GB/T 29791.4-2013 Active National standards

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 29791.4-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer (labelling)—Part 4:In vitro diagnostic reagents for selftesting

Publish Date: 2013-10-10 Implement Date: 2014-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 29791.4-2013

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: 2014-03-01

Pages: 11 pages

Scope

This part of GB/T 29791 specifies the requirements for information provided by manufacturers of in vitro diagnostic (IVD) reagents for self-testing.
This part also applies to the information provided by manufacturers of calibrators and control substances intended for use with in vitro diagnostic medical devices for self-testing.
This part also applies to IVD accessories.
This part applies to outer and inner packaging labels and user manuals.

Development Information

Word Count: 16 Thousand words Pages: 11 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 29791.3-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer(labelling)—Part 3:In vitro diagnostic instruments for professional use GB/T 29791.5-2013 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 EN 980

Adopt standards

ISO 18113-4:2009

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