility Regulations 2016 ensures that electrical and electronic equipment does not generate, or is not affected by, electromagnetic disturbance.

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The Regulations applies to:

  • Any “relevant apparatus”; basically, if EMC performance can be meaningfully measured, then the regulation applies.
  • Installations (i.e. an assembly of individual pieces of apparatus brought together on a specific site).
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There are some exclusions listed in the Regulations:

  • Equipment built or assembled by radio amateurs
  • Equipment intended for use in commercial aircraft
  • Equipment covered by regulations containing more specific EMC provisions (e.g. automobiles (2004/108/EC)
  • Weighing equipment (2004/22/EC)
  • Telecommunication apparatus (1999/5/EC)
  • The regulation does not recognise lower or upper frequency limits (“d.c. to light”) but in practice standards mainly provide for tests covering a range from 10kHz to 30GHz.

Please refer to the Electromagnetic Compatibility Regulations 2016 for detailed requirements. Electromagnetic-compatibility-regulations-2016

Services that we offer as an Approved Body

Technical File Review:

A Technical File is required in order to comply with the Electromagnetic Compatibility Regulations 2016. We will review your Technical File for conformity to the requirements of the regulations and provide recommendations on any areas requiring further action or improvements.

Technical File Lodging:

CEM will acknowledge receipt and provide secure storage for 10 years after the date of last manufacture.

EMC Testing Service:

If required, CEM can make necessary to have equipment tested in accordance with the requirements of the EMC Regulations.

Radio Equipment Regulations 2017

The essential requirements for radio equipment, which include constructing radio equipment to both effectively use and support the efficient use of radio spectrum in order to avoid harmful interference (article 3.2), are designated via the Radio Equipment Regulations 2017, came into force on the 1st of January 2021.

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The Regulations apply to:

  • any “relevant apparatus” basically, if Radio performance can be meaningfully measured, then the regulations apply.
  • Installations (i.e. an assembly of individual pieces of apparatus brought together on a specific site).
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There are some additional requirements listed in the Regulations:

  • Ships using inland waterways
  • Marine distress & safety equipment
  • Marine Identification System
  • COSPAS-SARSAT locator beacons
  • Avalanche beacons.

Please refer to the Radio Equipment Regulations 2017 for detailed requirements. Radio-equipment-regulations-2017

At the time of writing many standards which were designated under the old R&TTE directive are not as yet listed as designated under the new Radio Equipment Regulations 2017. If you need to use a standard which is not yet designated it is advisable to seek advice from an approved body as you will need the services of such to certify your product and therefore have sufficient evidence of compliance to the Radio Equipment Regulations 2017.

CEM International are an Approved Body for the Radio Equipment Regulations 2017 and can provide assistance with certification.

Services that we offer as an Approved Body

Technical File Review:

A Technical File is required in order to comply with the Radio Equipment Regulations 2017. We will review your Technical File for conformity to the requirements of the regulations and provide recommendations on any areas requiring further action or improvements.

Technical File Lodging:

CEM will acknowledge receipt and provide secure storage for 10 years after the date of last manufacture.

EMC and LVD Testing Service

CEM will arrange for equipment to be tested to ensure that it conforms to the requirements of the Radio Equipment Regulations 2017.

Technical documentation

The technical documentation shall be drawn up, in accordance with Article 21 of the Regulations, before the radio equipment is placed on the market and shall be continuously updated.

Construction Products Regulation 2011 (CPR)

The Regulation came into force on the 1st of January 2021 and imposes legal obligations on importers and distributors to participate in ensuring the compliance of the construction products they trade in. Importers and distributors need to adopt a ‘chain of custody’ approach to ensure the relevant supporting documents are able to be transferred from the manufacturer to the end user.

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The Regulation permits two methods of compliance:

  • UK Standards.
  • Technical Assessments

Note UK marking is only mandatory, where a designated standard is available against which to declare the performance of the product. Where there is no designated standard, the manufacturer may choose to demonstrate compliance via Technical Assessment. The information relevant to UKCA marking and declaration is always found in Annex ZA of each standard.

The Regulation continues to allow the development of TAs, which are specifications pertaining to a particular manufacturer and product type, particularly useful for innovative products or kits. The relevant issuing bodies are known as Technical Assessment Bodies (TABs).

