SinoVenture - Single-use hypodermic syringe and needle - VC.25.3
Non Technical and Terms
Inspection and testing will be performed prior to and during production along with a final random inspection of finished products by a Bank approved independent inspection agency. The inspection contract will be let by SinoVenture to the approved inspection agency with costs passed through to the Borrower to pay.
Upon receipt of a Borrowers completed ROI, SinoVenture will propose CIP pricing, which entails organizing the delivery and insurance of goods to the agreed destination. Some countries may wish to collect the products, which can be accommodated on request.
Indicative lead time is 30 days. Lead times will be confirmed on receipt of Registration of Interest (ROI).
10% payment within 5 days of signing the contract and balance of 90% on provision of the shipping documents listed in Contract Clause 7 to the Purchaser.
SinoVenture International Group is a private company, founded in Macau with the Central Asian region office located in Beijing. The company was founded in 2010 with the primary aim of establishing economic relations and promoting business between regions of China, including Hong Kong, Macao and Taiwan and the Portuguese speaking countries including Angola, Brazil, Cape Verde, Guinea Bissau, Mozambique, Portugal, São Tomé and Principe and East Timor.
SINGLE-USE HYPODERMIC SYRINGE AND NEEDLE
Purpose: The purpose of a single-use hypodermic syringe and needle is to inject fluid into or withdraw fluid from the body for medical purposes.
Description: The World Bank seeks to procure single-use hypodermic syringes and needles that meet the specifications below. Single-use hypodermic syringes come in a variety of volumes and may or may not be sold as a set with a hypodermic needle. Syringes proposed shall have fixed needles and auto-disable features.
1. Proposed syringe and needle shall be classified as a medical device and have approval by the US FDA, CE Mark or equivalent (e.g., FDA Class 2, 510(k)).
2. Device shall be disposable and intended for single patient use.
3. Device shall be supplied sterile and packaged in individual units.
4. Syringe shall meet the requirements of ISO 7886-1:2017.
5. Hypodermic needle shall meet material requirements of ISO 9626:2016.
6. Hypodermic needle shall meet the requirements of ISO 7864:2016.
7. Hypodermic needle shall meet the color code requirements per ISO 6009:2016.
8. Device shall have an auto-disable feature that complies with ISO 7886-3. The syringe must be passively and automatically rendered unusable upon delivering the intended dose. It must be impossible to re-use the syringe under normal conditions of use.
9. Syringe shall be 1ml or 3 ml in volume.
10. Needle size shall be:
a. Adults, 22-25 gauge with a length of 25-38mm (1-1.5”)b. Children ages 3-18, 22-25 gauge with a length of 16-25mm (5/8 – 1”)
11. Syringe shall be latex free.
12. Syringe barrel must be translucent.
13. Device shall be capable of being filled either directly or indirectly through a vial adapter or other transfer mechanism from a vaccine vial or ampoule, or from a needle.
14. Device shall be equally useable by left and right-handed health workers.
15. Syringes designed as low dead space or low dead volume are preferred.