BIS Notification Standard Revised For Medical Devices And Chemicals

The Bureau of Indian Standards (BIS), functioning under the Ministry of Consumer Affairs, Food and Public Distribution, plays a vital role in ensuring the quality and safety of products and services in India. By setting Indian Standards (IS) for various industries, BIS ensures that products manufactured in the country adhere to high quality standards. In March, 2025, BIS issued important notifications announcing the withdrawal of the old standards and introducing revised standards. This notification focuses on keeping the standards updated with technological advancements and international norms. This update will affect various sectors like medical devices, paints, industrial materials and more.

What is in the BIS Notification?

The BIS notification, outlines the establishment of several new or revised Indian standards across multiple industries. This step ensures that products and services produced in India meet the latest safety, performance and efficiency standards. It also aims to replace old standards with new ones that are more in line with global best practices. In the notification, BIS mentioned specific standards that have been established and others that are being withdrawn. 

The standards are organized into categories such as medical devices, industrial materials such as paint and equipment used in bulk handling. Each entry in the notification includes the title of the standard, the date it was established, and the old standard it supersedes. In addition, the notification specifies the date when the old version will no longer be valid, giving industry stakeholders enough time to transition to the revised version.

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Categories of Affected Standards

The notification addresses several areas, each with unique standards and requirements. Here are some of the major categories of standards affected by the BIS notification:

1. Medical devices and equipment: A significant portion of the notification focuses on medical devices, especially those used in surgery and treatment. Updates to these standards help ensure that medical devices remain effective and up-to-date with advances in medical science and technology. Some examples of updated standards include:

• Plastic surgery instruments: Various surgical tools such as Kilner and McIndoe scissors, which are crucial for performing surgery safely and efficiently.
• ENT surgery instruments: Instruments such as nasal speculums, tongue presses, and forceps, all of which play an essential role in ear, nose, and throat-related procedures.
• Blood transfusion equipment: The specification of filters and filter chambers used in blood transfusion procedures has been updated to ensure high safety and performance standards.

2. Industrial materials and chemicals: In the industrial sector, the BIS notification revises the standards for many materials used in manufacturing and construction. These updates ensure that materials used in industrial applications meet the highest quality standards, reduce risk, and improve equipment performance. These include:

• Paints and coatings: The standard for green oxides of chromium for paint has been revised to incorporate the latest research and development in the field.
• Bulk handling equipment: Many standards related to bulk handling equipment, such as crawler tractors and bag stackers, have been updated to increase efficiency and safety.

3. Hydrometry and environmental measurement: The notification also addresses standards related to hydrometry, which is necessary for monitoring water flow in open channels. By revising these standards, BIS ensures that flow measurement is accurate and reliable, especially in projects related to water management and environmental sustainability.

4. Electrical and electronic equipment: The updated standard also affects electrical equipment, such as rotating electrical machines and miniature fuses. These modifications ensure that electrical equipment adheres to safety guidelines, reducing the risk of malfunctions and accidents. They also align India’s electrical standards with international practices, making Indian products more competitive in global markets.

Table: Summary of Established and Withdrawn BIS Standards

The following table summarizes the selection of standards mentioned in the BIS Notification, showing the old and new versions with their establishment and withdrawal dates:

Read Our Blog: BIS Introduces Crucial Amendments to Indian Standards: Key Updates for 2025 in Technology, Sustainability, and Safety

Impact on Stakeholders

The BIS notification will have a significant impact on various stakeholders, including manufacturers, consumers, and regulatory bodies.

• Manufacturers: Manufacturers are required to follow updated standards, to ensure that their products meet new safety and quality standards. This helps manufacturers to remain competitive in both domestic and international markets. For industries such as medical devices, electrical machinery, and bulk handling, adhering to the latest standards will improve product reliability and safety, reducing the risk of legal or financial consequences for non-compliance. This will help in the BIS registration process.
• Consumers: For consumers, the revision of standards means that products and services in India will be safer, more reliable and better aligned with global standards. Whether its medical devices, industrial materials or household products, consumers can expect superior quality and performance. The revised standard also ensures that products are more durable, reduce the likelihood of failure, and increase user safety. Having BIS certification helps consumers to trust and gain confidence on the product.
• Regulatory bodies: For regulatory bodies, the notification serves as a clear directive to monitor and implement updated standards. It helps maintain consistency and transparency in the implementation of quality measures across industries. Regulatory bodies will need to ensure that only updated versions are being followed as old standards are withdrawn.

Conclusion

The BIS notification is an important step towards modernizing the standards governing various sectors of India. By revising existing standards and removing outdated standards, the BIS ensures that the country’s products and services remain in line with technological advancements and international norms. The categories affected by these changes, from medical devices to industrial materials, illustrate the wide scope of the impact of the notification. Stakeholders, including manufacturers, consumers, and regulatory bodies, will need to adapt to these changes to ensure compliance with the new standards. This shift will ultimately result in safer, higher-quality products and services, benefiting both Indian industry and its consumers. By regularly updating standards, BIS plays a significant role in shaping India’s industrial landscape and promoting quality, safety and innovation across various sectors.