Source: https://www.kimtech.eu/resources/legislation/
Timestamp: 2019-06-16 21:21:41
Document Index: 795962341

Matched Legal Cases: ['art 1', 'art 1', 'art 2', 'art 3', 'art 4', 'art 5']

EN 374 Glove Standards
Our objective is to help our valued clients achieve seamless protection in every process and situation – and this includes regulatory protection. In order to achieve this we not only provide a range of high-quality compliant products but we also look for opportunities to share our advice, insights and support to help your applications and facilities keep pace with current legislation.
In April 2018 the PPE Regulation (EU) 2016/425 came into effect across the European Union. This wide-ranging piece of legislation defines how personal protective equipment (PPE) is to be described, tested and provided across the region.
Who the legislation applies to – the PPE Regulation applies to the following groups:
Manufacturers, who need to ensure the products and equipment they produce are compliant.
Importers, who are tasked with bringing only sufficient quality products into their home market.
Distributors, who are required to verify regulatory compliance of any products they offer for sale.
How PPE is defined – PPE is defined in the regulation as:
(a) Equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person’s health or safety,
(b) Interchangeable components for equipment referred to in point (a) which are essential for its protective function (e.g. filters), and
Look for CE Certification
Anotified body gives CE certification by providing an EC certificate to PPE Cat III Gloves
To gain a CE marking, protective safety gloves for sale in Europe must meet a number of stringent European Standards, each with its own EN code.
PPE classification – in the Regulation PPE is classified into one of three categories:
1. Simple PPE (Category I) – designed to protect users against minimal risks. Products in this category include PPE designed to guard against superficial mechanical injury or prolonged contact with water.
2. Intermediate PPE (Category II) – designed to protect users against risks not specified in categories 1 and 2. Products in this category include standard safety goggles and cut resistant gloves.
3. Complex PPE (Category III) – designed to protect against risks that can cause the most serious consequences. Products in this category include equipment designed for extreme temperatures (above 100°C and below 0°C) and to guard against ionising radiation, bullet wounds or severely harmful noise.
PPE Category III:
Complex Design Gloves
EC certified to protect against mortal danger and irreversible harm
Look for a CE symbol followed by the notified body number
This means that the manufacturing facility is audited and certified and a technical file must be completed and submitted for EC type Examination by a notified body.
Also note that many products may still be covered by the PPE Directive previously in place, and it is important that you prepare for the certificates on those products to be renewed in line with the new guidance. For more information on these changes, and how the PPE Regulation might affect your business, please view our white paper
EN 420:2003+A1:2009 (EN 420) “Protective Gloves – General requirements and tests methods” is a well-established EU-wide reference standard defining how gloves and arm protectors should be manufactured and tested in terms of comfort, water resistance, innocuousness and efficiency. It does not cover all aspects of protection, and should therefore be used in conjunction with other relevant European Standards, but EN 420 does specify the markings manufacturers should use to demonstrate compliance.
For Example, for gloves protecting against chemicals, micro-organisms, mechanical or heat and flame, the following markings will appear on the product itself or packaging:
The primary criteria that gloves meeting EN 420 need to demonstrate are summarised as follows:
Gloves should offer the highest level of protection and avoid causing harm to the wearer.
If the gloves feature seams then these should not reduce performance.
Glove pH should be as close to neutral as possible, Chromium (VII) levels should be below detectable amounts, and any other substance used in the construction of gloves that is known to cause harm, irritation or allergic reaction (such as latex) should be clearly communicated in product information.
An agreed European-wide sizing reference standard is used to ensure consistency in sizes.
The EN 374 set of standards define how protective gloves for applications involving dangerous chemicals and micro-organisms should be manufactured, labeled and distributed. This suite of standards is arranged in five parts.
The EN 374 suite of standards specifies the protection capabilities of gloves to various chemicals and micro-organisms.
Summary of changes to EN 374
Part 1 - Terminology and performance requirements
(EN 374-1:2003)
Part 1 - Terminology and performance requirements for chemical risks (EN ISO 374-1:2016)
Part 2 - Determination of resistance to penetration
Part 3 - Determination of resistance to permeation
(EN 374-3:2003)
EN ISO 16523-1:2015 Permeation by liquid chemicals under condition of continuous contact
Part 4 - Determination of resistance to degradation
by chemicals (EN 374-4:2013)
Part 5 - Terminology and performance requirements for micro-organisms risk (EN ISO 374-5:2016)
Terminology and performance requirements for chemical risks. Gloves will be categorised into three Types (A, B or C) based on their chemical permeation performance against an extended list of chemicals, which has increased from 12 to 18.