In addition to declaring technical performance against the basic works requirements and in order to comply with the Construction Products Regulation 2011, products must meet certain factory production control requirements. The manufacturer must be able to demonstrate that their production methods will result in consistent product that continues to match the declared performance.

Declaration and marking

The manufacturer’s ‘declaration of performance’ must contain actual performance data in relation to the essential characteristics. This must be ‘made available’ to the end user. Additionally, some information must be marked on the product and/or its packaging.

CEM International are an Approved Body for the Construction Products Regulation and can provide assistance with certification.

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Download our Construction Products Regulation flyer Construction Products

Services that we offer as an Approved Body

Product Compliance Gap analysis

CEM as experts in the arena of UKCA marking are best placed to be able to analyse product and determine in what areas it may need to be improved in order to meet the regulations.

Factory Production Control Assessment

CEM are able to conduct factory production control assessments to determine that the measures in place are sufficient to ensure that all production complies with the standards applicable.

Testing Service

If required, CEM will arrange for product to be tested to ensure that it conforms to the requirements of the construction product regulations.

For further information specific to your products, please contact us at CEM and we will be pleased to discuss your needs.

Testing Services

With its extensive global reach CEM International can provide various types of testing services.

REACH Testing: covers a wide range of consumer goods related to industries, including groceries, children's products, furniture, textiles, shoes, luggage, stationery, sports, leisure goods and other public consumer goods.

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CEM can provide testing service of durable consumer products and feeding utensils for child covering over 10 categories, such as baby feeding-bottles and nipple, baby drinking bottle, soothers, baby strollers, baby cart, cradle, baby cribs, baby walking frames, high chairs, table chairs, play yards, rocking chairs, baby carriers and etc. We can test various items such as Mechanical and physical properties, Flammability, Migration of certain elements, Organic chemical compounds, REACH Regulation, SVHC, Cd, Phthalates, PAHs.

Test Standards
Area Regulations and standards
EU BS EN 1130-1/2 crib, EN 1888 baby strollers, BS 7409 baby strollers, EN 716-1/2 crib, EN 14988-1/2 high chair, EN 1273 baby walking frames, REACH Regulation, SVHC, Cd, Phthalates, PAHs
USA ASTM F833 baby strollers, ASTM F977 baby walking frames, ASTM F1821 Crib, F2194 cradle, ASTM F1169 Full size crib, ASTM F404 High Chair, CPSIA,Total Lead, 10P, Tracking label,CPC,CPSC, CHCCs, Sharp Points & Edges,Small parts, Mechanical and physical properties, Flammability, CA65
Other area AS/NZS 2195: 2010 Foldable crib, SOR 2010-261 Indoor crib
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CEM can organize the testing of toys intended for use in play by children less than 14 years, such as Plush toys, Plastic toys, Electronic toys, Wood toys and etc.

Test Standards
Area Regulations and standards
EU 2009/48/EC, EN 71-1 Mechanical and physical properties, EN 71-2 Flammability, EN71-3 Migration of certain elements, EN 71-8 Activity toys for domestic, EN 71-9 Organic chemical compounds, EN 71-12 N-Nitrosamines and N-nitrosatable, EN 62115 Electric toys, REACH Regulation, SVHC, Cd, Phthalates, PAHs
USA CPSIA, Total Lead, 10P, racking label, CPC,CPSC,ASTM F963,CHCCs,Sharp Points & Edges, Small parts, Mechanical and physical properties, Flammability, B/O TEST, CA65, PA Stuffed Toy Law
Canada SOR/2011-17 Toy safety regulation, SOR/2016-188 6P, SOR / 2018-83 Consumer Products Containing Lead, SOR/2018-82 Children’s Jewelry Regulations, Manitoba regulation 78/2004/ Ontario regulation 218/01 /Quebec Regulation respecting stuffing and upholstered and stuffed articles
Other area ISO 8124/IEC 62115, AS/NZS ISO 8124, MS ISO 8124, ST2016, NOM-252-SSA1-2011
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CEM testing available resource is accepted 3rd party laboratory by CPSC, and authorized cooperative laboratory by Amazon. Before entering the US market, all children products must be tested by a CPSC accredited testing lab for compliance with Consumer Product Safety Improvement Act (CPSIA) prescribed regulations.

CEM covers all the safety requirements of different types of infant and toddler tableware. Testing scope: infant and toddler’s drinking bottle, bowl, plate, dinner cup, knife, fork, spoon, chopsticks, etc.

