YY/T 0616.1-2016: Translated English of Chinese Standard. (YYT 0616.1-2016, YY/T0616.1-2016, YYT0616.1-2016): Medical gloves for single use - Part 1: Requirements and testing for biological evaluation
https://www.chinesestandard.net, 2018 M05 5 - 39 pages
This Part of YY/T 0616 specifies the requirements for the biological safety evaluation of medical gloves for single use, and gives the requirements for the labeling and disclosure of information for the test methods used. This Part applies to the biological safety evaluation of medical gloves for single use.
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Annex B informative Immunoassay method for natural rubber latex allergens
acid analytical method adverse reactions ALARP allergic amino acid analytical amino acid standard amount of ovalbumin analysis Annex average value batch biological evaluation bromophenol blue buffer solution A.3.2.2 calibration curve centrifuge tube A.4.3 chemicals concentration confirmed containing natural rubber cysteine determine the protein endotoxin evaluation of medical GB/T glove leaching solution gloves for single Hevb3 HPLC human IgE hydrochloric acid hydrolysis IgE antibodies improved Lowry method incubation label laboratories leachable proteins leachate leaching buffer solution Medical Device medical gloves micrograms per milliliter mol/L monoclonal antibodies natural rubber latex NOTE NRL allergens NRL gloves NRL products outer glove ovalbumin ovalbumin bound ovalbumin content polypropylene protein binding capacity protein content protein standard solution quantification of NRL re-dissolve reagents Requirements and testing rubber latex allergens sample solution Sodium carbonate Sodium hydroxide solvent spectrophotometer substances test methods test results tetrahydrofuran total amount triplicate valine valine-1 water and DILUTE YY/T