26 medical device industry standards are to be abolished! (with list)
On June 6, the CFDA issued the "Standards for the Approval of YY 0097-1992 <Magnetic Health Cup> and 26 Medical Device Industry Standards" (hereinafter referred to as "Opinions"). The "Opinions" pointed out that in accordance with the "Notice of the State Council on Printing and Deepening the Reform Plan for Standardization Work" (Guo Fa [2015] No. 13), the State Council intends to abolish the following 26 medical device industry standards through the integration and streamlined review of medical device industry standards. :
Serial number | standard encdoing | standard name |
1 | YY 0097-1992 | Magnetic therapy cup |
2 | YY 0005-1990 | Single-ring steel plastic intrauterine device |
3 | YY 0027-1990 | Heated Incubators |
4 | YY 0085.1-1992 | Pulsating vacuum pressure steam sterilizer |
5 | YY 0085.2-1992 | Pre-vacuum pressure steam sterilizer |
6 | YY 0088-1992 | Microsampler |
7 | YY 0115-1993 | Single use blood collection device |
8 | YY 0156-1994 | Micro oscillator |
9 | YY 0166-2002 | Sewing needle |
10 | YY 0284-2004 | General technical conditions for holmium laser intravascular irradiation therapy apparatus |
11 | YY 0305-1998 | Hydroxyapatite bioceramic |
12 | YY 0476-2004 | Intraocular irrigation perfusate |
13 | YY 91037-1999 | Electric thermostatic water bath |
14 | YY 91038-1999 | Constant temperature water tank |
15 | YY 91092-1999 | Phenotype magnetic therapy device |
16 | YY/T 0127.2-2009 | Biological evaluation of oral medical devices - Unit 2 : Test methods Acute systemic toxicity test: intravenous route |
17 | YY/T 0160-1994 | Straight tubular quartz UV low pressure mercury disinfection lamp |
18 | YY/T 0244-1996 | Short-term systemic toxicity test for oral material bioassay: oral route |
19 | YY/T 0280-1995 | Electric distilled water |
20 | YY/T 0456.1-2014 | Blood cell analyzer application reagent part 1 cleaning solution |
twenty one | YY/T 1162-2009 | Alpha-fetoprotein ( AFP ) quantitative assay reagent (box) (chemiluminescence immunoassay) |
twenty two | YY/T 1192-2011 | Human chorionic gonadotropin (HCG) quantitative assay reagent (box) (chemiluminescence immunoassay) |
twenty three | YY/T 1193-2011 | Quantitative determination of follicle stimulating hormone (FSH) kit (chemiluminescence immunoassay) |
twenty four | YY/T 91049-1999 | Medical device standard document three-category category expansion classification |
25 | YY/T 91056-1999 | Medical device metal chrome plating thickness test timing drip method |
26 | YY/T 91066-1999 | Small octagonal handle size and technical conditions |
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