June 20, 2003, the state food and drug administration, released hemodialysis, hemodialysis filtration and blood filtration equipment and a medical device industry standard. Industry standards and implementation date, name Numbers are as follows:
A mandatory standards
1 YY 0054-2003 hemodialysis, hemodialysis filtration and blood filtration equipment"
Instead 0054 YY (1991), -
2 YY 0109-2003 medical ultrasonic atomizer"
(instead of YY/T 0109-1993)
3 YY 0270-2003 dentistry - denture base polymer"
(instead of YY 0270-1995)
4 YY 0455-2003 medical electrical equipment part 2: baby radiation safety special to warm stage
O"
5 YY 0459-2003 surgical implants - acrylic resin bone cement"
6 YY 0460-2003 ultrasonic teeth cleaning equipment,
7. YY 0461-2003 anesthesia machine and breathing machines with breathing pipe"
8. 0462 YY - 2003 dental gypsum products"
9 YY 0463-2003 dental phosphate embedding materials casting"
10. 0464 YY - 2003 disposable blood perfusion implement"
11. 0465 YY - 2003 one-time use hollow fiber plasma separator"
12 YY 0466-2003 medical devices used in medical equipment labels, tags and provide the information
".
13. YY 1-2003 buoy type oxygen inhaler"
Instead 91107 YY (1999) and -
14 YY 1040.1-2003 anesthesia and breathing apparatus cone joints
Part 1: head and taper sleeve"
Instead 91013 YY (1999-91014 YY, 1999) -
15 YY 1042-2003 dentistry - polymer-based filling, repair and cementation materials"
Instead 91042 YY (1999) and -
16, YY 1145-2003 heart-lung machine term"
Instead 91145 YY (1999) and -
Second, the voluntary standards
1 YY/T 0316-2003 medical risk management for medical applications"
Replace YY/T 0316 (2000). -
2 YY/T 0452-2003 hemostatic plier,
(GB 2767-1988) instead of
3 YY/T 0453-2003 "tooth general technical condition of plier
(GB 8666.1-1998) instead of
4 YY/T 0454-2003 "aseptic plastic scalpel"
5 YY/T 0456.1-2003 "blood analyzer reagent in application of cleaning part 1:
6 YY/T 0456.2-2003 "blood analyzer reagent in section 2: the application of hemolysis agent,
7. YY/T 0456.3-2003 "blood analyzer reagent, part 3: the application of dilute"
8. YY/T 0457.1-2003 medical electrical equipment photoelectric X-ray image enhancement
Part 1: the determination of incident size
9 YY/T 0457.2-2003 medical electrical equipment photoelectric X-ray image enhancement
Section 2: transform coefficient of determination"
10. YY/T 0457.3-2003 medical electrical equipment photoelectric X-ray image enhancement
Part 3: brightness distribution and heterogeneity determination"
11. YY/T 0457.4-2003 medical electrical equipment photoelectric X-ray image enhancement
Part 4: image distortion measuring"
12 YY/T 0457.5-2003 medical electrical equipment photoelectric X-ray image enhancement
Part 5: the determination of detecting quantum efficiency,
13. YY/T 0457.6-2003 medical electrical equipment photoelectric X-ray image enhancement
Article 6: the contrast and dazzle light coefficient of determination"
14 YY/T 0457.7-2003 medical electrical equipment photoelectric X-ray image enhancement
Article 7: the determination of the transfer function modulation,
15 YY/T 0458-2003 doppler blood flow mode of imitation technology requirements"
16, YY/T 0467-2003 medical equipment safeguard medical equipment safety performance accepted standards of basic principles guide to choose
17. YY/T 0468-2003 named for the medical equipment management data communication system named"
.stop YY/T 103-2003 "the needle clamp general technical conditions"
Instead 91030 YY (1999) and -
The YY/T 1142-2003 medical ultrasound diagnosis and monitoring equipment frequency characteristic test method"
Instead 91142 YY (1999) and -
0243 and YY/T - 2003 "the disposable use asepsis injector with piston"
Above 36 standard since January 1, 2004. |
