Validations
Our team supports companies by verifying the validity and correctness of production processes, a mandatory step for organizations seeking to obtain declarations of conformity with applicable standards.
Obtaining an evaluation from an industrial testing laboratory is essential to ensure the efficiency and quality of business processes, as well as to guarantee the safety of manufactured devices.
We provide the following validation services:
- validation of cleaning and disinfection cycles for reusable medical devices (ISO 17664);
- validation of sterilization cycles for medical devices (ISO 17664, ISO/TS 15883-5);
- validation activities for obtaining CE marking;
- packaging validation (UNI EN ISO 11607-1/2);
- validation of bioburden analysis;
- conformity testing of medical devices (in accordance with relevant ISO or UNI standards).
Validation of Device Washing Cycles
ISO 17664
Cleaning and disinfection are key steps in the reprocessing of reusable medical devices.
We validate industrial washing cycles on behalf of companies to ensure that these processes comply with applicable regulatory standards.
Validation of Sterilization Cycles
ISO 17664, ISO/TS 15883-5
Achieving sterilization - defined as the complete and irreversible destruction of microorganisms and spores - is a crucial stage in the production cycle, particularly for biomedical devices intended for contact with the human body.
We perform sterilization cycle validations for medical devices, ensuring compliance with the relevant regulatory requirements.
Validation for CE Marking
One of the services provided by Techno Analisys is supporting companies in achieving CE marking.
We conduct the laboratory testing and process validations required to qualify and certify medical devices, enabling them to meet the regulatory requirements for market access.
Packaging Validation
UNI EN ISO 11607-1/2
Packaging validation consists of several tests, including:
- visual inspection (ASTM F1886-16);
- peel test (UNI EN 868-5 Annex E);
- verification of the absence of micro-perforations (UNI EN 868-5 Annex C);
- bubble test (ASTM F2096);
- verification of the absence of channel leaks in seals (ASTM F1929);
- tensile strength test of seals;
- microbial barrier test (DIN 58953-6).
These tests are essential to confirm the ability of the packaging to maintain the device sterile and intact.
Medical Device Validation
In accordance with relevant ISO or UNI standards
Medical device validation - such as for infusion sets, catheters and needles - is carried out according to the specific ISO standards applicable to each product (for example ISO 8536 for infusion sets).
These tests verify functionality, mechanical integrity and safety of use, ensuring that each device performs correctly under the intended conditions of use.