销往欧盟和英国市场的个人防护产品（PPE）提供CE和UKCA两种认证服务, PETE DOUGHTY将进行说明。
world-renowned for its testing and certification services in the field of personal protective equipment (PPE) such as safety footwear. Manufacturers of PPE can certify their products for sale in the European union (EU) by working with SATRA’s notified body in Ireland (an EU 27 member state), thus enabling them to CE mark their products. SATRA is now able to conduct conformity assessment work for manufacturers who want to mark their products as meeting the new ‘United Kingdom Conformity Assessment’ (UKCA) for sale in the UK after 1st January 2021.
SATRA在个人防护用品（PPE）领域（如安全鞋）的检测和认证服务享誉全球。PPE制造商可与设立于爱尔兰（27个欧盟成员国之一）的公告机构合作，对其销往欧盟（EU）的产品进行认证，使其产品获得CE标志。而且，对于希望其产品符合新的“英国合格评定”（UKCA）标志，以便于2021年1月1日以后在英国销售的制造商，现在也能够提供该合格性评估服务。
The UK has left the EU, and is in a transition phase where EU legislation still applies until the end of December 2020. It is almost certain that after this date the UK will adopt its own legislation with regard to placing PPE goods onto the UK market. The European PPE Regulation(EU) 2016/425 will be brought into UK law to become the UK PPE Regulations. For category II and III PPE (such as safety footwear), third-party certification will be required and all categories of PPE will need to be marked with a new UKCA mark. The process will be very similar to that currently used for CE marking which will require the manufacturer to work with a UK ‘Approved Body’ for categories II and III. SATRA will have Approved Body status in the UK from 1st January 2021 and can already carry out conformity assessment work in preparation for UKCA marking.
英国已退出欧盟，目前处于过渡阶段，欧盟立法在2020年12月底之前仍适用。几乎可以肯定的是，此后，英国将对投放到其市场的PPE产品采用本国法规。欧洲PPE条例(EU)2016/425将纳入到英国法规中，成为英国 PPE条例。对于第II类和第III类PPE（如安全鞋），将需要第三方认证，所有类别的PPE均需带有新的UKCA标志。这一过程与目前获得CE标志的过程非常相似，CE标志要求制造商与英国的“认证机构”就第II类和第III类PPE进行合作。自2021年1月1日起，SATRA将获得英国认证机构的资格，现已可开展合格评定工作，为UKCA标志做准备。
Starting from 1st January 2021, the UK is expected to adopt its own PPE legislation. While in the first instance this will be a copy of EU law, it is expected that over time there will be a gradual divergence away from such rulings. The UK legislation will involve the use of a new UKCA mark (shown in figure 1), which will need to be placed on products as a means of showing conformance with applicable UK legislation. At this time, SATRA Technology Centre Limited in the UK will become a UK Approved Body with the reference AB0321 – the prefix ‘AB’ denoting ‘Approved Body’. SATRA will still be able to offer CE marking services through SATRA Technology Europe Limited, which will remain a Notified Body (number 2777) based in Ireland (an EU 27 member state).
自2021年1月1日起，英国有望采用本国的PPE法规。尽管在最初，将仍沿用欧盟法规，但预计随着时间推移，将逐渐有所差异。英国法规将使用新的UKCA标志，该标志需要贴在产品上，以示符合适用的英国法规。对此，英国的SATRA Technology Centre Limited将成为英国认证机构，参考编号为AB0321- 前缀‘AB’表示“认证机构(Approved Body)”。SATRA仍能通过SATRA Technology Europe Limited提供CE标志服务，公司仍保留设在爱尔兰（27个欧盟成员国之一）的公告机构（编号2777）。
The UK’s equivalent of the CE mark will be the previously-mentioned UKCA mark. This means that to sell category II and III PPE in both the UK and EU 27 member states, a manufacturer will need an EU type-examination certificate under Regulation (EU) 2016/425 from an EU Notified Body such as SATRA Technology Europe Limited, plus a UKCA certificate from a UK Approved Body – for instance, SATRA Technology Centre Limited. Hence, SATRA is well placed to provide both certifications in the most efficient manner, and our staff in both Ireland and the UK will be able to organise this for our customers.
CE标志的英国等效标志将为前文提到的UKCA标志。这意味着，若要在英国和27个欧盟成员国销售第II类和第III类PPE，制造商将需要获得欧盟公告机构（如SATRA Technology Europe Limited）根据法规(EU)2016/425颁发的欧盟型式检验证书，以及英国认证机构（如SATRA Technology Centre Limited）颁发的UKCA证书。因此，SATRA完全有能力以最有效的方式提供这两种认证，我们的爱尔兰和英国员工能够为客户安排这两种认证。
Although it is part of the UK, products being sold into Northern Ireland will still require CE marking, and not the new UKCA mark.
