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标题: PPE指令更改的变化 [打印本页]

作者: zjq20 时间: 2017-9-11 14:46
标题: PPE指令更改的变化
TRANSITION OF PPE DIRECTIVE 89/686/EEC TO PPE REGULATION (EU) 2016/425时间： 09:07 分类：新闻中心作者： admin 0 评论 0喜欢

Transition of PPE Directive 89/686/EEC to PPE Regulation (EU) 2016/425

UNTIL 20TH APRIL 2018

The PPE Directive 89/686/EEC is valid without any restrictions!
New EC Type Examinations and extensions of already existing EC Type Examinations can only be issued according to PPE Directive.
It will be mandatory for Category III products to make a contract according to Annex VII (product inspection) or VIII (production inspection) with the entity responsible for inspection.

Note: We advise not to produce and store too many user manuals and packaging materials, as these have to be updated according to Regulation (EU) 2016/425 (e.g. Declaration of Conformity, number of the inspecting entity)!

FROM 21ST APRIL 2018

Production: The Regulation (EU) 2016/425 is valid!
New products are certified according to the Regulation.
Hearing protectors are now classified as Category III and no longer as Category II.
The Declaration of Conformity according to Regulation has to be issued and published (user manual / internet) also for products which are still produced. It has to contain all relevant directives and regulations.
EC-Type Examination Certificates according to Directive 89/686/EEC will not be amended before the expiration date. They are a basis for the new Declaration of conformity according to Regulation (EU) 2016/425.
Products in stock, which were produced before 21st April 2018, can continue to be sold.

Note: The same applies to PPE imported to the EU!

Contracts with Notified Bodies according to Annex VII or Annex VIIImust be available.
If inspection controls were agreed upon according to Annex VIII, such a production control must have been carried out.
Traders have now the full responsibility for a product, not only the manufacturer or the importer (market surveillance).

FROM 21ST APRIL 2019

Products which are already put on the market and which were produced or imported before April 2018 can be sold until 2023.
EC-Type Examination Certificates according to Directive will still be valid until their expiration date. Certificates without an expiration date will be invalid in 2023.
Product inspections according to Annex VII must have been conducted.

中文对照翻译部分：

(EU)2016/425PPE规则中89/686/EEC指令的变化

到2015.04.20之前

指令 89/686/EEC的有效性没有任何限制

新的CE实验和现有的CE实验只能根据PPE指令来完成

第三类产品必须根据附录７或８来与检验单位订立合同

注意：我们不建议生产和储存过多的用户手册和包装材料，这些都必须按照（欧盟）规定来完成（如符合性声明，样品的数量）

从2018.04.21起

产品：规定（EU）2016/425生效
新产品的认证按照规定
听力保护产品现在被归为第三类，不再属于第二类
符合性声明根据规定，必须被发布和出版（用户手册/互联网），另外产品也仍然要生产。它必须包含所有的指令和法规。
CE证书根据指令89／686／EEC，不会在证书到期之前修改
他们是依据按照（欧盟）2016/425规定新的符合性声明。

产品的库存，在2018年4月21日之前，可以据需销售。

注：这同样适用于PPE进口到欧盟

与发证机构的合同根据附录7或附录8必须是有效的。
如果检查组同意根据附录8，这样的生产控制必须被执行。
贸易商现在拥有一个产品的全部责任，不仅仅限于制造商或进口商（市场监管）

从2019.04.21起

在2018年4月以前产品已经投放市场，并且已经被生产或者出口的能出售到2023年。
CE证书在其到期之前仍然有效，而没有截止日期的将在2023年到期。
产品检验必须根据附录7来进行管理。

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