医疗器械指令ROHS认证

推出原因
注意到电气、电子设备中含有对人体健康有害的重金属是2000年荷兰在一批市场销售的游戏机的电缆中发现镉。事实上，电气电子产品在生产中大量使用的焊锡、包装箱印刷的油墨都含有铅等有害重金属。
何时实施编辑
欧盟将在2006年7月1日实施RoHS，届时使用或含有重金属以及多溴二苯醚PBDE，PBB等阻燃剂的电气电子产品限值**标将不允许进入欧盟市场
适用产品及地区编辑
欧盟27个成员国： 英国（2016年退出欧盟），法国、德国、意大利、荷兰、比利时、卢森堡、丹麦、爱尔兰、希腊、西班牙、葡萄牙、奥地利、瑞典、芬兰、塞浦路斯、匈牙利、捷克、爱沙尼亚、拉脱维亚、立陶宛、马耳他、波兰、 斯洛伐克、斯洛文尼亚、保加利亚、罗马尼亚 。

豁免项
简述
由于技术问题，部分材料或者产品的制造技术还做不到ROHS指令要求，在经过向欧盟的特殊申请后，以下项目可以获得豁免（部分豁免是有期限的）：
RoHS ExemptionsEU RoHS
Items Exemption Clauses
原有
1 Mercury in compact fluorescent lamps not exceeding 5 mg per lamp
2 Mercury in straight fluorescent lamps for general purposes not exceeding:
- halophosphate 10 mg
- triphosphate with normal lifetime 5 mg
- triphosphate with long lifetime 8 mg.
3 Mercury in straight fluorescent lamps for special purposes.
4 Mercury in other lamps not specifically mentioned in this Annex.
5 Lead in glass of cathode ray tubes, electronic components and fluorescent tubes.
6 Lead as an alloying element in steel containing up to 0.35% lead by weight, aluminium containing up to 0.4% lead by weight and as a copper alloy containing up to 4% lead by weight.
7 - lead in high melting temperature type solders (i.e. lead-based alloys containing 85 % by weight or more lead)
- lead in solders for servers, storage and storage array systems, network infrastructure equipment for switching, **ling, transmission as well as network management for telecommunications
- lead in electronic ceramic parts (e.g. piezoelectronic devices).
8 Cadmium and its compounds in electrical contacts and cadmium plating except for applications banned under Directive 91/338/EEC (1) amending Directive 76/769/EEC (2) relating to restrictions on the marketing and use of certain dangerous substances and preparations
9 Hexavalent chromium as an anti-corrosion of the carbon steel cooling system in absorption refrigerators.
10 Lead used in compliant pin connector systems
11 Lead as a coating material for the thermal conduction module c-ring
12 Lead and cadmium in optical and filter glass
13 Lead in solders consisting of more than two elements for the connection between the pins and the package of microprocessors with a lead content of more than 80% and less than 85% by weight
14 Lead in solders to complete a viable electrical connection between semiconductor die and carrier within integrated circuit Flip Chip packages
15 DecaBDE in polymeric applications
16 Lead in lead-bronze bearing shells and bulbs
17 Lead in linear incandescent lamps with silicate coated tubes
18 Lead halide as radiant agent in High Intensity Discharge (HID) lamps used for professional reprography applications
19 Lead as activator in the fluorescent powder (1% lead by weight or less) of discharge lamps when used as sun tanning lamps containing phosphors such as BSP (BaSi2O5:Pb) as well as when used as specially lamps for diazo-printing reprography, lithography, insect traps, photochemical and curing processes containing phosphors such as SMS ((Sr,Ba)2MgSi2O7:Pb)
20 Lead with PbBiSn-Hg and PbInSn-Hg in specific compositions as main amalgam and with PbSn-Hg as auxiliary amalgam in very compact Energy Saving Lamps (ESL)
21 Lead oxide in glass used for bonding front and rear substrates of flat fluorescent lamps used for Liquid Crystal Displays (LCD)
22 Lead and cadmium in printing inks for the application of enamels on borosilicate glass.
23 Lead as impurity in RIG (rare earth iron gamet) Faraday rotators used for fibre optic communication systems.
24 Lead in finishes of fine pitch components other than connectors with a pitch of 0.65mm or less with NiFe lead frames and lead in finishes of fine pitch components other than connectors with a pitch of 0.65mm or less with coppler lead frames.
25 Lead in solders for the soldering to machined through hole discoidal and planar array ceramic multilayer capacitors.
26 Lead oxide in plasma display panels (PDP) and surface conduction electron emitter displays (SED) used in structural elements, notably in the front and rare glass dielectric layer, the bus electrode, the black stripe, the address electrode, the barrier ribs, the seal frit and frit ring as well as in print pastes.
27 Lead oxide in the glass envelope of Black Light Blue (BLB) lamps.
28 Lead alloys as solder for transducers used in high-powered (designated to operate for several hours at acoustic power levels of 125 dB SPL and above) loudspeakers.
29 Hexavalent chromium in corrosion preventive coatings of unpainted metal sheetings and fasterners used for corrosion protection and Electromagnetic Interference Shielding in equipment falling under category three of Directive 2002/96/EC (IT and telecommunications equipment). Exemption granted until 1 July 2007.
30Lead bound in crystal glass as defined in Annex I (Category 1,2,3 and 4) of Council Directive 69/493/EEC
新增
2009年6月11日，欧盟OJ刊登了2009/443/EC，新增了6项RoHS指令的豁免，分别如下：
33. Lead insolders for the soldering of thin copper wires of 100 μm diameter andless in power transformers. 电力变压器中直径100微米及以下细铜线所用焊料中的铅
34. Lead in cermet-based trimmer potentiometer elements. 金属陶瓷质的微调电位计中的铅
6月5，欧盟刊登了2009/428/EC，从2011年1月1日起，将原豁免的*22点“光纤通讯系统稀土铁石榴石法拉*旋转器中作为杂质的铅”从豁免列表中移除。