Test Standards
Area Regulations and standards
EU EN 14350 Drinking equipment, REACH Regulation,SVHC,Cd,Phthalates,(EU) No.10/2011
USA CPSIA,Total Lead,10P,Tracking label,CPC,CPSC, CHCCs,Sharp Points & Edges,Small parts,Mechanical and physical properties,FDA
Other area Japan JFSL 370, Korea KFAD

Test Items:
mechanical and physical properties, VOC content, phthalates, heavy metals, FCM testing requirements, REACH Regulation, CPC. It depends on the product and testing standards.

CEM International has the necessary resource to organize various Electronic & Electrical Appliances and Machinery safety compliance testing and activities.

CEM can organize all necessary testing services for medical devices (including: thermometers, oximeters, sphygmomanometers, fetal heartbeat detector, electrocardiographs Color ultrasound system, X-ray machines, etc.) such as Testing of active medical device, EMC testing and debugging service, Reliability Testing, NMPA registration testing service, Biocompatibility test, Software evaluation as the basis for medical devices to enter the global market. If a product is to be exported to the European Union or the United States, then corresponding tests will need to be done to meet the EU or US standards. Among the testing services we provide are included: Transformer Double Voltage/ Double Frequency Testing, Transformer Overload and Short Circuit Testing, Defibrillation Testing, Single Failure Testing, Mold Pressing Testing, Ball Pressure Testing, etc.

Medical Device Testing Standards List
SN Title International Standard
1 Medical safety and electrical essential equipment performance - Part 2-25: of electrocardiographs Particular requirements IEC/EN 60601-2-25
2 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type EN ISO /ISO 81060-1
3 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems EN 1060-3
4 Medical electrical equipment -- Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems IEC/EN 60601-1-1
5 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment IEC/EN 60601-2-27
7 Medical electrical equipment-Part 2-26: Particular requirements for the safety of electroencephalographs IEC/EN 60601-2-26:2012 IEC 80601-2-26:2019
8 Medical safety and electrical essential equipment-Part performance2-56: of clinical Particular thermometers requirements for basic body temperature measurement ISO/ EN ISO 80601-2-56
9 Non-invasive automated sphygmomanometers ANSI/AAMI SP10
10 Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use IEC/EN 60601-2-57
11 Medical Basic Safety Electrical And Equipment Essential -Performance Part 2-2: Particular Of High Requirements Frequency For Surgical Equipment And High Frequency Surgical Accessories IEC/EN/EN IEC 60601-2-2
12 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance ANSI/AAMI ES60601-1 EN /IEC60601-1
13 Medical electrical equipment - Part 2-10 : particular requirements for the safety of nerve and muscle stimulators IECC/EN 60601-2-10
14 Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers IEC/EN 80601-2-30
15 Medical electrical equipment-Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment EN ISO /ISO 81060-1
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CEM can provide all necessary safety performance tests of electronic and electrical products: Input Power Testing, Residual Voltage Testing, Ground Resistance Testing, dielectric withstand voltage test, Current Leakage Testing, Stability test.

Main product types, standards and sample quantity of testing
No. Product Type Test Standards
1 Information Technology and Communication Equipment GB 4943.1-2011、IEC 60950-1:2005+A1:2009、IEC 60950-1:2005+A1:2009+A2:2013、EN 60950-1:2006+A11:2009+A1:2010+A12:2011、EN 60950-1:2006+A11:2009+A1:2010+A12:2011+A2:2013、AS/NZS 60950.1:2015、UL 60950:2007
2 Audio and Video Equipment GB 8898-2011、IEC 60065:2001+A1:2005+A2:2010、IEC 60065:2014、EN 60065:2002+A1:2006+A11:2008+A2:2010+A12:2011、EN 60065:2014、AS/NZS 60065:2018、UL 60065:2007
3 Household Appliances GB 4706.1-2005、IEC 60335-1:2010、IEC60335-1:2010+AMD1:2013、IEC 60335-1:2010+AMD1:2013+AMD2:2016 、EN60335-1:2012、EN60335-1:2012+AC:2014+A11:2014、EN60335-1:2012+AC:2014+A11:2014+A12:2017、EN60335-1:2012/A13:2017、EN60335-1:2012/A1:2019、EN60335-1:2012/A2:2019、EN60335-1:2012/A14:2019、AS/NZS60335.1:2011+AMD1:2012+AMD2:2014+AMD3:2015、AS/NZS 60335.1/AMD 4/2017-06-30
4 Lighting Electrical Equipment GB 7000.1-2015、EN 60598-1:2008+A11:2009、AS/NZS 60598.1:2003、AS/NZS 60598.1:2013、EN 60598-1:2015、EN 60598-1:2015+A1:2018、IEC 60598-1:2014+A1:2017、IEC 60598-1:2008、AS/NZS 60598.1:2017、IEC 60598-1:2014
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CEM International will arrange all necessary Reliability testing for Electronic & Electrical Appliances such as: Electronic Component Testing, Test of Connectors, Cable Testing, Communications/Communications Equipment Testing, Printed boards or printed board assemblies Testing, Electronic Soldering Materials Testing.

