BIS ISI Mark Certification for Surgical Face Masks – IS 16289:2014

If you are a manufacturer, importer, or supplier of surgical face masks in India, you are required to obtain BIS certification as per IS 16289:2014. This standard, issued by the Bureau of Indian Standards (BIS), defines the safety, filtration efficiency, and performance requirements for surgical masks used in medical and healthcare environments.

This guide explains what IS 16289:2014 covers, why certification is mandatory, and how Standphill India can help you complete the process smoothly and compliantly. It is written to help users and search engines find clear, trustworthy answers to questions related to BIS certification for medical textiles.

What is IS 16289:2014?

IS 16289:2014 is the Indian Standard for surgical face masks. It covers the essential quality parameters masks must meet to be safe and effective in clinical settings. This includes:

Bacterial filtration efficiency (BFE)

Breathability (Delta P or differential pressure)

Resistance to synthetic blood penetration

Microbial cleanliness

Material safety and construction

Masks that conform to this standard are suitable for use in surgeries, hospitals, and healthcare applications where infection control is critical.

Is BIS Certification Mandatory for Surgical Masks?

Yes. Under the Quality Control Orders (QCOs) issued by the Indian government, it is mandatory for all surgical masks manufactured, imported, or sold in India to be certified by BIS and carry the ISI mark. This regulation is enforced under the BIS Act, 2016.

Failing to comply may result in:

Seizure of non-compliant stock

Legal penalties or fines

Disqualification from tenders and supply contracts

Removal from online and retail platforms

BIS Certification Process for Surgical Face Masks (IS 16289:2014)

If you're searching for how to get BIS certification for surgical masks, here is a step-by-step breakdown:

Step 1: Register on the BIS Manakonline Portal

Create a manufacturer profile and submit:

Factory details and legal documents

Production flow and machinery list

Raw material sources and quality control procedures

Step 2: Product Testing in BIS-Approved Laboratory

Submit mask samples to a BIS-recognized lab for testing:

Bacterial Filtration Efficiency (BFE) > 95%

Breathability test (Delta P)

Splash resistance using synthetic blood

Bioburden (microbial cleanliness)

Tensile strength and construction checks

Step 3: Factory Inspection by BIS Officials

BIS will conduct an on-site inspection to verify:

Hygiene standards and cleanroom setup (if applicable)

Labeling and traceability

Equipment and in-house testing protocols

Process control and documentation

Step 4: Grant of BIS License and ISI Marking

Once testing and inspection are successful, BIS issues a license to use the ISI mark along with the standard number IS 16289:2014. You must mark this on:

Product packaging

Inner cartons or labels

Step 5: Ongoing Compliance

After certification:

Maintain batch-wise testing records

Renew your BIS license annually

Participate in routine surveillance audits

Why Choose Standphill India for BIS Certification?

Standphill India is a professional BIS certification consultancy helping brands across India comply with standards for PPE, medical textiles, and healthcare equipment.

Services We Offer:

Application documentation and BIS portal registration

Testing coordination with BIS-accredited labs

Factory audit preparation and mock inspections

License tracking, renewal, and expansion

Benefits of Working with Standphill:

Faster approvals with expert support

Reduced chances of application rejections

End-to-end handling of BIS procedures

Trusted by leading medical mask manufacturers

Frequently Asked Questions (FAQs)

Q1: Is BIS certification mandatory for surgical masks in India?

Yes. As per government QCOs, surgical masks must be ISI certified under IS 16289:2014.

Q2: How long does BIS certification take?

The full process, including testing and inspection, may take 4 to 8 weeks depending on documentation readiness.

Q3: Can imported surgical masks be sold without BIS?

No. Imported masks must be certified and carry the ISI mark before being marketed in India.

Final Thoughts

With BIS certification now mandatory for surgical face masks, compliance with IS 16289:2014 is critical to remain legally and commercially viable in India. Certification is not just a regulatory formality – it builds credibility, ensures safety, and protects public health.

Whether you're a new startup or an established manufacturer, Standphill India can help you navigate the entire BIS certification journey efficiently.

Standphill India – Reliable BIS Certification Partner for Medical and Healthcare Products.

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