Safety, Efficacy Tests and Classification of Medical Devices

Make sure that your medical devices comply with national, international and European standards and regulations

Do you want to make sure your Medical Device is safe and efficient?

Abich - Lifeanalytics laboratory can test any product and device with diagnostic or therapeutic purposes.

From design to marketing, one of the crucial stages in the creation of an innovative medical device is making sure that it complies with standards and regulations.

Regulation (EU) 2017/745 and Regulation (EU) 2017/746 are the reference points specifying that the difference with a medication is the mode of action, which is physical for medical devices: electrical conduction, mechanical stimulation, thermal activity, etc. The regulations provide that these devices must comply with specific and detailed essential requirements. Therefore, they need to undergo numerous safety and efficacy tests in compliance with the strict protocols of the international (ISO), European (EN) and national (UN) technical reference standards and also classification tests in line with the new European regulation on medical devices.

Medical device means “any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

  • Diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
  • Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
  • Investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
  • Providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,

and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.”

The Italian laws transposing the European Community Directives divide medical devices into three different categories:

  • Active Implantable Medical Devices (Directive 90/385/EEC; Italian legislative decree 14 December 1992, No. 507),
  • Medical Devices (in general), (Directive 93/42/EEC; Italian legislative decree 24 February 1997, No. 46),
  • In vitro Diagnostic Medical Devices, (Directive 98/79/EEC; Italian legislative decree 8 September 2000, No. 332).

In addition, medical devices are divided into 4 classes, from the least critical to the most critical, as described in Annex IX of Italian Legislative Decree 24 February 1997, No. 46: I, IIa, IIb, III.

The classification depends on the complexity of the medical device and the potential risk for the patient on the basis of three factors:

  • Invasiveness: depending on the degree of penetration of the medical device into the human body,
  • Duration of use: if the medical device needs to be used only once or for a longer period of time,
  • Dependence on sources of energy.

On the basis of this classification, medical devices have to follow very different procedures to obtain conformity (CE marking):

  • Class I: the compliance evaluation procedures can be ‘self-certified’ by the manufacturer under its sole responsibility,
  • Class IIa: the notified body intervenes only for controls during manufacturing; the package leaflet is not required,
  • Class IIb: the notified body intervenes both during design and manufacturing. The package leaflet is required,
  • Class III: the notified body intervenes both during design and manufacturing. A prior authorisation with regard to the conformity of the device is required. The package leaflet is required.

The Regulation introduced the concept of ‘devices composed of substances‘. Their classification is defined on the basis of the new Rule 21 (Annex VIII).

What does Rule 21 envisage?

The devices composed of substances or of combination of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body are classified as:

  • Class III if they, or their products of metabolism, are systemically absorbed by the human body in order to achieve the intended purpose,
  • Class III if they achieve their intended purpose in the stomach or lower gastrointestinal tract and they, or their products of metabolism, are systemically absorbed by the human body,
  • Class IIa if they are applied to the skin or if they are applied in the nasal or oral cavity as far as the pharynx, and achieve their intended purpose on those cavities,
  • Class IIb in all other cases.
Effettua l'analisi sui tuoi dispositivi medici con Lifeanalytics
lifeanalytics icon

Lifeanalytics, your safest choice in the Medical Device industry

Abich – Lifeanalytics, the Group’s Competence Center for Pharma and Cosmetic industries, will be your one-stop shop and will support you in all the necessary stages of your medical device, from research and development to market release.

Our services include:

  • Consultancy for formulation and development
  • Regulatory support
  • Drawing up technical files
  • Risk evaluation
  • Drawing up the list of Essential Safety Requirements (ESR)
  • Safety and efficacy studies
  • Characterisation of materials
  • Clinical data analysis
  • Registration assistance (first notification and market release)

Browse the full range of services in our website:

  • Determination of breathability (differential pressure) on surgical masks
    The test is designed to be applied to raw materials and finished products with the purpose of substantiating the claim “Determination of breathability”.
    Determination of the differential pressure is an indicator of the “breathability” of the mask. Air permeability is measured by determining the pressure difference across the mask under specific conditions of airflow, temperature and humidity.

