Tuesday, December 14, 2010

Bureau of traditional Chinese medicine is released implement occupation standard of 73 medical devices - 2008


Marijuana: For Medical Purposes Only Pt. 2

Supervisory management board of national provision medicines and chemical reagents releases executive YY0001 - 2008 " technology of clastic rock equipment is caused to ask outside body " wait for occupation standard of 73 medical devices to was released on May 4, 2008 a few days ago, national provision medicines and chemical reagents supervises announcement of management board print and distribute, released already authorized the YY0001 ~ that pass 2008 " technology of clastic rock equipment is caused to ask outside body " wait for occupation standard of 73 medical devices. Among them mandatory occupation standard 33, recommend a gender occupation standard 40, rise from December 1, 2009 respectively and carry out since June 1, 2009. [relevant link] about releasing executive YY0001 - 2008 " technology of clastic rock equipment is caused to ask outside body " the announcement that waits for occupation standard of 73 medical devices

About releasing executive YY0001 - 2008 " technology of clastic rock equipment is caused to ask outside body " the announcement that waits for occupation standard of 73 medical devices

The country feeds medical inspect to fetters [2008]192 date was released on April 25, 2008

Medicines and chemical reagents of food of each province, municipality, municipality directly under the Central Government controls management board (medicines and chemical reagents controls management board) ,

YY0001 - 2008 " technology of clastic rock equipment is caused to ask outside body " etc occupation standard of 73 medical devices is already authorized through, give now release. Its level number, name reachs executive date to be as follows:

One, mandatory occupation standard
1. YY 0001 - 2008 " technology of clastic rock equipment is caused to ask outside body " (replace YY 0001 - 1990)
2. YY 0053-2008 " the heart and vessels is embedded content and dialyzer of artificial organ blood, blood is dialytic filtration implement, haemal filtration implement with haemal concentrator " (replace YY 0053-1991)
3. YY 0068.1-2008 " medical endoscope rigid endoscope the 1st part: Optical function and test method " (the part replaces YY0068-1992)
4. YY 0070-2008 " esophagus peeps lens " (replace YY0070-1992)
5. YY 0071-2008 " colon of shape of rectum, second peeps lens " (replace YY0071-1992)
6. YY 0267-2008 " the heart and vessels is embedded the body outer circulation of content and purifying device of artificial organ blood hematic road " (replace YY0267-1995)
7. YY 0286.5-2008 " special infusion implement the 5th part: Type of bottle of one-time use condole and bag type infusion implement "
8. YY0315-2008 " titanium and titanium alloy are artificial the tooth cultivates style " (replace YY0315-1999)
9. YY 0319 - 2008 " medical and electric equipment the 2nd part: Agitate general Lang is disrelished uncut jade of crotch of beat up cabin goes to toad of  of blown away by wind of ㄓ stepping on  to punish ù  ?YY0319-2000)
10. YY 0620-2008 " tooth science casts golden alloy "
11. YY 0621-2008 " system of rehabilitate of the dentistry metal porcelain that bake "
12. YY 0622-2008 " dentistry colophony base nest channel closes agent "
13. YY0623-2008 " dentistry material but dissolve gives fluorine determine method "
14. YY 0624-2008 " dentistry learns abnormal product: abnormal elastomer accessory "
15. YY 0625-2008 " dentistry learns abnormal product: abnormal silk "
16. YY0626-2008 " the dentistry casting alloy of 25%-75% of precious metal content "
17. YY 0627-2008 " medical and electric equipment the 2nd part: Operation shadowless lamp and diagnose with floodlight safety special requirement " (replace YY0102 ~ 0103-1993, YY 0568-2005)
18. YY 0633-2008 " ophthalmic instrument is indirect ophthalmoscope "
19. YY 0634-2008 " camera of ophthalmic instrument eye ground "
20. YY 0635.1-2008 " system of anaesthesia of cell to cell the 1st part: Adult anaesthesia respiratory system "
21. YY 0636.1-2008 " medical attract facility the 1st part: Dynamoelectric attract equipment safety to ask " (replace YY0099 ~ 0100-1993)
22. YY 0636.2-2008 " medical attract facility the 2nd part: Artificial drive attracts facility " (replace YY0101-1993)
23. YY 0636.3-2008 " medical attract facility the 3rd part: Attract facility for dynamic with negative pressure or pressure source "
24. YY 0637-2008 " medical and electric equipment is radiative the safety that treats plan system asks "
25. YY 0645-2008 " successional blood purifying device "
26. YY 0646-2008 " small-sized vapour sterilization implement automata "
27. YY 0647-2008 " passive surgery is embedded content breast is embedded the special requirement of content "
28. YY 0648-2008 " measure, control and lab ask with the safety of electric equipment 2-101 part: Diagnose outside body (IVD) medical the special requirement of equipment "
29. YY 0649-2008 " high potential treats equipment "
30. YY 0650-2008 " radio frequency of department of gynaecology treats appearance "
31. YY 1070-2008 " dentistry radical is held in the palm / modelling wax " (replace YY91070-1999)
32. YY 1079 - 2008 " heart report guards appearance " (replace YY91079 - 1999)
33. YY 1105 - 2008 " machine of dynamoelectric gastric lavage " (replace YY91105 - 1999)
Above medical devices is mandatory occupation standard is carried out since December 1, 2009.

