Standards for In Vitro Diagnostic Medical Devices

This issue of safe medication, let’s popularize knowledge together!

Standards for Instruments and Equipment for In Vitro Diagnostics

General standards for instruments and equipment

In addition to meeting the corresponding standard requirements for basic performance, the safety of in vitro diagnostic instruments should also meet relevant safety standards. The general standards are GB/T 18268.26 and YY 0648.

GB/T 18268.26 specifies the basic requirements for electromagnetic compatibility in terms of immunity and emission based on the characteristics of in vitro diagnostic devices and their electromagnetic environment. Similar to conventional medical electrical equipment, in vitro diagnostic devices are widely used in various electromagnetic environments. They should work normally in typical medical environments (hospitals, clinics, etc.) and also operate normally and safely in home environments. In other words, in vitro diagnostic devices should have basic immunity levels suitable for these environments.

YY 0648 is one of the specific standards under the mandatory national standard GB 4793.1, applicable to medical laboratory instruments intended for in vitro diagnostic medical purposes. Due to the special expected use of in vitro diagnostic devices, operators may come into contact with various biohazardous human samples and chemical reagents. To ensure operator safety, YY 0648 is equivalent to IEC 61010-2-101, which is a safety standard that alerts operators to potential biohazards, electrical hazards, etc., to protect them from electric shocks and biohazards. The entire content of this standard is related to the mandatory national standard GB 4793.1.

Standards for Hematology and Flow Cytometry Testing Instruments

Blood cell analysis is one of the routine clinical tests. Blood cell analyzers integrate multidisciplinary technologies such as biology, chemistry, optics, fluid mechanics, electronic circuits, and computer software. Since the 1950s, after years of development and technological innovation, they can not only count and quantitatively analyze the formed elements in blood such as red blood cells, white blood cells, and platelets but also identify, distinguish, and analyze cell populations. Meanwhile, with the powerful signal acquisition, analysis, and computing capabilities of computers, more clinically significant parameters have been discovered. With the advent of high-performance computers, high-precision and fast image acquisition devices, and large databases, automated cell image analysis devices are entering clinical laboratories with high accuracy, speed, networked, and user-friendly characteristics.

Flow cytometry is a cell parameter analysis technology that uses flow cytometers to count and quantitatively analyze various biological and physical, biochemical characteristics of formed elements in human samples, including cells, platelets, organelles, sperm, microorganisms, and artificially synthesized microspheres, and can sort specific cell populations. Flow cytometers are high-throughput, multiparameter instruments for analyzing and sorting cells or particles, integrating lasers, ultraviolet light, monoclonal antibodies, fluorescent dyes, labeling techniques, computers, and their software. They are characterized by fast speed, high precision, and good accuracy, making them an advanced cell quantitative analysis technology.

In addition, there are related standards for thromboelastography devices (such as blood rheometers, platelet aggregometers, coagulation factor analyzers, and sedimentation rate analyzers) and blood typing identification devices (such as blood type identification instruments).

YY/T 0588 is applicable to flow cytometers that are clinically used for quantitative analysis and sorting of biochemical and biophysical characteristics of single cells or other non-biological particles (limited to flow cytometers with sorting function). This standard specifies performance indicators such as fluorescence detection limit, fluorescence linearity, forward angle light scattering detection limit, instrument resolution, forward angle light and side angle light scattering resolution, ploidy analysis linearity, surface marker detection accuracy, surface marker detection repeatability, carry-over contamination rate, and instrument stability.

YY/T 0653 is applicable to blood analyzers that analyze formed elements in human blood and provide relevant information, not applicable to reticulocyte project detection. This standard specifies performance indicators such as blank counting, linearity, accuracy, precision, carry-over contamination rate, and histogram.

Standards for Biochemical Testing Instruments

In the diagnosis of diseases, monitoring of conditions, observation of treatment effects, prognosis judgment, and prevention, biochemical analysis and testing equipment is one of the basic and indispensable medical devices. The diagnosis of acid-base balance and electrolyte disorders caused by acute pancreatitis, diabetic ketoacidosis, myocardial infarction, uremia, dehydration, or edema among emergency patients relies on biochemical analysis and testing equipment. Liver function, kidney function, protein balance, lipid metabolism, glucose metabolism, potassium, sodium, chloride, calcium, phosphorus, magnesium, and trace elements are all quantitatively tested by biochemical analysis and testing equipment. Urinalysis, glycosylated hemoglobin analysis, electrolyte analysis, etc., also have relevant standards.

