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BIS ISI Certification for Surgical Face Masks – IS 16289
Surgical face masks play a critical role in protecting patients and healthcare professionals from the transmission of infections, microorganisms, and body fluids. In India, BIS ISI certification is mandatory for surgical face masks to ensure consistent quality, safety, and performance in medical and healthcare environments.
BIS certification for Surgical Face Masks is governed by Indian Standard IS 16289:2014. This standard specifies requirements related to design, construction, filtration efficiency, breathability, resistance to fluids, and microbial cleanliness of surgical masks.
BIS ISI Mark certification under IS 16289 allows manufacturers to legally manufacture and sell surgical face masks in India and builds trust among hospitals, healthcare institutions, and regulatory authorities.
IS 16289:2014 – Key Quality & Performance Requirements for Surgical Face Masks
- (i) Design and construction suitable for medical and surgical use
- (ii) Adequate bacterial and particle filtration efficiency
- (iii) Breathability to ensure comfort during prolonged use
- (iv) Resistance to penetration by synthetic blood and fluids
- (v) Microbial cleanliness within prescribed limits
- (vi) Proper ear loops or ties and secure facial fit
- (vii) Non-toxic materials with no adverse skin reaction
- (viii) Mandatory marking, labeling, batch identification, and ISI Mark
Overview of ISI Mark Certification for Surgical Face Masks (IS 16289)
IS 16289:2014 is the Indian Standard that specifies performance and safety requirements for surgical face masks intended for use in hospitals, clinics, laboratories, and healthcare facilities. The standard ensures that masks provide effective protection against fluids, particles, and microorganisms.
The standard covers requirements related to filtration efficiency, breathability, resistance to synthetic blood penetration, microbial cleanliness, and overall construction quality to ensure user safety and comfort.
BIS grants ISI Mark certification for surgical face masks only after successful factory inspection, evaluation of quality control systems, and testing of samples in BIS-recognized laboratories. Certified masks are authorized to carry the ISI Mark, confirming compliance with Indian Standards and suitability for medical use.
Process Required for BIS ISI Mark Certification for Surgical Face Masks (IS 16289:2014)
To obtain the BIS ISI Mark for Surgical Face Masks under Indian Standard IS 16289:2014, manufacturers must comply with the BIS Product Certification Scheme (Scheme-I). This certification ensures that surgical masks meet mandatory requirements related to filtration efficiency, breathability, resistance to synthetic blood, and microbial cleanliness before being manufactured or sold in the Indian market.
Estimated Timeline: The BIS ISI certification process for surgical face masks generally takes around 30–45 days for Indian manufacturers and up to 5–6 months for foreign manufacturers, depending on factory preparedness, inspection scheduling, and laboratory testing.
Step-by-Step Certification Process
- Application Submission: Submit the BIS application through the Manak Online portal by providing product details, applicable Indian Standard (IS 16289:2014), factory address, manufacturing process, machinery, and quality control setup.
- Testing Readiness: Ensure availability of testing facilities for bacterial filtration efficiency (BFE), differential pressure (breathability), synthetic blood penetration resistance, microbial cleanliness, and visual inspection as prescribed under IS 16289.
- Factory Inspection: A BIS officer conducts an on-site inspection to verify raw material sourcing, production process, sterilization (if applicable), quality control systems, marking practices, and compliance with the approved Scheme of Inspection and Testing (SIT).
- Sample Drawing and Testing: Surgical mask samples are drawn during inspection and tested in BIS-recognized laboratories as per IS 16289:2014 requirements.
- Grant of BIS License: Upon successful inspection and satisfactory test results, BIS grants the Certification Marks License (CM/L), authorizing the manufacturer to use the ISI Mark on surgical face masks.
Requirements to Obtain BIS License for Surgical Face Masks (IS 16289)
- Compliance of surgical masks with design, performance, and safety requirements specified under IS 16289:2014.
- Use of non-toxic, skin-safe materials with adequate filtration layers.
- Availability of testing facilities for BFE, differential pressure, synthetic blood penetration, microbial cleanliness, and visual checks.
- Appointment of qualified quality control personnel to ensure consistent production conformity.
