OECD 209: Activated sludge respiration inhibition test

The purpose of cleaning validation studies is to show that reusable medical devices can be reprocessed effectively between uses so that patients are not exposed to pathogens. Depending on the device’s intended use and classification, appropriate reprocessing steps may include cleaning, disinfection, and/or sterilization. For cleaning validation more specifically, the testing procedure consists of three steps: Simulated contamination with artificial soils that accurately reflect clinically relevant soils, such as blood and other bodily fluids. , Cleaning (manual and/or automated), carefully following the manufacturer's instructions for parameters such as detergents, cleaning tools, water quality, and temperature. , Inspection, both visually and using quantitative methods relevant to the test soil (e.g., proteins, total organic carbon, or hemoglobin), to assess whether residual contaminants remain on the device.. Successful cleaning validation is often sufficient for non-critical reusable devices, such as blood pressure cuffs, monitors, and clutches. Semi-critical and critical devices will require further disinfection and/or sterilization validation studies, which we can also offer. The displayed example price covers a manual cleaning validation study with 6 reprocessing cycles and cleanability evaluations with visual inspection & protein content measurement. Test protocol formulation and reporting are also included.

The substances of very high concern (SVHC) analysis provides comprehensive material screening for SVHC substances as listed in the Registration, Evaluation, and Authorization of Chemical Substances (REACH). The substance list for analysis is updated regularly as new revisions are received from ECHA (twice per year). The maximum allowed concentration of any substance on the SVCH list is 0.1 mass-%. If the product contains more than 0.1% w/w of an SVHC substance, ECHA has to be notified and information on the safe use of the article must be provided to customers upon request. Contact us to request a quote for screening your material for SVHCs. The price of the analysis depends on the sample type.

Determination of selected volatile organic compounds (VOC) in water using the GC-MS and GC-FID techniques. Analysis can be conducted according to the following standard methods: EPA 624, EPA 5021A, EPA 8260, EPA 8015, EN ISO 10301, ISO 11423-1, and EN ISO 15680 The results of the analysis are reported in µg/L. Analysis includes the following analytes: Analyte: Reporting limits: chloromethane 1 µg/l bromomethane 1 µg/l dichloromethane 0.1 µg/l dibromimetaani 1 µg/l bromochloromethane 2 µg/l trichloromethane (chloroform) 0.1 µg/l tribromomethane (bromoform) 0.2 µg/l bromodichloromethane 0.1 µg/l dibromochloromethane 0.1 µg/l sum 4 trihalometanit 0.5 µg/l tetrachloromethane 0.1 µg/l trichlorofluoromethane 1 µg/l dichlorodifluoromethane 1 µg/l monochloroethane 1 µg/l 1,1-dichloroethane 0.1 µg/l 1,2-dichloroethane 0.1 µg/l 1,2-dibromietaani 0.5 µg/l 1,1,1-trichloroethane 0.1 µg/l 1,1,2-trichloroethane 0.1 µg/l 1,1,1,2-tetrachloroethane 0.1 µg/l 1,1,2,2-tetrachloroethane 1 µg/l vinyl chloride 0.1 µg/l 1,1-dichloroethene 0.1 µg/l cis-1,2-dichloroethene 0.1 µg/l trans-1,2-dichloroethene 0.1 µg/l amount of 1,2-dichloroethene 0.2 µg/l trichloroethylene 0.1 µg/l sum of 11 chlorinated hydrocarbons 1.1 µg/l tetrachloroethene 0.1 µg/l Sum of trichloroethylene and tetrachloroethylene 0.2 µg/l sum 5 chlorinated ethylenes 0.5 µg/l 1,2-dichloropropane 1 µg/l 1,3-dichloropropane 1 µg/l 2,2-dichloropropane 1 µg/l 1,2,3-trichloropropane 1 µg/l 1,2-dibromo-3-chloropropane 1 µg/l 1,1-dichloro-1-propene 1 µg/l cis-1,3-dichloro-1-propene 1 µg/l trans-1,3-dichloropropene 1 µg/l hexachlorobutadiene 1 µg/l 2-chlorotoluene 1 µg/l 4-chlorotoluene 1 µg/l monochlorobenzene 0.1 µg/l bromobenzene 1 µg/l 1,2-dichlorobenzene 0.1 µg/l 1,3-dichlorobenzene 0.1 µg/l 1,4-dichlorobenzene 0.1 µg/l amount of 3 dichlorobenzene 0.3 µg/l 1,2,3-trichlorobenzene 0.1 µg/l 1,2,4- trichlorobenzene 0.1 µg/l 1,3,5-trichlorobenzene 0.1 µg/l amount of 3 trichlorobenzene 0.4 µg/l benzene 0.1 µg/l toluene 0.5 µg/l ethylbenzene 0.1 µg/l o-xylene 0.1 µg/l m/p-xylene 0.2 µg/l sum of xylenes 0.3 µg/l sum of BTEX 1 µg/l styrene 0.2 µg/l isopropylbenzene 1 µg/l n-propylbenzene 1 µg/l 1,2,4-trimethylbenzene 1 µg/l 1,3,5-trimethylbenzene 1 µg/l n-butylbenzene 1 µg/l sec-butylbenzene 1 µg/l tert-butylbenzene 1 µg/l p-isopropyltoluene 1 µg/l naphthalene 1 µg/l Diisopropyl ether (DIPE) 0.6 µg/l ETBE (ethyl tert-butyl ether) 0.2 µg/l MTBE (methyl tert-butyl ether) 0.2 µg/l tert-amyl ethyl ether (TAEE) 0.2 µg/l TAME 0.2 µg/l tert-butyl alcohol (TBA) 5 µg/l ethanol 100 µg/l A customized offer can also be prepared if you are interested in analyzing only individual compounds from a sample. Suitable sample containers for analysis can be ordered through us. Sample containers picked up from Measurlabs are included in the price of the analysis, but sample containers can also be shipped to the customer for a separate fee.