YY/T 0654 is applicable to fully automated biochemical analyzers that perform quantitative analysis of various samples using ultraviolet-visible spectrophotometry. This standard specifies performance indicators such as stray light, absorbance linear range, absorbance accuracy, stability, repeatability, temperature accuracy and fluctuation, sample carry-over contamination rate, sample addition accuracy and repeatability, and intra-assay precision for clinical projects.

YY/T 0475 is applicable to urinalysis instruments that analyze urine test strips based on chemical principles. This standard specifies performance indicators such as repeatability, accuracy with compatible urine test strips, stability, and carry-over contamination.

Standards for Molecular Biology Testing Instruments

Polymerase chain reaction (PCR) is a molecular biology technique that can rapidly replicate DNA, allowing trace amounts of genetic material to be amplified millions of times within hours. Continuous breakthroughs in gene sequencing technology and decreasing costs have gradually introduced sequencing technology into the clinical field, enabling the prediction of individual future health conditions through gene detection, allowing for targeted personalized healthcare and treatment, helping individuals move from passive prevention and treatment to proactive health awareness. Related standards include YY/T 1154 and YY/T 1173.

Standards for Microbiology Testing Equipment

The instruments and equipment for identifying suspicious pathogenic bacterial colonies and performing antimicrobial susceptibility tests are the main and important components of clinical microbiological testing, with relevant standards including YY/T 0656 and YY/T 1531.

Standards for Immunology Testing Equipment

Immunological testing based on immunological theories and principles plays an important role in the diagnosis, treatment, and pathogenesis research of many clinical diseases. With the development and cross-integration of biotechnology and laboratory medicine, many high-end, automated new immunological testing devices have been introduced into the clinical testing field, significantly promoting the development of immunological testing. Enzyme-linked immunoassay analyzers, fully automated chemiluminescence immunoassay analyzers, etc., all have relevant standards.

YY/T 1529 is applicable to the reading modules of enzyme-linked immunoassay analyzers and fully automated enzyme-linked immunoassay analyzers. This standard specifies performance indicators such as wavelength accuracy, absorbance accuracy, linearity, absorbance repeatability, absorbance stability, sensitivity, and channel differences.

YY/T 1533 is applicable to fully automated time-resolved fluorescence immunoassay analyzers. This standard specifies performance indicators such as detection items, linear range, repeatability, accuracy, stability, sample addition accuracy, sample addition precision, sample needle carry-over contamination, wash residuals, temperature accuracy and fluctuation, and clinical project detection repeatability.

Other Testing Equipment Standards

In addition to the above categories, there are other testing equipment standards, such as YY/T 0087, YY/T 0657, YY/T 0996, etc.

Standards for In Vitro Diagnostic Reagents

General standards for in vitro diagnostic reagents

The general standards for in vitro diagnostic reagents cover various professional fields, such as clinical chemistry in vitro diagnostic reagent kits, tumor marker quantitative determination reagent kits, immunoturbidimetric detection reagent kits, etc.

GB/T 26124 is applicable to in vitro diagnostic reagents (kits) based on spectrophotometry principles used for quantitative testing of clinical chemistry projects in medical laboratories, not applicable to performance evaluation reagents (such as reagents for research use only), POCT (point-of-care testing) clinical chemistry in vitro diagnostic reagents. This standard specifies performance indicators such as reagent blank, analytical sensitivity, linear range, measurement precision, accuracy, and stability.

YY/T 1255 is applicable to reagent kits used for quantitative detection based on the principle of transmission immunoturbidimetry, performed on semi-automatic, fully automatic biochemical analyzers, or other types of analyzers. This standard specifies performance indicators such as blank limit, linearity, repeatability, inter-batch differences, traceability, accuracy, and stability.