怎样测试
其实，RoHS认证并非那么神秘，与人们所熟悉的CE认证、FCC认证、等认证大同小异，只要具备相应资质和能力的第三方公证实验室均可为企业提供类似服务，无非是把相关产品送往专业实验室进行检测、分析，其中铅、镉、汞、六价铬、(PBB)、多溴二苯醚(PBDE)等六种有害物质是否符合RoHS指令要求，若符合就可获得RoHS合格报告和证书，若不符合，就得另找符合要求的产品进行替代。
涉及产品
主要包括：日常家电，如电冰箱，洗衣机，微波炉，空调，吸尘器，热水器等；和家电，如音频、视频产品，DVD，CD，电视接收机，IT产品，数码产品，通信产品等；电动工具，电动电子玩具医疗电气设备,使用的电力，包括小型和大型家电，IT和电信设备和消费品，如收音机，电视机，摄像机和音响系统。
如何运作
指令处置阻止成千上万吨违禁物质可能释放到环境中，并在电气和电子产品的设计带来了重要的变化，增加生产者的产品的成分和毒性的认识。其他国家，包括欧盟的主要贸易伙伴，都遵循欧盟的例子，并带来了类似的立法。符合RoHS要求的制造商较好的准备，以面对这一**性挑战。国家主管部门已加强合作，发现和删除不符合规定的产品从市场，产品的贸易和市场结构，由于其性质，体积较容易造成环境问题的基础上他们的做法。

法源依据
*共和国，*共和国国家发展和改革会，*共和国，*共和国，*共和国国家工商行政管理总局，*共和国国家质量监督检验检疫总局，*共和国国家环境保护总局联合会签的《电子信息产品污染控制管理方法》（*39号）
（Management Methods for Controlling Pollution by Electronic Information Products / Ministry of Information Industry Order #39）
适用范围
在*共和国境内生产、销售和进口电子信息产品过程中控制和减少电子信息产品对环境造成污染及产生其它公害，适用本办法。但是，出口产品的生产除外。
摘要内容
电子信息产品在设计、生产和销售过程中应当符合电子信息产品有毒、有害物质或元素控制国家标准或行业标准，分两阶段施行：
阶段
投放市场的电子信息产品上应标识环保使用期限，标识其中含有的有毒、有害物质或元素名称、含量、所在部件及其可否回收利用等；电子信息产品包装物上，应标注包装物材料名称。可按照标准SJ/T 11363-2006、SJ/T 11364-2006、SJ/T 11365-2006.GB/T 26125-2011的要求进行。
*二阶段
进入重点管理目录（2010年公布首批三大类：移动用户终端、电话机、与计算机相连的打印设备） 的产品必需确保产品中有毒有害物质已被替代，或含量不**过标准且通过强制性产品认证（CCC认证）
欧盟RoHS体系与中国RoHS体系在具体执行上有不同：欧盟做法是首先立法禁止电子产品含有六种有害物质，然后列出一系列暂时**标的种类，等以后技术条件成熟了再移出这个目录。中国是反过来的：一旦某个产品技术条件成熟了就放入目录，在目录内的产品是不能**标的。
*三阶段
国推RoHS自愿性认证是指企业自愿申请，通过认证机构证明相关电子信息产品符合相关污染控制标准和技术规范，由国家推行、统一规范管理的认证活动。获证后的认证产品可以加施国推RoHS 认证标志C-RoHS （ABCDE表示认证机构简称）

-/gbafaec/-

佛山市瑞欧检测技术服务有限公司位于佛山市南海区狮山镇，是一家专业从事商品技术咨询的第三方服务公司。对机械与电气、锂电池和化学方面有着丰富的工作经验，旨在为中国的工业制造厂商进军**市场提供专业、便捷的产品认证及技术支持服务。遵循“专业、高效、共赢”的服务宗旨。目前已获得众多**认证机构的合作认可，并与国内有资质的实验室建立良好的合作关系，能为客户提供一系列优质的服务。

公司开展的项目有：欧盟CE认证，其中CE认证和**多个公告机构合作。美国FDA注册、FCC认证、沙特SASO/SABER、MSDS、RoHS、LFGB、玩具EN71、ASTM、纺织品AZO、REACH、IEC测试报告、CB认证、IP防护等级测试等、国内检测报告、企业标准及备案、ISO体系、欧盟授权代表注册。涉及范围**械设备、电子电器、电池、灯具、通信、食品接触材料、玩具、建材、纺织鞋类、箱包皮具等相关产品的出口委托验货检验等业务。