Determination of microbial contamination according to PN-EN ISO 11737-1

WHAT TESTS DO WE OFFER?

Determination of the population of microorganisms on non-sterile products intended for:

1. Sterilization to determine the initial microbiological contamination to determine the effective conditions of the sterilization process
2. Other medical devices that will not be sterilized

We perform tests according to:

PN-EN ISO 11737-1 standard

WHO DO WE DIRECT OUR SERVICE TO?

Plants producing medical devices such as: dressing materials, diagnostic tools and instruments, prostheses, cameras, needles, probes, etc.

LEGAL REQUIREMENTS:

Medical directives were introduced into the Polish legal system by the Act of 20 May
2010 on medical devices and executive acts issued on its basis. According to
by law, medical devices must be designed and manufactured in such a way that they
the use did not endanger the health and safety of patients. Products must comply
appropriate criteria of microbiological purity.

OUR CERTIFICATES AND AUTHORIZATIONS:

Mikrolab has the permission of the Chief Pharmaceutical Inspector for the production (testing) of medicinal products and investigational medicinal products (for clinical trials) in the field of microbiological quality control of non-sterile products.

Mikrolab has a GMP certificate approved by the Chief Pharmaceutical Inspector.

Mikrolab has a research laboratory accreditation certificate issued by the Polish Center for Accreditation, accreditation number AB 1531.

Mikrolab has been approved by the State Sanitary Inspection for water testing. The test results are honored by the Sanitary and Epidemiological Stations.

WHY SHOULD I DETERMINE MICROBIOLOGICAL CONTAMINATION IN NON-STERILE PRODUCTS ACCORDING TO ISO 11737-1?

Medical devices include:

1. dressing materials,
2. diagnostic tools and instruments,
3. prostheses, appliances.

The presence of microorganisms in the product may adversely affect the health of patients.
Determining the population of microorganisms (bioburden) on products makes it possible to determine the appropriate sterilizing dose needed to obtain the required sterility of the product.