CE PPE


 

What is the PPE Regulation?


On April 21, 2018, the Regulation (EU) 2016/425-Personal Protective Equipment (PPE) officially replaced the Directive 89/686/EEC-Personal Protective Equipment (PPE). The personal protective products to be exported to the EU must obtain a CE certificate under the PPE Regulation.




What products are covered by the PPE Regulation?


The PPE products refer to any devices or tools worn or held by individuals to protect against one or more health and safety hazards during the users’ activities. For example: respiratory protection products (dust masks, gas masks, etc.), head protection products (industrial helmets, safety helmets, etc.), eye protection products (sunglasses, industrial goggles, etc.), hearing protection products (earmuffs, earplugs, etc.), and chemical protection products (biochemical clothing, protective clothing, etc.).



How to classify the products in the PPE Regulation?


In the PPE Regulation, according to the complexity of the product and the importance of the protection, products are divided into three classes:

Class I: products for minimal risks/hazards and providing minimal protection, such as: garden gloves and cleaning gloves.

Class II: protective products that are neither simple nor complicated, and are of neither Class I nor Class III, such as: knitted gloves and simple goggles.

Class III: protective products in complicated design that are used to protect the users from fatal hazards or serious unrecoverable health damage, such as dust masks and chemical protective clothing.





Certification mode and requirements


For different classes of products, there are different certification modes and requirements, as shown in the table below:


 Class

 Certification mode

 Requirement

 Is the certificate required   to be issued by a notified   body (NB)

 Class I

 Internal production control   (Module A)

 +manufacturer’s self-   declaration

 Meet the basic health and safety requirements

 Prepare the technical documentation

 EC declaration of conformity

 CE marking

 No

 Class II

 EC type examination (Module B)

 Internal quality control (Module   C)

 Meet the basic health and safety requirements

 Prepare the technical documentation

 Type examination

 EC declaration of conformity

 CE marking

 Establish and operate a quality management system

 Yes for Module B

 No for Module C

 Class III

 EC type examination (Module B)

 +random production verification   in the period (Module C2)

 or

 EC type examination (Module B)

 +production process quality  assurance (Module D)

 Meet the basic health and safety requirements

 Prepare the technical documentation

 Type examination

 EC declaration of conformity

 CE marking

 Establish and operate a quality management system

 Yes for Module B

 Yes for Module C2

 Yes for Module D





Our services


SUNGO has nearly 10 years of experience in PPE project consulting and counseling, and can provide the following services for the majority of protective equipment enterprises:

1)  Technical documentation preparation service: guide the enterprises in preparing the basic materials (labels, instructions for use, drawings, etc.), and compile a full set of technical documentation complying with the PPE Regulation.

2)  Quality system and on-site audit counseling: in accordance with the requirements of ISO9001 and PPE Regulation, help the enterprises plan the quality management system, and provide the consulting and counseling services, so as to ensure that they meet the audit requirements of the notified bodies.

3)  Testing laboratory liaison and testing rectification counseling: assist the enterprises in testing liaison and communication, and provide suggestions for the preparation of samples by the enterprises, as well as the testing rectification counseling service.

4)  PPE related training: provide the customized training service based on the enterprise needs.




Consultation and certification process



  Step

 Specific task

 Division of work

 Cycle

    1

 Confirming the product class and certification mode

 Sungo

 2 working days

    2

 Confirming the product testing standards and arranging the delivery  of the products for testing

 Sungo & enterprise

 4-8 weeks (different cycles for   different products)

    3

 The enterprise provides the basic materials, and SUNGO prepares   the technical documentation

 Sungo & enterprise

 2-4 weeks after the materials are  complete

    4

 SUNGO conducts management system consulting and counseling

 Sungo

 On-site counseling, about 4-6   person-days

    5

 The notified body conducts on-site audit (initial audit)

 Notified body

 On-site audit, about 1-3 days

    6

 Rectifying the nonconforming items pointed out in on-site audit   and technical documentation review

 Sungo & enterprise

 With the support from the   enterprise, the non-testing   problems will be rectified within   1  week

    7

 Issuance of certificate (the certificate is valid for 5 years)

 Notified body

 4-8 weeks after the   nonconforming items are closed

     8


 Annual surveillance audit (D mode)

 Notified body

 Once a year, and no more than  12  months since the last audit;   on-site audit, 1-2 days