Ppe


Personal Protective Equipment

1. THE SCOPE OF PPE FOR WHICH CE MARK IS NECESSARY

1.1. Definition of Personal Protective Equipment

PPE is defined as "any device or appliance designed to be worn or held for protection against one or more safety and health hazards"

1.2. Type product scope of PPE directive 89/686/EEC

The Directive also covers combined PPE intended to protect the user against multiple hazards, and interchangeable components essential to its satisfactory functioning.

Directive does not differentiate between PPE used for work activities and for leisure. All protective equipment is required to comply, whether it is intended for use at work or in the home, even at sporting activities.

Responsibility for deciding if a product is PPE or not rests with the manufacturer (or his authorized representative).

2. The Directive defines three classes of PPE:

2.1 Simple PPE - Category I

Article 8.3 of the Directive defines the ‘PPE of simple design‘ exclusively as the PPE intended to protect the wearer against:

     Mechanical action whose effects are superficial (gardening gloves, thimbles etc.);
    Cleaning materials of weak action and easily reversible effects (gloves affording protection       against diluted detergents, aprons etc.);
     Risks encountered in the handling of hot components which do not expose the user to a       temperature exceeding 50 degrees C, or to dangerous impacts (gloves, aprons for       professional use etc.);
     Atmospheric agents of a neither exceptional nor extreme nature (headgear, seasonal       clothing, footwear etc.);
     Mminor impacts and vibrations etc. which do not affect vital areas of the body and whose       effects cannot cause irreversible lesions (light anti-scalping helmets, gloves, light footwear       etc.);
     Sunlight (sunglasses).

2.2 Complex PPE - Category III

Article 8.4(a) of the Directive defines the ‘PPE of complex design‘ as the PPE's intended to protect against mortal danger, or against dangers that may seriously and irreversibly harm the health of an individual, the immediate effects of which cannot be identified in sufficient time. This category III covers exclusively:

     Filtering respiratory devices for protection against solid and liquid aerosols or irritant,       dangerous, toxic or radio-toxic gases;
     Respiratory protection devices providing full insulation from the atmosphere, including       those for use in diving;
     PPE providing only limited protection against chemical attack or against ionising radiation;
     Emergency equipment for use in high-temperature environments, the effects of which       are comparable to those of an air temperature of 100 degrees C or more and which may       or may not be characterised by the presence of infra-red radiation, flames or the       projection of large amounts of molten material;
     Emergency equipment for use in low-temperature environments the effects of which are       comparable to those of an air temperature of -50 degrees C or less;
     PPE to protect against falls from a height;
     PPE to protect against electrical risks and dangerous voltages or that used as insulation in       high-tension work.

2.3 PPE which is neither simple nor complex - Category II

The equipment in categories I and III are listed in the Directive. These lists are comprehensive and items which do not clearly fall within the descriptions of one list or the other must be either Category II PPE, or not PPE at all.

Similar and exchangeable equipment not included in the scope of the PPE Directive:

     Protective equipment for military use;
     Protective equipment for self-defense;
     Protective equipment for use by consumers to protect against: moisture, heat, certain       weather conditions
     Protective equipment intended for rescue activities on board ship or aircraft.

3. PPE DIRECTIVE

This directive describes general provisions and requirements for specific products and features of products:

GENERAL REQUIREMENTS APPLICABLE TO ALL PPE

  1.1  Design principles (ergonomics, classification)
  1.2  Harmlessness of protective equipment (materials, hindrance)
  1.3  Comfort and efficiency
  1.4  Information supplied by the manufacturer

ADDITIONAL REQUIREMENTS COMMON TO SEVERAL CLASSES OR TYPES OF PPE

  2.1  Protective equipment incorporating adjustment systems.
  2.2  Protective equipment ,enclosing' the parts of the body to be protected.
  2.3  Protective equipment for the face, eyes and respiratory tracts.
  2.4  Protective equipment subject to ageing.
  2.5  Protective equipment which may be seized during use.
  2.6  Protective equipment for use in explosive atmospheres.
  2.7  Protective equipment intended for emergency use or rapid installation and/or removal.
  2.8  Protective equipment for use in very dangerous situations.
  2.9  Protective equipment incorporating components which can be adjusted or removed by         the user.
  2.10  Protective equipment for connection to another, external complementary device.
  2.11  Protective equipment incorporating a liquid or gas circulation system.
  2.12  Protective equipment bearing one or more identification or recognition marks directly          or indirectly relating to health and safety.
  2.13  Protective equipment in the form of clothing capable of signalling the user's presence          visually.
  2.14  'Multi-risk' protective equipment.