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Training and Events

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CEM can provide training courses related to UK and EU regulations, aiming to help companies from different industries better understand relevant regulations and standard requirements, including the UKCA certification process.

CEM will carefully listen to your individual training needs and then develop a course specifically for you, avoiding large and empty training content. We will carefully design the training program according to the requirements of each organization, so that you can apply the gained knowledge to your enterprise's product design and compliance process.

CEM trainers are experts with extensive industry knowledge and many years of experience in their respective fields.

Should you need our training services, please do not hesitate to contact us. We are confident that in our portfolio of training courses there are suitable options for you.

机械供应(安全)法规2008

机械供应(安全)法规2008规定了机械设备的英国市场准入要求。 自 2021 年 1 月 1 日起,机械供应(安全)法规(2008)正式生效,它取代了机械指令2006/42/EC。 虽然UKCA法规和欧盟的机械指令无论在在合规性还是技术方面的要求差异并不是很大,但进口商还须要了解它们,否则会影响机械产品进入英国市场。

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法规的主要要求:

  • 任何带有移动部件的动力设备的安全性
  • 动力可以是电动、气动、液压或其他;
  • 防护要求、装载安全要素、安全系统的可靠性、标记和说明;
  • 对标记和说明的广泛要求
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法规中列出了一些例外情况:

  • 与患者接触的医疗器械
  • 乘客电梯和矿井绕线机
  • 锅炉和压力容器
  • 交通工具
  • 军事装备

详细要求请参考机械法规: 机械安全法规2008指南

我们的服务

CEM 是机械供应(安全)法规2008的批准机构(Approved Body),从事UKCA认证以下服务,我们的产品范围覆盖了机械法规附录 IV 的所有产品:

型式检验/全面质量控制:

CEM可以通过两种模式对产品进行认证,型式认可及全面质量保证模式,即对产品的设计进行型式认可评审或对企业的产品管理体系进行评审,并在此基础上发放证书,确认其符合机械法规的要求。

技术文件备案:

按照法规要求,产品的技术应在英国由相关方对技术文件进行保存,以便于产品进入英国市场后,由政府组织实施的市场抽查活动。

我们将为我们所有的获证企业,按照法规要求保留技术文件,以满足法规的要求,但对于非获证企业,尤其十那些在英国境外的生产商,可以将其产品的技术文件提交给CEM。 公司将确认收到并提供安全储存,储存期为最后一次生产日期后的10年。

电磁兼容性法规2016

电磁兼容性法规2016取代了 EMC 指令 2014/30/EU。 电磁兼容性法规2016确保电气和电子设备不会产生或不受电磁干扰的影响。

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本法规适用于:

  • 任何“相关设备”; 只要设备具备EMC性能,该法规均适用。
  • 安装(即在特定地点组装的单个设备)。
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本法规中列出了一些例外情况:

  • 无线电爱好者制造或组装的设备;
  • 用于商用飞机的设备;
  • 受包含更具体 EMC 规定的法规约束的设备(例如汽车 (2004/108/EC);
  • 称重设备(2004/22/EC);
  • 电信设备(1999/5/EC);
  • 该法规不区分频率下限或上限,但在实践中,标准主要规定进行测试的覆盖范围从 10kHz 到 30GHz;

详细要求请参阅《电磁兼容法规2016》。 电磁兼容法规2016

我们的服务

UKCA型式认可:

