EN ISO 11133:2014

 

As announced in 2015, we are pleased to confirm you that all bioMérieux culture media intended for foodborne and water analyses are fully manufactured and tested in accordance with the requirements of EN ISO 11133: 2014 " Preparation, production, storage and performance testing of culture media".

Implementation of the standard and bioMérieux certificates of control

After an assessment of the standard and its impacts, each new quality control protocol was evaluated on 3 batches of each medium.

Certificates of control now indicate "Controlled according to ISO 11133" replacing "Conforms to XP CEN ISO / TS 11133-2 (Jan 2004) and A1" and meet the requirements of ISO 11133 (§ 6.4. 2) specifying the expected and obtained results.

Simplify performance testing for laboratories

In accordance with ISO 11133: 2014, users of our ready-to-use culture media are not required to carry out extensive tests.

Indeed, simplification of performance testing is permitted if the manufacturer has an ISO 9001 certification, has a Quality program in place and issues quality certificates with the product (§ 6.4.2).

bioMérieux meeting these requirements, simplified performance checks of prepared media employment is permitted. The laboratory must only ensure that the storage conditions recommended by the manufacturer are met and hold documentary evidence to ensure that the acceptance criteria meet its requirements.

In addition, bioMérieux provides a certificate of stability and validation of the transport conditions (available on request). The lifetimes of our culture media are determined by a real-time stability study. The application of a thermal shock procedure simulating transport conditions and demonstrating the maintenance of the quality of the media during transport may also enable laboratories to simplify periodic checks (§ 6.4.2).

In order to simplify the work of the laboratories, bioMérieux also proposes ready-to-use reference media (TSA-ISO 11133 and SDA-ISO 11133) that have already been checked according to the requirements of the standard for relevant Productivity tests.

BioMérieux, a permanent commitment to maintain compliance

The ISO 11133: 2014 standard is intended to remain a general reference document for the implementation of performance tests. However, the tests described in Annexes E and F of the standard will not be revised but will be included in the specific standards (e.g., ISO 6579 for Salmonella) when they are revised.

For all its media intended for foodborne analyses, bioMérieux is committed to maintain compliance with the performance tests described in specific standards that are published subsequently to the ISO 11133: 2014.

Then, the quality control certificates will indicate the revised specific standard, for the concerned medium, in addition to the reference to ISO 11133: 2014.

For information, two amendments to ISO 11133: 2014 are currently under preparation:

Ø  AMD1: corrects and clarifies the text for a better application
(publication expected at the end of 2017 / beginning of 2018)

Ø  AMD2: describes performance tests for confirmatory media and reagents
(expected in 2018)

We hope that this information will give you complete satisfaction, is a good support to justify the simplification of performance tests of our ready to use media and a guarantee for the reliability of your microbiological analyzes.

Our Customer Service is at your disposal to answer any questions you may have.

 

 

 

 

 
 
Pioneering diagnostics