  • In vitro skin irritation test according to ISO 10993-23:2021
    The test is designed to be applied to raw materials and finished products with the purpose of substantiating the claim “Biocompatible”. In vitro skin irritation test for solid medical devices according to ISO 10993-23:2021.

  • Bioburden: Microbiological cleanliness analysis according to UNI EN ISO 11737-1:2018 and UNI EN 14683:2019
    The test is designed to be applied to raw materials and finished products with the purpose of substantiating the claim “Determination of bacterial charge”.
    The Bioburden analysis is designed to determine the microbiological cleanliness of medical face masks in order to evaluate their suitability for medical usage.

  • Bacterial Filtration Efficacy (BFE) testing according to ISO 14683
    The test is designed to be applied to raw materials and finished products with the purpose of substantiating the claim “BFE (Bacterial Filtration Efficiency)”.
    Bacterial Filtration Efficacy (BFE) testing according to EN 14683:2019 (B) through Andersen six stage viable impactor. The analysis is performed on textile samples for the production of surgical masks or on finished surgical masks.

  • Evaluation of barrier effects on 3D reconstructed human epidermis according to proprietary method
    The test is designed to be applied to topical products with the purpose of substantiating the claim “Protects and repairs the cutaneous barrier”.
    Evaluation on 3D in vitro epidermis of the efficacy of a product in protecting against acids, alkalis or solvents.

  • Evaluation of barrier effects on 3D reconstructed human epidermis and analysis of inflammatory cytokines according to proprietary method
    The test is designed to be applied to topical products with the purpose of substantiating the claim “Protects and repairs the cutaneous barrier”.
    Evaluation of the protective efficacy against acids, alkalis or solvents on in vitro 3D human epidermis, paired with evaluation of the protection against pro-inflammatory substances.

  • Barrier effect test on 3D reconstructed skin by analysis of the transcutaneous passage of caffeine according to proprietary method
    The test is designed to be applied to solutions or finished products with the purpose of substantiating the claim “Barrier effect”.
    Quantification by HPLC of the amount of caffeine permeating the skin barrier of in vitro 3D skin in Franz’s cells, compared to the total titer of the same substance in the applied product.

  • Barrier effect test on 3D reconstructed skin by analysis of the transcutaneous passage of testosterone according to proprietary method
    The test is designed to be applied to solutions or finished products with the purpose of substantiating the claim “Barrier effect”.
    Quantification by HPLC of the amount of testosterone permeating the skin barrier of in vitro 3D skin in Franz’s cells, compared to the total titer of the same substance in the applied product.

  • Protection and barrier effect test on oral epithelium with analysis of IL1-Alpha expression according to proprietary method
    The test is designed to be applied to topical products with the purpose of substantiating the claim “Protects and repairs the cutaneous barrier”.
    Measurement of inhibitory efficacy of an active ingredient or finished product against the adhesion of Staphylococcus aureus to epithelial cells.

  • Barrier effect test against microbial strains according to proprietary method
    The test is designed to be applied to raw ingredients or finished products with the purpose of substantiating the claim “Inhibition of bacterial adhesion”.
    Measurement of inhibitory efficacy of an active ingredient or finished product against the adhesion of Staphylococcus aureus to epithelial cells.

  • Percutaneous absorption test according to proprietary method
    The test is designed to be applied to solutions or finished products with the purpose of substantiating the claim “Evaluation of transcutaneous absorption”.
    Quantification by HPLC of the amount of an active ingredient permeating the skin barrier of artificial or in vitro 3D skin in Franz’s cells, compared to the total titer of the same substance in the applied product.
  • Stability test according to ICH and ISO
    The test is designed to be applied to medical devices and cosmetics with the purpose of substantiating the claim “Accelerated stability tests”.
    Accelerated stability test according to ICH guidelines and ISO regulatory requirements, for medical devices and cosmetics.

