ISO 19337:2023 Certification
Introduction
ISO 19337:2023 describes the characteristics of operating suspensions of nano-objects to be considered when performing in vitro assays to evaluate intrinsic nano-object toxicity. This standard certification has started to reflect the new advancements in nanotechnology. The ISO 19337:2023 Certification includes the best practices and most detailed discoveries in the field of nanotechnology.
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ISO 19337:2023 Certification
ISO 19337 certification defines the features of working suspensions of nano-objects that should be considered when performing in vitro assays to evaluate intrinsic nano-object toxicity. In addition, the certification identifies the measurement system applicable to these characteristics.
This certification applies to nano-objects and Their agglomerates and aggregates larger than 100 nm. This certification intends to support defining whether observed toxic results come from uncontrolled sources or the tested nano-objects.
ISO 19337 standard evaluates your organization’s overview of technological objects. It is designed to become the basis for technology development and research. The last change to this certification was made on June 7, 2023. Before this, there was the ISO 19337:2016 certification. Nanotechnology was highlighted in this certification. The ISO 19337:2023 standard is the latest standard in this field. This certification ensures up-to-date information.
Measurement Methods And Characteristics
1. The Stability of Working Suspension
The stability of the functional suspension is an important characteristic since it straight impacts the in vitro assay conditions in betting the dosage of nano-objects in cells. Aggregation of nano-objects and gravity settling are important issues that can impact the strength of suspended nano-objects. Suspension stability will evaluated for two factors, i.e. The related modification of the usual size of 2-second particles of nano-objects and the connected modification of attention of nano-objects in functional suspension.
The modification in the size of 2-second particles of nano-objects may outcomes from the agglomeration of more smallish particles in the culture media. The related modification of nano-object engagement may outcome from the gravity settling period of the in vitro toxicity assay, about the experimental duration period needed for the in vitro toxicity assay. The valuation outcomes of stability will be expressed in the unit of the ratio over the time structure for the in vitro toxicity assay.
The Representative Size Modification of 2-second Particles of Nano-objects:- An appropriate system shall select to straight measure representative size modifications of second particles of nano-objects, from among, DLS, SLS, and LD. Other systems not listed in this certification may reported and utilized according to the Alternative system.
Concentration Modification of Nano-objects:- To measure the attention changes of nano-objects suspended in, an appropriate method, biological media shall select from among inelastic light distribution, ICP-MS, UV-Vis absorption, total organic carbon analysis, and X-ray transmission. Other systems not listed in this certification may be reported and utilized according to the Alternative system.
2. Metal Ions Concentration
Metal ions made as an outcome of the disintegration of the nano-object test model may contribute to the observed cell toxicity. The concentration of metal ions in the functioning suspension shall measured after the separation of the particulate topic. The particulate topic may separated from the ionic trace by C-U/ U/F, centrifugation, or F TFF. The measure shall performed for all metal elements that are contained in the nano object model.
A suitable method is select from among ICP-MS, ICP-AES, AAS, and colorimetry systems to estimate metal ion concentrations. It noted that many elements in culture media like Cl and Na may interfere with metal analysis for specific spectrometry methods, particularly ICP-M. Another system not listed in this certification may reported and used according to the alternative system. The measurement outcomes of concentrations must expressed in units of mass, molarity, or volume. When no toxic impact on the cells in the functional suspension is observed, the measurement can omitted.
3. Culture Medium Elements Concentrations
The nano-object model was add to the culture medium to develop a functional suspension that may adsorb elements of the culture medium. This adsorption may outcomes in starvation pressure in the trial cells. The engagements of protein calcium and components for nutritional elements in the solvent shall measured after allowing a satisfactory period after adding the nano-object model to the culture medium.
Suppose culture medium elements other than calcium and protein that may significantly impact the stability of the functional break for the in vitro toxicity assay are current. In that case, the engagements of those elements are also measured. When no toxic effects are observed on the cells in the functional suspension. the measurement may omit.
