This document discusses standards required for medical textiles in India. It summarizes the classification of medical textiles and the logic for developing standards to protect domestic industry. It outlines draft standards developed by SITRA for several products and their current status. Finally, it identifies additional medical textile products that require standards to be developed and provides timelines.

1. S Standards Required for the Medical Textiles
Presented by
K.Balasubramaniyan, Assistant Director
The South India Textile Research Association (SITRA),
Coimbatore.

2. CLASSIFICATION OF MEDICAL
TEXTILES
Medical Textile Products can be classified as:
Healthcare and hygiene products: Surgical clothing,
Covers, Beddings, Sanitary napkins, Baby diapers,
Adult incontinence.
 Non-implantable materials: Bandages, Wound care
dressings, Plasters, Gauze.
Implantable materials: Sutures, Soft tissue implants,
Hard tissue implants, Cardio vascular implants.
 Extra corporeal materials: Artificial kidney, Artificial
liver, Mechanical lungs.

3. DEVELOPMENT OF MEDICAL TEXTILE
STANDARDS – LOGIC BEHIND
Important to protect the existing industry from cheap
imports / dumping, as otherwise, the zeal / enthusiasm
for future investment will get wiped out
 To develop standard for low value, mass consumption
medical textile goods on urgent basis

4. DRAFT STANDARDS PREPARED BY
SITRA
 Surgical gown
 Surgical drapes
 Surgical face masks
 Cellulose wadding
 Vapour permeable water proof plastic wound dressings
 Non-woven gauze
 Paraffin Gauze dressings
 Knitted viscose primary dressings
 Perforated film absorbent dressings

5. STATUS ON THE PREPARED
STANDARDS
The following draft standards have been analyzed
recently at BIS Tx36 Sectional Committee’s sitting
and have been marked for wide circulation in order
to elicit comments from the stake-holders.
Surgical gown
Surgical drapes
Surgical face masks

6. STATUS ON THE PREPARED
STANDARDS (Contd..)
Next in the pipeline are draft standards that have
already been prepared and submitted to BIS on the
under mentioned 6 items:
 Cellulose wadding
 Vapour permeable water proof plastic wound
dressings
 Non-woven gauze
 Paraffin gauze dressings
 Knitted viscose primary dressings
 Perforated film absorbent dressings

7. STATUS ON THE PREPARED
STANDARDS (Contd..)
The standards pertaining to Cellulose Wadding and
Non-woven Gauze have been taken up for review
during the recent meeting of BIS Sectional
Committee Tx 36 on 30th
September, 2011 and it was
decided to issue the same for wide circulation in
order to elicit comments from the stake-holders.

8. STATUS ON THE PREPARED
STANDARDS (Contd..)
 Proposed draft standard for surgical face masks; one of
the characteristics laid out for the product is “ Splash
Resistance ” and its acceptable minimum value has been
fixed at 80mm Hg when tested accordance with ISO
22609.
 Facilities required for subjecting a product to Splash
Resistance Test is currently available with Nelson
Laboratories, United States only

9. STATUS ON THE PREPARED
STANDARDS (Contd..)
SITRA should develop, all on its own, the necessary
instrument / infrastructure related to the said test
routine and that too, on fast track basis, as the same
should go on stream well before Bureau of Indian
Standards comes out with the published standard.

10. STANDARDS TO BE DEVELOPED
SITRA also identified some of the Meditech products
for standards to be formulated on immediate basis
 Tubular bandages
 Swab with X – ray detectable filaments
 Orthopedic Stock knit
 Primary wound dressings
 Compression bandages
 Burn dressings
 Combined wound dressings
 Baby diaper
 Adult incontinence products

11. STANDARDS TO BE DEVELOPED
(Contd..)
Artificial Implantable products like Vascular grafts or
Hernia mesh or Heart patch fabric belong to
technology-intensive category and are life saving items;
an in-depth study of the same, including their behavioral
characteristics, will have to be under-taken before any
attempt to set standards could be taken up
These clearly are reserved for long-term objectives and
considering the fact that almost the whole lot of these
products are only imported at present, it may be
appreciated that the formulation of standards for the
same could be slated for end of 2014 – early 2015.