European Standards
You will find hereafter detailed explanation on the various European Quality Standards related to our product ranges and industries: Please click on the following links to learn more about Gloves standards, Protective workwear standards, Food safe standards, HACCP standard.
Gloves
Gloves are regulated under 2 categories: medical and non-medical gloves. The inspection level is higher and stricter for medical gloves than non-medical gloves to protect from blood and associated medical pathogens.
MEDICAL GLOVES
Our medical gloves are: Handsafe®/Finetouch®and HPC Healthline® ranges.
Medical Devices Directive: 93/42/EEC
This is the European Directive presenting the safety standards for medical devices. Compliance with this Directive is indicated by affixing a CE pictogram. CE marking is a self accreditation process which is regularly monitored and audited.
EN455
Medical Gloves are regulated under the EN455 standards belonging to the Medical Directive. This standard is divided into 3 sections specifying the various inspection levels and methods.
Part 1: Requirements and testing for freedom from holes:
AQL 1.5 (Acceptable Quality Level)
Eg: a 500,000 pieces batch will require 500 samples for testing.
Up to 14 failures = Pass, 15 failures and above = Fail.
Part 2: Requirements and testing for physical properties:
Gloves inspected according to: their dimensions (length, width, thickness), their strength (force at break in Newtons and Mpa, before and after ageing) and their elasticity (elongation in %).
Part 3: Requirements and testing for biological evaluation:
Gloves tested to protect users and their health against chemicals, endotoxins, proteins, pyrogens…
Content limits as well as labeling are highlighted to protect users. (eg: claim of hypoallergenic shall not be used).
NON MEDICAL GLOVES
Our non-medical gloves Shield® are used in any other market sectors: food, janitorial and safety.
PPE Directive: 89/686/EEC
This is the European Directive presenting the safety standards for industrial devices. Compliance with this Directive is also indicated by affixing a CE pictogram. The PPE Directive covers a wide range of head to foot protective workwear (disposable and non-disposable). This Directive classifies protective workwear into 3 categories:
Simple Design: Products offering protection against hazards of minimal risk.
Intermediate Design: Products offering protection against hazards that are not in the other 2 categories.
Complex Design: Products offering protection against hazards of serious or mortal risk.
Our disposable and industrial gloves comply with the PPE Directive. Single use disposable gloves are for minimal risks whereas industrial gloves cover intermediate and complex risks.
The following standards regulate gloves under the PPE Directive.
EN420: General Requirements for Gloves:
This standard defines general requirements for ergonomy, product design, construction, comfort, efficiency and marking. It also details the relevant pictograms related to each product category
EN388: 2003: Protection against Mechanical Hazards:
Specifies the requirements against abrasion, blade cut, puncture and tear.
EN374: 2003: Protection against Chemical and/or Biological Hazards:
Specifies the requirements against penetration and permeation of chemicals and/or biological hazards.
EN421: Protection against Radioactive Hazards:
Specifies the requirements against Radioactive contamination and ionising radiation.
EN407: Protection against Thermal Hazards:
Specifies the requirements against fire and/or heat hazards.
Protective Workwear
Our range of apparel is also regulated by the PPE Directive 89/686/EEC. Most of our workwear will fall under the minimal risk category. However certain items are also regulated by specific industry standards.
HAZARD PROTECTIVE COVERALLS, Category 3:
Our Shield® Plus, Shield® Advance and Shield® Ultimate coveralls.
EN340: General Requirements for Protective Clothing:
This standard defines general requirements for ergonomy, product design and comfort, sizing requirements according to wearer’s height, chest and waist circumference and specific labelling of the garment. We refer to numerical types of protection to define the level of protection of each coverall.
Type 4: Liquid spray Hazards
Type 5: Dry particles Hazards
Type 6: Liquid splashes Hazards
In order to classify coveralls into types, other specific industry standards require testing:
EN374: 2003: Protection against Chemical and/or Biological Hazards:
Specifies the requirements against penetration and permeation of chemicals and/or biological hazards.
EN14126: Protection against Biological Hazards:
Specifies the requirement of protective clothing against Infective Agents such as Bird Flu, Swine Flu.
EN1073-2: Protection against Radioactive Hazards:
Specifies the requirement of protective clothing against Radioactive contaminations.
EN1149: Test method for Anti-static properties:
Specifies the requirements and test method for measurement of electrostatic charge decay.
FACE MASKS
Our medical facemasks DK01 are regulated by the Medical Devices Standards.
EN14683: Protection against bacterial contamination:
This standard defines the Bacterial Filtration Efficiency of the facemasks and divides its tests under 3 categories.
Part 1: Bacterial Filtration Efficiency in vitro (BFE).
Testing of the filtration of a controlled concentration of Staphylococcus aureas.
Results: BFE of 95% = Type I, BFE of 98% = Type II
Part 2: Breathing Resistance (Delta P).
Testing of the air flow pressure passing through the mask.
Results: Type I & II (non splash resistant) = <3.0 mmH2O/cm2. Type IR & IIR (splash resistant) = <5.0 mmH2O/cm2
Part 3: Splash Resistance:
Testing of a determined quantity of artificial blood sprayed on the mask.
Results:
Type I & II not applicable.
Type IR & IIR minimum 120 mmHg.
Our new range of FFP masks is regulated by the Respiratory protective devices standards.
EN149: Protection against hazardous particles for Respiratory masks
Specifies the requirement of Respiratory Protective Face Masks. This standard is divided into 3 categories, which will define the level of filtering protection from each disposable face mask. The level of protection is calculated on the Nominal Protection Factor (NPF), the acceptable level of filtering efficiency based on the amount of hazardous substance in the air. The greater the number, the greater the protection.
FFP1 mask: Protection from low toxicity levels - 4.5 x NPF - Filtration efficiency of 78%
FFP2 mask: Protection from medium toxicity levels - 12.5 x NPF - Filtration efficiency of 92%
FFP3 mask: Protection from high toxicity levels - 50 x NPF - Filtration efficiency of 98%
Food Safe
A wide selection of our product range is food safe, suitable for food contact and therefore can be used in a food preparation environment. Materials and articles, intended to come into contact with food, in their finished state, must be regulated according to European Regulation (EC) 1935/2004.
The framework of this regulation is to ensure that all materials coming into contact with food are tested, so that in their normal use they will not transfer, in quantities, their constituents to food. These could endanger health, cause unacceptable changes in the composition of food or deteriorate its organoleptic properties (taste, texture, aroma, appearance). Specific labeling requirements are affixed on packaging and products confirming their suitability with food contact. To complete this general Regulation, specific Directives per material categories have been put in place in order to set the framework of the testing procedures and acceptability levels. Plastics in contact with food: Directive 2002/72/EC
The SHIELD® Range and the HACCP standard
The HACCP standard was set up to minimise cross contamination during food processing. Food factories have the responsibility to control and establish high level of hygiene at all stages within the food manufacturing process.
This standard puts into place a large range of controlling measures and on-line checks during the manufacturing process. The HACCP standard also includes hygiene measures for personnel handling food lines.
In order to avoid any cross contamination between food preparation and handlers, all staff working in a food environment must respect a high level of hygiene and must wear clean and appropriate workwear.
Recommended workwear: Shoes or shoecovers specifically for the work area. Headwear covering the hair completely. Facemasks. Disposable gloves.
Recommendations for the correct usage of disposable gloves: Wash hands prior to donning the gloves. Cover all wounds or cuts. Change gloves every 4 hours.
HPC Healthline offers a complete hygiene solution adapted to the HACCP requirement with its full range of disposable gloves and workwear.
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