  • Biocompatibility test according to ISO 10993-10
    The test is designed to be applied to finished products, textiles, solid products by eluate with the purpose of substantiating the claim “biocompatible”.
    Biocompatibility test: triple analysis for irritation, cytotoxicity and sensitization potential.

  • Evaluation of bacterial adhesion on mammal cells according to proprietary method
    The test is designed to be applied to medical devices design to inhibit bacterial adhesion with the purpose of substantiating the claim “Inhibition of bacterial adhesion”.
    Evaluation of bacterial adhesion on mammal cells, performed on the CACO-2 cell line.

  • Challenge Test according to ISO 11930 for cosmetics and European Pharmacopoeia for medical devices
    The test is designed to be applied to cosmetics and medical devices with the purpose of substantiating the claim “Efficacy of preservatives”.
    Challenge test for the evaluation of the efficacy of preservative systems according to ISO guidelines (for cosmetics) and European Pharmacopoeia (for medical devices).
  • Mucoadhesion test according to proprietary method
    The test is designed to be applied to finished products for direct application on external mucosae with the purpose of substantiating the claim “mucoadhesive effect”.
    Gravimetric analysis of the adhesion of a product on a layer of mucin against the same product on an untreated plane. Detachment kinetics in terms of percentage of adhesion against a non-adhesive control.
  • Resistance to washing off by saliva according to proprietary method
    The test is designed to be applied finished products for oral application with the purpose of substantiating the claim “mucoadhesive effect”.
    Analysis of the resistance to washing off by artificial saliva by gravimetric analysis of the dry weight of the sample before and after washes in controlled conditions.

  • Mucoadhesion test: gravimetric variant using the dry weight of the product according to proprietary method
    The test is designed to be applied to finished products for direct application on external mucosae with the purpose of substantiating the claim “mucoadhesive effect”.
    Analysis of the resistance to washing off with and without a basal layer of mucin. Determination of the percentage of resistance against the same product on substrate without mucin.

  • Quantification of the titer of substances according to Regulation 1223/209
    The test is designed to be applied to preservatives, dyes and sunscreen filters with the purpose of substantiating claims “Titer of substances” and “Limit of preservatives”.
    Quantification method for the measurement of the titer of substances by HPLC, UPLC, GC-MS after preparative steps.

  • Stability test according to ICH and ISO
    The test is designed to be applied to medical devices and cosmetics with the purpose of substantiating the claim “Accelerated stability tests”.
    Accelerated stability test according to ICH guidelines and ISO regulatory requirements, for medical devices and cosmetics.

  • Biocompatibility test according to ISO 10993-10
    The test is designed to be applied to finished products, textiles, solid products by eluate with the purpose of substantiating the claim “biocompatible”.
    Biocompatibility test: triple analysis for irritation, cytotoxicity and sensitization potential.

  • Challenge Test according to ISO 11930 for cosmetics and European Pharmacopoeia for medical devices
    The test is designed to be applied to cosmetics and medical devices with the purpose of substantiating the claim “Efficacy of preservatives”.
    Challenge test for the evaluation of the efficacy of preservative systems according to ISO guidelines (for cosmetics) and European Pharmacopoeia (for medical devices).
  • Clinical tests with high resolution infrared camera using healthy volunteers according to proprietary method
    The test is designed to be applied to raw materials and finished products with the purpose of substantiating the claim “Infrared thermography”.
    Simulation in conditions of long or short term use of the medical device. The test includes mathematical processing of physical data in order to have a quantitative result of the change in the temperature of the skin treated by the product over time.