The 48-hour acute daphnid immobilisation test according to OECD 22 assesses short-term aquatic toxicity by measuring immobilisation of daphnids, usually Daphnia magna, and using those observations to derive concentration–response values. The primary reported metric is the EC50 at 48 hours, with an optional EC50 at 24 hours calculated from dose–response analysis. The protocol is the following: The test begins with neonates less than 24 hours old exposed for 48 hours to at least five concentrations plus a control, with a minimum of twenty animals per concentration typically arranged in replicate groups (for example, four replicates of five). , Immobilisation is observed and recorded at 24 and 48 hours, and the numbers or proportions immobilised at each concentration and in the control are tabulated for statistical modelling. , Test solutions are prepared by diluting the substance into acceptable test water, avoiding solvents or emulsifiers when possible. Analytical measurements of test substance concentration, dissolved oxygen, and pH are performed at the start and end of the exposure to document conditions. , The biological endpoint is direct observation of loss of swimming activity consistent with immobilisation, EC50 values are derived from dose–response modelling and are normally reported in concentration units such as mg/L.. The report includes the counts or proportions immobilised per concentration and control at each time point, the calculated EC50(s), and supporting water chemistry and analytical concentration data. The method is accepted under REACH for aquatic hazard characterization in registration dossiers submitted to ECHA, where OECD TG 202 is equivalent to EU Method C.2 under Commission Regulation (EC) No. 440/2008. Under the U.S. Toxic Substances Control Act (TSCA), EPA may require daphnid acute toxicity testing to OPPTS 850.1010/OECD 202 for new chemical substances expected to be acutely toxic.

The bacterial reverse mutation (AMES) test is used to evaluate the genotoxic effect of a medical device or its extract when in contact with a bacterial suspension. The test is conducted according to OECD 471 and ISO 10993-3 by exposing a bacterial suspension of Salmonella spp and Escherichia coli to 5 concentrations of the medical device or its pure extracts. The AMES test is a preliminary "screening test" for genotoxicity. A full genotoxicity evaluation usually includes testing the device with two in vitro methods, of which AMES is typically performed first. An additional in vivo method can be used if needed. Measurlabs can support you with the full genotoxicity evaluation. Please contact our experts for a quote.

We offer several accredited methods for determining the total fluorine (TF) content of combustible materials: EN 14582, based on combustion ion chromatography (CIC). The method is recommended by the Nordic Council of Ministers as a quick and powerful total fluorine screening technique., EN 15408 using oxygen bomb combustion treatment followed by ion chromatography (IC). This method can be applied to plastic sheets and granules, and it is also possible to determine the total content of S, Cl, and Br., ASTM D7359-23, based on oxidative pyrohydrolytic combustion, followed by CIC.. The most suitable method is typically selected based on the sample matrix. However, please let us know if you wish a specific standard to be followed. Sample preparation (air drying and milling of the sample to particles <1 mm) is included in the displayed price. This analysis is commonly used to evaluate packaging materials' compliance with the PFAS restriction outlined in the new EU Packaging and Packaging Waste Regulation (PPWR). If TF content does not exceed 50 mg/kg (ppm), the material can be considered compliant without further testing.

