The state administration of drug administration announced that 28 medical device industry standards have been approved by the state administration of drug administration on May 8, and will be implemented on April 1, 2018.
These new standards include:
YY/T 0326-2017 "disposable plasma separator"
This standard instead of YY - 2002-0326.1 the single-use centrifugal plasma separator part 1: plasma separation "cup, YY0326.2-2002" single-use centrifugal plasma separator part 2: plasma line "and YY0326.3-2005" one-time use of centrifugal plasma separator part 3: plasma bag ".
YY/T 0490-2017 "tracheobronchial tube specification and labeling."
This standard replaces YY/T 0490-2004 "recommended specifications and labels for tracheobronchial intubation."
YY/T 1137-2017 "the technical conditions for bone saw"
This standard replaces YY 1137-2005.
YY/T 1293.15-2017 "the fifth part of the contact wound dressings: alginate dressings."
YY/T 1511-2017 collagen sponge
YY/T 1514-2017 the human immunodeficiency virus (1 + 2) antibody test kits (immune imprinting)
YY/T 1515-2017 "human immunodeficiency virus (I) nucleic acid quantitative test kit"
YY/T 1517-2017 "the EB virus capsid antigen (VCA) IgA antibody test kit"
YY/T 1525-2017 "methamphetamine test kits"
YY/T 1526-2017 "human immunodeficiency virus antigen antibody joint test kits (luminescence)"
YY/T 1529-2017 the enzyme association immunoanalyzer
YY/T 1537-2017 "the performance and testing methods of radiotherapy for laser positioning system"
YY/T 1538-2017 "the performance and testing methods of automatic scanning water module system for radiotherapy."
YY/T 1539-2017 "medical clean table"
15 and YY/T 1540-1540 "medical grade Ⅱ biological safety cabinet inspection guide"
YY/T 1541-2017 "the technical conditions for high voltage cable assemblies and receptacles for mammography"
YY/T 1542-2017 "digital medical X-ray equipment automatic exposure control evaluation method"
YY/T 1543-2017 "nasal oxygen tube"
YY/T 1544-2017 "requirements for the safety and effectiveness of epoxy ethane."
YY/T 1545-2017 "the evaluation of the connection between the concentration of blood dialysis and blood dialysis equipment"
YY/T 1546-2017 "test method for SPECT imaging CT attenuation correction"
YY/T 1547.1-2017: the first part of the fixed device for radiotherapy: thermoplastic membrane.
YY/T 1547.2-2017 "radiotherapy with body part 2: vacuum negative pressure pad."
YY/T 1548-2017 "dosage measurement for radiotherapy"
YY/T 1549-2017 "the calibration of biochemical analysis"
YY/T 1554-2017 "fallopian tubes"
YY/T 1570-2017 "the terms and classification of skin substitutes for the tissue engineering medical devices"
This standard replaces YY/T 0606.4-2007: the term and classification of skin substitutes (objects) in the fourth part of the organization engineering medical product.
YY/T 1571-2017 "tissue engineering medical device product hyalurate."
This standard replaces YY/T 0606.9-2007 "part 9 of organizational engineering medical products: hyalurate."
|
