GB/T 29791.3-2013 Active National standards

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 In vitro diagnostic medical devices—Information supplied by the manufacturer(labelling)—Part 3:In vitro diagnostic instruments for professional use

Publish Date: 2013-10-10 Implement Date: 2014-02-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 29791.3-2013

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Laboratory medicine

Publish Date: 2013-10-10

Implement Date: 2014-02-01

Pages: 10 pages

Scope

This part of GB/T 29791 specifies the requirements for information provided by manufacturers of professional in vitro diagnostic (IVD) instruments.
This part also applies to devices and equipment intended for use with professional in vitro diagnostic medical instruments.
This part also applies to IVD accessories.

Development Information

Word Count: 16 Thousand words Pages: 10 pages

Same series standard

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 29791.4-2013 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

Referenced Standards

ISO 14971 ISO 15223-1 ISO 18113-1 IEC 61010-1 IEC 61010-2-101 IEC 61326-2-6 IEC 62366 EN 980

Adopt standards

ISO 18113-3:2009

Related Standards

YY/T 0456.1-2003 Replaced

YY/T 0456.1-2003 Regents for hematology analyzer use—Part 1:Rinse

Publish Date: 2003-06-20

YY/T 0456.2-2003 Replaced

YY/T 0456.2-2003 Regents for hematology analyzer use—Part 2:Hemolysin

Publish Date: 2003-06-20

YY/T 0456.3-2003 Replaced

YY/T 0456.3-2003 Regents for hematology analyzer use—Part 3:Diluent

Publish Date: 2003-06-20

YY/T 0475-2004 Replaced

YY/T 0475-2004 General technical requirements for urine analyzer

Publish Date: 2004-03-23

YY/T 0478-2004 Replaced

YY/T 0478-2004 General technical requirements for chemical reagent strips for urinalysis

Publish Date: 2004-03-23

YY/T 0032-2004 Active

YY/T 0032-2004 Haemoglobin instrument

Publish Date: 2004-11-08