The new EN ISO 374-1:2016 classifications
Min. Number of Chemicals
from the 18 listed
Level 2 (≥30 min breakthrough) 6
Level 2 (≥30 min breakthrough) 3
Level 1 (≥10 min breakthrough) 1
EN ISO 374-1:2016 glove permeation test list
Acetone 67-64-1 Ketone
Acetonitirle 75-05-8 Nitrile Compound
Dichloromethane 75-09-2 Chlorinated parafﬁn
Carbon disulphate 75-15-0 Sulpher containing organic compound
Toluene 108-88-3 Aromatic hydrocarbon
Diethylamine 109-89-7 Amine
THF 109-99-9 Heterocyclic and ether compound
Ethyl Acetate 141-78-6 Ester
N-Heptane 142-82-5 Saturated hydrocarbon
Sodium Hydroxide 40% 1310-73-2 Inorganic base
Sulphuric Acid 96% 7664-93-9 Inorganic mineral acid
Nitric Acid 65% 7697-37-2 Inorganic acide, oxidising
Acetic Acid 99% 64-19-7 Organic acid
Ammonia 25% 1336-21-6 Organic base
Hydrogen Peroxide 30% 7722-84-1 Peroxide
Hydrogen Fluoride 40% 7664-39-3 Inorganic mineral acid, contact poison
Formaldehyde 37% 50-00-0 Aldehyde
The most visible change will be new icons on glove packaging to reflect the new standard
The beaker pictogram currently used for EN374-1:2003
for chemical splash risk, will no longer be used.
Chemical permeation performance levels will be standardised with the erlenmeyer flask pictogram and information booklet pictogram.
Type A, B or C will be differentiated with the letters associated with the tested chemicals:
The letters in the first column of the glove permeation test list detail the tested chemicals.
Determination of resistance to penetration.
Example of watertightness test according to EN374-2.
This standard replaced EN 374-2:2003 with no major technical changes.
Continues to specify the air and water leak test method for the penetration resistance of protective gloves.
Reference to EN 374-3:2003 has changed to EN ISO 16523-1:2015
EN374-3:2003 withdrawn
Determination of resistance to permeation by chemicals.
EN 374-3 has been superseded by EN ISO 16523-1:2015.
Easier to understand testing procedures across a wide range of PPE.
Very similar to EN 374-3:2003.
Minor changes to apparatus dimensions.
Higher level of specificity for analytical techniques.
Not expecting major differences in results.
All data to EN374-3 remains valid.
All new chemical permeation tests to use new standard.
EN374-4:2013
Determination of resistance to degradation by chemicals.
To become mandatory for each chemical tested for permeation as stated in EN ISO 374-1:2016.
The degradation test includes.
test principles and methods.
mandatory puncture resistance test for natural or synthetic gloves.
non-mandatory weight change test for lined gloves.
experimental equipment and reporting of results as % degradation.
For protection against bacteria and fungi a penetration test is required using EN 374-2:2014: air-leak/water-leak tests.
For protection against viruses, compliance to ISO 16604:2004 (method B) standard is necessary.
New marking on packaging for gloves protecting against bacteria and fungi, and for gloves protecting against bacteria, fungi and viruses:
For more information on the EN 374 standards please view our white paper
In order to ensure that your facilities, personnel and product portfolios remain compliant with all relevant legislation on an ongoing basis, and in an efficient manner, the following steps are recommended:
1. Keep all existing certificates and documentation organised and easily accessible to relevant staff. Records should be kept for at least 10 years and may include compliance certificates, examination certificates, and declarations of conformity.
2. Log the expiry dates of all documents to ensure that updates and obsolescence are carefully planned to a schedule that better suits your operations. Note that certificate validity dates do not always correspond directly to the date that new legislation comes into force. For example, products governed with certificates from the PPE Directive are valid until 2023, although this legislation was replaced by the PPE Regulation in 2018.
3. Ensure that all relevant user instructions are in the correct language. Protective products can only perform effectively when they are used correctly, so customers need to understand instructions.
4. Develop an approach to continuously monitoring the certification and compliance status of your product portfolio. This process can integrate with other timelines and systems used in your company to assess and monitor operations.
5. Finally, engagement with your suppliers and providers can help ensure that all parties are committed to the same level of customer/user protection and adherence to legislation.
When you work with expert partners and high-quality equipment manufacturers, regulatory compliance should be a given. However, it is your responsibility to ensure this, along with protection for all other aspects of processes and equipment use that relate to your operations.
Familiarisation with the important aspects of relevant legislation will simplify this process – and if you need any additional help or advice please feel free to contact us today in order to discuss your needs