Regulations govern the quality of our products.
Our international certification bodies, after numerous tests and inspections, certify that our products and raw materials strictly comply with the set of rules pertaining to a specific discipline or industry. The products we market are regulated by regulations related to Medical Devices (MD), Personal Protective Equipment (PPE), and their dual compliance (MD and PPE).
UNI EN 455-1:2022
Specifies the requirements and provides the test method for the examination gloves in order to determine their freedom from holes.
UNI EN 455-2:2015
Specifies the requirements and provides the test methods for the physical properties of disposable medical gloves to ensure an adequate level of protection for both the patient and the wearer against mutual contamination during their use.
UNI EN 455-3:2024
Specifies the requirements related to the evaluation of the biological safety of disposable medical gloves. It provides requirements for labeling, packaging, and disclosure of information regarding the test methods employed.
UNI EN 455-4:2009
Specifies the requirements for the shelf-life of disposable medical gloves.
UNI EN ISO 10993-5
Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity. Describes the test methods for evaluating the in vitro cytotoxicity of medical devices.
UNI EN ISO 10993-10
Biological evaluation of medical devices – Part 10: Tests for skin sensitization. Describes the procedure for evaluating medical devices and their constituent materials for their potential to produce skin sensitization.
UNI EN ISO 10993-23
Biological evaluation of medical devices – Part 10: Tests for skin irritation. Describes the procedure for evaluating medical devices and their constituent materials for their potential to produce skin irritation.
ASTM F1671/F1671M-13
Standard test method for resistance of materials used in protective clothing to penetration by blood-borne pathogens using the viral penetration as a test system. Describes the properties of penetration resistance and test methods for materials used in the manufacturing of protective clothing.
ASTM D6319
Describes the test methods for performance and safety of nitrile rubber medical gloves used in medical examinations, diagnostics, and treatment procedures.
ASTM D3578
Describes the test methods for performance and safety of latex medical gloves used in medical examinations, diagnostics, and treatment procedures.
UNI CEI EN ISO 15223-1:2017
Requirements and symbols for the labeling of medical devices.
UNI EN ISO 11137-1
Sterilization of health care products – Radiation – Part 1: Requirements for the development, validation, and routine control of sterilization processes for medical devices.
EN ISO 374-1:2016 + A1:2018
Specifies the terminology and performance requirements for gloves intended to protect the user against hazardous chemicals. It should be used in conjunction with UNI EN 420. The standard does not specify requirements for protection against mechanical hazards.
EN 374-2:2014
Specifies a test method for the resistance to penetration of protective gloves against chemicals and/or hazardous microorganisms.
EN 374-4:2013
Specifies the test method for determining the resistance of protective glove materials to degradation when in continuous contact with hazardous chemicals.
EN ISO 374-5:2016
Specifies the requirements and test methods for gloves intended to protect the user against microorganisms.
EN 16523-1:2015
Specifies a test method for determining the resistance of protective clothing mateials, gloves, and footwear to permeation by potentially hazardous liquid chemicals under continuous contact conditions. The method is not suitable for evaluating chemical mixtures, except for aqueous solutions.
EN 420:2003 + A1:2009 / EN ISO 21420:2020
Defines the general requirements and corresponding test procedures for the design and manufacture of gloves, resistance of glove materials to water penetration, innocuousness, comfort, efficiency, marking, and information supplied by the manufacturer applicable to all protective gloves.
UNI ISO 2859-1:2007
Sampling procedures for inspection by attributes – part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection. Describes the system of acceptance sampling inspection for attributes. It is indexed based on the acceptable quality limit (AQL).
For further information on the Current Regulations, please contact our Quality Office
+39.0444.240522 qualita@bericah.it
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Italy
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Italy
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Arcugnano (VI)
Italia
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