622 Provinces, autonomous regions and municipalities food Drugs Administration (Drug Administration):
2004, the State Food and Drug Administration Organization On the one-time use of sterile Syringe (Pin), one-time use Anesthesia Puncture bag (anesthesia catheter), single use Infusion (Needle) and one-time use of burette type infusion sets for a product quality supervision testing. Now testing information is as follows:
One testing situation (A) one-time use of sterile syringes (needles)
The sampled 96 production companies and 103 operating units of the 277 batches of products to use, involving 164 manufacturers. According to national standard GB15810-2001 "sterile syringes for single use" and GB15811-2001 "single-use sterile needles," for examination. Test items are: sterile, pyrogen, easy oxide, the body of seal resistance, the nominal capacity of tolerance, size of outer cone joints, outer cone joint cone separating force, residual capacity, appearance, scale Print , Tip appearance, needle toughness, corrosion resistance, the needle firmly connected, needle piercing force of 16 indicators. Upon examination, 275 projects approved products are tested qualified, 2 batches were unsatisfactory inspection items (see Annex). Substandard products, the main problem is the body of seal resistance, residual volume, appearance and other indicators does not meet standard requirements.
(B) one-time use of epidural anesthesia bag (anesthesia catheter)
The sampled 14 companies and 55 production units operating using 71 batches involving 33 manufacturers. Basis Industry standards YY0321.1-2002 "Disposable anesthesia puncture package", YY0321.2-2002 "single-use anesthesia needle" and YY0321.3-2002 "single-use anesthesia Filter "Inspection. Test items: the basic configuration, to connect firmly with a needle anesthesia degree of toughness anesthesia needle with a needle, anesthesia liquid filter filtration rate, anesthesia liquid filter liquid flow, catheter fracture force, catheter locking connectivity, conduit connector seal sexual, narcotic rigid needle with a needle, the largest single use sterile needles piercing force, sterile, Epoxy Oxide residues in 12 indicators. Upon examination, 61 projects approved products are tested qualified products have been tested 10 batches of projects fail (see Annex). The main problem is that substandard products anesthesia liquid filter filtration rate, anesthesia liquid filter liquid flow, rigid needle with a needle anesthesia, the largest single use sterile needles piercing power and other indicators does not meet standard requirements.
(C) Disposable Infusion Products The announcement of these products is on the 2005 testing the first three countries Medical Devices Quality Notice to continue. Testing five production companies and eight business units to use disposable infusion (needle) of 13 batches involving 13 manufacturers; testing two manufacturers of disposable burette-type infusion of 2 approved. Upon examination, the products are test items were satisfactory (see Annex).
2, processing requirements On this oversight of unqualified products and companies, the provinces (autonomous regions and municipalities), food and drug supervision and management departments should follow the "Medical Devices Regulations" requirement to be investigated, and earnestly strengthen quality control, non-defective products factory ; on substandard products have been listed to take necessary corrective measures to ensure their safe and effective.
Investigate the problem, please on January 20, 2006 to the State Food and Drug Administration Drug Market Supervision Department.
State Food and Drug Administration
[Keywords]: Sterile syringe Testing Medicine Comment Large In Small I am a professional writer from China Auto Suppliers, which contains a great deal of information about baby phat womens clothing , body fat for women, welcome to visit!
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