The nano-object example in the culture medium will be incubated with the exact conditions of in vitro testing. Nano-objects may impact the culture medium’s osmolality and other essential pH elements.
The Protein:- A proper system from among the Bradford, BCA, ultraviolet and Lowry, refractive index, and SLS system shall be selected for protein engagement measurement. When the BCA, Bradford, or Lowry system is select, the protein engagement in the solvent is measure after separating the particulate issue from the functional suspension. The outcomes of protein engagement measurement are express in units of volume.
The Calcium:- An appropriate measure system shall determine the calcium concentration measure from among ICP-MS, ICP-AES, AAS, and the colorimetric system. Outcomes of calcium concentration measure shall express in the unit of molarity, mass, or volume.
4. The Contamination
The contamination can be a source of additional toxic movement. mycoplasma and Endotoxins should determined via the appropriate system. Endotoxin measures are available with the LAL test, MAT, chromogenic-based LAL assay, recombinant elements C test, and high-performance liquid chromatography associated with the mass spectrometry system. Mycoplasma contamination is a significant topic in in vitro tests. Mycoplasmas are detecting via PCR base systems, culture systems, and fluorescence microscopy systems. Nano-object examples should treated in an aseptic manner. It should confirm that there is no record of contamination other than that defined in this subsection.
The Reporting of The ISO 19337 Standard
The General:- The outcomes of evaluations and measurements obtained by this certification shall report describing the components and source of the culture medium, serum, and nano-objects.
The Manufacturing Information And Name of Nano-objects:- Name, catalog, and lot number of manufacturer information and nano-objects including name
Metallic And Composition Elements Contained in The Nano-object Model:- Define accessory and principal materials, catalytic materials, coating materials, and impurities, including their known or counted quantity.
The Serum And Culture Medium:- The name, manufacturer, and batch digit of the type, concentration, and medium of added serum (volume fraction %), pH weights of original pH and medium values during type and assessment, and concentration of additional additives, if any, shall report.
The Measurement of Results:- The following reporting is require for different measurement and dosing time frames of the functional suspension. However, test outcomes for adulterations may report for stocks of nano-objects rather than particular doses. Reporting of culture medium elements, metal ions, and adulterants is not need when toxicity is not observ for individual doses of the functional suspension.
The stability of the working suspension –
- Representative size modification and concentration modification,
- The date of measurement,
- Employed measure systems for representative size modification and concentration modification.
- The data reliability information and performing institution.
- Supporting knowledge on the preparation system of functioning suspension, and
- Additional special supporting details if any.
The Metal Ions –
- Metal ions names and concentrations.
- Measurement date
- Employed measurement system
- The data reliability information and performing institution
- Other special supportive details if any
Required Documents For ISO 19337 Certification
- System Manual of the institution
- System Procedure of the Institution
- Policy of the institution
- Objectives of the institution
- Mission & Vision of the institution
- Standard Operating Procedure of the institution
- Checklist of the institution
- Forms of the institution
- Formats of the institution
- Records of the institution
- Size of the institution
- Activities performed via the institution
- Processes undertaken via the institution
- Services and Products offered via the institution
- The complexity of processes undertaken by the institution
- Qualification of employee in the institution
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How to Achieve The ISO 19337 Standard?
Application: Firstly you apply for ISO 19337:2023 Certification.
Documents Proof: You will provide proof of the Organization, its name, size, and related records and documents to the certification body for checking.
Audit Organization: In the audit, An offline or online audit of the Organization is done successfully. in which all the policies and procedures of your Organization are inspect.
Achieve Certification: In this step, you achieve ISO19337 certification.
Read Also: ISO Certification Process
Conclusion
Nanotechnology is rapidly evolving and it is important to keep this certification up to date. Therefore, ISO 19337:2023 Certification is up to date with the latest standards. This standard evaluates the overview of nano-objects. It is design to the basis for technology development and research.
