In healthcare, accurate and timely diagnostic tools are critical to patient care, especially in high-risk situations like emergency rooms (ERs) or intensive care units (ICUs). These devices contain blood gas analyzers, which help doctors measure many important health parameters in the blood. These analyzers are used to monitor dangerous conditions such as respiratory failure, heart attack, kidney failure, diabetes, and electrolyte imbalances. One such standard is BIS IS 17716:2024, an Indian standard that outlines specifications and test procedures for blood gas analyzers used in in vitro diagnostics (IVD). This standard plays a dynamic part in healthcare and certifies that these devices function optimally and gives accurate information, which is necessary for doctors to make fast and informed decisions.

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What is IS 17716: 2024 In-vitro Diagnostic (IVD) Device-Blood Gas Analyzers?

IS 17716:2024 is an Indian standard that defines specifications, performance testing and quality assurance procedures for blood gas analyzers. This Indian standard was adopted by the Bureau of Indian Standards (BIS), after which the draft was finalized by the In Vitro. Diagnostic Medical Devices and Biological Evaluation of Medical Devices by the sectional committee approved by the Medical Devices and Hospital Planning Division Council. For these BIS registration is required.

This standard describes the specifications and standard performance test procedures for standard blood gas analyzers which are used for the quantitative determination of various levels pH, pCO2, pO2, hematocrit (Hct), Na+ , K+ , Cl- , iCa, Li, Glu (glucose) and other metabolites and electrolytes in heparinized whole blood. These measurements help doctors assess important health functions such as pulmonary gas exchange, acid-base balance, and electrolyte regulation. IS 17716:2024 ensures that blood gas analyzers used for these tests are accurate, reliable, and consistent in providing the data needed for life-saving medical decisions.

Significance of IS 17716: 2024 

Blood gas analyzers are not just common laboratory instruments, they are critical tools used to diagnose and monitor critical conditions. The correctness of these measurements is indispensable for patient care. Errors in blood gas testing can lead to misdiagnosis and treatment, which can put the patient's health and even life at risk. By following IS 17716:2024, blood gas analyzers help reduce these risks, ensuring that healthcare professionals can trust the results and provide the best possible care. By adhering to this standard, manufacturers and healthcare providers can make sure that these devices provide perfect results. This, in turn, helps doctors make quick decisions in critical situations, such as:

• Respiratory failure: Diagnosis of problems with lung function
• Acid-base disturbances: Identification of imbalances in the body's pH levels
• Electrolyte disorders: Monitoring levels of important minerals such as sodium and potassium
• Diabetes management: Monitoring glucose and lactate levels

Also Read: IS 19085: 2024 - Glass Containers for Homoeopathic Pharmaceutical Preparations - Specification

Key Components of IS 17716:2024 In-vitro Diagnostic (IVD) Device-Blood Gas Analyzers

The key or main components of IS 17716:2024 in-vitro diagnostic (ivd) device-blood gas analyzers includes: 

1. Terminology

The standard outlines key terms related to blood gas analysis. Key terms include pCO2 and pO2, which describe the partial pressures of carbon dioxide and oxygen in the blood, respectively. Hematocrit indicates the percentage of red blood cells in the blood, while oxygen saturation indicates the amount of oxygen bound to hemoglobin. 

Base access and standard bicarbonate are measures related to the acid-base balance of the blood. The standard also covers the use of calibrants for calibration, quality control, and accurate measurement. It defines verification and validation procedures, as well as terms such as accuracy, specificity, and performance characteristics. In addition, it mentions safety standards for blood gas analyzers and measurement limits for diagnostic devices.

2. Principle

The principles behind blood gas analyzers involve measuring ions such as sodium, potassium, and calcium using an ion-selective electrode (ISE). These electrodes measure the electrical potential across a membrane that is specific to each ion. pCO2 and pO2 are measured using special electrodes that detect changes in pH and current, respectively. 

Hematocrit is measured based on electrical resistance, while glucose and lactate levels are determined through enzymatic reactions that produce hydrogen peroxide, which is then detected by electrodes. The analyst also calculates values such as bicarbonate, base access, and oxygen content using mathematical equations that depend on the measured values with adjustments for temperature and pH variations. These principles help in the efficient assessment of various blood parameters.

