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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