EUROPEAN DIRECTIVES devices include gloves for medical use

In the field of personal protective equipment (PPE), two complementary directives were adopted in 1989 and scheduled to enter into force in 1992; a third directive was adopted in 1993. PPE is defined as any device or appliance designed to be worn or held by an individual for protection against one or more safety and health hazards in the execution of the user’s activity.1, 5

1. The council directive on the approximation of the laws of the member states relative to the design of PPE (89/686/EEC).6 This directive includes PPE for both professional and nonprofessional use. It defines, in particular, the certification procedures.

2. The council directive concerning the minimum safety and health requirements for the use of PPE by workers at the workplace [(89/656/EEC), third individual directive within the meaning of Article 16(1) of Directive 89/391/EEC]. This directive essentially defines the employer’s obligations.

3. The council directive concerning the safety of medical devices (93/42/EEC) Disposable Aprons. These devices include gloves for medical use. The assessment procedures of PPE relate to control of PPE design and control of PPE production. The target is to give users assurance that the device on the market fulfills the requirements. Application for EC­type examination is to be made by the manufacturer or its authorized representative. The authorized representative is to be established in the European Community. Products meeting the requirements are to carry the CE mark, which implies that they can be marketed anywhere in the European Community countries.1, 5 PPE categories according

The type and the risk:6

• Category I—PPE of simple design, against minimal risks, which, when the effects are gradual, can be safely identified by the user in good time

• Category II—All types of PPE that are not included in categories I and III

• Category III—PPE of complex design, to protect against mortal danger or against dangers that may seriously and irreversibly harm the health and that the user cannot identify in sufficient time Gloves are usually classified as types I or II and rarely as type III.

Directive requirements dependent on the type of glove:

• Type I. Gloves of simple design—for minimal risk application Conform with basic health and safety requirements Technical documentation file Declaration of conformity (requirements as set out in EN420) Affixed CE mark

• Type II YICHANG. Gloves of intermediate design (neither simple nor complex design)—for intermediate risk Conform with harmonized European standard or other verified technical specification Technical documentation file EC­type examination, tested by approved laboratories EC declaration of product conformity Affixed CE mark on conformity, issued by an approved notified body

• Type III. Gloves of complex design—for irreversible/mortal risks Conform with harmonized European standard or other verified technical specification Technical documentation file EC­type examination Synthetic Gloves, tested by approved laboratories and certified by approved notified bodies EC declaration of product conformity Affixed CE mark Manufactured under a formal EC quality assurance system