subject: Hebei Province In 2006 Quality Supervision And Testing Of Medical Devices Communicate The Results - [print this page] Hebei Province in 2006 under the Medical Device Quality Supervision and testing program, Hebei Food and Drug Administration Organization disposable medical equipment, sanitary materials, medical appliances were some quality control testing. Now testing briefing (armed wing Food Drug Administration [2007] 84) as follows:
First, testing conditions (1) Disposable Infusion Set A total of 63 batches of sampling, according to GB8368? 1998 "disposable infusion set" for inspection, testing project: All projects, by examination, qualified 58 batches, pass rate 92.1%. Main unqualified projects: dropper drip loss.
(B) disposable sterile syringe A total of 72 batches of sampling, according to GB15810? 2001 "disposable sterile syringes" to test, test items are: all items, after testing 67 batches of qualified, qualified rate of 93.1%. Main unqualified projects: sliding performance, capacity tolerance, appearance.
(C) Disposable anesthesia puncture package A total of 45 batches of sampling, according to YY0321.1-2000 "Disposable anesthesia puncture package" to test, test items: some of the projects, by examination, qualified 44 batches, the passing rate was 97.8%. Main unqualified projects: Air filters filter out rate, air filter housing seal.
(D) single-use sterile vaginal dilator A total of 61 batches of sampling, according to YY0336-2002 "single-use sterile vaginal dilator" for inspection, test items: some of the projects, by examination, qualified 18th batch, the passing rate of 29.5%. Main failure items are: sterile, deflection, tip bias, the basic size, a single package mark.
(5) Medical Catgut A total of 29 batches of sampling, according to YY1116-2002 "Medical catgut" to test, test items are: some of the projects, by examination, qualified 23 batches, the passing rate of 79.3%. Main failure items are: tensile strength, length.
(F) Medical cotton A total of 68 batches of sampling, according to YY0330-2002 "Medical absorbent cotton" inspection, test items are: all items, after testing 55 batches of qualified, qualified rate of 80.9%. Main failure items are: pH, water absorption, fluorescence material, easily oxides, Residue on ignition, traits.
(7) medical gauze (block) A total of 58 batches of sampling, according to YY0331-2002 "Medical absorbent gauze" to test, test items: some of the projects, by examination, qualified 41 batches, the passing rate of 70.7%. Major failure project: surface active substances, fluorescent materials, Residue on ignition, whiteness, small package symbol.
(8) Medical electrical appliances A total of 33 lots of sampling, according to company standards registered product testing, test items: some of the projects, by examination, qualified 26th batch, 78.8% pass rate. Main unqualified projects: reset after power failure, protective earth resistance, ultrasonic atomization, dielectric strength, a heating pad.
The above test, we find that the one-time use of sterile vaginal speculum, medical catgut, medical cotton wool, medical gauze (block), there are still a lot of medical electrical products quality, and the situation is not optimistic, especially individual products to protect ground impedance, dielectric strength, air filter filtration rate, sterile and so affect the key indicators of product safety failed to bring masses of people to use hidden.
