RequiredOEM Authorization Certificate Bid to RA enabled Yes Disposable Syringes ( 105000 pieces ) Technical Specifications * As per GeM Category Specification Specification Specification Name Values Bid Requirement (Allowed Values) Performance Parameters Type of Syringe Sterile hypodermic syringe for single use with needle Sterile hypodermic syringe for single use with needle Design
Requiredmaterial
Requiredmini mum safety require ments
Requiredtolerance and capacity of Syringes confirming to Indian Standard IS 10258-2002 latest for Sterile Hypodermic Syringe for single use with and without needle IS 10258-2002 latest for Sterile Hypodermic Syringe for single use with and without needle Nominal capacity of Syringe(ml) 2 2 1/4 BIS Marking No Yes
RequiredNo BIS Licence No (if BIS Marked if not indicate NA) - * Design
Requiredmaterial
Requiredmini mum safety require ments
Requiredtolerance and capacity of Needles confirming to Indian Standard IS 10654:2002 latest for sterile hypodermic needles for single use IS 10654:2002 latest for sterile hypodermic needles for single use Sterile Yes * No of users Single(Disposable) * Syringe type based on Number of pieces 3 piece 3 piece Shelf life (Year(s)) 5 * DIMENSIONAL & MATERIAL PARAMETERS Material of Barrel Polypropylene Polypropylene
RequiredPolystyrene Material of Plunger Polypropylene Polypropylene
RequiredPolystyrene Material of gasket (For 3 piece) Rubber Rubber
RequiredSynthetic rubber Material of Needle Tube (As per ISO 9626) Stainless Steel Stainless Steel PACKING Packing as per specification and provision of Drug & cosmetic act. Yes * All supplies shall have a remaining self life of at least Five -Sixth (5/6rd) of the stipulated shelf life at the time of delivery Yes * Type of packing Ribbon Packing * Recalling of Product Yes * Certification and Reports Availability of valid drug licence Yes * Drug License no & Date of manufacturers and incase of resller
RequiredDrug License no & Date (for sale) of Authorized reseller also to be indicated - * Manufacturer or the seller must not be under conviction in Yes * 2/4 terms of provision of drug and cosmetic act Availablitiy of latest non conviction certificate issued by concerned Drug authorities Yes * Availability of Certificate for Manufacturing such as GMP under revised Schedule-`M' of Drugs & Cosmetics Act 1940 Or WHO-GMP or COPP for imports Yes * Details of above Mentioned Certificate such as Type of certificate
RequiredNumber
Requireddate and validity - * Availability of any other certification such as CE/FDA/CSA/PQS ISOetc… No * Details of above Mentioned Certificate such as Type of certificate
RequiredNumber
Requireddate and validity if Yes Otherwise put NA - * Copies of batch in house Test report to be forwarded with each supply Yes * Copies of certificates to be provided to buyer on demand at the time of supplies Yes * * Bold specifications are the golden parameters. * Bidders may note that In respect of non-golden Parameters
Requiredthe specifications 'Values' chosen by Buyer will generally be preferred over 'Bid requirement ( allowed Values) by the Buyer.