3. Operator menu flow chart

Operational and performance specifications of a medical analyzer. The operator menu is divided into several sections: Diagnostics, Users, and Setup. The diagnostics menu includes options such as Daily Cleaner, Maintenance, Sensors, Flow, Hardware, and New Reagent Pack, each designed to assist with device maintenance and troubleshooting. The user menu gives permission to users to set various parameters such as normal range, calibration frequency, sip frequency, and correction factor, as well as manage precision testing.

4. Performance specifications and features

In terms of performance, the accuracy of the analyzer is assessed using the CLSI EP05 guideline, which ensures that the reagent pack produces consistent and accurate results over multiple tests. Linearity or assay reportable limits for various analytes including electrolytes and blood gases are validated through linear regression analysis according to CLSI EP06. The traceability of the analyte is ensured by referencing validated methods such as flame emission spectrophotometry or UV–VIS spectroscopy, ensuring accurate and reliable measurements. Stability tests are also performed for reagents according to EP25-A guidelines to ensure long-term reliability and performance.

5. Analytical specificity

Analytical specificity refers to the ability of an arterial blood gas analyzer to accurately measure specific substances in a sample without interference from others. This is necessary to ensure that the results are accurate. The analyzer uses ion-selective electrodes that are designed to measure only specific ions. To verify its specificity, the reagent pack should be tested several times a day with quality control samples and external controls. These tests ensure that the reagent can accurately assess the chemical content in the sample and provides accurate readings for the desired substances, proving that the analytical specificity is reliable.

6. Comparison studies

Method comparison studies are important to confirm that an arterial blood gas analyzer produces results that are consistent with a standard or "predictive" instrument. According to guidelines, such as CLSI EP09-A3, quality control samples of different levels should be run on three different analyzers over three days. The results of these tests should be compared with the results of the predicate device to ensure consistency and accuracy. This helps establish that the new analyzer is performing as expected and is delivering results comparable to equipment already established in the market.

7. Marking and certification

Arterial blood gas analyzers must be clearly labelled to comply with regulatory requirements. The label should contain important information such as the product name, voltage, storage temperature, and manufacturer details. Additionally, it must include any safety precautions or relevant signs. For products that meet the required standards, they may also carry the BIS certification mark, which confirms compliance with regulations. Proper packaging and transportation is also crucial and must adhere to relevant standards such as ASTM D4169 to ensure that the product arrives safely and functions correctly.

Benefits of IS 17716:2024 

IS 17716:2024 offers a number of benefits for healthcare providers, including:

• Improved accuracy and consistency: Standards ensure that blood gas analyzers provide accurate and reliable results. This is critical for the diagnosis and monitoring of life-threatening conditions.
• Consistency across laboratories: Following this standard blood gas analyzers produce consistent results across different clinical laboratories. This improves the comparability of clinical outcomes, allowing healthcare providers to trust the data regardless of location.
• Timely decision-making: With accurate and reliable results, healthcare providers can quickly make informed decisions, which is essential in high-stakes settings like the ICU and ER.
• Increased patient safety: By reducing errors in blood gas analysis, IS 17716:2024 helps reduce the risk of misdiagnosis or inappropriate treatment, which supports overall patient safety.

Also Read: IS 19084: 2024 Plastic Containers and Closures for Homoeopathic Pharmaceutical Preparations - Specification

Implications of IS 17716:2024 for Stakeholders

Various stakeholders benefit from the IS 17716:2024 standard. Healthcare providers can provide better patient care with more accurate blood gas analyzers. Manufacturers improve their product reliability and business by meeting the standard’s performance criteria. Patients receive a more accurate diagnosis, which leads to better treatment and results. Clinical laboratory technicians gain confidence and adeptness in their work with clear guidelines for the use of analytes. Researchers and academics have a reliable reference to develop new techniques to support innovation and progress in the field of diagnosis.

Conclusion

IS 17716:2024 is an important standard for blood gas analyzers used in in-vitro diagnostics, ensuring the accuracy and reliability of vital measurements such as pH, pCO2, PO2, electrolytes and glucose in whole blood. It plays a critical role in patient care, especially in emergency settings such as ICUs and hospitals, by providing essential data for the diagnosis of life-threatening conditions. This standard promotes consistency across laboratories and is aligned with international guidelines, supporting timely decision-making and patient safety. Manufacturers, healthcare providers, and regulatory authorities benefit from its clear framework, ensuring quality control, regulatory compliance, and improved diagnostic outcomes. Ultimately, IS 17716:2024 promotes high standards in medical technology, benefiting patients, healthcare professionals, and stakeholders alike.