CEM通过对技术文件的评审,确定产品符合电磁兼容性法规(2016)的要求。为此,需要您按照我们的文件要求提供技术文件。我们收到文件后,将按照公司的流程对文件内容进行评审,在所有不符合项关闭后,CEM将发放型式认可证书。您可以据此签署符合性声明(DoC)并在产品上贴附UKCA标记。

技术文件备案:

按照法规要求,产品的技术应在英国由相关方对技术文件进行保存,以便于产品进入英国市场后,由政府组织实施的市场抽查活动。

我们将为我们所有的获证企业,按照法规要求保留技术文件,以满足法规的要求,但对于非获证企业,尤其十那些在英国境外的生产商,可以将其产品的技术文件提交给CEM。公司将确认收到并提供安全储存,储存期为最后一次生产日期后的10年。

EMC 测试服务

CEM与全球多家实验室合作,如果需要,CEM 将安排设备进行测试,以确保其符合 EMC 法规的要求。

无线电设备法规 2017

无线电设备法规2017生效于2021年1月1日,该法规规定了无线电设备的基本要求,包括构建无线电设备,以有效使用和支持高效使用无线电频谱,且避免有害干扰(第3.2条),

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本法规适用于:

  • 基本上适用于任何“相关设备”,只要产品存在无线电性能本法规均适用。
  • 安装(即在特定地点组装的单个设备)。
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本法规中列出了一些附加要求:

  • 使用内河航道的船舶
  • 海上遇险和安全设备
  • 海洋识别系统
  • COSPAS-SARSAT 定位信标
  • 雪崩信标

有关详细要求,请参阅《无线电设备法规2017》。 无线电设备法规2017

在编写本报告时,根据旧R&TTE指令指定的许多标准尚未被列为2017年新的无线电设备法规指定的标准。如果您需要使用尚未指定的标准,建议向认可机构寻求建议,因为您将需要该机构的服务来认证您的产品,因此有足够的证据证明符合2017年《无线电设备条例》。

我们的服务

产品型式认可:

CEM作为UKCA无线电设备批准机构,可以按照《无线电设备法规2017》对产品的技术文件进行评审,在所有不符合项关闭之后,CEM将发放无线电法规型式认可证书。

技术文件备案:

CEM还可以应制造商的要求,保存无线电产品的技术文件,文件保存期可为最后一次生产日期后的10年。

EMC 和 LVD 测试服务

CEM与多个实验室建立合作关系,通过公司的实验室资源,您可以进行无线电法规相关的测试,以确保其符合《无线电设备法规2017》的要求。

建筑产品法规 2011

该法规于 2021 年 1 月 1 日生效,并规定进口商和分销商有法律义务确保其交易的建筑产品的合规性。进口商和分销商需要采取“监管链”的方式来确保终端用户可以获取相关证明的文件。

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该法规允许两种合规方法:

  • 英国标准
  • 技术评估

注意!当产品有相应的产品标准时,UKCA的认证是强制性的。 如果没有相关的产品指定的标准,制造商可以选择通过技术评估来证明其合规性。

有关UKCA和声明的信息可在每个标准的附录中找到。

除了根据基本工程要求声明技术性能外,为了符合《建筑产品法规2011》,产品还必须满足某些工厂生产控制要求。制造商必须能够证明他们的产品始终与声明的性能相一致。

声明和标记

制造商的“性能声明”必须包含与基本特性相关的实际性能数据。此外,必须在产品或其包装上标记相关信息。

CEM 是《建筑产品法规2011》的批准机构,可提供该法规的UKCA认证服务。

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请下载我们的建筑产品法规手册 建筑产品法规手册

我们的服务

产品合规差距分析

CEM 作为 英国合格评定的专业机构,能够提供专业的合规性分析并确定需要改进的领域,以满足法规要求。我们的服务内容包括:

工厂生产控制评估(FPC)

