BIS Certification for Surgical Face Masks IS 16289:2014

Let’s break down what this means, why it matters, and how manufacturers can obtain the ISI Mark for surgical face masks.

What is IS 16289: 2014?

IS 16289:2014 is the Indian Standard for surgical face masks, specifying the design, performance, and testing requirements that these masks must meet. This standard ensures that surgical masks offer adequate protection against fluids, particles, and microorganisms, making them fit for use in medical settings.

Complying with IS 16289 helps ensure:

In short, it sets a benchmark for safety and quality.

Why is BIS Certification Important?

The Bureau of Indian Standards (BIS) is India’s national standards body responsible for ensuring that products meet the necessary safety and quality requirements. For products like surgical masks, BIS operates under a mandatory certification scheme, meaning manufacturers cannot legally sell surgical face masks in India without first obtaining the ISI Mark certification for surgical face masks.

The ISI Mark is the official certification mark from BIS. When you see the ISI Mark on a product, it signals compliance with relevant Indian standards — in this case, IS 16289: 2014 for surgical face masks.

Benefits of ISI Certification for Surgical Face Masks

Here’s why obtaining the ISI certification for surgical face masks is essential:

● Market Access: Only ISI-certified masks can be sold or distributed legally in India under this standard.

● Consumer Trust: Healthcare providers and institutions look for the ISI Mark for surgical face masks as a sign of reliability.

●Quality Assurance: Regular audits and inspections ensure that the manufacturing process remains consistent and aligned with IS 16289: 2014.

●Competitive Advantage: Certified products stand out in a crowded market where quality and safety matter most.

How to Get ISI Mark Certification for Surgical Face Masks

Obtaining BIS certification for surgical face masks involves the following steps:

1. Application Submission: Submit the completed application form with necessary documentation to BIS.
2. Document Review: BIS evaluates the submitted documents to verify accuracy and completeness.
3. Factory Inspection: BIS officials conduct on-site inspections to assess manufacturing processes and quality control systems.
4. Sample Testing: Product samples are collected and tested at BIS-approved laboratories to verify compliance with Indian standards.
5. Certification Grant: Upon successful inspection and testing, the BIS issues the certification, allowing the use of the ISI Mark. 

Documents Required for BIS Certification 

To apply for ISI Certification for surgical face masks, manufacturers must provide the following documents:

● Completed application form

● Detailed manufacturing process information

● Quality control plans and test reports

● Factory layout and equipment details

● Product specifications and technical details

● Business registration proof

● Declaration of conformity to Indian standards

BIS Documents For Domenstic and Foreign Manufacturer Check

BIS ISI Mark Certification Costing And Timeline

Conclusion

The Indian Standard for surgical face masks (IS 16289: 2014) is not just a technical specification — it’s a trust mark for healthcare quality. Obtaining the ISI Mark certification for surgical face masks reassures buyers and users that the product has passed stringent testing and adheres to national safety benchmarks.

For manufacturers, staying compliant is not only a legal requirement but also a powerful way to position themselves as responsible and quality-focused players in the healthcare industry.

If you are a manufacturer or distributor, ensure your products carry the ISI Mark for surgical face masks; it’s your gateway to regulatory approval and market confidence.