  • Skin tolerability test under dermatological supervision according to Guidelines to Commission Regulation (EU) No 655/2013
    The test is designed to be applied to heating and cooling medical devices and cosmetic products with the purpose of substantiating the claim “Dermatologically tested”.
    • Measurement at T=0 before the application and after a preset duration agreed upon with the sponsor;
    • Temperature control using an infrared non-invasive thermometer;
    • Evaluation of the erythemal response through skin colorimetry using a Mexameter® MX18 colorimeter (Courage-Khazaka GmbH – Germany);
    • Evaluation by clinical experts of the general conditions of the skin and epidermal tolerability during use;
    • Subjective evaluation through predefined questionnaire with numerical score system (visual analogical scale) and judgement of the tolerability and heat/chill feeling as perceived during the application of the product;
    • Comparative photography with colorimetric reference captured with a 100 mm macro objective and normalization of the color with coaxial circular flash.

  • Quantification of the titer of substances according to Regulation 1223/209
    The test is designed to be applied to preservatives, dyes and sunscreen filters with the purpose of substantiating claims “Titer of substances” and “Limit of preservatives”.
    Quantification method for the measurement of the titer of substances by HPLC, UPLC, GC-MS after preparative steps.

  • Stability test according to ICH and ISO
    The test is designed to be applied to medical devices and cosmetics with the purpose of substantiating the claim “Accelerated stability tests”.
    Accelerated stability test according to ICH guidelines and ISO regulatory requirements, for medical devices and cosmetics.

  • Biocompatibility test according to ISO 10993-10
    The test is designed to be applied to finished products, textiles, solid products by eluate with the purpose of substantiating the claim “biocompatible”.
    Biocompatibility test: triple analysis for irritation, cytotoxicity and sensitization potential.

  • Challenge Test according to ISO 11930 for cosmetics and European Pharmacopoeia for medical devices
    The test is designed to be applied to cosmetics and medical devices with the purpose of substantiating the claim “Efficacy of preservatives”.
    Challenge test for the evaluation of the efficacy of preservative systems according to ISO guidelines (for cosmetics) and European Pharmacopoeia (for medical devices).
  • Compatibility test for use with condoms according to proprietary method based on ISO 4074
    The test is designed to be applied to vaginal products and lubrificants with the purpose of substantiating the claim “Compatible with latex condoms”.
    The test evaluates the compatibility of the product with latex, polyurethane or polyisoprene condoms analyzing any variation in the mechanical resistance to traction and bursting following contact with the lubricating medical device being analyzed in comparison with appropriate controls.

  • Biocompatibility test according to ISO 10993-10
    The test is designed to be applied to finished products, textiles, solid products by eluate with the purpose of substantiating the claim “biocompatible”.
    Biocompatibility test: triple analysis for irritation, cytotoxicity and sensitization potential.

  • Challenge Test according to ISO 11930 for cosmetics and European Pharmacopoeia for medical devices
    The test is designed to be applied to cosmetics and medical devices with the purpose of substantiating the claim “Efficacy of preservatives”.
    Challenge test for the evaluation of the efficacy of preservative systems according to ISO guidelines (for cosmetics) and European Pharmacopoeia (for medical devices).

  • Percutaneous absorption test according to proprietary method
    The test is designed to be applied to solutions or finished products with the purpose of substantiating the claim “Evaluation of transcutaneous absorption”.
    Quantification by HPLC of the amount of an active ingredient permeating the skin barrier of artificial or in vitro 3D skin in Franz’s cells, compared to the total titer of the same substance in the applied product.

  • Quantification of the titer of substances according to Regulation 1223/209
    The test is designed to be applied to preservatives, dyes and sunscreen filters with the purpose of substantiating claims “Titer of substances” and “Limit of preservatives”.
    Quantification method for the measurement of the titer of substances by HPLC, UPLC, GC-MS after preparative steps.

  • Biocompatibility test according to ISO 10993-10
    The test is designed to be applied to finished products, textiles, solid products by eluate with the purpose of substantiating the claim “biocompatible”.
    Biocompatibility test: triple analysis for irritation, cytotoxicity and sensitization potential.

