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28 Posts in this encyclopedia categoryElongation at Break
This measurement parameter refers to the elongation in % at the moment of tearing compared to the initial gauge length.
EN ISO 13485
Medical devices - Quality management systems - Requirements for regulatory purposes.
EN ISO 15223-1
Medical devices - Symbols for use in the information to be provided by the manufacturer - Part 1: General Requirements.
EN ISO 374-1
EN ISO 374-1: Protective gloves against hazardous chemicals and micro-organisms - Part 1: Terminology and performance requirements for chemical risks.
EN ISO 374-2
EN 374-2: Protective gloves against hazardous chemicals and micro-organisms - Part 2: Determination of resistance to penetration. EN ISO 374-2 regulates the test procedure for protective gloves intended to protect against micro-organisms (bacteria and fungi).
EN ISO 374-4
EN 374-4: Protective gloves against chemicals and micro-organisms - Part 4: Determination of resistance to degradation by chemicals.
EN ISO 374-5
EN ISO 374-5:2015: Protective gloves against hazardous chemicals and micro-organisms - Part 5: Terminology and performance requirements for risks from micro-organisms.
EN ISO 9001
Quality management systems: Requirements ISO 9001 is recognised worldwide. It defines and establishes the minimum requirements for effective quality management in a company.
EU Declaration of Conformity
The EU declaration of conformity is a document in which the manufacturer declares on his own responsibility and in his own name in a legally binding manner that his product complies with the applicable EU regulations or EC directives and that the harmonised standards are observed.
EU Representative
If goods or services are distributed in the EU internal market by a company whose registered office is not in the EU, an EU representative must be named who is based in the EU.
EU Type Examination
The EU type examination is part of the conformity assessment procedure. These tests are carried out by a Notified Body. These tests must be carried out, for example, for PPE of categories II and III and for medical devices that do not correspond to class I.
Examination Glove
Medical examination gloves are class I medical devices and serve to protect patients.