CEM 能够进行工厂生产控制评估,以确定采取的措施足以确保所有生产符合相关的标准。

测试服务

CEM在全球有多家合作实验室,如果需要,CEM 将安排对产品进行测试,以确保其符合建筑产品法规的要求。

有关产品的更多信息,请与我们联络。

测试服务

凭借其多年的行业经历及多领域的专业资质,CEM可以提供多种的测试服务。

REACH限用物质测试:涵盖与行业相关的广泛消费品,包括杂货、儿童用品、家具、纺织品、鞋、箱包、文具、体育、休闲用品等消费品。

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CEM可提供耐用消费品和儿童用品的检测服务。产品范围涵盖婴儿奶瓶和奶嘴、婴儿奶瓶、奶嘴、婴儿推车、婴儿车、摇篮、婴儿床、婴儿行走架、高脚椅、桌椅、游乐场、摇椅、婴儿车等10多个类别。我们还可以提供检测多种检测项目,如机械和物理性能、易燃性,有机化合物、REACH法规、SVHC、Cd、邻苯二甲酸盐、多环芳烃。 而测试依据则覆盖全球不同国家和地区的法规及标准,

测试标准
国家和地区 法规及标准
欧盟及英国 BS EN 1130-1/2 crib, EN 1888 baby strollers, BS 7409 baby strollers, EN 716-1/2 crib, EN 14988-1/2 high chair, EN 1273 baby walking frames, REACH Regulation, SVHC, Cd, Phthalates, PAHs
美国 ASTM F833 baby strollers, ASTM F977 baby walking frames, ASTM F1821 Crib, F2194 cradle, ASTM F1169 Full size crib, ASTM F404 High Chair, CPSIA,Total Lead, 10P, Tracking label,CPC,CPSC, CHCCs, Sharp Points & Edges,Small parts, Mechanical and physical properties, Flammability, CA65
其它地区 AS/NZS 2195: 2010 Foldable crib, SOR 2010-261 Indoor crib
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CEM可以进行14岁以下儿童玩具类产品的测试,如毛绒玩具、塑料玩具、电子玩具、木制玩具等。

测试标准
国家和地区 法规及标准
欧盟及英国 2009/48/EC, EN 71-1 Mechanical and physical properties, EN 71-2 Flammability, EN71-3 Migration of certain elements, EN 71-8 Activity toys for domestic, EN 71-9 Organic chemical compounds, EN 71-12 N-Nitrosamines and N-nitrosatable, EN 62115 Electric toys, REACH Regulation, SVHC, Cd, Phthalates, PAHs
美国 CPSIA, Total Lead, 10P, racking label, CPC,CPSC,ASTM F963,CHCCs,Sharp Points & Edges, Small parts, Mechanical and physical properties, Flammability, B/O TEST, CA65, PA Stuffed Toy Law
加拿大 SOR/2011-17 Toy safety regulation, SOR/2016-188 6P, SOR / 2018-83 Consumer Products Containing Lead, SOR/2018-82 Children’s Jewelry Regulations, Manitoba regulation 78/2004/ Ontario regulation 218/01 /Quebec Regulation respecting stuffing and upholstered and stuffed articles
其它地区 ISO 8124/IEC 62115, AS/NZS ISO 8124, MS ISO 8124, ST2016, NOM-252-SSA1-2011
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我们的测试资源包括美国消费品安全委员会认可的第三方实验室(CPSC)以及亚马逊授权的合作实验室。 在进入美国市场之前,所有儿童产品都必须由 CPSC 认可的测试实验室进行测试,以符合消费品安全改进法案 (CPSIA) 的规定。

CEM涵盖了不同种类婴幼儿餐具的所有安全要求。测试范围:婴幼儿饮水瓶、碗、盘、餐杯、刀、叉、勺、筷子等。

测试标准
国家和地区 法规及标准
欧盟及英国 EN 14350 Drinking equipment, REACH Regulation,SVHC,Cd,Phthalates,(EU) No.10/2011
美国 CPSIA,Total Lead,10P,Tracking label,CPC,CPSC, CHCCs,Sharp Points & Edges,Small parts,Mechanical and physical properties,FDA
其它地区 Japan JFSL 370, Korea KFAD

检测项目:
机械物理性能、VOC含量、邻苯二甲酸盐、重金属、FCM检测要求、REACH法规、CPC。 项目决于产品和测试标准。

CEM 的实验室资源有能力从事各种电子电气设备和机械安全合规性测试活动。

作为医疗器械进入全球市场的基础,CEM可以安排进行医疗器械(包括:体温计、血氧仪、血压计、胎心检测仪、心电图机、彩超、X光机等)所有必要的检测服务,如有源医疗器械的检测、EMC检测和调试服务, 可靠性测试、NMPA注册测试服务、生物相容性测试、软件评估等。

