In the health care sector, validation plays an important role in the safety, quality and reliability of medical devices and patient results. An infusion set, generally used to administer fluids, medications, and blood products, is a single piece of equipment that is required to maintain standard health care safety. IS 18879 (Part 8): 2024, based on the ISO 8536-8: 2015 standard, addresses the specifications for "Infusion Sets for Single Use with Pressure Infusion Apparatus." This standard is crucial for ensuring that infusion sets, when used with pressure infusion devices, meet the highest quality and safety requirements.

What is IS 18879 (Part 8): 2024 and ISO 8536-8: 2015?

IS 18879 (Part 8): 2024 is an Indian Standard that is identical to the internationally documented ISO 8536-8: 2015, which is a part of the comprehensive ISO 8536 series dealing with infusion equipment for medical use. This standard was 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.

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This standard is specifically focused on infusion sets for single use with pressure infusion device. The implementation of these standards by the Bureau of Indian Standards (BIS) confirms that the specifications are in line with global standards, which form the basis of quality of infusion equipment in common use in India.

The ISO 8536-8:2015 standard, developed by the International Organization for Standardization (ISO), plans technical necessities and performance criteria for infusion sets intended for use in pressure infusion equipment with pressure ratings up to 200 kPa (2 bar). It is authoritative that these infusion sets are sterile, free from pyrogens or bacterial endotoxins, and projected for single-use only. The Indian adoption of this standard specifies that manufacturers and healthcare providers in India must follow to these strict requirements.

Scope and Application of IS 18879 (Part 8): 2024

This part of ISO 8536 gives users information on sterilized infusion sets for single use with pressure infusion apparatus up to a maximum of 200 kPa (2 bar). These sets are for single use only and are suitable for medical applications where controlled pressure conditions and infusion of normal fluids are required. In critical care settings, including emergency rooms, intensive care units (ICUs) and surgical operations, a valid infusion set is necessary, where saline, medications or blood products and fluids need to be delivered under controlled pressure.

This standard offers important information related to the materials, performance, design, and testing of infusion sets to confirm that the required levels of safety and reliability during the medical process are met. These infusion sets are intended to operate in pressure conditions up to 200 kPa (2 bar), which is an adequate range for most clinical requirements associated with intravenous fluid administration.

It is also essential that some countries may take precedence over the provisions of the Standard National Pharmacopoeia or other national regulations, and health care professionals should always refer to local rules when valid.

Key Normative References

IS 18879 (Part 8):2024 Validating Compatibility and Stability of Medical Devices, references numerous ISO standards. These references ensure that the infusion sets follow to global standards, making them safe and dependable for medical use. Some of these references include:

• ISO 594-2: Conical fittings with 6% (Luer) taper for syringes, needles, and other medical equipment.
• ISO 7000: Graphical symbols for use on equipment – Registered symbols.
• ISO 8536-4: Infusion equipment for medical use – Part 4: Infusion sets for single use, gravity feed.
• ISO 15223-1: Medical devices – Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements.

Also Read: 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

Terminology and Definitions

The standard presents a number of key terms and definitions explaining pressure infusion equipment, infusion sets, and operations. It is important for both manufacturers and health care professionals to really understand these terms. Some of the most significant terms consist of:

• Filling Volume (VF): The volume of the tube during "pressure-less" filling, or when filling by gravity. The tube remains unstressed during this process.
• Storage Volume (VS): The volume of the tube during pressurization, which is the sum of the filling volume (VF) and the bolus volume (VB).
• Bolus Volume (VB): The increased tube volume during pressurization, which occurs in comparison to the unstressed tube (filling volume VF).

Labelling Requirements

Labeling is also an important aspect of any medical device standard and IS 18879 (Part 8): 2024 information set provides the exact labeling requirements. A Suitable labeling ensures that customers can identify the product, understand its proper use and are aware of any safety measures. Standard labeling actually specifies the following key requirements:

• Label on Unit Container:

1. The name and address of the manufacturer.
2. A textual description of the contents.
3. Indication that the infusion set is sterile.
4. The lot (batch) designation.
5. Expiry date information.
6. Indication that the infusion set is for single-use only.
7. Instructions for use, including any warnings.
8. The letter “P” to signify pressure compatibility.

• Label on Shelf or Multi-Unit Container:

1. The name and address of the manufacturer.
2. A textual description of the contents.
3. Lot (batch) designation.
4. Expiry date information.
5. Instructions for use and warnings.
6. The letter “P” clearly indicating pressure compatibility.

Additionally, graphical symbols can also be used to increase clarity of information, especially in multilingual settings or where packaging is limited.

Disposal and Environmental Considerations

IS 18879 (Part 8): 2024 pacts with Single-use infusion sets, it is imperative to highlight the correct disposal of these devices after use. The Infusion set possibly contain thousands of liquids that could be contaminated, such as blood or medicines, and improper disposal could pose health risks. The standards outlines the significance of providing end-user instructions on safe and environmentally friendly disposal of equipment. An example of these instructions could be: "Always dispose of blood-contaminated products in a manner consistent with established biohazard procedures." Health care providers must ensure that all disposable infusion sets are disposed of safely to reduce the risk of contamination and infection.

Also Read: IS 18853: 2024 ISO 11978: 2017 + AMD 1: 2020 Ophthalmic Optics — Contact Lenses and Contact Lens Care Products Labelling

Conclusion

In Conclusion, the adoption of IS 18879 (Part 8): 2024, which is similar to ISO 8536-8:2015, reflects India's commitment to upholding high standards in the safety and quality of medical devices. By aligning with international standards, the country make sure that health care professionals and manufacturers of pressure infusion equipment are properly equipped to handle all infusion sets in use, thereby increasing safety and reliability.

The standard addresses a number of critical areas, containing the design, labeling, disposal, and terminology related with infusion sets. Obedience to these standards confirms that medical devices are safe, effective, and compliant with global quality expectations. In fact, manufacturers' adherence to these standards not only ensures the quality of their products but also eases access to the global market, specifically in countries that adhere to ISO standards.

In addition, IS 18879 (Part 8):2024 works as a fundamental reference for medical device manufacturers, health care providers and regulatory bodies to make sure the safe and effective use of infusion sets in severe medical procedures.