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35 Posts in this encyclopedia categoryElongation at Break
Elongation at break is the percentage increase in length of a material at the moment of rupture and describes how far a glove material can stretch. It is determined in a tensile test to ISO 37. For medical single-use gloves, EN 455-2 specifies force at break, not elongation.
EN 1149
EN 1149 is the standard series for protective clothing with electrostatic dissipative properties. It covers test methods for surface resistivity (Part 1), vertical resistance (Part 2) and charge decay (Part 3), while Part 5 sets the performance requirements for the finished garment.
EN 13034
EN 13034 sets requirements for protective clothing with limited performance against liquid chemicals, known as Type 6. It protects against light spray mist and small splashes, not against pressurised jets or full liquid tightness. Type 6 is the lowest level of chemical protective clothing.
EN 14126
EN 14126 sets performance requirements and test methods for protective clothing against infective agents. It supplements the existing chemical protection types with the suffix B, for example Type 4-B or Type 5-B. Barrier performance is tested against blood, body fluids, contaminated liquids, aerosols and contaminated dust.
EN 16523
EN 16523 is a standard series for measuring the permeation of hazardous chemicals through protective clothing and gloves. EN 16523-1 replaces the former EN 374-3 and defines permeation classes 1-6. The standard is the basis for type classification in EN ISO 374-1 (chemical protective gloves).
EN 374
EN 374 is the standard series for protective gloves against chemicals and micro-organisms. The series comprises EN ISO 374-1 (Type A/B/C, terminology), EN ISO 374-2 (penetration), EN ISO 374-4 (degradation), and EN ISO 374-5 (micro-organisms). Chemical protective gloves per EN 374 are PPE Category III.
EN 374-3
EN 374-3 is the withdrawn predecessor standard for permeation measurement of chemical protective gloves. It was replaced by EN 16523-1:2015, which defines the procedure for determining breakthrough time and permeation rate. EN 16523-1 is the current reference standard for classification in EN ISO 374-1.
EN 388
EN 388 is the European standard for protective gloves against mechanical risks. It tests abrasion resistance, cut resistance (Coup test and TDM test), tear resistance, and puncture resistance. Since 2016, EN 388 optionally includes an impact protection test. Gloves complying with EN 388 are PPE Category II.
EN 407
EN 407 is the European standard for protective gloves against thermal risks (heat and fire). It defines six performance parameters with classes 0-4: flammability, contact heat, convective heat, radiant heat, small molten metal splashes, large molten metal splashes. EN 407 gloves are PPE Category II (limited risk) or III.
EN 455
EN 455 is the European standard series for medical single-use gloves. It comprises four parts: EN 455-1 (leak resistance), EN 455-2 (physical properties), EN 455-3 (biological evaluation), and EN 455-4 (shelf life). Gloves complying with EN 455 are Class I medical devices under MDR (EU) 2017/745.
EN 455-1
EN 455-1 is Part 1 of the EN 455 series for medical single-use gloves and covers leak resistance requirements. The test method is the water leak test: gloves are filled with 1,000 ml of water and checked for leaks. Acceptance limits: AQL 1.5 for examination gloves, AQL 0.65 for sterile surgical gloves.
EN 455-2
EN 455-2 covers the physical properties of medical single-use gloves: minimum dimensions, minimum length and force at break. The minimum values are 9.0 N for sterile surgical gloves, 6.0 N for latex and nitrile examination gloves and 3.6 N for examination gloves made from thermoplastic materials such as vinyl or PE. Testing is carried out before and after accelerated ageing.
EN ISO 13485
EN ISO 13485 is the international standard for quality management systems (QMS) in the medical device industry. It sets requirements for manufacturers and suppliers of medical devices in development, production, and distribution. EN ISO 13485 is not a legal obligation but is globally recognised by Notified Bodies and regulators as evidence of a robust QMS.
