ppe is short for personal protective equipment, which refers to any device or appliance that is worn or carried by an individual in preparation for one or more hazards to health and safety. ppe is primarily used to protect people from serious work injuries or illnesses caused by exposure to chemical radiation, electrical equipment, human equipment, machinery or some hazardous workplaces. in addition to face shields, safety glass, and safety shoes, ppe includes a large number of respiratory protection equipment and protective clothing, including safety helmets, goggles, auditory protectors (earplugs), safety gloves, safety shoes, respirators and seat belts.
in the european union and the european economic area, the sale of personal protective equipment must comply with the technical requirements of regulation (eu) 2016/425. the directive sets out the basic health and safety requirements for personal protective equipment, as well as common additional requirements for certain categories or types of ppe and additional requirements for specific risks. the regulations apply to manufacturers of ppe and their authorized representatives, importers, etc. who are obliged to comply with their regulations.
ce marking and the eu declaration of conformity ensure that ppe can flow freely in the european market. for ppe with risk levels ii and iii, a certificate of conformity must be issued by a third-party notified body recognized by the european union for the type of risk involved.
additionally, for personal protective equipment with a risk level of class i, we can also provide compliance assessment certification services to assist chinese companies in compiling technical documents and reducing the burden of document preparation.
aenor spanish standards certification association, an organization dedicated to the advancement of standardization and certification in all industries and service industries. aneor is a notified body (eu nb number 0099) authorized by the national accreditation body (enac).
since the development of aenor, more than 80,000 enterprises and organizations around the world have obtained aenor certificates, more than 106,000 products and services have passed aenor certification. and more than 400 environmental verification activities and more than 6,000 inspection activities have been implemented. aenor services are available to customers worldwide and in a variety of fields. from pharmaceutical to chemical, from electrical to industrial, from consumer goods to manufacturing, from agricultural products to food, from materials to construction, from service standards to service innovation, using a global network to provide multi-dimensional professional quality assurance services such as testing, inspection, certification, audit, compliance assessment, etc., to ensure that the ability and competitiveness of customers around the world are improved, and to ensure that products meet the needs of the local public.
aenor certification services (shanghai) co., ltd. (aenor china) is the only body established by aenor in china for inspection, assessment, testing and certification. aenor china adheres to the principles and persistence of aenor's rigor and independence, and runs this valuable throughout each piece work of aenor.
the risk level of personal protective equipment is divided into three categories:
category i "simple design" no notified body intervention is required. such products include: protection against surface mechanical injury (gardening gloves); cleaning materials with weak protective effect (cleaning gloves); protection against daylight (sunglasses); everyday atmospheric environment (raincoats, etc.).
category ii "neither a simple design nor a complex design" module b type test must be applied to a notified body. the vast majority (80%) of the products on the market fall into this category. (goggles, cut-proof gloves, etc.)
class iii "complex design"
module b type inspection must be applied to a notified body and, at the same time, an application for an audit of the production management system must also be submitted. complex design is designed to protect against serious or irreversible harm to life, such as death. such products include:
1. equipment for protecting solid particles, mixtures and chemical agents that can cause harm to the body;
2. support equipment in hypoxic environments, including diving equipment;
3. devices to isolate ionizing radiation;
4. a device that provides protection in a high temperature environment for environments of 100 °c and above;
5. a device that provides protection in low temperature environment for environments of -50 °c and below;
6. anti-fall device;
7. anti-high voltage power and insulation protection device; 8. anti-noise device.
by applying for ce certification of ppe, you can obtain a certificate of conformity, and the product can enter the european market quickly and smoothly, and gain the trust of end users. we are your reliable business partner.
application - application confirmation - submission of technical data - technical assessment and audit - audit of production management system - issuance of certificates
for the same product, can the same model be applied to the different institutions?
no. according to the ppe regulation (eu) 2016/425, the same model of a product is only allowed to apply for ce certification to one certification body.
when applying for certification, must the client applies for both module b and module d to the same institution?
no. according to the ppe regulation (eu) 2016/425, module b and module d models can apply for certification in different institutions, but must first obtain the module b certificate before applying for the module d certificate.
for category iii products, there are two certification modes of module b module c2 and module b module d.are module c2 and module d the same? what's the difference?
there is a difference between the two. module c2 involves a random product check, i.e. taking samples on a production line for compliance testing; module d, on the other hand, is an audit of the production management system to ensure that the manufacturer has a quality management system suitable for continuous production.
what is certification?
certification refers to the qualification evaluation conducted by a notified body about products, services, and systems in accordance with the requirements or standards of relevant technical specifications. certification refers to the process in which a third-party notified body recognizes the products, services, and organizations of the applicant.
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