YY/T 1997-2026 Pending Industry standards-Medicine

YY/T 1997-2026 Management requirements for specimen in clinical studies of IVD reagents

Publish Date: 2026-03-09 Implement Date: 2027-03-01 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: YY/T 1997-2026

Standard Type: Industry standards

Standard Status: Pending

is_force_gb: no

CCS Name: Medical devices

ICS Name: Medical equipment

Publish Date: 2026-03-09

Implement Date: 2027-03-01

Pages: 12 pages

Scope

This document specifies the general requirements for the management of human biological samples during the clinical trials of in vitro diagnostic (IVD) reagents, including confidentiality requirements, ethical requirements, and requirements for sample collection, transportation, storage, pre-processing, testing, disposal, biosafety documents, and records.
This document applies to clinical trials of in vitro diagnostic reagents conducted for registration purposes.