GB/T 29791.5-2013
In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling).Part 5:In vitro diagnostic instruments for selftesting (English Version)
- Standard No.
- GB/T 29791.5-2013
- 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 29791.5-2013
- Scope
- This part of GB/T 29791 specifies the requirements for information provided by manufacturers of in vitro diagnostic (IVD) instruments for self-test. This standard also applies to devices and equipment intended to be used with in vitro diagnostic medical instruments for self-testing. 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) professional in vitro diagnostic instruments.
GB/T 29791.5-2013 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 29791.5-2013 history
- 2013 GB/T 29791.5-2013 In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling).Part 5:In vitro diagnostic instruments for selftesting
GB/T 29791.5-2013 -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