  • Challenge Test according to ISO 11930 for cosmetics and European Pharmacopoeia for medical devices
    The test is designed to be applied to cosmetics and medical devices with the purpose of substantiating the claim “Efficacy of preservatives”.
    Challenge test for the evaluation of the efficacy of preservative systems according to ISO guidelines (for cosmetics) and European Pharmacopoeia (for medical devices).
  • Determination of breathability (differential pressure) on surgical masks according to UNI EN 14683:2019 Annex C
    The test is designed to be applied to raw materials and finished products with the purpose of substantiating the claim “Determination of breathability”.
    Determination of the differential pressure is an indicator of the “breathability” of the mask. Air permeability is measured by determining the pressure difference across the mask under specific conditions of airflow, temperature and humidity.
  • In vitro skin irritation test according to ISO 10993-23:2021
    The test is designed to be applied to raw materials and finished products with the purpose of substantiating the claim “Biocompatible”.
    In vitro skin irritation test for solid medical devices according to ISO 10993-23:2021.
  • Bioburden: Microbiological cleanliness analysis according to UNI EN ISO 11737-1:2018 and UNI EN 14683:2019
    The test is designed to be applied to raw materials and finished products with the purpose of substantiating the claim “Determination of bacterial charge”.
    The Bioburden analysis is designed to determine the microbiological cleanliness of medical face masks in order to evaluate their suitability for medical usage.
  • Bacterial Filtration Efficacy (BFE) testing according to ISO 14683
    The test is designed to be applied to raw materials and finished products with the purpose of substantiating the claim “BFE (Bacterial Filtration Efficiency)”.
    Bacterial Filtration Efficacy (BFE) testing according to EN 14683:2019 (B) through Andersen six stage viable impactor. The analysis is performed on textile samples for the production of surgical masks or on finished surgical masks.
  • Wound healing test according to proprietary method
    The test is designed to be applied to wound healing products with the purpose of substantiating the claim “Improves cicatrization”.
    Analysis of the regenerative efficacy on epidermal cell cultures after simulated wounding. Results in terms of percentage of improvement in the regeneration kinetics versus untreated substrate.
  • Mucoadhesion test according to proprietary method
    The test is designed to be applied to finished products for direct application on external mucosae with the purpose of substantiating the claim “mucoadhesive effect”.
    Gravimetric analysis of the adhesion of a product on a layer of mucin against the same product on an untreated plane. Detachment kinetics in terms of percentage of adhesion against a non-adhesive control.
  • Mucoadhesion test: gravimetric variant using the dry weight of the product according to proprietary method
    The test is designed to be applied to finished products for direct application on external mucosae with the purpose of substantiating the claim “mucoadhesive effect”.
    Analysis of the resistance to washing off with and without a basal layer of mucin. Determination of the percentage of resistance against the same product on substrate without mucin.
  • Quantification of trace substances and impurities according to UE Regulation
    The test is designed to be applied to cosmetics and medical devices with the purpose of substantiating the claim “Titer of substances”.
    Analysis of trace substances, residues and impurities for quality control purposes through UPLC or GC-MS. Includes sample preparation.