虽然北爱尔兰是英国的一部分，但销往该地的产品仍要求CE标志，而非新的UKCA标志。
In terms of the transition to the new UKCA marking system for the UK market (excluding Northern Ireland), there are several notable phases.
对于英国市场（除北爱尔兰以外），向新的UKCA标志体系过渡而言，有几个值得注意的阶段。
1st January to 31st December 2021
2021年1月1日至12月31日
During this time, it will be possible to place on the UK market either products carrying the UKCA mark or a CE mark. However, where that CE mark needs to be supported by certification from a Notified Body (that is, for category II and III PPE), that Body must be based in an EU 27 member state. It will no longer be possible to place CE-marked products on the UK or EU market where the supporting CE certification is from a UK-based Notified Body. Effectively, all CE certifications issued by UK Notified Bodies will expire on 31st December 2020. During this time, the manufacturer can affix the UKCA mark to the packaging instead of the product.
在此期间，向英国市场投放带有UKCA标志或者CE标志的产品都是可以的。但如果CE标志需要获得公告机构的认证支持（即，对于第II类和第III类PPE），则该机构必须位于欧盟27个成员国内。如果CE认证是来自位于英国的公告机构，则不能再投放到英国或欧盟市场。实际上，英国公告机构颁发的所有CE认证将于2020年12月31日到期。在此期间，制造商可将UKCA标志贴在包装上而非产品上。
1st January to 31st December 2022
2022年1月1日至12月31日
During 2022, it will only be possible to place on the UK market products carrying the UKCA mark. It will no longer be possible to place on the UK market products that only carry a CE mark. During this time, the manufacturer can affix the UKCA mark to the packaging instead of the product.
到2022年，在英国市场投放的产品必须带有UKCA标志。仅带有CE标志的产品将不能投放到英国市场。在此期间，制造商可将UKCA标志贴在包装上而非产品上。
From 1st January 2023
自2023年1月1日以后
After 1stJanuary 2023, it will only be possible to place on the UK market products carrying the UKCA mark. The UKCA mark must ordinarily be affixed to the product. However, if this is not possible (for instance, due to the characteristics of the product), the UKCA mark can be placed on the packaging instead of the product.
在2023年1月1日之后，只有带UKCA标志的产品才能在英国市场上投放。UKCA标志通常必须贴在产品上。然而，如果不可行（例如，受产品特点所限），UKCA标志可贴在包装上而非产品上。
It is important to note that the UK’s withdrawal from the EU will not affect the validity of existing or future test reports issued by SATRA’s testing facilities in the UK. These test reports will continue to be accepted for certification purposes by SATRA Technology Europe Limited and other PPE Notified Bodies. This is because testing that supports PPE certification does not need to be carried out in the EU.
值得注意的是，英国退出欧盟不会影响SATRA英国的检测机构发布的现有或未来检测报告的有效性。这些检测报告将继续为SATRA Technology Europe Limited和其他PPE公告机构所接受以用于认证。原因是支持PPE认证的检测不一定要在欧盟内进行。
The testing laboratories at SATRA are accredited by the United Kingdom Accreditation Service (UKAS) to the internationally-recognised standard ISO/IEC17025:2017 – ‘General requirements for the competence of testing and calibration laboratories’. UKAS, along with other European Accreditation Bodies, is a signatory of the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Agreement.
SATRA的检测实验室经英国皇家认可委员会(UKAS)认可，满足国际公认标准ISO/IEC 17025:2017 -检测和校准实验室能力的通用要求。UKAS与其他欧洲认可机构共同签署了《国际实验室认可合作组织(ILAC)多边互认协议》。
In conclusion
总结
The withdrawal of the UK from the European union has required new national legislation which, initially, will mirror that of the EU. This will require PPE being placed on the UK market, excluding Northern Ireland, to carry a new UKCA mark. This legislation becomes effective on 1st January 2021 and, depending on circumstances, will apply to PPE either on that date or 12 months later on 1st January 2022. SATRA is now in a position to certify PPE products for both CE marking and UKCA marking, enabling manufacturers to continue to supply PPE into both the European and UK markets.
英国因退出欧盟而需制定新的本国法规，最初这些法规将反映欧盟的立法。它将要求在英国市场（不包括北爱尔兰）上投放的PPE带有新的UKCA标志。这项法规将于2021年1月1日起生效，并视情况而定，将于该日或12个月后的2022年1月1日适用于PPE。SATRA现能认证PPE产品的CE和UKCA两种标志，使制造商能够继续向欧洲和英国市场供应PPE。
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