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India Introduces Draft Specifications for Disposable Tampons Image

India Introduces Draft Specifications for Disposable Tampons

Date
11 Feb 2026

Reference source : BIS

BIS Labelling Indian Standards IS

On 2 February, the Bureau of Indian Standards (BIS) issued a Wide Circulation Draft of the Indian Standard titled “Medical Textiles — Disposable Tampon — Specifications” through its Technical Textiles for Medtech Applications, (TXD 36). The draft was prepared under document number TXD 36 (28740).  Stakeholders and interested parties are invited to submit their comments and suggestions by 4 March 2026.

Scope

This standard specifies the requirements for single-use disposable tampons intended for internal use during menstrual periods.

Specifications

The draft standard specifies key performance requirements for disposable tampons, including:.

  • Length of withdrawal cord: Minimum 80 mm
  • Absorptive capacity: Ranges from <6 g (light flow) to 18–21 g (super heavy flow)
  • pH value: Between 4 and 7.5
  • Pull strength of withdrawal cord: Minimum 28 N
  • Hygiene standards: Microbial limits, and the absence of harmful bacteria such as Staphylococcus aureus, E. coli, Candida albicans, and Pseudomonas aeruginosa

The draft also includes biocompatibility testing requirements for cytotoxicity, irritation, and skin sensitization, as well as optional compostability tests (optional).

Chemical Safety Requirements

Chemical safety requirements cover formaldehyde, heavy metals, phthalates, pesticides, and banned azo dyes. The tampon shall conform to the chemical requirements as specified in the table below.

SI No.

Characteristics

Requirements

1.

Formaldehyde, mg/kg (ppm)

20

2.

Extractable heavy metals, mg/kg (ppm)

 

 

a) Antimony

b) Arsenic

c) Cadmium

d) Chromium

e) Cobalt

f) Copper

g) Lead

h) Mercury

i) Nickel

30

0.2

0.1

1

1

25

0.2

0.02

1

3.

Phthalate test (individual or in combination)

< 0.1 percent

4.

Pesticide test (sum parameter), mg/kg (ppm)

0.5

5.

Banned azo dyes, mg/kg

20

 

Marking, Labelling and Packaging

BIS also provides marking and labelling requirements,  which include:

  • Manufacturer details, batch number, type/variety, country of origin, number of tampons per pack
  • Instructions for disposal and warnings about Toxic Shock Syndrome (TSS)
  • Accompanying leaflet with directions for use, hygiene instructions, and TSS information

The draft also covers packaging requirements to maintain product quality, including individual wrapping, rigid or flexible outer packaging, and damage-free materials.

Certification and Next Steps

Products that conform to the draft standard may apply for BIS certification and the Standard Mark under existing regulations.

Comments on the draft should be submitted in the prescribed template via the BIS portal. In case no comments are received by the deadline, approval will be presumed.

 

 

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