RequiredExperience with Government
RequiredAnnual Turnover
RequiredCertificate (Requested in ATC)
RequiredOEM Authorization Certificate
RequiredOEM Annual Turnover Bid to RA enabled No Note: 1. OEM Turn Over Criteria: The minimum average annual financial turnover of the OEM of the offered product during the last three years
Requiredending on 31st March of the previous financial year
Requiredshould be as indicated in the bid document. Documentary evidence in the form of certified Audited Balance Sheets of relevant periods or a certificate from the Chartered Accountant/Cost Accountant indicating the turnover details for the relevant period shall be uploaded with the bid. In case the date of constitution/incorporation of the OEM is less than 3 year old
Requiredthe average turnover in respect of the completed financial years after the date of constitution shall be taken into account for this criteria. Disposable Syringes ( 17000 pieces ) Technical Specifications 1/7 * 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
RequiredSterile hypodermic syringe for single use without needle
RequiredAuto disable syringe for fixed dose immunization with fixed needle
RequiredAuto disable syringe for fixed dose immunization with detachable needle
RequiredSafety Syringes with retraction features to avoid needle stick injuries Design
Requiredmaterial
Requiredmini mum safety require ments
Requiredtolerance and capacity of Syringes confirming to Indian Standard IS 10258(Part -3):2010 latest for Autodisable syringes for fixed dose immunization IS 10258(Part -3):2010 latest for Autodisable syringes for fixed dose immunization
RequiredIS 10258-2002 latest for Sterile Hypodermic Syringe for single use with and without needle
RequiredISO 7886 for Syringe with saftey features to prevent needle stick injuries Nominal capacity of Syringe(ml) 5 5 BIS Marking Yes Yes 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
RequiredNA Sterile Yes * No of users Single(Disposable) * Syringe type based on Number of pieces 2 piece 2 piece
Required3 piece Shelf life (Year(s)) 3 * DIMENSIONAL & Material of Barrel Polypropylene Polypropylene
Required2/7 MATERIAL PARAMETERS Polystyrene
RequiredStyerene Material of Plunger Polypropylene Polypropylene Material of gasket (For 3 piece) Rubber 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 terms of provision of drug and cosmetic act Yes * 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
Required- * 3/7 date 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 * * Specifications highlighted in bold 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. Additional Specification Documents
