Absorbent Cotton Gauze refers to medical textiles, which are extensively used during wound dressing. Other areas of application include operations and other medical procedures that require absorption of blood and sterility near the surgical area. The Cotton Gauze is made from quality cotton yarns knitted together to create a lightweight fabric to facilitate effective absorption of bodily fluids and air circulation near the affected area.
Adherence to IS 758:2023 provides a necessary benchmark to assess the quality and safety of medical textiles. In addition to testing for its absorbency capacity, pH value, whiteness index, presence of residual impurities, and sterility, BIS certification includes testing for consistency of the fabric used and its tensile strength. It is important to make sure that all these parameters comply with high medical standards before allowing the use of such a biomedical material in hospitals.
What is IS 758: 2023?
This is the Indian Standard for Absorbent Cotton Gauze used in medical and surgical applications. It specifies the quality, absorbency and hygiene requirements to ensure safe and effective use in the healthcare sector. As per the BIS (Bureau of Indian Standards), these Cotton Gauze are:
- Evaluated for sterility and cleanliness
- Tested for strength
- Checked for absorbency and purity
- Assessed for weave construction
Eligibility Criteria for Surgical Gauze BIS License
BIS authorisation under IS 758: 2023 is required for businesses involved in manufacturing, importing, or supplying medical textiles in India.
Applicable to:
- Manufacturers (India) - Must get BIS approval if Wound Dressing Gauze are covered under QCO.
- Foreign Manufacturers - Need certification to export the product to India.
- Importers/Brand Owners - Must ensure that the products are BIS-certified before sale.
- Sellers/Distributors - Should only sell certified Medical Absorbent Gauze.
Testing and Inspection Requirements
Absorbent cotton gauze used for clinical purposes is required to meet certain standards of quality as stated in IS 758: 2023. This standard provides for proper absorbency, cleanliness, strength, and suitability of the product for application in the healthcare industry. The BIS testing parameters and quality checks for the Cotton Gauze are listed below:
| Test Group | What is Tested | Purpose |
|---|
| Yarn Quality Test | Cotton yarn conformity as per IS 171 requirements | Ensures suitable raw material quality for gauze manufacturing |
| Fibre Identification Test | Verification of cotton fibre composition | Ensures the gauze is made from specified cotton fibres |
| Cloth Construction Test | Cloth structure and conformity with IS 758 requirements | Ensures proper fabric construction and uniformity |
| Count of Yarn Test | Yarn count and thread characteristics | Ensures consistency in fabric quality and performance |
| Threads per Decimetre Test | Number of threads in warp and weft direction | Ensures proper weave density and dimensional consistency |
| Mass Test | Weight of gauze material | Ensures uniform material weight and product quality |
| Length & Width Test | Roll dimensions and size accuracy | Ensures dimensional compliance with standard requirements |
| Absorbency Test | Water absorption capability of gauze | Ensures effective absorbent performance for medical use |
| pH Value Test | pH level of aqueous extract | Ensures the gauze is safe and non-irritating for skin contact |
| Scouring Loss Test | Removal of impurities and processing residues | Ensures proper cleaning and processing of gauze fabric |
| Optical Whitener Test | Presence of optical whitening agents | Ensures absence of prohibited whitening substances |
| Microbial/Bioburden Test | Cleanliness and microbial contamination level | Ensures hygiene and suitability for medical applications |
Step-by-Step BIS Approval Process for Surgical Gauze
The BIS Authorisation process ensures that the Medical Absorbent Cotton Gauze meet the required safety standards. This process is set by the Bureau of Indian Standards (BIS) and includes the following steps:
- Online Registration: Manufacturers register on the BIS Manak portal by submitting company, factory, and product details. Foreign manufacturers must appoint an Authorized Indian Representative (AIR).
- Testing at BIS-Approved Laboratory: Product samples are tested in BIS-approved laboratories for absorbency, fabric quality, tensile strength, cleanliness and uniformity of weave.
- Application Submission: The application is submitted along with test reports, technical documents, and factory details. Foreign manufacturers must also submit AIR-related documents.
- Factory Inspection: BIS officials visit the manufacturing facility to evaluate production processes, safety measures, and the quality control system.
- Grant of BIS License: After all compliance requirements are satisfactorily met, BIS grants the certification license under Scheme-I.
- Use of ISI Mark: Following approval, the manufacturer is authorized to use the ISI Mark on the product along with a valid CM/L number, confirming that the product meets BIS standards.
