1. Scientist - C, Textiles Department Bureau of Indian Standards
STANDARDS FOR CLEAN AND HEALTHY INDIA 4th NATIONAL CONCLAVE ON STANDARDS FOR TECHNICAL TEXTILES
DHARMBEER
Scientist - C, Textiles Department
Bureau of Indian Standards
New Delhi

2. MEDTECH SECTOR
Out of total Indian textile industry, only 13% contributes to technical textiles, and out of this 13%, the share of Meditech, in technical textiles market is in the range of 6-8%.
Medtech is projected to reach Rs crore by growing at 9% CAGR and further to Rs crore by
The main volume growth driver in Meditech is the Non-implantable segment which includes surgicals & healthcare/hygiene products.
Lack of basic infrastructure in terms of testing facilities,Skilled manpower, Research & Developement, Absence of regulatory measures, Lack of standards and awareness among users are hindering the growth rate of Indian Meditech industry.

3. Classification of Medical Textiles
1.HEALTHCARE AND HYGIENE PRODUCTS
Healthcare and hygiene textiles materials are mainly used for protection from infections in hospital environment. They are used either in the operation theatre or in the hospital wards for hygiene care safety for the staff and patients.
e.g. Surgical caps, masks, gowns, drapes and shoe covers, disposable bed sheets, Baby Diapers/Adult Diaper, Sanitary napkins, Under pads, Wipes etc.
2.NON-IMPLANTABLE MEDICAL TEXTILE: 
This is used for external application on the body with or without skin contact. This is used for protection against infection, absorption, and exudation of blood & excess fluids, healing applications etc
e.g. wound dressing, plaster, bandage, gauge, compression stocking etc.

4. Classification of Medical Textiles cont.…
3. IMPLANTABLE MEDICAL TEXTILE: 
Implantable medical textiles are partly or totally inserted into the human body. These materials are used in effecting repair to the body whether it is wound closure or replacement surgery.
e.g. suture, Vascular grafts , Artificial Heart Valve, Artificial ligament, Artificial joint etc.
4. EXTRA CORPOREAL
Extracorporeal mainly deals with artificial organ which are made from specialized textile implants that can function as a part of human body.
e.g. Artificial kidney, Artificial lever, Artificial valves and Artificial Lungs etc.

5. STANDADISATION IN MEDICAL TEXTILES
In order to take up the standardization of medical textiles on fast track basis, BIS has constituted a Sectional Committee on Medical Textiles -
TECHNICAL TEXTILES FOR MEDTECH APPLICATION, TXD36
Scope of TXD 36 : To formulate Indian Standards for terminology, testing and specifications for technical textiles for medtech applications such as healthcare and hygiene textile products, implantable and non-implantable and extra corporeal textile products.
Number of standards published/ Finalized - 52
Number of documents/new subjects under development -35

6. Important Products of Medtech
SURGICAL FACE MASK CAST PADDING FOR PLASTER BABY DIAPER
ELASTIC BANDAGE PARAFFIN GAUZE SURGICAL DRAPE/ GOWN SANITARY NAPKIN

7. Important standards Formulated on Medtech
IS SPECIFICATION FOR SANITARY NAPKINS
This standard covers the requirements for sanitary napkins for external use.
This standard specifies the following requirements-
MATERIALS- Absorbent Filler, Covering
SIZES – Regular, Large, Extra Large or as agreed between purchaser and supplier
REQUIREMENTS-Absorbency and Ability to withstand pressure after absorption , pH Value
The above standard is under revision.
Additional requirement such as Hygiene Testing
Biocompatibility Evaluation
Optional requirement of Biodegradability, Composability has been specified.
Sampling and Criteria for Conformity
Disposability requirement has been excluded
Marking and packing clause has been modified etc…

8. Important standards Formulated on Medtech
IS 4605 : 1981 SPECIFICATION FOR CREPE BANDAGE
IS : 2013 ELASTIC BANDAGE
IS 16289:2014 Medical Textiles — Surgical Face Masks — Specification
IS : 2016 Medical Textiles- Absorbent cotton (sterile and non-sterile) – Specification
IS : 2017 Medical Textiles — Nonwoven bandage rolls — Specification

9. Other Important standards Formulated on Medtech
IS : 2018 , Medical Textiles — Adhesive Extension Plaster — Specification
IS : 2018, Medical Textiles — Permeable Nonwoven Surgical Adhesive Tape — Specification
IS : 2018, Medical Textiles — Elasticated Tubular Bandages — Specification
IS : 2018, Medical Textiles — X-Ray Detectable Absorbent Cotton Gauze — Specification
IS : 2017 Medical Textiles - Elastic adhesive dressing- Specification
IS : 2017 Medical Textiles - Salicylic acid adhesive plaster - Specification
IS : 2016 Medical Textiles - Povidone Iodine Ointment based Knitted Dressing - Specification

10. Other Important standards Formulated on Medtech
IS : 2016 Medical Textiles - Graduated medical compression stockings- Specification
IS : 2016 Medical Textiles - Open weave bandages- Specification
IS : 2014 Medical Textiles - Knitted Viscose Primary Dressings – Specification
IS : 1995 Swabs Small In Bag Of 50
IS : 1989 Wool polyamide Blended Flannel Hospital Grey
IS : 1985 First-aid Dressings
IS : 1993 X-Ray Detectable Gauze Swabs and Laparotomy Sponges
IS 863 : 1988 Handloom Cotton Bandage Cloth Non-Sterilized
IS 758 : 1988 Handloom Cotton Gauze Absorbent Non-Sterilized

