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The NF Mark Male condoms is a fundamental element to enhance the quality, performance and reliability of your products (natural rubber latex condoms and additional lubricants) in the European market and to differentiate you from your competitors. The NF Mark brings additional quality guarantees to the requirements of the European Medical Devices directive to which your products must comply.

Presentation of the certification

Based on the control of each batch produced by tests at the LNE laboratories before being placed on the market, the NF Mark Male Condoms guarantees to your customers (hypermarkets and supermarkets, pharmacists, central purchasing organizations, e-commerce company, etc.) that your condoms consistently and systematically comply with the requirements of the European Medical Devices Directive (93/42 / EEC) and the applicable French standard NF EN ISO 4074.

How?

For condoms, tests are carried out on each batch produced before they are placed on the market, in order to ensure compliance with the applicable product standard and the announced characteristics:

  • Measurement of length
  • Measurement of width
  • Measurement of thickness (if ≤ 55 μm)
  • Measurement of bursting volume and pressure
  • Measurement of bursting volume and pressure after steaming (7 days at 70 ° C)
  • Detection of perforation
  • Detection of visible defects

For lubricants, tests are regularly carried out on samples taken at the manufacturing site to verify their compatibility with condoms and the absence of degradation of the physical properties of condoms.

In all cases, the quality control system and the testing facilities set up by the manufacturer are regularly checked to ensure consistency in the quality of the products supplied.

Why choose the NF Mark Male condoms?

By placing the NF mark on your products, you give your customers certainty to comply with the regulations in force in the European Economic Area and to provide them with products whose manufacture, quality and reliability are constantly controlled.

Obtaining certification

Consult the rules defining the scope of certification management, namely: the field of application, the set of requirements to be respected by the applicant/owner, the certification granting and monitoring protocol, and the stakeholders. Certificate issuance is overseen by Part 3 of the certification rules.

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