GB/T 29791.3-2013
In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling).Part 3:In vitro diagnostic instruments for professional use (English Version)
- Standard No.
- GB/T 29791.3-2013
- Language
- Chinese, Available in English version
- Release Date
- 2013
- Published By
- General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
- Latest
- GB/T 29791.3-2013
- Scope
- This Part of GB/T 29791 specifies the requirements for information provided by manufacturers of in vitro diagnostic (IVD) instruments for professional use. This section also applies to devices and equipment intended to be used with in vitro diagnostic medical instruments for professional use. This section also applies to IVD accessories. This section does not apply to: a) instructions for instrument maintenance or repair; b) in vitro diagnostic reagents, including calibrators and control substances used to control the reagents; c) in vitro diagnostic instruments for self-test.
GB/T 29791.3-2013 Referenced Document
- EN 980 Graphical Symbols for Use in the Labelling of Medical Devices
- GB 4793.1-2007 Safety requirements for electrical equipment for measurement,control,and laboratory use.Part 1:General requirements
- IEC 61326-2-6 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment*， 2020-10-28 Update
- IEC 62366 Medical devices - Application of usability engineering to medical devices*， 2014-01-01 Update
- ISO 18113-1 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirements*， 2022-10-06 Update
- YY 0648-2008 Safety requirments for electrical equipment for measurement,control and laboratory use.Part 2-101:Particular requirments for in vitro diagnostic(IVD）medical equipment
- YY/T 0316-2008 Medical devices.Application of risk management to medical devices
- YY/T 0466.1-2009 Medical devices.Symbols to be used with medical device labels,labelling and information to be supplied.Part 1:General requirements
GB/T 29791.3-2013 history
- 2013 GB/T 29791.3-2013 In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling).Part 3:In vitro diagnostic instruments for professional use
GB/T 29791.3-2013 -All Parts
GB/T 29791.1-2013 In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling).Part 1:Terms, definitions and general requirements
GB/T 29791.2-2013 In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling).Part 2:In vitro diagnostic reagents for professional use
GB/T 29791.3-2013 In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling).Part 3:In vitro diagnostic instruments for professional use
GB/T 29791.4-2013 In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling).Part 4:In vitro diagnostic reagents for selftesting
GB/T 29791.5-2013 In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling).Part 5:In vitro diagnostic instruments for selftesting