tender for supply of cssd consumables-1 bowie dick test pack single use test packs for monitoring vacuum formation in autoclave chambers.test sheet along with penetration challenge material.should be lead free. test sheet color change should be from blue/yellow to black for easy identification after processed in steam autoclaves of different time.and temperature requirements, within 15 minutes at 121oc and 3.5 minutes at 134ocshould be compliance to iso 11140-1a valid manufacture license or import license from cdsco to be enclosed as a class b medical devicemanufacturing license no. to be mentioned on packing. 2 chemical integrator (steam)chemical integrator for steam sterilization and verify the effectiveness of the sterilization process.moving front chemical integrators, indicating accept or reject, to verify all parameters of steam sterilization together i.e. time, temperature and quality of steamtype of chemical integrator is class -5 and work 121 to 134degree celsiusshould be compliance to iso standard.a valid manufacture license or import license from cdsco to be enclosed as a class b medical device.manufacturing license no. to be mentioned on packing 3 chemical integrator (eo)chemical integrator for eo sterilization and verify the effectiveness of the eo sterilization process.type of chemical integrator is class -5 and work 45 to 55degree celsius.color change from original color to recommended color by the manufacturer’s instructioncan be used for pack control monitoring of all 45-55ºc gas sterilization cycles.should be compliance to iso standard. a valid manufacture license or import license from cdsco to be enclosed as a class b medical device.manufacturing license no. to be mentioned on packing 4 documentation label roll [steam]double self adhesive three line documentation label for steam sterilization.each documentation label roll have minimum 700 labels.class-1 as per iso 11140-1.it should be lead free.three line label color change should be from pink/blue to black for easy identification after processed in steam autoclaves of different time and temperature requirements, worked as temp 121 to 134 degree celsiusvendor should provide two compatible label gun free of cost and replace/repair as per department requirement.a valid manufacture license or import license from cdsco to be enclosed as a class b medical device.manufacturing license no. to be mentioned on packing 5 documentation label roll [eo]double self adhesive three line documentation label for eo sterilization.each documentation label roll have minimum 700 labels.class-1 as per iso 11140-1.it should be lead free.three line label color change should be from original to recommended color as per manufacturers instruction, for easy identification after processed in eo sterilization of different time and temperature working temperature 45 to 55 degree celsius.vendor should provide two compatible label gun free of cost and replace/repair as per department requirement.a valid manufacture license or import license from cdsco to be enclosed as a class b medical device.manufacturing license no. to be mentioned on packing. 6 sterilization reel 100mm x 200 mtrs- steam/eoheat-sealable sterilization reels should be constructed from transparent pet/pp multi-layers copolymer film and medical grade paper.process indicator for steam and ethylene oxide sterilization are applied on the paper surface of the reel and help to differentiate between processed and unprocessed packages.superior barrier with minimum 60-80gsm medical grade paper.conforming en 868-3 & en iso 13485 transparent, reinforced multilayer co-polymer pet/pp film three independent seal lines.certification of analysis of medical grade paper to be enclosed shelf life study report to be enclosed.stability study report to be enclosed from govt approved laboratorya valid manufacture license or import license from cdsco to be enclosed as a class b medical device.manufacturing license no. to be mentioned on packing 7 sterilization reel 150mm x 200 mtrs-steam/eoheat-sealable sterilization reels should be constructed from transparent pet/pp multi-layers copolymer film and medical grade paper.process indicator for steam and ethylene oxide sterilization are applied on the paper surface of the reel and help to differentiate between processed and unprocessed packages.superior barrier with minimum 60-80gsm medical grade paper.conforming en 868-3 & en iso 13485 transparent, reinforced multilayer co-polymer pet/pp film three independent seal lines.certification of analysis of medical grade paper to be enclosed shelf life study report to be enclosed.stability study report to be enclosed from govt approved laboratorya valid manufacture license or import license from cdsco to be enclosed as a class b medical device.manufacturing license no. to be mentioned on packing 8 sterilization reel 300mm x 200 mtrs-steam/eoheat-sealable sterilization reels should be constructed from transparent pet/pp multi-layers copolymer film and medical grade paper.process indicator for steam and ethylene oxide sterilization are applied on the paper surface of the reel and help to differentiate between processed and unprocessed packages.superior barrier with minimum 60-80gsm medical grade paper.conforming en 868-3 & en iso 13485 transparent, reinforced multilayer co-polymer pet/pp film three independent seal lines.certification of analysis of medical grade paper to be enclosed shelf life study report to be enclosed.stability study report to be enclosed from govt approved laboratorya valid manufacture license or import license from cdsco to be enclosed as a class b medical device.manufacturing license no. to be mentioned on packing 9 sterilization reel 400mm x 200 mtrs- steam /eoheat-sealable sterilization reels should be constructed from transparent pet/pp multi-layers copolymer film and medical grade paper.process indicator for steam and ethylene oxide sterilization are applied on the paper surface of the reel and help to differentiate between processed and unprocessed packages.superior barrier with minimum 60-80gsm medical grade paper.conforming en 868-3 & en iso 13485 transparent, reinforced multilayer co-polymer pet/pp film three independent seal lines.certification of analysis of medical grade paper to be enclosed shelf life study report to be enclosed.stability study report to be enclosed from govt approved laboratorya valid manufacture license or import license from cdsco to be enclosed as a class b medical device.manufacturing license no. to be mentioned on packing 10 sterilization reel 450mm x 200 mtrs- steam /eoheat-sealable sterilization reels should be constructed from transparent pet/pp multi-layers copolymer film and medical grade paper.process indicator for steam and ethylene oxide sterilization are applied on the paper surface of the reel and help to differentiate between processed and unprocessed packages.superior barrier with minimum 60-80gsm medical grade paper.conforming en 868-3 & en iso 13485 transparent, reinforced multilayer co-polymer pet/pp film three independent seal lines.certification of analysis of medical grade paper to be enclosed shelf life study report to be enclosed.stability study report to be enclosed from govt approved laboratorya valid manufacture license or import license from cdsco to be enclosed as a class b medical device.manufacturing license no. to be mentioned on packing 11 helix pcd test strips (steam) type 2 chemical indicator self adhesive.helix process challenge device- its a testing tool used to monitor the effectiveness of steam sterilizers, particularly for hollow and porous loads.should be provide five compact process challenge device free of cost and repair/replace as per department need, it should have torturous path with a metal capsule having provision to insert type-2 chemical indicator strip. according to en iso 11140-1.test strip color change should be turns to black or manufacturers’ instruction for easy identification after processed in steam autoclaves of different time and temperature requirements, within 15 minutes at 121oc and 3.5 minutes at 134oc.it should be lead free.a valid manufacture license or import license from cdsco to be enclosed as a class b medical device.manufacturing license no. to be mentioned on packing 12 helix pcd test strips (eo)type 2 chemical indicator self adhesive.helix process challenge device- its a testing tool used to monitor the effectiveness eo sterilizers, particularly for hollow and porous loads.should be provide five compact process challenge device free of cost and repair/replace as per department need, it should have torturous path with a metal capsule having provision to insert type-2 chemical indicator strip. according to en iso 11140-1.test strip color change as per manufacturers instruction when expose to eo sterilization.a valid manufacture license or import license from cdsco to be enclosed as a class b medical device.manufacturing license no. to be mentioned on packing