Mandatory Documents for IS 758: 2023 Approval
| Document Category | Documents Required |
|---|
| Basic Details | GST Certificate, Email ID & Contact Number, Factory & Office Address, Rent Agreement / Lease Deed (if applicable),Partnership Deed (if applicable for partnership firms) |
| Manufacturing Details | List of Machinery, Process Flow Chart, Factory Layout Plan |
| Raw Material Details | List of Raw Materials, Supplier Details, Raw Material Invoices, Raw Material Test Certificates |
| Testing & Quality Control | List of Testing Equipment, Calibration Certificates, QC/Lab In-charge Appointment Letter & Qualification |
| Production Details | Annual Installed Capacity, Last Year Production Value |
| Product & Packaging Details | Quantity per Package, Nature of Packing, Product Printing / Marking Details |
| Management Details | Top Management Details, BIS Communication Contact Person |
| Brand & Certification Documents | Trademark / Brand Certificate, Consent Letter from BIS Recognized Laboratory |
| Additional Documents | Weekly Off Details, Hygiene Document (if applicable), Relaxation Letter (if applicable), Any Other Relevant Document |
| Foreign Manufacturer Requirement | Appointment of Authorized Indian Representative (AIR) for BIS coordination and compliance in India |
The Foreign manufacturers must designate an Authorized Indian Representative (AIR) in India. The representative is the local point of contact for the Bureau of Indian Standards (BIS) and manages all compliance and regulatory requirements in India.
Marking Requirements & License Validity
Marking Requirements
After the manufacturer obtains a BIS license, the ISI Mark for Sterile Cotton Gauze must be written clearly and permanently either on its packaging or on the product. The marking should also include essential details, such as the manufacturer’s identification and licence number (CM/L). Additional information is provided below:
| Requirement | Details |
|---|
| ISI Mark | Indicates that the product is BIS certified and conforms to standards |
| Standard Number | IS 758: 2023 |
| CML Number | Certification Marks License (CML) number issued by BIS |
| Manufacturer Details | Name of manufacturer or registered trademark |
| Batch / Date | Batch number, heat number, or manufacturing date for traceability |
Note: Marking is typically applied using durable stamping, tagging, or permanent printing to ensure clear identification during handling, storage, and transportation, as per BIS marking requirements.
Validity for Surgical Gauze BIS License
| particulars | Details |
|---|
| Initial Validity | Typically 1 to 2 years, depending on BIS approval conditions |
| Renewal | Must be renewed before expiry by submitting the application along with the prescribed fee and updated documents |
| Surveillane | Includes periodic factory inspections and market sample testing conducted by BIS |
| Compliance | Continuous following to standard and applicable Quality Control Orders (QCOs) is mandatory |
| Risk | Non-compliance or failed sample testing may lead to suspension or cancellation of the BIS license |
Fee Structure for Sterile Cotton Gauze BIS Approval
The cost of BIS Approval for a Medical Textile includes charges for application, inspection, license, testing, and marking. These fees are paid to BIS as per Scheme I guidelines.
| Charge Type | Indian Manufacturers | Foreign Manufacturers |
|---|
| Application Fee | INR 1,000 | USD 15 |
| Audit Charges | INR 7,000 | USD 3,200 – 5,900 |
| License Fee | INR 1,000 | USD 15 |
| Marking Fee | As applicable | As applicable |
| Testing Charges | As applicable | As applicable |
| EVTL India Consultancy Fee | As per actual | As per actual |
Note:
- Application fee for foreign manufacturers is payable via SWIFT (SAARC countries may pay in INR with applicable GST).
- Audit charges for foreign manufacturers vary based on country/location.
- The marking fee is determined based on the product category and production volume (MSME benefits may apply).
- Testing charges are to be paid directly to BIS-recognised laboratories.
- Consultancy fees can vary depending on product type and factory location.
Conclusion
Absorbent cotton gauze as per IS 758:2023 is designed to provide a regulated medical textile with assured quality for medical usage. With BIS certification, the product is able to provide high absorbency properties, the right level of sterility, and standardized textile construction that would ensure the safety of medical operations conducted with its help. Therefore, this will significantly decrease the chances of infections, skin irritation, and ineffectiveness of absorption. The process of obtaining BIS certification can be simplified by getting assistance from EVTL India. They will help you in preparing the documents required to submit your application and pass the tests at the laboratories.