EN ISO 14971
EN ISO 14971 is the international standard for risk management of medical devices. It describes a systematic process for identifying, evaluating, and controlling risks throughout the entire lifecycle of a medical device. MDR (EU) 2017/745 requires a documented risk management system as a mandatory component of technical documentation.
EN ISO 15223-1
EN ISO 15223-1 defines symbols for medical devices used on labelling and accompanying documents. The symbols are internationally recognised and enable language-independent product information. Examples: REF (product reference), LOT (batch number), expiry date, STERILE, NON STERILE, manufacturer.
EN ISO 21420
EN ISO 21420 sets general requirements and test methods for all protective gloves. It covers design principles, harmlessness, water penetration, comfort, and marking requirements. EN ISO 21420 replaced the withdrawn EN 420 in 2020 and serves as the base standard for all PPE protective gloves.
EN ISO 22610
EN ISO 22610 specifies the test method for resistance to wet bacterial penetration. A donor contaminated with a bacterial suspension is moved across the test material under defined mechanical friction. The result is the barrier index, describing retention under simultaneous moisture and abrasion.
EN ISO 22612
EN ISO 22612 specifies the test method for resistance to dry microbial penetration. Talc powder loaded with bacterial spores is applied to the material under defined vibration. The number of colony-forming units reaching the reverse side is measured.
EN ISO 374-1
EN ISO 374-1 defines terminology and performance requirements for protective gloves against hazardous chemicals. It classifies chemical-resistant gloves into Type A (≥6 test chemicals, Class 2+), Type B (≥3 chemicals, Class 2+), and Type C (≥1 chemical, Class 1). All three types are PPE Category III.
EN ISO 374-2
EN ISO 374-2 defines the test procedure for penetration of water and air through protective gloves. The test detects macroscopic defects (holes, tears). It is the basis for micro-organism protection per EN ISO 374-5 and is methodologically related to the water leak test in EN 455-1.
EN ISO 374-4
EN ISO 374-4 defines the test procedure for determining degradation of protective glove materials by chemical contact. Changes in wall thickness and tensile strength after chemical exposure are measured. Degradation is distinct from permeation and penetration and describes physico-chemical material change.
EN ISO 374-5
EN ISO 374-5 sets requirements for protective gloves against micro-organisms (bacteria, fungi, viruses). Gloves protecting against bacteria and fungi must pass the penetration test per EN ISO 374-2. Virus protection is an additional requirement tested per ISO 16604 (Method B). Gloves meeting EN ISO 374-5 are PPE Category III.
EN ISO 9001
EN ISO 9001 is the general international standard for quality management systems (QMS). It sets requirements that organisations of any type can meet to consistently deliver products and services that satisfy customers. In the medical device sector, EN ISO 9001 is replaced or supplemented by the stricter EN ISO 13485.
EU Declaration of Conformity
The EU Declaration of Conformity is the legally binding document in which the manufacturer declares on their own responsibility that their product meets all applicable EU requirements. It is a mandatory component of the CE marking procedure and must be retained for the product's lifetime.
EU Representative
The EU Authorised Representative (AR) is a natural or legal person established in the EEA who has been formally designated in writing by a manufacturer outside the EEA to act on their behalf. They are the contact point for EU authorities and bear specific obligations under MDR (EU) 2017/745.
EU Type Examination
EU type-examination is a conformity assessment procedure in which a Notified Body examines and certifies a representative sample of a product, confirming that it meets the essential safety requirements of the applicable EU regulation. It is mandatory for medical devices from Class IIa (MDR Annex X) and PPE Categories II and III.
EUDAMED
EUDAMED (European Database on Medical Devices) is the EU's central database for medical devices, operated by the European Commission. It centralises registration, UDI, certification, and vigilance data. Manufacturers, authorised representatives, and importers are required to register under MDR (EU) 2017/745.
Examination Glove
Examination gloves are medical single-use gloves per EN 455, classified as Class I medical devices. They protect patients and healthcare workers during examinations and procedures. The leak-tightness requirement is AQL 1.5 per EN 455-1. They are supplied NON STERILE – unlike surgical gloves.