  • Quantification of the titer of substances according to Regulation 1223/209
    The test is designed to be applied to preservatives, dyes and sunscreen filters with the purpose of substantiating claims “Titer of substances” and “Limit of preservatives”.
    Quantification method for the measurement of the titer of substances by HPLC, UPLC, GC-MS after preparative steps.
  • Stability test according to ICH and ISO
    The test is designed to be applied to medical devices and cosmetics with the purpose of substantiating the claim “Accelerated stability tests”.
    Accelerated stability test according to ICH guidelines and ISO regulatory requirements, for medical devices and cosmetics.
  • Determination of breathability (differential pressure) on surgical masks according to UNI EN 14683:2019 Annex C
    The test is designed to be applied to raw materials and finished products with the purpose of substantiating the claim “Determination of breathability”.
    Determination of the differential pressure is an indicator of the “breathability” of the mask. Air permeability is measured by determining the pressure difference across the mask under specific conditions of airflow, temperature and humidity.
  • In vitro skin irritation test according to ISO 10993-23:2021
    The test is designed to be applied to raw materials and finished products with the purpose of substantiating the claim “Biocompatible”.
    In vitro skin irritation test for solid medical devices according to ISO 10993-23:2021.
  • Bioburden: Microbiological cleanliness analysis according to UNI EN ISO 11737-1:2018 and UNI EN 14683:2019
    The test is designed to be applied to raw materials and finished products with the purpose of substantiating the claim “Determination of bacterial charge”.
    The Bioburden analysis is designed to determine the microbiological cleanliness of medical face masks in order to evaluate their suitability for medical usage.
  • Bacterial Filtration Efficacy (BFE) testing according to ISO 14683
    The test is designed to be applied to raw materials and finished products with the purpose of substantiating the claim “BFE (Bacterial Filtration Efficiency)”.
    Bacterial Filtration Efficacy (BFE) testing according to EN 14683:2019 (B) through Andersen six stage viable impactor. The analysis is performed on textile samples for the production of surgical masks or on finished surgical masks.
  • Determination of antiviral activity of textile products according to ISO 18184:2019 (E)
    The test is designed to be applied to raw materials and finished products with the purpose of substantiating the claim “Antiviral activity”.
    The test can be performed on textiles (wool, fibers, spun materials, bundles, knitwear fabrics). Tested products can be used in hospitals and healthcare facilities, or as upholstery materials on transports. The virus strands used in the test are “Type A flu” and “Feline carcinovirus”. Other virus strands can be tested upon requests, following a feasibility study.
  • Antiviral activity on plastics and other non-porous surfaces according to ISO 21702:2019 (E)
    The test is designed to be applied to raw materials and finished products with the purpose of substantiating the claim “Antiviral activity”.
    The protocol reported by the standard requires the exposure of material specimens, with and without antiviral treatment, to two viral strains (H1N1 or H3N2 flu virus and Feline calicivirus) for a defined time.
    We can also test the antiviral activity against the following strains:
    • Human coronavirus 229 E,
    • Vaccinia virus Ankara,
    • Human adenovirus type 5,
    • Murine norovirus (MNV),
    • Human adenovirus type 5,
    • Poliovirus type 1 (SABIN),
    • Murine norovirus (MNV),
    • Rotavirus A,
    • Human herpesvirus 1 (HSV-1).