- Strict adherence to the Scheme of Inspection and Testing (SIT) and BIS ISI certification guidelines applicable to medical face masks.
To obtain BIS ISI certification for Surgical Face Masks under Product Certification Scheme-I, manufacturers are required to submit documents broadly classified into the following categories:
- Administrative Details: Business registration documents, factory address proof, GST registration, and statutory approvals.
- Technical Details: Product specifications, mask type, layer construction, filtration media details, and compliance declaration as per IS 16289:2014.
- Quality Control Personnel Details: Qualifications, experience, and responsibilities of personnel managing quality assurance and testing.
- Commercial Details: Brand name, trademark ownership (if applicable), and authorization documents.
Cost of BIS ISI Certification for Surgical Face Masks (IS 16289)
The following are indicative statutory charges involved in obtaining BIS ISI certification for Surgical Face Masks under Product Certification Scheme-I. All government fees are payable directly to the Bureau of Indian Standards (BIS).
| S. No. | Particular | Amount (INR) | Remarks |
|---|---|---|---|
| 1 | Application Fee | ₹1,000 | Payable to BIS |
| 2 | Inspection / Audit Fee | ₹7,000 | Payable to BIS |
| 3 | Product Testing Fee | As applicable | Depends on mask type & laboratory |
| 4 | Marking Fee | As per BIS norms | Based on annual production |
Important Note: Product testing as per IS 16289:2014 is a critical stage in the BIS ISI certification process. BIS may conduct a factory pre-assessment to evaluate readiness prior to inspection. Charges mentioned above are indicative and may vary depending on mask type and testing scope.
Benefits of Getting ISI Mark Certification for Surgical Face Masks (IS 16289:2014)
Obtaining the ISI Mark for Surgical Face Masks under Indian Standard IS 16289:2014 provides essential regulatory, commercial, and quality advantages. ISI certification confirms that surgical masks meet prescribed Indian requirements for filtration efficiency, breathability, fluid resistance, and microbial cleanliness, making them legally approved for manufacture and sale in India.
1. Mandatory Legal Compliance
Surgical face masks are regulated medical products in India. ISI Mark certification under IS 16289:2014 is mandatory for lawful manufacturing, sale, or distribution in the Indian market.
2. Acceptance in Hospitals & Healthcare Institutions
ISI-certified surgical masks are widely accepted by hospitals, clinics, laboratories, and healthcare facilities. Certification simplifies procurement approvals and compliance audits.
3. Assured Safety, Performance & Protection
Certified masks are tested for bacterial filtration efficiency, breathability, resistance to synthetic blood penetration, and microbial cleanliness, ensuring reliable protection for medical use.
4. Enhanced Brand Credibility & Market Trust
The ISI Mark builds confidence among healthcare professionals, procurement authorities, and end users. Certified surgical masks are recognized as compliant with national quality and safety standards.
5. Competitive Advantage & Business Growth
ISI-certified surgical face masks gain preference in government tenders, hospital supply contracts, and institutional procurement, enabling manufacturers to expand market reach and credibility.
Frequently Asked Questions (FAQs) – BIS ISI Certification for Surgical Face Masks (IS 16289:2014)
1. Is BIS ISI certification mandatory for surgical face masks?
Yes. Surgical face masks must comply with Indian Standard IS 16289:2014. BIS ISI Mark certification is mandatory before manufacturing, selling, or distributing surgical masks in India.
2. Which Indian Standard governs surgical face masks?
Surgical face masks are governed by Indian Standard IS 16289:2014, which specifies design, performance, and testing requirements.
3. What are the key performance requirements under IS 16289?
Key requirements include bacterial filtration efficiency (BFE), breathability, resistance to synthetic blood penetration, microbial cleanliness, and proper construction quality.
4. What tests are conducted on surgical face masks under IS 16289?
Testing includes bacterial filtration efficiency, differential pressure (breathability), synthetic blood penetration resistance, microbial cleanliness, and visual inspection.
5. What are the consequences of supplying non-ISI certified surgical face masks?
Supplying non-ISI certified surgical face masks may result in penalties, product seizure, rejection in hospital procurement, and legal action under the Bureau of Indian Standards Act, 2016.
