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
 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. 4281 crore by 2015-16 growing at 9% CAGR

and further to Rs. 5142 crore by 2017-18.

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.
 Classification of Medical Textiles
 [Link] 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.

 [Link]-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.
 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.
 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
 Important Products of Medtech
 SURGICAL FACE MASK CAST PADDING FOR PLASTER BABY DIAPER

 ELASTIC BANDAGE PARAFFIN GAUZE SURGICAL DRAPE/ GOWN SANITARY NAPKIN

 Important standards
Formulated on Medtech
 IS 5405 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…
 Important standards
Formulated on Medtech
 IS 4605 : 1981 SPECIFICATION FOR CREPE
BANDAGE
 IS 16111 : 2013 ELASTIC BANDAGE
 IS 16289:2014 Medical Textiles — Surgical Face
Masks — Specification
 IS 16468 : 2016 Medical Textiles- Absorbent cotton
(sterile and non-sterile) – Specification
 IS 16660 : 2017 Medical Textiles — Nonwoven
bandage rolls — Specification
 Other Important standards
Formulated on Medtech
 IS 16949 : 2018 , Medical Textiles — Adhesive Extension Plaster —
Specification
 IS 16948 : 2018, Medical Textiles — Permeable Nonwoven Surgical
Adhesive Tape — Specification
 IS 16946 : 2018, Medical Textiles — Elasticated Tubular Bandages —
Specification
 IS 16950 : 2018, Medical Textiles — X-Ray Detectable Absorbent Cotton
Gauze — Specification
 IS 16669 : 2017 Medical Textiles - Elastic adhesive dressing-
dressing Specification
 IS 16668 : 2017 Medical Textiles - Salicylic acid adhesive plaster -
Specification
 IS 16466 : 2016 Medical Textiles - Povidone Iodine Ointment based Knitted
Dressing - Specification
 Other Important standards
Formulated on Medtech
 IS 16467 : 2016 Medical Textiles - Graduated medical compression
stockings-
stockings Specification
 IS 16469 : 2016 Medical Textiles - Open weave bandages-
bandages Specification
 IS 16290 : 2014 Medical Textiles - Knitted Viscose Primary Dressings –
Specification
 IS 14316 : 1995 Swabs Small In Bag Of 50
 IS 12839 : 1989 Wool polyamide Blended Flannel Hospital Grey
 IS 11163 : 1985 First-aid Dressings
 IS 10829 : 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
 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
 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.
 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 ([Link]/Watt)
 Cleanliness – Microbial (CFU/100 cm2)
 Resistance to microbial penetration – Dry (CFU)
 Resistance to microbial penetration – Wet (IB)
 Biocompatibility
 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 13485 etc….
 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..
 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
 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
 New Subjects for
Standardization
 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
 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
 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
 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.
Thank You