UPCOMING QCO ON TEXTILE GOODS BY MINISTRY OF TEXTILE
BIS Certification for Adult Diapers IS 17508
Indian Standard IS 17508:2020 specifies the quality, safety, and performance requirements for adult diapers manufactured or sold in India. Adult diapers are designed for prolonged and direct contact with human skin, making it essential that they meet strict safety, hygiene, and comfort standards. The standard focuses on ensuring that adult diapers provide effective absorbency, leakage protection, skin friendliness, and overall user comfort during regular use.
All raw materials used in the manufacture of adult diapers must comply with the requirements specified under Clause 3 of IS 17508:2020 and must undergo biocompatibility evaluation as prescribed under Clause 7.4. This evaluation is required to be conducted at least once for existing materials and must be repeated whenever there is any change in the raw material composition or the source of supply.
IS 17508 specifies the quality parameters or characteristics of Adult Diapers
- (i) Top sheet material for prolonged skin contact comfort
- (ii) Highly absorbent core for effective liquid retention
- (iii) Leak-proof outer barrier and back sheet
- (iv) Types, sizes, and shapes suitable for adult users
- (v) pH value to ensure skin friendliness and prevent irritation
- (vi) Rate of absorption, rewet under load, and minimum absorption capacity
- (vii) Fastening, securing system, and fit for mobility support
- (viii) Permissible limits for bacterial and fungal bioburden
Mandate for ISI Mark Certification of Adult Diapers (IS 17508)
The Government of India, in consultation with the Bureau of Indian Standards (BIS), has introduced mandatory compliance requirements for adult diapers to protect public health and ensure user safety. These requirements are notified under the provisions of the Bureau of Indian Standards Act, 2016, empowering BIS to regulate the quality and safety of adult hygiene products sold in the Indian market.
Process Required for BIS ISI Mark Certification for Adult Diapers (IS 17508)
To obtain the BIS ISI Mark for adult diapers under Indian Standard IS 17508:2020, manufacturers must comply with the Product Certification Scheme (Scheme I) of BIS. A crucial requirement is the establishment of a dedicated in-house testing laboratory in accordance with the Scheme of Inspection and Testing (SIT). This ensures that every batch of adult diapers meets prescribed safety, hygiene, absorbency, and performance standards before market release.
Estimated Timeline: The BIS ISI certification process for adult diapers generally takes around 30 to 45 days, subject to factory preparedness, inspection scheduling, and laboratory testing timelines.
Step-by-Step Certification Process
- Application Submission: Submit Form-V through the BIS Manak Online portal by providing adult diaper product details, applicable Indian Standard (IS 17508), factory layout, manufacturing process, and machinery details.
- In-House Laboratory Setup: Establish an in-house testing laboratory equipped with mandatory test equipment specified under IS 17508. All instruments must be calibrated with valid NABL calibration certificates.
- Factory Inspection and Audit: A BIS officer conducts an on-site audit to verify manufacturing operations, quality control systems, testing facilities, and the competency of quality control personnel.
- Sample Drawing and Testing: During the inspection, samples of adult diapers are sealed by the BIS officer. One set is tested in the manufacturer’s in-house laboratory, while another set is sent to a BIS-recognized third-party laboratory for independent verification.
- Grant of BIS License: Upon satisfactory test results and audit compliance, BIS grants the Certification Marks License (CM/L), authorizing the manufacturer to use the ISI Mark on adult diaper products.
Requirements to Obtain BIS License for Adult Diapers (IS 17508)
- Conformity of all raw materials used in manufacturing adult diapers as per the requirements of Indian Standard IS 17508:2020.
- Availability of a dedicated in-house testing laboratory capable of performing all mandatory tests specified under IS 17508 for adult diapers.
- Appointment of competent and qualified Quality Control personnel to monitor testing, hygiene, absorbency, and overall product quality.
- Strict adherence to BIS guidelines and the Scheme of Inspection and Testing (SIT) applicable to adult diaper products.
To obtain BIS certification for adult diapers 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, PAN, and other statutory approvals.
- Technical Details: Adult diaper specifications, raw material details, manufacturing process flow, and applicable test parameters as per IS 17508.
- Quality Control Personnel Details: Qualification, experience, appointment letters, and roles of QC staff responsible for testing and compliance.
- Commercial Details: Brand ownership details, trademark registration (if applicable), and authorization documents.
Cost of BIS Certification for Adult Diapers (IS 17508)
The following are indicative government and related charges involved in obtaining BIS certification for adult diapers under Product Certification Scheme-I. All statutory 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 | Audit Fee | ₹7,000 | Payable to BIS |
| 3 | Sample Testing Fee | As applicable | Depends on lab & product |
| 4 | Marking Fee | As per actual | Varies by IS |
Important Note: Product testing is a critical stage of the BIS certification process and determines compliance with IS 17508. Manufacturers must invest in suitable in-house testing facilities for adult diapers. In certain cases, BIS may conduct a pre-visit to the factory to assess readiness and conformity with certification requirements. The above charges are indicative and exclusive of additional laboratory or inspection-related expenses.
Benefits of Getting ISI Mark Certification for Adult Diapers
Obtaining the ISI Mark for adult diapers under Indian Standard IS 17508 provides important legal, commercial, and quality-related advantages. ISI certification confirms that adult diaper products meet prescribed safety, hygiene, absorbency, and performance standards and are legally permitted for sale in the Indian market.
1. Mandatory Legal Compliance
Adult diapers are a regulated hygiene product in India, making ISI Mark certification mandatory under applicable regulations. Certified manufacturers and importers can legally manufacture, import, and sell adult diapers, while non-compliant products may face penalties, market restrictions, or seizure.
2. Wider Market Acceptance
ISI-certified adult diapers are more readily accepted by pharmacies, hospitals, distributors, and e-commerce platforms. Certification improves market access and supports expansion across organized and institutional sales channels.
3. Enhanced User Safety and Confidence
Adult users and caregivers prefer ISI-certified products as the mark assures compliance with hygiene, skin safety, absorbency, and biocompatibility requirements. Certification builds confidence in products designed for prolonged skin contact and daily use.
4. Strong Brand Credibility and Trust
Consistent quality supported by ISI certification helps manufacturers build a strong and trustworthy brand image. Positive user experience and compliance-driven quality contribute to long-term brand loyalty and market reputation.
5. Competitive Advantage and Premium Positioning
ISI-certified adult diapers clearly stand apart from uncertified alternatives. Certification allows manufacturers to benchmark product quality, justify pricing, and position their adult diaper products as reliable, compliant, and suitable for healthcare and personal care use.