如果产品要出口到英、美或欧盟,则需要进行相应的测试以符合英、美或欧盟的标准。 我们提供的测试服务包括:变压器双电压/双频测试、变压器过载和短路测试、除颤测试、单故障测试、压模测试、球压测试等。

医疗器械测试标准包括
序号 名称 标准
1 Medical safety and electrical essential equipment performance - Part 2-25: of electrocardiographs Particular requirements IEC/EN 60601-2-25
2 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type EN ISO /ISO 81060-1
3 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems EN 1060-3
4 Medical electrical equipment -- Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems IEC/EN 60601-1-1
5 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment IEC/EN 60601-2-27
7 Medical electrical equipment-Part 2-26: Particular requirements for the safety of electroencephalographs IEC/EN 60601-2-26:2012 IEC 80601-2-26:2019
8 Medical safety and electrical essential equipment-Part performance2-56: of clinical Particular thermometers requirements for basic body temperature measurement ISO/ EN ISO 80601-2-56
9 Non-invasive automated sphygmomanometers ANSI/AAMI SP10
10 Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use IEC/EN 60601-2-57
11 Medical Basic Safety Electrical And Equipment Essential -Performance Part 2-2: Particular Of High Requirements Frequency For Surgical Equipment And High Frequency Surgical Accessories IEC/EN/EN IEC 60601-2-2
12 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance ANSI/AAMI ES60601-1 EN /IEC60601-1
13 Medical electrical equipment - Part 2-10 : particular requirements for the safety of nerve and muscle stimulators IECC/EN 60601-2-10
14 Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers IEC/EN 80601-2-30
15 Medical electrical equipment-Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment EN ISO /ISO 81060-1
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CEM可以提供电子电气产品所有必要的安全性能测试:输入功率测试、残余电压测试、接地电阻测试、介电耐压测试、漏电流测试、稳定性测试。

主要产品种类、标准及检测样品数量
序号 产品类别 测试标准
1 信息技术及通讯设备 GB 4943.1-2011、IEC 60950-1:2005+A1:2009、IEC 60950-1:2005+A1:2009+A2:2013、EN 60950-1:2006+A11:2009+A1:2010+A12:2011、EN 60950-1:2006+A11:2009+A1:2010+A12:2011+A2:2013、AS/NZS 60950.1:2015、UL 60950:2007
2 音视频设备 GB 8898-2011、IEC 60065:2001+A1:2005+A2:2010、IEC 60065:2014、EN 60065:2002+A1:2006+A11:2008+A2:2010+A12:2011、EN 60065:2014、AS/NZS 60065:2018、UL 60065:2007
3 家用电器 GB 4706.1-2005、IEC 60335-1:2010、IEC60335-1:2010+AMD1:2013、IEC 60335-1:2010+AMD1:2013+AMD2:2016 、EN60335-1:2012、EN60335-1:2012+AC:2014+A11:2014、EN60335-1:2012+AC:2014+A11:2014+A12:2017、EN60335-1:2012/A13:2017、EN60335-1:2012/A1:2019、EN60335-1:2012/A2:2019、EN60335-1:2012/A14:2019、AS/NZS60335.1:2011+AMD1:2012+AMD2:2014+AMD3:2015、AS/NZS 60335.1/AMD 4/2017-06-30
4 照明电器 GB 7000.1-2015、EN 60598-1:2008+A11:2009、AS/NZS 60598.1:2003、AS/NZS 60598.1:2013、EN 60598-1:2015、EN 60598-1:2015+A1:2018、IEC 60598-1:2014+A1:2017、IEC 60598-1:2008、AS/NZS 60598.1:2017、IEC 60598-1:2014
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CEM 测试实验资源可以进行电子和电气设备所有必要的可靠性测试,例如:电子元件测试、连接器测试、电缆测试、通信/通信设备测试、印制板或印制板组件测试、电子焊接材料测试。

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培训

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CEM能够向各界提供与英国及欧盟法规相关的培训课程,旨在帮助企业更好地理解相关的法规及标准要求,包括UKCA认证的流程。

培训课程内容与形式不拘一格,避免大而空的培训内容。我们将按照企业的要求精心设计培训方案,以便学员们能学以致用,将所学用于企业的产品设计及合规过程。

CEM培训教师均为是有丰富行业学识的专家,并在其专业领域中拥有多年经验。

若需要我们的培训服务,可直接点击这里,深信我们培训课程总有一款适合您。