GB/T 29791.2-2013 Active National standards

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 29791.2-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer (labelling)—Part 2:In vitro diagnostic reagents 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 29791.2-2013

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: 12 pages

Scope

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

Development Information

Word Count: 20 Thousand words Pages: 12 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 29791.3-2013 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

Referenced Standards

ISO 8601 ISO 14971 ISO 15223-1 ISO 18113-1 EN 980

Adopt standards

ISO 18113-2:2009

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