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( 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
. ( ii ) 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 STERILIZED
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 Licensing Authority …
 Tensile strength : The Umbilical Cotton Tape shall
have a Tensile strength of not less than 4kg 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 ) M ( iii ) Batch number ( iv )
License number under which the tape is manufactured
. ( v ) Date of Manufacture and the date of expiry ( VI )
Length and width of the Tape anufacture's name and
address.
 Storage condition ▸ It should be stored in a cool place
protected from light .

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SCHEDULE F3.pptx

  • 1.
  • 2. ( 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 .
  • 3.  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 .
  • 4. 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 .
  • 5.  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 . ( ii ) 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 .
  • 6.  Storage condition . It should be stored in a cool place protected from light .
  • 7. B ) STANDARDS FOR STERILIZED 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 Licensing Authority …
  • 8.
  • 9.  Tensile strength : The Umbilical Cotton Tape shall have a Tensile strength of not less than 4kg 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 .
  • 10. 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 ) M ( iii ) Batch number ( iv ) License number under which the tape is manufactured . ( v ) Date of Manufacture and the date of expiry ( VI ) Length and width of the Tape anufacture's name and address.
  • 11.  Storage condition ▸ It should be stored in a cool place protected from light .