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

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Scope

This part of GB/T 29791 specifies the requirements for information provided by professional in vitro diagnostic (IVD) instrument manufacturers.
This section also applies to devices and equipment intended for use with professional in vitro diagnostic medical devices.
This section also applies to IVD attachments.
This section does not apply to.
a) instructions for servicing or repairing the instrument;
b) in vitro diagnostic reagents, including calibrators and control substances used to control the reagents;
c) In vitro diagnostic equipment for self-test.

Basic Data

Standard ID	GB/T 29791.3-2013 (GB/T29791.3-2013)
Description (Translated English)	In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 3: In vitro diagnostic instruments for professional use
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C44
Classification of International Standard	11.100
Word Count Estimation	11,128
Quoted Standard	ISO 14971; ISO 15223-1; ISO 18113-1; IEC 61010-1; IEC 61010-2-101; IEC 61326-2-6; IEC 62366; EN 980
Adopted Standard	ISO 18113-3-2009, IDT
Regulation (derived from)	National Standards Bulletin No. 21 of 2013
Issuing agency(ies)	General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Summary	This standard specifies the professional use in vitro diagnostic (IVD) equipment manufacturers to provide information on request. This standard also applies to devices and equipment are expected to use and professional in vitro diagnostic medical devices