On May 1, 2025, the Bureau of Indian Standards (BIS) under the Department of Consumer Affairs announced the establishment of 16 new Indian standards. These were officially established on April 10, 2025, and include medical equipment, safety equipment, and engineering services. The standards issued under Rule 15(1) of the BIS Rules, 2018 aim to improve product quality, patient safety and performance in the healthcare and industrial sectors. Some of these standards are revised versions of existing standards, which will remain in effect until their return on October 10, 2025. With this update, BIS reinforces its commitment to align with global norms and ensure continued progress in critical industries.

Updated Standards for Dental and ENT Equipment

Several long-standing standards for dental and ENT surgical instruments have undergone significant revisions. The authorities updated IS 6815 to reflect modern specifications for dental matrix retainers, replacing the 1972 version by October 2025. IS 7066, IS 10088 and IS 10309 now provide better guidelines for instrument-cabinet trays, dental retractors and torquing keys, increasing usability and consistency of construction. ENT equipment also saw changes, with IS 8825 and IS 8837 now better aligning suction irrigation cannulas and suction tubes with stylets to current medical practices, incorporating advances in design, materials and international compatibility.

New Standards Promote Safer Respirators and Implantable Devices

BIS has also issued a new version of IS 10245 (Part 3) relating to respiratory protective equipment. This revised standard outlines specifications for fresh air hose and compressed air line breathing apparatus used in hazardous environments. The latest version takes into account the new test methods and materials used in the manufacture of these safety devices. Another important addition is IS 17750 (Part 4), which focuses on implantable infusion pump systems. This standard is adapted from ISO 14708-4:2022, which reflects global harmonization and ensures Indian manufacturers meet international performance levels. These standards support BIS certification efforts, enabling products to gain both national and international trust.

Focus on Modern Healthcare Devices and Biocompatibility

Standards such as IS 18766 (Part 4) and IS/ISO 11979-7 place an increasing focus on regulating advanced healthcare products. IS 18766 ensures patient safety by setting clear test parameters for leachable in condensate, important for biocompatibility in healthcare devices. Adapted from ISO 18562-4:2024, it guides manufacturers in meeting security standards. IS/ISO 11979-7 and IS/ISO 11979-9 address intraocular lenses, including both diagnostic examination and multifocal design. These updates help medical device manufacturers align with BIS registration requirements and international standards, ensuring safe, high-quality products in the evolving healthcare landscape.

Updates in Engineering and Refrigeration Sectors 

The latest information presents key updates in the engineering and refrigeration sectors. IS 19235 sets clear requirements for geotechnical engineering services, which increases safety and accuracy in construction and infrastructure projects. In refrigeration, IS 19106 and IS 19099 establish general requirements and test methods for vaccine carriers and refrigeration units. These standards aim to improve the reliability of vaccine storage, especially in areas with limited or unstable power supply where intermittent mains-powered refrigerators are common.

A complete list of the newly established standards, including their revisions and withdrawal dates, is provided in the table below:

Impact on Stakeholders

The establishment of new BIS standards will have a significant impact on many stakeholders. For manufacturers, it ensures clear guidelines for BIS certification and product quality improvement, helping them access domestic and international markets. Healthcare professionals benefit from safer, more reliable medical devices, which enhances patient care. Regulatory bodies will find it easier to enforce compliance with the updated norms. For consumers, especially patients, the changes translate into better safety and performance of healthcare products. Exporters can now align with global norms, especially standards aligned with ISO norms.

These new standards introduced by BIS are part of an ongoing effort to modernize and align Indian products with global norms. The update provides better guidance for manufacturers, regulators, and users, ensuring safer and more effective products. BIS certification and BIS registration under these updated norms will further enhance product credibility, especially in global markets.