Traditional Culture Encyclopedia - Photography major - Excuse me, where can I get the national medical device standard?
Excuse me, where can I get the national medical device standard?
Catalogue of mandatory national standards for medical devices (users please follow up the latest information) Standard number Year number Standard name Implementation date GB 1037 1988 Test method for water vapor permeability of plastic films and sheets Cup method1989 February 1 GB 10382000 Test method for gas permeability of plastic films and sheets Pressure difference. June1GB12201992 stainless steel bar 65438+June1GB15882001thermometer April 20021GB 2024. 262006 Respiratory protective articles-self-priming filter respirator for preventing particles+February 2006 1 GB 3053 1993 sphygmomanometer and sphygmomanometer 65438+June 20061GB 3151995 Ocu IUD. Kloc-0/ Test method for sharpness and strength of needle tip with accelerated aging and heat resistance of hot air 4506 1984 1 985 February1GB 4793.11995 Safety requirements for electrical equipment for measurement, control and laboratory/Kloc-0- Limits and measurement methods of electromagnetic disturbance characteristics of scientific and medical (ISM) RF equipment February 2005 1 GB 48522002 Test method of initial viscosity of pressure-sensitive adhesive tape (rolling ball method) February 2005 12 GB 5579 1985 Connection of high-voltage cable plug and socket of medical diagnostic X-ray equipment1. B 6657 1986 measurement method of electroacoustic characteristics of hearing AIDS 1 987 June1determination of the thickness of plastic film and sheet GB 6672200 1 mechanical measurement method May 20021GB 7247.6438+0200/kloc. Safety requirements and user's guide for laser products 50086 May 1 2004 GB 7966 1987 Acoustics 0.5-65438 Measurement of ultrasonic sound power 1 988 April 1 GB 8279200 1 Medical diagnostic X-ray health protection standard 2000. GB 83682005 disposable infusion set gravity infusion set July 2006 1 GB 83692005 disposable blood 8599 1988 technical conditions of automatic control pressure steam sterilizer1July 988 1 GB 8600 1998 effect of pressure steam sterilizer. Kloc-0/988 July 1 GB 8662 1988 The matching size of surgical blade and surgical handle is 65438. 1 day GB 8982 1988 Medical oxygen 1 9881February1day GB 9706. 1 1995 Medical electrical equipment Part I: General requirements for safety/kloc. Part 5438+06: Special requirements for the safety of hemodialysis and hemodialysis filtration equipment 65438+ 10/,2004 GB 9706.32000 Medical electrical equipment Part 2: Special requirements for the safety of diagnostic X-ray generator (with amendments) 2000gb9706.3438+February. Special safety requirements for medical electron accelerator1May 2000 GB 9706.5 1992, special safety requirements for microwave therapy equipment of medical electrical equipment GB 9706.6 1993, GB 965458686 GB 9706.7 1 994 Special Safety Requirements for Medical Electrical Equipment and Cardiac Defibrillator and Cardiac Defibrillator Monitor1996 June 1 GB 9708+ Special Safety Requirements for Medical Ultrasonic Diagnosis and Monitoring Equipment1998 May1GB 9706.10/ 997 Medical electrical equipment Part 2: Special requirements for the safety of therapeutic X-ray generators1September 1998 1 GB 9706.607 Part 2: Special safety requirements for medical diagnostic X-ray source assemblies and X-ray tube assemblies1September 1998/GB 9706./KLOC-0. 997 Medical electrical equipment Part 9: General safety requirements III. General requirements for radiation protection of parallel standard diagnostic X-ray equipment 1 September 19981Japan GB 9706. 13 1997 Medical electrical equipment Part 2: Special requirements for the safety of remote-controlled automatic γ -ray afterloading equipment/KLOC-0. Kloc-0/ day GB 9706.6706 Medical electrical equipment Part 8+0999 Medical electrical equipment Part 2: Special safety requirements for radiotherapy simulators1August 2, 999 GB 9706.17 1999 Medical electrical equipment Part 2: Special safety requirements for gamma-ray therapy equipment/Kloc. Special requirements for the safety of tomographic equipment (with amendments) July 2007 1 GB 9706. 192000 Medical electrical equipment Part 2: Requirements for the safe use of endoscopic equipment June 65438+February 2000 1 GB 9706.202000 Medical electrical equipment Part 2: Diagnosis and treatment. 