YY/T 1194-2011
α-Amylase test reagent(kit)(continuous-monitoring procedure) (English Version)
- Standard No.
- YY/T 1194-2011
- Language
- Chinese, Available in English version
- Release Date
- 2011
- Published By
- Professional Standard - Medicine
- Latest
- YY/T 1194-2011
- Scope
- This standard specifies the terms and definitions, classification and nomenclature, technical requirements, test methods, labels, instructions for use, packaging, transportation and storage of α-amylase assay reagents (kits). This standard applies to α-amylase assay reagents (boxes) that use continuous monitoring methods to quantitatively detect α-amylase activity in serum, plasma, urine and other body fluids, including manual reagents and semi-automatic and fully automatic biochemical analyzers. Reagents used.
YY/T 1194-2011 Referenced Document
- YY/T 0316 Medical devices.Application of risk management to medical devices*， 2016-01-26 Update
- YY/T 0466.1 Symbols for medical devices used for information provided by manufacturers Part 1: General requirements*， 2023-09-05 Update
YY/T 1194-2011 history
- 2011 YY/T 1194-2011 α-Amylase test reagent(kit)(continuous-monitoring procedure)
