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