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STANDARDS FOR CLEAN AND HEALTHY INDIA 4th NATIONAL CONCLAVE ON STANDARDS FOR TECHNICAL TEXTILES

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.

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STANDARDS FOR CLEAN AND HEALTHY INDIA 4th NATIONAL CONCLAVE ON STANDARDS FOR TECHNICAL TEXTILES

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  1. STANDARDS FOR CLEAN AND HEALTHY INDIA4th 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. 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.

  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 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…

  8. 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

  9. 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- Specification IS 16668 : 2017 Medical Textiles - Salicylic acid adhesive plaster - Specification IS 16466 : 2016 Medical Textiles - Povidone Iodine Ointment based Knitted Dressing - Specification

  10. Other Important standards Formulated on Medtech IS 16467 : 2016 Medical Textiles - Graduated medical compression stockings- Specification IS 16469 : 2016 Medical Textiles - Open weave 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

  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 13485 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 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

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