At the customer’s request, further additional viruses can be tested.

  • Barrier effect test on 3D reconstructed skin by analysis of the transcutaneous passage of caffeine according to proprietary method
    The test is designed to be applied to solutions or finished products with the purpose of substantiating the claim “Barrier effect”.
    Quantification by HPLC of the amount of caffeine permeating the skin barrier of in vitro 3D skin in Franz’s cells, compared to the total titer of the same substance in the applied product.
  • Quantification of trace substances and impurities according to UE Regulation
    The test is designed to be applied to cosmetics and medical devices with the purpose of substantiating the claim “Titer of substances”.
    Analysis of trace substances, residues and impurities for quality control purposes through UPLC or GC-MS. Includes sample preparation.
  • UV protection of textile products (UPF) according to BS EN 13758-1:2001
    The test is designed to be applied to textile fabrics, clothes, bandages with the purpose of substantiating the claim “UV protection factor for textiles (UPF)”.
    Evaluation of the protection in the UV spectrum granted by textile protective items or similar products through analysis of the absorbance.
  • Biocompatibility test according to ISO 10993-10
    The test is designed to be applied to finished products, textiles, solid products by eluate with the purpose of substantiating the claim “biocompatible”.
    Biocompatibility test: triple analysis for irritation, cytotoxicity and sensitization potential.
  • Stability test according to ICH and ISO
    The test is designed to be applied to medical devices and cosmetics with the purpose of substantiating the claim “Accelerated stability tests”.
    Accelerated stability test according to ICH guidelines and ISO regulatory requirements, for medical devices and cosmetics.
  • Determination of breathability (differential pressure) on surgical masks according to UNI EN 14683:2019 Annex C
    The test is designed to be applied to raw materials and finished products with the purpose of substantiating the claim “Determination of breathability”.
    Determination of the differential pressure is an indicator of the “breathability” of the mask. Air permeability is measured by determining the pressure difference across the mask under specific conditions of airflow, temperature and humidity.
  • In vitro skin irritation test according to ISO 10993-23:2021
    The test is designed to be applied to raw materials and finished products with the purpose of substantiating the claim “Biocompatible”.
    In vitro skin irritation test for solid medical devices according to ISO 10993-23:2021.
  • Bioburden: Microbiological cleanliness analysis according to UNI EN ISO 11737-1:2018 and UNI EN 14683:2019
    The test is designed to be applied to raw materials and finished products with the purpose of substantiating the claim “Determination of bacterial charge”.
    The Bioburden analysis is designed to determine the microbiological cleanliness of medical face masks in order to evaluate their suitability for medical usage.
  • Bacterial Filtration Efficacy (BFE) testing according to ISO 14683
    The test is designed to be applied to raw materials and finished products with the purpose of substantiating the claim “BFE (Bacterial Filtration Efficiency)”.
    Bacterial Filtration Efficacy (BFE) testing according to EN 14683:2019 (B) through Andersen six stage viable impactor. The analysis is performed on textile samples for the production of surgical masks or on finished surgical masks.
  • LAL (Lysate of Limulus Amaebocytes) test according to USP85
    The test is designed to be applied to raw ingredients and finished products with the purpose of substantiating the claim “Absence of bacterial endotoxins”.
    Lysate of Limulus amaebocytes (LAL) is an acqueous extract obtained by Limulus polyphemus amaebocytes. The LAL reacts strongly to endotoxins in Gram-negative bacterial membranes (lypopolysacchartides), resulting in coagulation. This property is exploited in the LAL test to detect endotoxins.
  • H295R Steroidogenesis Assay according to OECD 456
    The test is designed to be applied to raw ingredients and finished products with the purpose of substantiating the claim “No endocrine disruption”.
    The purpose of the test is identifying substances that interfere with 17-ß estradiol and testosterone production.
  • Mucoadhesion test according to proprietary method
    The test is designed to be applied to finished products for direct application on external mucosae with the purpose of substantiating the claim “mucoadhesive effect”.
    Gravimetric analysis of the adhesion of a product on a layer of mucin against the same product on an untreated plane. Detachment kinetics in terms of percentage of adhesion against a non-adhesive control.
  • Mucoadhesion test: gravimetric variant using the dry weight of the product according to proprietary method
    The test is designed to be applied to finished products for direct application on external mucosae with the purpose of substantiating the claim “mucoadhesive effect”.
    Analysis of the resistance to washing off with and without a basal layer of mucin. Determination of the percentage of resistance against the same product on substrate without mucin.
  • Quantification of trace substances and impurities according to UE Regulation
    The test is designed to be applied to cosmetics and medical devices with the purpose of substantiating the claim “Titer of substances”.
    Analysis of trace substances, residues and impurities for quality control purposes through UPLC or GC-MS. Includes sample preparation.
  • Quantification of the titer of substances according to Regulation 1223/209
    The test is designed to be applied to preservatives, dyes and sunscreen filters with the purpose of substantiating claims “Titer of substances” and “Limit of preservatives”.
    Quantification method for the measurement of the titer of substances by HPLC, UPLC, GC-MS after preparative steps.

Browse our specialised services 

lifeanalytics icon

Contact us

Would you like to get more information or request a personal consultation for your company?

Fill in the form and you will be contacted as soon as possible.

  • Questo campo serve per la convalida e dovrebbe essere lasciato inalterato.