DZ/T 0101.12-1994
Active
GB/Z 157-2026
Active
National standards
GB/Z 157-2026 In vitro diagnostic test systems—Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods
GB/Z 157-2026 In vitro diagnostic test systems—Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods
Price:
$ 114
Basic Information
Standard Code:
GB/Z 157-2026
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
-
Publish Date:
2026-01-28
Implement Date:
1970-01-01
Pages:
44 pages
Scope
This document sets out requirements and recommendations for the design, development, validation, confirmation, and implementation of nucleic acid amplification tests for the detection of SARS-CoV-2. It covers the pre-test, test, and post-test procedures for human specimens.
This document is applicable to medical laboratories. It is also intended for use by in vitro diagnostic developers, manufacturers, and institutions and organizations supporting SARS-CoV-2 research and diagnosis.
This document is not applicable to environmental samples.
Development Information
Adopt standards
ISO/TS 5798:2022
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