subject: Sfda On The Contact Lens Product Quality Supervision And Testing Results Such As The Notification - [print this page] . According to the 2005 National Medical Devices Quality control testing program, the National Bureau of organizations contact lenses, surgical sutures and suture needles, dental alginate impression material for the product quality supervision and testing. Now testing the results of the following:
One testing situation (1) contact lens The testing of 11 manufacturing enterprises and business units 8 to 20 batches involving 18 manufacturers mark. According to national standard GB11417.2-89 "soft hydrophilic contact lens" and amended in 1997 the standard one, a registered product standard, ISO10344: 1996 "contact lens optics and optical instruments Test Salt solution ", ISO8599: 1994" Optics and optical instruments contact lens transmittance spectra and determination ", ISO9337-1: 1999" contact lens vertex focal power measured after the first part of the use of hand-tune focus focal Testing Methods ", ISO9338: 1996 "Optics and optical instruments measured the diameter of contact lens", ISO9913-1: 1996 "Optics and optical instruments FATT contact lens oxygen permeability coefficient of determination of volume and oxygen", ISO9914: 1995 "Optics and optical instruments for contact lens measuring the refractive index ", GB/T14233.1" Infusion, transfusion, Syringe A test method ", GB/T14437-93" product quality supervision and sampling inspection procedures counting time ", ISO10338: 1996" Optics and optical instruments measured radius of curvature of contact lenses "for testing. Test items are: vertex, Foot Inch (central region radius, total diameter), impurities and Table Surface defects, seven indicators. The test product was tested 18 batches of qualified projects, two projects approved products have been tested fail (see annex).
(B) surgical sutures and suture needles
The testing of 23 manufacturing enterprises and business use of units from 65 to 116 batches, the production company involved in the 34 mark. According to industry standards YY1116-2002 "absorbable surgical suture", YY0167-1998 "non-absorbable surgical suture", YY0166-2002 "with a suture needle" for testing. Test items are: tensile strength, needle and thread connection strength, heavy metals and other five indicators. After testing, 106 test items approved products are qualified products have been tested 10 batches of projects fail (see annex).
(3) dental alginate impression material The testing a production enterprise and a business unit of two batches, involving two label manufacturer. Based on industry standards YY1027-2001 "Dental alginate impression material", YY/T0127.9-2001 "Biological Evaluation of Dental Materials Part 2: Test methods for dental materials, bio-toxicity test (agar diffusion and molecular filtration Act) "for testing. Test items: Powder , Harmonic performance, time to reconcile the 8 indicators. After testing, a batch of test items to be qualified products, a batch of unqualified products are test items (see annex).
2, processing requirements On the supervision 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, 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 Security Effective.
Investigate the problem, please on July 31, 2006 to the State Bureau of Drug Market Supervision Department.
Annex: National Medical Device Quality Announcement (2006) No. 6, the total section 29