438+0 GB 9706.2 12003 Medical electrical equipment Part 2: Special safety requirements for dosimeters that come into contact with patients and have electrically connected radiation detectors during radiotherapy 2003 121GB 9706.222003 Medical electrical equipment Part 2: Special safety requirements for extracorporeal lithotripsy equipment 2003/KLOC-0. 8+0 days GB 9706.232005 Medical electrical equipment Part 2-43: Special requirements for the safety of X-ray equipment in interventional surgery August 2005 1 GB 9706.242005 Medical electrical equipment Part 2-45: Special requirements for the safety of mammography equipment and mammography stereotactic device August 2005 1 GB 9706.242002006 Part 2-27: Special requirements for the safety of mammography equipment.282006 Medical electrical equipment Part 2: Special requirements for the safe treatment of ventilators May 2007 1 GB 9706.292006 Medical electrical equipment Part 2: Special requirements for the safety and basic performance of anesthesia system May 2007 1 GB 9937 1988 Terminology in Dental Materials, Instruments and Equipment, Testing and Operation 1 September 989 1 Day GB 993865438438+000352006 Balloon External Counterpulsation Device June 5438+1October/KLOC. 2006 GB 1 01491988 medical x-ray equipment terms and symbols June 5438+July10989 GB 10658. Technical specifications for plug and socket of high-voltage cable 65438+July 1 0,0989gb 1 0/52 1 997b ultrasonic diagnostic instrument1month10,0998gb/kloc-0. 006 disposable medical rubber examination gloves 38. 38438+0 days GB 1 1 239.12005 surgical microscope part1:requirements and test methods July 20051day GB1/. 8+0 12442005 General requirements for medical endoscopes and accessories 65438+February 1, 2005 GB11417.438+01989 rigid contact lenses 6549. 1989 Soft hydrophilic contact lens 1 990 February 1 daily GB15331989 standard logarithmic visual acuity chart1990 May1daily GB. General technical conditions of 8+022572000 He-Ne laser therapy machine: June 65438+February 1, 2000 GB 122602005 rolling blood pump of artificial heart-lung machine September 1, 2005 GB 122632005 artificial heart-lung machine. General specification of 38+0990 artificial heart valve199012.08.10.06 electric wheelchair12995200612.06.10.02. . 1, 2003 GB 1004 Bagged plastic containers for human blood and blood components Part 1: Traditional blood bags September 20041GB152131994. Epylene Plastic1995 65438+February1GB158102001Disposable Sterile Syringe (including revision) February 20021GB/KLOC-0. 1 day GB 159792002 hygienic standard for disposable sanitary articles September 2002 GB 15980 1995 hygienic standard for disposable medical articles June 1 July 9961day GB/kloc-0. Price and standard 1 July 19961GB174. 1996 pacemaker part1:implantable pacemaker 1996 10 year. Kloc-0/996 65438+February1GB 65438+15438+0998 May1GB16886.102005 Biological Evaluation of Medical Devices No. Kloc-0/GB 65438+2005.500555666 Requirements for Instruments or Places-Medical Places June 2006 1 GB 176 GB 17432 1998 Ophthalmic Instruments Optometry Mirror/Kloc-0 Kloc-0/8 1432000 Auditorium for Ophthalmic Instruments 200 1 Apr/YYY 1 YYY GB 65438. Industrial hygrothermal sterilization 20065438+0 May10 October GB 182792000 Medical devices-ethylene oxide sterilization confirmation and routine control 20065438+0 May 1 5 May GB 182802000 Medical care 438+0828 1. 12000 Biological indicator for sterilization of health products Part 65438 +0: General rules 200 1 May1Month GB 1828 1.22000 Biological sterilization of health products. .32000 2002.2002.20006566686 5 Special infusion set Part 3: Disposable light-proof infusion set July 2006 1 GB 1 86712002 Disposable intravenous infusion needle July 20021GB/. 90822003 Technical Requirements for Disposable Medical Protective Clothing June 2003 15 GB 654333 Technical Requirements for Protective Masks June 2003 GB 19 1922003 Hygienic Requirements for Contact Lens Care Solution February 2004 GB 1 9192223. Technical requirements for transfer vehicles (for trial implementation) June 30, 2003 GB 192 182003 Technical requirements for medical waste incinerators (for trial implementation) June 30, 2003 GB 192582003 Ultraviolet germicidal lamp 20031. General technical requirements April 2004 1 GB198152005 centrifuge safety requirements February 20051.
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