The following analyses are included in this nanoparticle analysis package, intended to characterize nanoforms according to the REACH Regulation. Particle size distribution and aspect ratios by SEM-EDX Preparation with isopropanol, Sample dispersion on a slide, with centrifugation, SEM analysis and particle count by image analysis, Nanoparticle detection and classification according to the 2022 EC recommendation on the definition of nanomaterial, Reporting of PSD parameters for ~300 particles, including the following: PSD diagram, accumulated and individual., Feret min (min, d10, d25, d50, d75, d90, d95, max), Feret max (min, d10, d25, d50, d75, d90, d95, max), Equivalent circular diameter (min, d10, d25, d50, d75, d90, d95, max), Aspect ratio (calculated based on individual Feret min and Feret max measurements), Number based nano-fraction (%).. Crystal phase analysis by XRD/Rietveld method Sample preparation: drying, grinding, X-ray preparation, XRD analysis over an angular range extending from 10° to 90°, Identification of the crystalline phases present in the sample, Semi-quantitative analysis of phase distribution, using the Rietveld method, Interpretation of diffractograms. Chemical composition/purity by ICP-AES and CHNS analysis ICP-AES quantification of inorganic and metallic elements: Ag, Al, As, B, Ba, Be, Bi, Ca, Cd, Co, Cr, Cu, Fe, K, Li, Mg, Mn, Mo, Na, Ni, P, Pb, S, Se, Sb, Si, Sn, Sr, V, Zn, Ti, and Tl, Determination of C, H, N, and S with an elemental analyzer. Volume-specific surface area (VSSA) and VSSA diameter calculations (optional) BET specific surface area measurement of powder by nitrogen adsorption, True (skeletal) density measurement by He pycnometry, excluding intergranular and intragranular porosity, Both analyses include sample preparation. You can request a quote for the analysis using the form below. Please note that the OECD 125 guideline does not apply to this analysis.

GC-MS analysis of 16 PAH compounds, which are listed as high-priority pollutants by the U.S. Environmental Protection Agency (EPA). The analyzed PAH compounds are: naphthalene [CAS: 91-20-3], acenaphthylene [CAS: 208-96-8], acenaphthene [CAS: 83-32-9], fluorene [CAS: 86-73-7], phenanthrene [CAS: 85-01-8], anthracene [CAS: 120-12-7], fluoranthene [CAS: 206-44-0], pyrene [CAS: 129-00-0], benz(a)anthracene [CAS: 56-55-3], chrysene [CAS: 218-01-9], benzo(b)fluoranthene [CAS: 205-99-2], benzo(k)fluoranthene [CAS: 207-08-9], benzo (a) pyrene [CAS: 50-32-8], dibenzo(ah)anthracene [CAS: 53-70-3], benzo (ghi) perylene [CAS: 191-24-2], indeno (123cd) pyrene [CAS: 193-39-5].

Assessment of the effects of a test substance on seedling emergence and early growth of higher plants according to OECD Test Guideline 208. The substance is applied to the soil surface or incorporated into the soil, using water, acetone, or ethanol as a carrier where needed; crop protection products may be spray-applied to mimic field use, and poorly soluble materials can be incorporated as weighed additions to dry soil. Seeds of at least six species from different plant families are sown in treated natural soil or artificial substrate and observed for 14 to 21 days after 50% emergence in the controls. Measured endpoints include: Percent seedling emergence, Shoot dry or fresh weight, Shoot height (where required by the regulatory authority), Visual phytotoxicity score on a uniform injury scale (chlorosis, necrosis, wilting, deformation, mortality). Analytical verification of test substance concentrations is performed where soluble formulations allow; insoluble substances are confirmed by weighed additions and, where necessary, soil homogeneity analysis. Single-rate studies report the observed level of effect or its absence. Multi-rate studies are modelled to derive ECx/ERx values (e.g., EC25/ER25, EC50/ER50) with confidence intervals and, where applicable, NOEC and LOEC. Emergence data are analysed as quantal responses using logit, probit, Weibull, or Spearman–Kärber models. OECD TG 208 is accepted for non-target plant effect assessment in EU regulatory frameworks, including REACH (where ECHA has issued guidance on its use for terrestrial plant hazard characterization) and Regulation (EC) No. 1107/2009 on plant protection products (with test methods listed in Commission Communication (2023/C 344/02)). In the U.S., aligned EPA guidelines include OCSPP 850.4100 (Seedling Emergence and Seedling Growth) and OCSPP 850.4230 (Early Seedling Growth Toxicity Test).

A biological evaluation plan (BEP) is a critical part of assessing the safety of a medical device. It involves a detailed examination of various aspects such as the device's design & structure, its material composition, manufacturing process & potential contaminants, the intended use, existing test results, and clinical history. The BEP ensures that the device undergoes sufficient biocompatibility testing, with parameters selected from the ISO 10993-1 standard. As a manufacturer, you will need to have a BEP during the regulatory approval process to demonstrate the safety of your medical device. The BEP should be developed during the initial design phase of the medical device. At this stage, manufacturers can identify potential biological risks associated with the device's intended use, materials, and components. A new BEP or updates to the existing one may also be needed if changes are made to the device's design or material composition at a later point. At Measurlabs, we can provide a BEP for a range of medical devices while also guiding manufacturers throughout the process. Do not hesitate to contact us if you are developing a new device, seeking regulatory approval, making changes to an existing product, conducting post-market surveillance, or performing preclinical testing.  We are also happy to create an offer for biocompatibility testing according to the BEP, as well as a biological evaluation report (BER) to summarize the results of the biological evaluation.