F (III)

(See rule 124-D) STANDARDS FOR UMBILICAL TAPES (A) Standards for Sterilised Umbilical Polyster Tape. Description. - A uniform strand of Polyester yarn prepared by braiding and may be finished with a suitable silicone finishing material, white to yellowish-white in colour. Tape shall be sterilized by Gamma Radiation or other suitable method approved by the Licensing Authority. Other requirements. - The Umbilical Polyester Tape shall conform to the claims made on the label in respect of length and width. Tensile strength. - The Umbilical Polyester Tape shall have Tensile strength of not less than 4 kg. on straight pull. Packing and labelling. - The Umbilical Polyester Tape shall be packed in sealed Polythene bags or sealed plastic containers which ensure that when packed, the tape is sterile. The packing shall protect the tape from contamination and damage. Every packing offered for sale shall bear a clear and permanent marking with the following particulars: - (i) The proper name of the drug i.e. Umbilical Polyester Tape ‘Sterile’ (ii) Manufacturer’s name and address. (iii) Batch number. (iv) Licence number under which the tape is manufactured. (v) Date of manufacture and date of expiry. (vi) Length and width of the Tape. Storage condition. - It should be stored in a cool place protected from light. (B) Standards for Sterilised Umbilical Cotton Tape– Description. - A uniform strand of cotton yarn prepared by braiding and may be finished with a suitable silicone finishing material, white to yellowish-white in colour. The tape shall be sterilized by Gamma Radiation or by any other suitable method approved by the Licesing Authority. Other Requirement. - The Umbilical Cotton Tape shall conform to the claims made on the label in respect of length and width. Tensile strength. - The Umbilical Cotton Tape shall have a Tensile strength of not less than 4 kg. on straight pull. Packing and labelling. - The Umbilical Cotton Tape shall be packed in sealed Polythene bags or sealed plastic containers which ensure that when packed the tape is sterile. The packing shall protect the tape from contamination and damage. Every packing offered for sale shall bear a clear and permanent marking with the following particulars:- (i) The proper name of drug i.e. Umbilical Cotton Tape “Sterile”. (ii) Manufacturer’s name and address. ______________________________________________________________ Drugs and Cosmetics Rules, 1945 359 (iii) Batch number. (iv) Licence number under which the tape is manufactured. (v) Date of manufacture and the date of expiry. (vi) Length and width of the Tape. 1. Ins. by G.S.R. No.1115(E), dt.. 30-9-1986. Storage condition.- It should be stored in a cool place protected from light.] Drugs and Cosmetics Rules, 1945 360