MEDICAL GLOBAL TRADING
PPE REGULATION
MEDICAL GLOBAL TRADING
THE PPE REGULATION (EU) 2016/425
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THE PPE REGULATION (EU) 2016/425
In April 2018, a new PPE Regulation (EU) 2016/425 has become applicable and replace the existing PPE Directive 89/686/EEC .
The Declaration of Conformity for PPE-labelled gloves is accessible on our website and packaging will include a direct link to access the Declaration of Conformity for each product.
THE NEW EN ISO 374-1:2016 STANDARD FOR CHEMICAL PROTECTIVE GLOVES
The new standard considers three types of chemical protective gloves:
TYPE A GLOVES
need to achieve at least a permeation level of 2 (longer than 30 min.) against six of the chemicals listed in EN ISO 374-1. As a minimum the six tested chemicals shall be identified by their code letters under the flask pictogram.
TYPE B GLOVES
need to achieve at least a permeation level of 2 (longer than 30 min.) against at least three of the chemicals listed in EN ISO 374-1. The tested chemicals shall be identified by their code letter under the flask pictogram.
TYPE C GLOVES
need to achieve at least a permeation level 1 (longer than 10 min.) against one of the chemicals listed in EN ISO 374-1.
The list of challenge chemicals in EN ISO 374-1 was enlarged by 6 additional chemicals:
The NEW EN 374-4 specifies the determination of resistance to degradation by chemicals.
Coming into contact with a chemical can have an impact on the material properties of a protective glove, not only during contact with the chemical but also subsequently. Degradation testing therefore includes the testing of the change of material’s properties after exposure to chemicals.
The Manufacturer‘s notify Body has issued new EU type examination certificates (avaible on request).
The Manufacturer has also issued Declarations of Conformity in accordance with PPE Regulation (EU) 2016/425.
Although EN ISO 374-1 contains no performance requirements for degradation, the EN 374-4 result will need to be included in the user instructions and is indicated as a percentage degradation.
DOWNLOAD
English
DECLARATION OF CONFORMITY VINYL GLOVES MD AND PPE – CCIR
French
DECLARATION CE DE CONFORMITÉ- GANTS D’EXAMEN EN NITRILE NON POUDRÉS – CCIR
DECLARATION CE DE CONFORMITÉ- GANTS D’EXAMEN EN LATEX – CCIR
DECLARATION DE CONFORMITÉ – GANTS D’EXAMEN EN VINYLE – CCIR
Spanish
DECLARACION CE DE CONFORMIDAD GUANTES DE LATEX EXAMINATION GLOVES DM Y EPI
