Modern health care environment depends on the safe and effective delivery of medicines to the patient. Infusion therapy is the foundation of medical treatment for many conditions. The infusion set has been developed with advanced techniques to meet the constantly changing demands of health care. As part of this development, IS 18879 (Part 15), which aligns with ISO 8536-15:2022, addresses the requirement for light-protective infusion sets. This set of light-sensitive drugs is necessary to reduce the risk to patients and increase the quality of care.

Understanding IS 18879 (Part 15): 2024

This Indian Standard (Part 15) which is identical to ISO 8536-15: 2022 ‘Infusion equipment for medical use Part 15: Light-protective infusion sets for single use’ issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on the recommendation of the Hospital Equipment and Surgical Disposable Products Sectional Committee and after approval of the Medical Equipment and Hospital Planning Division Council. This standard is part of a broad range of products whose purpose is to regulate infusion equipment and materials, so that they meet worldwide safety and performance standards. These are fifteen parts of the series, including everything from infusion glass bottles to accessories for pressure infusion equipment.

The main purpose of IS 18879 (Part 15) is to form the requirements for light-protective infusion sets. Sodium nitroprusside, nitro-glycerine and vitamin B2 are light-sensitive drugs because these sets are important for their safe administration. Exposure to light can reduce these pharmaceuticals, rendering them ineffectual or harmful. This standard ensures that ingredients used in the fluid path of the infusion sets safeguard these drugs from any harmful exposure to light, as result preserving the competence and security during infusion.

This standard underlines the physical, performance and quality stipulations including light-transmission necessities for drip chambers and tubing. This highlights the significance of optimizing the infusion set to fulfill specific clinical requirements, particularly for sensitive drugs, and providing norms to ensure that the fluid remains safe, effective healthcare settings.

Purpose of Light-Protective Infusion Sets

Many medicines are acutely sensitive to light, which can be harmful, can lose effectiveness or even harm the patient. These medications comprise of maternal sodium nitroprusside, nitro-glycerine and vitamin B2, and are restricted to maternal medications, which are commonly taken in serious care conditions. When exposure to light, the chemical structure of the drugs may break down, minimizing the therapeutic effectiveness, or harmful compounds may be formed.

IS 18879 (Part 15) provides solutions to the challenges mentioned in light-protective infusion tank sets. These sets are designed to prevent the drugs from exposure to light during infusion by using light-protective agents incorporated into the materials of the fluid path, such as the tubing and drip chamber. This standard guarantees that medicines are effective all over the infusion process, protecting patient health and improving clinical results.

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Scope of IS 18879 (Part 15)

This document specifies the requirements for infusion sets for single use that use light-protective agents in the fluid path materials (henceforth abbreviated as "light-protective infusion sets”). These standards are vital for the operative and safe delivery of light-sensitive medications.

The document offers detailed guidance on the performance parameters of the light-protective infusion set, which includes several aspects such as light transmission, biocompatibility and detail testing. The physical assets of the infusion sample set, including transparency and colour decolourization tests, have been specified to ensure that no one is exposed to harmful light during the whole procedure.

Benefits of Light-Protective Infusion Sets

There are several benefits of Light- Protective Infusion Sets. Some of the key benefits are:

Protection against Light Degradation: The main advantage of these infusion sets is that they prevent corrosion caused by light-sensitive drugs. By mitigating the risk of chemical failure, this set confirms that the drug maintains its therapeutic usefulness throughout the infusion.
Improved Patient Safety: By medications like sodium nitroprusside and nitro-glycerine are delicate to light, they can potentially become dangerous compounds when exposed to light. Light-protective infusion sets minimize risk, subsidizing to safer outcomes for patients.
Enhanced Clinical Performance: The use of light-protective infusion sets allows more precise administration of vital medications. Health care professionals rely on light-sensitive drugs as well as can provide stable and effective drugs.
Regulatory Compliance: IS 18879 (Part 15) is adopted to ensure that hospitals and healthcare facilities comply with both Indian and international standards. By following to ISO standards, health care workers validate their commitment to providing high quality care.
Economic Efficiency: Proper light protection can help to prevent degradation of medicines and reduce the cost of medicines. This is especially important for expensive light-sensitive drugs.

Terminology and Key Concepts

It is important to understand some key terms and concepts when discussing light-protective waterproofing sets. The critical definitions of IS 18879 (Part 15) are:

Light-Protective Infusion Sets: Infusion sets that are specifically designed with materials that prevent light from penetrating the fluid path, thereby protecting light-sensitive medications from degradation.
Light Transmittance: The ability of a material, such as the tubing or drip chamber, to allow light to pass through. For light-protective infusion sets, this should be controlled to minimize light exposure to the medication.
Decolourization: The process by which the material of the infusion set changes colour, typically due to exposure to light or temperature. The standard specifies tests to ensure that materials do not discolour when used with light-sensitive drugs.
Spectrophotometer: A device used to measure the amount of light transmitted through a material. The spectrophotometer is used to assess the light transmittance of the materials used in light-protective infusion sets.
Biocompatibility: The ability of a material to be compatible with biological systems, ensuring that it does not cause harm to patients when used in medical devices.

Physical Requirements and Testing

To ensure the infusion sets meet the needed standards, IS 18879 (Part 15) highlights several physical requirements that the light-protective sets must meet:

Transparency: The tube and drip chamber must be adequately transparent or translucent so that the health care provider can see the flow of the fluid and detect air bubbles in the system. It is ensured that the infusion process can be observed without compromising the safety of the drug from the light.
Light Transmittance Testing: The infusion set components, including the drip chamber and tubing, must undergo rigorous light transmittance testing. A spectrophotometer is used to measure the light passing through the materials in the wavelength range of 290 nm to 450 nm. This test ensures that the materials offer adequate protection from light exposure.
Decolourization Testing: The infusion sets go through a decolourization test, where they are uncovered to high temperatures for prolonged periods to accelerate possible colour change. This test helps ensure that the infusion sets does not leave injurious elements in the air when exposed to light or temperature or stress.
Biocompatibility: The infusion sets must be biocompatible to prevent any harmful interactions with the patient’s body. Testing is done to ensure that the material does not cause an allergic retort or toxicity.

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Conclusion

In Conclusion, IS 18879 (Part 15), aligned with ISO 8536-15:2022, plays an important role in the safe and effective administration of light-sensitive medicines. By setting stringent standards for light-protective hydration sets, it ensures that vital drugs uphold their stability and effectiveness during the infusion process. These benefits of infusion sets, which include increased patient safety, improved clinical outcomes and compliance with international standards, make them an important part of modern medical practices. Health care providers must obey to these standards so that patients receive the highest level of care, especially when receiving light-sensitive medications. Development of infusion techniques continues, IS 18879 (Part 15) standards in clinical settings play an important role in ensuring that patient safety is a top priority in clinical settings.

Including these guiding principle into everyday clinical practice not only protects the reliability of sensitive medicines but also adds to a more reliable, consistent and effective distribution throughout the health care system.

IS 18879 (Part 15): 2024 ISO 8536-15: 2022 + AMD 1: 2023 Infusion Equipment for Medical Use Part 15 Light-Protective Infusion Sets for Single Use

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