11. Important standards under development on Medtech
Under Finalization Stage
Chlorhexidine Gauze dressings
Polyurethane foam dressing
Test methods for compresses for wound management and surgical procedures
Sterilization wrap material — Requirements and test methods
Revision of IS 5405 ‘Sanitary Napkin’
Wide Circulation Stage
Elastic crepe bandage
Surgical Drapes
Surgical Gowns
Nonwoven gauze swab

12. Important standards under development on Medtech
Draft Document TXD 36 (12492) Surgical Drapes/Gowns
Surgical gown – Protective clothing that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate matter.
Surgical drape - A covering for the patient for the prevention of transfer of infective agents.
Surgical gowns and drapes are fabricated from either multiple- or single-use materials. Reusable materials are typically composed of different tightly-woven textiles and/or knitted cotton, or other fabrics possibly blended with polyester and/or chemically treated.
Disposable surgical drapes and gowns are typically composed of non-woven materials of synthetic and/or natural origin, possibly combined with chemical treatment.

13. Important standards under development on Medtech
TXD 36 (12492) Surgical Drapes/Gowns cont..
Performance Requirement
Impact penetration ( g)
Hydrostatic resistance (cmwc)
Blood resistance
Viral resistance a
Linting log10 (Lint count)
Cleanliness – Particulate Matter (IPM)
Tensile strength (Dry & Wet) (N)
Bursting strength (Dry & Wet) (kPa) a
Water vapour resistance (m2.pa/Watt)
Cleanliness – Microbial (CFU/100 cm2)
Resistance to microbial penetration – Dry (CFU)
Resistance to microbial penetration – Wet (IB)
Biocompatibility

14. Important standards under development on Medtech
TXD 36 (12492) SURGICAL DRAPE AND GOWN cont..
Suggestion under consideration
Critical Zones and selection guidelines
Barrier performance and anticipated risks of exposure
Frequency of testing and sampling plan/batch size,
Destructive testing should be limited to the fabric (raw material) or to the final product.
Packaging, Labelling and marking requirements
Requirement of ISO etc….

15. New Subjects for Standardization
Sanitary Napkin Incinerators under TXD 14
More than 336 million girls and women of reproductive age, most of whom experience menstruation every month
12 billion pads (approximately) disposed yearly, majority of which are not biodegradable
Disposal of Sanitary Napkins
-Thrown with routine waste
-Thrown in open
-Burial
- Open burning
- Throw them in toilet etc..

16. New Subjects for Standardization
Sanitary Napkin Incinerators cont.
Top Layer made of polypropylene,
Leak proof materials such as plastic film,
Absorbent core wood pulp mixed with plastic gel, super absorbent materials
Sanitary waste disposal has become an increasing problem in India as the plastic used in disposable sanitary napkins are not bio-degradable and lead to health and environmental hazards
The Indian Solid Waste Rules (2016) consider menstrual waste as solid waste and define it as sanitary waste Rules specify responsibilities of the waste generator, local authorities and gram panchayats and producers of sanitary products

17. New Subjects for Standardization
Technical Inputs required from stakeholders
Scope Size capacity, type (Manual, automatic/semi-automatic, electrical),
Constructional requirement as raw material, design , different sizes,
Instruction for Handling of  sanitary waste including sorting, segregation, collection before putting in sanitary napkin incinerator machine
Performance parameter such as operational temperature, combustion conditions, pressure etc. with specified values along with tolerance. Operation efficiency and how it will be decided
Electrical and mechanical safety requirement, maintenance etc…
Safe disposal for ash generated
Compliance to General Emission Standards for air pollutants notified under E (P) Act, 1986 or as may be prescribed by SPCBs/PCCs or The emission from incinerators shall comply the General Emission Standards mentioned under Standard for incineration section in SWM Rules, 2016

18. New Subjects for Standardization
Baby Diaper-Used to absorb and retain body fluids of infants in period b/w birth and 24 months
Product Characteristics
Generally 4 sizes-small, medium, large and extra large
Super absorbent material, should ensure complete dryness and prevent growth of bacteria pH
Absorption capacity
Fastening mechanism
Breathable and Prevent fluid leakage

19. New Subjects for Standardization
Adult Diapers
Reusable Cloth Pad
Wipes, Under Pads, Tampon
Disposable- Bed Sheets/Curtain/Pillow Cover
Disposable Caps and Shoe Cover
Wound Care – Wadding, Cotton Lint
Healthcare and Surgical Disposables

20. New Subjects for Standardization
Dental Floss, Eye Pads for Health/Medical Purpose,
Surgical Sutures, Umbilical Tape
Artificial Heart Valves and Heart Patches
Artificial Vascular Grafts, Hernia Mesh
Artificial Tendon/Ligaments
Orthotics and Prosthetics
Artificial Kidney, Artificial Lungs
Artificial Joints, Artificial Liver
Artificial vein made up of textile material

21. CONCLUSION
I call upon all the stakeholder of Medtech TXD 36 committee to actively participate in the standard setting process for furthering the cause of National Standardization.
Nominating the suitable technical person for standardization work
Timely scrutiny and comments on draft Indian Standards under wide circulation
Timely scrutiny and comments on ISO drafts
Implement Indian Standards in their area of activity.

22. Thank You