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 (English Version)

Standard No.: GB/T 29791.2-2013
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 29791.2-2013

Scope: This part of GB/T 29791 specifies the requirements for information provided by manufacturers of in vitro diagnostic (IVD) reagents for professional use. This section also applies to information provided by manufacturers of calibrators and control substances intended to be used with professional in vitro diagnostic medical devices. This section also applies to IVD accessories. This section applies to outer and inner packaging labels and instructions for use. This section does not apply to: a) in vitro diagnostic instruments or equipment; b) in vitro diagnostic reagents for self-test.

GB/T 29791.2-2013 Referenced Document

EN 980 Graphical Symbols for Use in the Labelling of Medical Devices
GB/T 7408-2005 Data elements and interchange formats-Information interchange-Representation of dates and times
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/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

2013 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