Regulations

Regulations govern the quality of our products

normative
normative

Our international certification bodies, following numerous tests and inspections, certify that the products and raw materials strictly comply with the set of standards applicable to a given discipline or sector.

normative

The products we market are regulated by standards related to Medical Devices (DM), Personal Protective Equipment (PPE), and their corresponding dual compliance (MD and PPE).

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Regulations

MD – Medical Devices EU Regulation 2017/745

Specifies the requirements and provides the test method for disposable medical gloves to determine the absence of holes.

Specifies the requirements and provides test methods for the physical properties of disposable medical gloves, in order to ensure an adequate level of protection for both the patient and the user against cross-contamination during use.
Specifies the requirements for the evaluation of the biological safety of disposable medical gloves. It also provides requirements for the labeling and packaging of the gloves, as well as for the disclosure of information regarding the test methods used.
Specifies the requirements for the shelf life of disposable medical gloves.
Biological evaluation of Medical Devices – Part 5: tests for in vitro cytotoxicity. Describes the test methods used to evaluate the in vitro cytotoxicity of medical devices.
Biological evaluation of Medical Devices – Part 10: skin sensitization tests. Describes the procedure for evaluating medical devices and their constituent materials based on their potential to cause skin sensitization.
Biological evaluation of Medical Devices – Part 10: skin irritation tests. Describes the procedure for evaluating medical devices and their constituent materials based on their potential to cause skin irritation.
Standard test method for the resistance of materials used in protective clothing to penetration by blood-borne pathogens using bacteriophage penetration as the test system. Describes the penetration resistance properties and test methods for materials used in the manufacture of protective clothing.
Describes the test methods for the performance and safety of nitrile rubber medical gloves used in medical examinations, diagnostics, and treatment procedures.
Describes the test methods for the performance and safety of latex medical gloves used in medical examinations, diagnostics, and treatment procedures.
Requirements and symbols to be used in the labeling of Medical Devices.
Sterilization of healthcare products – Radiation – Part 1: Requirements for the development, validation, and routine control of sterilization processes for Medical Devices.
PPE – Personal Protective Equipment EU Regulation 2016/425
Specifies the terminology and performance requirements for gloves intended to protect the user against hazardous chemicals. It must be used in conjunction with UNI EN 420. The standard does not specify requirements for protection against mechanical risks.
Specifies a test method for the resistance to penetration of protective gloves against hazardous chemicals and/or microorganisms.
Specifies the test method for determining the resistance of protective glove materials to degradation caused by continuous contact with hazardous chemicals.
Specifies the requirements and test methods for gloves intended to protect the user against microorganisms.
Specifies a test method for determining the resistance of materials used in protective clothing, gloves, and footwear to permeation by potentially hazardous liquid chemicals under conditions of continuous contact. The method is not suitable for evaluating chemical mixtures, except for aqueous solutions.
Defines the general requirements and corresponding test procedures for glove design and manufacture, the resistance of glove materials to water penetration, harmlessness, comfort and efficiency, marking, and the information supplied by the manufacturer applicable to all protective gloves.
Sampling procedures for inspection by attributes – Part 1: sampling schemes indexed by the Acceptable Quality Limit (AQL) for lot-by-lot inspection. Describes the acceptance sampling system for inspection by attributes, indexed according to the Acceptable Quality Limit (AQL).
IVD – In Vitro Diagnostic Medical Devices EU Regulation 2017/746
In Vitro Diagnostic Medical Devices – Single-use containers for the collection of human specimens, other than blood.
CHEMICAL SUBSTANCES AND MIXTURES Regulation (EC) No 1272/2008
COSMETIC PRODUCTS Regulation (EC) No 1223/2009
For more information on current regulations, please contact our Quality Department.
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Dr. Protec is a brand owned by Bericah S.p.A.

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