The protocol for validating microbiological test kits has been revised to ensure that requirements are harmonized at the international level following the release of ISO 16140-2. This move comes as good news for NF Validation-certified manufacturers, since the new international standard will simplify the process of gaining recognition for the reliability and performance of their kits around the world.
Are you familiar with NF Validation? If you use microbiological test kits, then the answer is “definitely”. Companies manufacturing such products use certification as official confirmation of their performance and reliability. But until now, French manufacturers looking to sell their kits on the American market have had to conform to the US national certification standard (AOAC), whose requirements are clearly different to those applicable in Europe.
Two-in-one
In an effort to harmonize the technical requirements of the various standards, AFNOR Certification took advantage of the decision to revise international standard ISO 16140-2, which describes the validation protocol for kits, to set up a cooperative arrangement with AOAC. The NF Validation standard has therefore been aligned with the new changes in ISO 16140, which will be officially released in the summer of 2016.
Dual NF Validation and AOAC certification is still essential for breaking into the US market, but manufacturers can now share the tests on their products within the same laboratory and thereby reduce their certification costs.
Certified manufacturers will be able to show their credentials on both sides of the Atlantic.
In case of kits that have already been certified to NF Validation, the new requirements of ISO 16140-2 must be applied no later than when their certification is renewed. In case of newly certified products, the requirements will be applicable when the standard is released.
Reminder
AFNOR Certification issues NF Validation certificates to manufacturers of rapid test kits to confirm their performance and reliability. The NF Validation product certification standard meets European regulatory requirements and enjoys a high international profile. It applies to the microbiological analysis of food and water.
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