ADDITIONAL REQUIREMENTS SPECIFIC TO PARTICULAR RISKS

  Protection against mechanical impact.
  Protection against (static) compression of a part of the body.
  Protection against physical injury (abrasion, perforation, cuts and bites).
  Prevention of drowning (lifejackets, armbands and lifesaving suits).
  Protection against the harmful effects of noise.
  Protection against heat and/or fire.
  Protection against cold.
  Protection against electric shock.
  Radiation protection.
  Protection against dangerous substances and infective agents.
  Safety devices for diving equipment.

3.2 Conformity assessment procedures and affixing of CE marking

Conformity assessment procedures are different for each PPE category.

3.2.1 Category I (Conformity Assessment Module A)

In this category, the manufacturer can take responsibility for ensuring that the product complies with the PPE Directive and can affix the CE Marking. This Category is sometimes referred to as 'self-certification'.

     In this case the manufacturer does not apply for the services of a Notified Body.
     Conformity assessment procedure is complete provided when the manufacturer fully       realizes following steps according to Directive:
     to ensure that his product complies with the essential health and safety requirements
     to assemble technical documentation
     to draw up a EC Declaration of Conformity
     to affix the CE Marking

3.2.2 Category II (Module B)

     In this case the manufacturer applies for the services of a Notified Body.
     Conformity assessment procedure is complete provided when the manufacturer realizes       following steps according to Directive:

  (a) to ensure that the product complies with harmonized European Standards (and with the       essential requirements of the PPE Directive if they are not completely covered by       harmonized standard) or the product complies with verified technical specifications.
  (b) to assemble technical documentation for submission to the Notified Body
  (c) to make application for EC Type Examination to the Notified Body and to receive
       EC Type Examination Certificate for PPE
  (d) to draw up a EC Declaration of Conformity
  (e) to affix CE marking

3.2.3 Category III (Module B+C or Module B+E)

     In this case the manufacturer applies for the services of a Notified Body.
     Conformity assessment procedure is complete provided when the manufacturer realizes       following steps according to Directive:

  (a) to ensure that the product complies with harmonized European Standards (and with the       essential requirements of the PPE Directive if they are not completely covered by       harmonized standard) or the product complies with verified technical specifications.
  (b) to assemble technical documentation for submission to the Notified Body
  (c) to make application for EC Type examination to the Notified Body and to receive
       EC Type Examination Certificate for PPE
  (d) to draw up a Declaration of Production Conformity

    to affix CE marking
    to assure a surveillance of the PPE manufacturing process - manufacturer must realize,       according to his choice, one of the two check procedures:

  (1) "EC quality control system for the final product”- the Manufacturer requests a Notified       Body to ensure that the PPE conforms with the EC Type Examination Certificate by       checking random production samples at least once a year. The Notified Body then issues       the manufacturer with a test report (Article 11A of the PPE  directive 89/686/EEC)
  (2) "System for ensuring EC quality of production by means of monitoring" - the       manufacturer has his quality control system approved by a Notified Body (Article 11B of       the PPE directive 89/686/EEC), which performs continuous monitoring of keeping the       system's parameters and requirements.

NOTE:

This conformity assessment procedure is possible to identify as:
  -  Module B+C where was used checking procedure according to Article 11A of the Directive
     or
  -  Module B+E where was used checking procedure according to Article 11B of the Directive.

4. ITC'S ACTIVITIES IN THE FIELD OF PPE CONFORMITY ASSESSMENT

On this basis, the ITC and its foreign partner could offer to customers services according to following table, where items are arranged from the simplest to the most complex :