01 Personal Protective Equipment (PPE) exported to Europe

Personal Protective Equipment (PPE) means an appliance or device worn and equipped by an individual to protect against one or more hazards to health and safety. The scope includes personal protective devices, homemade, sports and entertainment facilities and other protective equipment, under the current level of science and technology, to achieve comfort, protection and safety, practical play a good effect.

With the rapid development of China's economy, the export volume of products is increasing, and the export of personal protective equipment is also increasing, and the export of personal protective equipment (PPE) to Europe needs to implement CE certification, according to Regulation (EU) 2016/425.

02 Personal Protective Equipment (PPE) EU Regulation

Since July 1995, The export of Personal protective equipment (PPE) to Europe is mandatory under Directive 686 (Directive 89/686/EEC Personal) adopted by the European Community (EC-European Community), now the EUROPEAN UNION (EU-EUROPEAN Union) Protective quipment). On 9 March 2016, Regulation (EU) 2016/425 was adopted and published in the Official Journal of the European Union. On 21 April 2018, the old PPE Directive 89/686/EEC was withdrawn.

03 Product risk categories under PPE (Regulation (EU) 2016/425)

According to the risk categories for protecting users. Personal protective equipment is divided into three categories:

CATEGORY I

The first category includes only the following minimal risks:

(a) Surface mechanical damage;

(b) Exposure to weak cleaning materials or prolonged exposure to water;

(c) Contact with a hot surface not exceeding 50°C;

(d) damage to the eyes due to exposure to sunlight (except when observing the sun);

(e) Atmospheric conditions of a non-extreme nature.

For example: gardening gloves, sunglasses.

CATEGORY II

The second category includes risks other than those listed in Categories I and III; For example: safety glasses and goggles, industrial helmets and crash caps, high visibility clothing.

CATEGORY III

The third category includes only risks that could have very serious consequences, such as death or irreversible health damage:

(a) Substances and mixtures harmful to health;

(b) atmospheric anoxic environment;

(c) harmful biological agents;

(d) Ionizing radiation;

(e) The effect of a high temperature environment is comparable to an air environment of at least 100°C;

(f) The effect of low temperature environments is comparable to that of air environments at or below -50°C;

(g) Falling from a height;

(h) Electric shock and live work;

(i) drowning; (Note: Old regulations are CATEGORY II)

(j) Cutting with a hand-held chain saw; (Note: Old regulations are CATEGORY II)

(k) High-pressure ejectors; (Note: Old regulations are CATEGORY II)

(l) Gunshot or knife wounds; (Note: Old regulations are CATEGORY II)

(m) Harmful noise. (Note: Old regulations are CATEGORY II)

For example: protective clothing, protective gloves, masks.

Thinking 1: Embrace emerging technologies and develop high-end products

Even for basic personal protection products such as masks, respirators and gloves, overseas leading manufacturers still have obvious advantages over China in product quality and technology. Therefore, starting from the basic one-time/multiple consumables, integrating new materials and new technologies, upgrading to multi-functional modular products with medical protection capabilities and intelligent technical support, and opening up the global high-end market will be a feasible future route. For example, the concept of "respirator" can be upgraded to "intelligent respirator", starting from environmental protection, skin friendly, comfortable, intelligent, reusable, emergency medical, respiratory assistance and other aspects, from shallow to deep, from a single product to a full set of protective equipment, to develop the next generation of personal protective equipment.