Certificates and Standards

High quality assured by the EN 455 and EN 374 standards.

Preview - CE 2777

DoC

EN 455

The EN 455 standard: It tests medical gloves for quality (AQL) and properties such as Dimensions, tear strength, product labelling, ingredients and shelf life.

– DIN EN 455-1: Requirements and testing for tightness and freedom from holes.

– DIN EN 455-2: Requirements and testing of physical properties, e.g. length.

– DIN EN 455-3: Requirements and testing for biological evaluation.

 

EN374

EN 374: Compliance with this standard for personal protective equipment is not prescribed for medical devices, but becomes necessary if Gloves also put on for the protection of the user (and not only the patient) are used, e.g. in contact with disinfectants, laboratory chemicals or preparation, transport or administration of cytostatic drugs. The necessity of personal protective equipment is divided into three categories:

Besides different performance requirements,

the determination of the resistance to penetration and

permeation of chemicals, this standard refers to other standards:

 

EN420

EN 420: This standard specifies the test methods to be applied to all protective gloves. Also it determines general requirements for design principles, glove assembly and resistance of the glove material against water penetration, harmlessness, comfort and Capacity. The standard also prescribes how the manufacturer should label his product and which product information he has to provide.

 

ASTM

ASTM (American Society for Testing and Materials): The US American standard test method

 

ASTM F1671 provides information on the resistance of the material to pathogens that can be transmitted via blood are transmitted, e.g. viruses. ASTM is not a European standard but provides information about the material quality with regard to virus-proofing of products.

Category Designation Required for …

I Protection against low risks – Diluted disinfectants

– Diluted cleaning agents

– Diluted chemicals II Protection against risks not included in category I still fall in category III

– Protection of the user against bacteria and germs (when handling test materials such as e.g. for urine samples)

– Disinfection of work surfaces in the treatment room III Protection against lethal high, irreversible risks

– As splash protection when handling concentrated disinfectants, chemicals and cytostatics

– Preparation of dilute