2, recommend a gender occupation standard
1. YY/T 0108-2008 " method of experiment of mode of M of ultrasonic diagnostic device " (replace YY0108-1993)
2. YY/T 0127.12-2008 " biology of medical devices of tooth science oral cavity evaluates the 2nd unit: Experiment means small nuclear test "
3. YY/T 0245-2008 " kiss (seam) close implement current technology condition " (replace YY/T 0245.1-1997)
4. YY/T 0268-2008 " biology of medical devices of tooth science oral cavity evaluates the 1st unit: Evaluation and experiment " (replace YY/T 0268-2001)
5. YY/T 0316-2008 " the application that risk of medical devices runs pair of medical devices "
(replace YY/T 0316-2003)
6. YY/T 0606.7-2008 " product of constituent project medical treatment the 7th part: Housing gets together candy "
7. YY/T 0606.8-2008 " product of constituent project medical treatment the 8th part: Algal acid natrium "
8. YY/T 0606.10-2008 " product of constituent project medical treatment the 10th part: Repair or cartilaginous of second birth joint evaluate a guideline inside embedded object "
9. YY/T 0606.13-2008 " product of constituent project medical treatment the 13rd part: The cell is automatic counting method "
10. YY/T 0628-2008 " dentistry equipment graphic symbol "
11. YY/T 0629-2008 " dentistry equipment Gao Rong measures the capacity in mixing to attract a system "
12. YY/T 0630-2008 " dentistry learns dentistry cure chance the 2nd part: Water supply and air feed "
13. YY/T 0631-2008 " of dentistry material lubricious stability determine "
14. YY/T 0632-2008 " the tooth blanchs what material crosses oxide content to determine method "
15. YY/T 0638-2008 " the metrology traceability that in the measurement of the quantity in sample of biology of medical devices is being diagnosed to calibration is tasted and control material outside body, enzymatic catalysis chroma assigns "
16. YY/T 0639-2008 " manufacturer of medical devices is diagnosed to be the information that biologic tragacanth diagnoses reagent to offer outside body outside body "
17. YY/T 0640-2008 " passive surgery is embedded other people is general requirement "
18. YY/T0641-2008 " hot analysis law measures NiTi alloy photograph to change the standard method of temperature "
19. YY/T 0642-2008 " character of supersonic sound field is affirmatory and medical diagnostic ultrasonic field heats up the experiment method with mechanical index "
20. YY/T 0643-2008 " performance of diagnostic equipment of supersonic pulse echo checks a method "
21. YY/T 0644-2008 " the measurement that system of supersonic and surgical operation outputs character basically and announce "
22. YY/T 0651.1-2008 " complete hip joint of surgical and embedded content is false of body wear away the 1st part: Hip joint wears away the load of experiment machine and displacement parameter and relevant experiment ambient conditions "
23. YY/T 0651.2-2008 " complete hip joint of surgical and embedded content is false of body wear away the 2nd part: Measurement technique "
24. YY/T 0652-2008 " of embedded content material wear away polymer and metallic stuff grind bits depart, token and quantitative analysis method "
25. YY/T 0653-2008 " haemal analyzer "
26. YY/T 0654-2008 " full automatic biochemical analyzer "
27. YY/T 0655-2008 " appearance of chemical analysis doing type "
28. YY/T 0656-2008 " automation blood develops a system "
29. YY/T 0657-2008 " medical centrifugal " (replace YY91046-1999, YY 91100-1999)
30. YY/T 0658-2008 " semi-automatic cruor analyzer "
31. YY/T 0659-2008 " full automatic cruor analyzer "
32. YY/T0660-2008 " surgical and embedded content is used get together ether aether ketone (PEEK) the standard of polymer is normative "
33. YY/T 0661-2008 " surgical and embedded content is used get together (L- lactic acid) resinous standard standard "
34. YY/T 0662-2008 " whorl of asymmetry of surgical and embedded content and globose the demand of performance of machinery of bolt of metallic set a broken bone of next surfaces and experiment method "
35. YY/T 0663-2008 " passive surgery is embedded the special requirement of the bracket of special requirement artery of content heart and hemal and embedded content "
36. YY/T 0664-2008 " process of life cycle of software of software of medical devices "
37. YY/T 0665-2008 " MH agaragar is fostered base "
38. YY/T 1078 - 2008 " appearance of graph of blood stream of direct form impedance " (replace YY 91078-1999)
39. YY/T 1106 - 2008 " dynamoelectric operating-table " (replace YY91106-1999)
40. YY/T 1143 - 2008 " appearance of graph of blood stream of bridge type impedance " (replace YY 91143-1999)
Above medical devices recommends a gender occupation standard is carried out since June 1, 2009.


National provision medicines and chemical reagents controls management board
28 years on April 25


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