GB/T 19702-2021 Active National standards

GB/T 19702-2021 In vitro diagnostic medical devices—Measurement of quantities in samples of biological origin—Requirements for content and presentation of reference measurement procedures

Publish Date: 2021-03-09 Implement Date: 2022-04-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: GB/T 19702-2021

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Medical equipment

Publish Date: 2021-03-09

Implement Date: 2022-04-01

Pages: 20 pages

Scope

This standard specifies the requirements for the content of reference measurement procedures used in vitro diagnostic medical devices and medical laboratories.
Note 1: This standard expects that an experienced laboratory worker, operating in accordance with the measurement procedures established in accordance with this standard, can obtain measurement results with measurement uncertainty that do not exceed the specified range.
This standard applies to reference measurement procedures that provide differential values or proportional quantities. Appendix A provides information on nominal characteristics and quantities.
This standard applies to all individuals, institutions, or research institutes that need to prepare reference measurement procedure documents in various branches of laboratory medicine.
Fully described measurement methods are usually published in scientific literature. These methods, which are described in sufficient detail, can serve as the basis for documented reference measurement procedures.
Note 2: In this standard, "international measurement standards" are defined as material standards. The term "international standards" is used in the WHO as a reference substance.