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Obtain BIS Certification is mandatory for Disposable Baby Diapers, which are specially designed for newborns and toddlers. Disposable baby diapers, tailored specifically for newborns and toddlers, consist of various materials, featuring an absorbent core capable of efficiently retaining significant fluids often crafted from superabsorbent polymers. The exterior layer is typically composed of waterproof material, preventing leaks, while the inner layer prioritizes softness and comfort. These diapers play a pivotal role in maintaining baby cleanliness, fostering practicality, and enhancing the overall well-being of infants and their caregivers. Recognized as essential items for ensuring a baby's comfort and cleanliness, they are available in a diverse range of sizes to accommodate the developmental stages of newborns as they grow.

Key highlights

Product Name Disposable Baby Diaper Specification
Applicable Indian Standard IS 17509: 2021
Applicable Certification Scheme Product Certification Scheme (ISI Mark Scheme) Scheme 1 - Schedule 2
Compliance Requirement Mandatory
QCO Link Quality Control Order
Scope as per Standard This standard covers the requirements for disposable (non-reusable) baby diaper for external use.


  • Top cover or the top sheet
  • Absorbent Core
  • Outer protective barrier or back sheet
  • Fastening and Securing mechanism
  • Manufacture, workmanship and finish
  • Type and Size

Performance requirements

  • pH value
  • Rate of Absorption, Rewet under Load and Minimum Absorption Capacity
  • Biocompatibility Evaluation - Cytotoxicity, Irritation and Skin Sensitization

Hygiene Testing Requirement

  • Bacterial and Fungal Bioburden
  • Test for Common Skin Pathogen - Staphylococcus Aureus
  • Biocompatibility Evaluation - Cytotoxicity, Irritation and Skin Sensitization
  • Pthalate test
  • Anti-Bacterial Activity Value

As per IS 17509:2021, all disposable baby diapers are covered under mandatory ISI certification scheme, and without ISI mark this product cannot be imported or exported to the Indian consumer market. IS 17509:2021 delineates the quality parameters or characteristics of the Disposable Baby Diaper, including the top cover or top sheet, absorbent core, outer protective barrier, back sheet, types and shapes, pH value, rate of absorption, rewet under load, minimum absorption capacity, as well as the fastening and securing mechanism, and bacterial and fungal bioburden.

BIS Certification Process

Obtaining a BIS license involves a thorough assessment of manufacturing infrastructure, quality control capabilities, testing facilities, and production processes. This comprehensive evaluation ensures that the products not only comply with regulations but are also safe and reliable for consumers.

isi mark


For Detailed Information about the Procedure for BIS ISI Certification, Visit :

Timeline for BIS Certification

The approximate timeline to obtain BIS Certification for Disposable Baby Diapers to use ISI mark as Per IS 17509:2021 is given below:

  • For Indian Manufacturers (Standard Timeframe - 30 days)
  • For Foreign Manufacturers (Standard Timeframe - 180 days)


The implementation of the Medical Textiles (Quality Control) Order, 2023, is ushering in a transformative era for the market of Disposable Baby Diapers in India. Manufacturers, by embracing these guidelines and securing BIS certification, are not merely complying with regulations; they are setting new benchmarks for excellence in the industry. Opting for BIS-certified Disposable Baby Diapers signifies more than a product purchase; it represents a commitment to dependability, superior quality, and safety.

BIS certification for Disposable Baby Diapers goes beyond meeting regulatory checkboxes, assuring the highest performance standards in these products. In an era where quality takes precedence, choosing BIS-certified Disposable Baby Diapers guarantees a product that is not only dependable but also of the finest quality.

In this landscape of evolving standards, Aleph INDIA stands as a leading BIS consultant in India, dedicated to assisting manufacturers and importers in obtaining BIS licenses for their products. With a commitment to excellence, Aleph INDIA ensures that your products not only meet but exceed the required quality benchmarks. Aleph INDIA has been serving the industry as a single-window operator for all product regulatory compliance. We can assist importers or manufacturers in meeting all criteria for importing or selling a product in the Indian market.

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