On the IUD and other product quality supervision testing briefing – intrauterine
632 Provinces, autonomous regions and municipalities food
Drugs Administration (Drug Administration): 2004, the State Food and Drug Administration
Organization On the IUD, Glass Thermometer, acupuncture needles, Synthetic resin Teeth and dental composite resin materials of the product quality supervision and testing. Now testing information is as follows:
One testing situation (A) of the IUD The sampled nine manufacturing enterprises and 33 business units in 52 batches used, involving 12 manufacturers. According to national standard GB11236-1995 "TCu IUD", GB11234-1995 "uterine-shaped IUD", GB3156-1995 "OCu IUD" and GB11235-1997 "VCu IUD" inspection . Test items: TCu IUD:
Copper Surface area, restorative, brass fastness, tail strands force, positioning block displacement resistance, peel force of six indicators; uterine-shaped IUD: corrosion resistance, surface roughness, flatness testing, deformation, steel wire coil diameter, copper surface area of six indicators; OCu intrauterine device: copper surface area, structural strength, corrosion resistance, tensile deformation, the degree of partial torsion, spiral spring size and other six indicators; VCu IUD : copper surface area, corrosion resistance, tensile wire end, the center length of copper wire inserted into the positioning block
Mobile Resistance, peel force of six indicators. Upon examination, 48 were test items approved products pass four batches were tested failed project (see Annex). The main problem is that substandard products of copper (wire) surface area of target does not meet standard requirements.
(B) of the glass thermometer The sampled five manufacturing enterprises and 74 business units in 79 batches used, involving 16 manufacturers. According to national standard GB1588-2001 "glass thermometer" to test. Test projects are: the internal standard thermometer scale plate, thermometer the temperature of the bubble quality indication, interrupt, gravity, etc. Indicator 5. Upon examination, 77 products have been approved test items qualified, 2 batches were unsatisfactory inspection items (see Annex). The main problem is that substandard products Indication target does not meet standard requirements.
(3) Acupuncture Needles The sampled six manufacturing enterprises and 70 business units in 76 batches used, involving 19 manufacturers. According to national standard GB2024-1994 "acupuncture needles" for testing. Test items are: hardness, corrosion resistance, tip sharpness, the needle body with needle and handle the connection solidity
Sterilization Acupuncture needles should be sterile and so on 6 indicators. Upon examination, 69 products have been approved inspection program qualified, 7 batches were unsatisfactory inspection items (see Annex). The main problem is that substandard products needle body and a strong degree of needle handle the connection indicator does not meet standard requirements.
(D) of synthetic resin teeth The sampled 15 companies and 28 production units in operation 47 using the batch product, involving 20 manufacturers mark, 12 of which domestic manufacturers, foreign enterprises 8. Basis
Industry standards YY0300-1998 "dentistry synthetic resin teeth" for testing. Test items are: size, cell toxicity test, no porosity and other defects, bonding properties, color stability, anti-whitening resistance to deformation of micro-crack resistance, dimensional stability, small packaging and label size model maps index, etc. 9. Upon examination, 36 products have been approved qualified testing program, 11 products have been approved failed test items (see Annex). The main problem is that substandard products anti-whitening micro-crack resistance against deformation, size, small package, label size and other indicators of model profiles do not meet the standard requirements.
(5) dental composite resin filling material
The sampled three production enterprises and 22 business units in 32 batches used, involving 13 manufacturers mark, three of which domestic manufacturers and foreign companies 10. Based on industry standards YY1042-2003 "dentistry
Polymer Based filling, restoration and luting materials "for testing. Test items: cytotoxicity test, working time, curing time, flexural strength, water sorption, dissolution value, color stability, container signs, packaging and product specification information of 10 indicators. The test product was tested on 26 projects approved qualified project 6 batches were tested failed (see Annex). The main problem is that unqualified product packaging, product brochures and other indicators of information does not meet standard requirements.
2, processing requirements On this oversight of unqualified products and companies, the provinces (autonomous regions and municipalities), food and drug supervision and management departments shall "
Medical Devices Supervision and Management Regulations "requirement to be investigated, ordered manufacturers for rectification, effectively strengthening quality control, non-substandard products factory; on substandard products have been listed to take necessary corrective measures to ensure their safe and effective.
Investigate the problem situation, reported to the State Food and Drug Administration Drug Market Supervision Department.
State Food & Drug Administration [Key words]: IUD Medicine Medical Devices Comment Large In
Small
We are high quality suppliers, our products such as CRI Tester manufacturer , HUS-1000 Test Bench manufacturer for oversee buyer. To know more, please visits repair test equipment suppliers.
Processing your request, Please wait....
