GB/T 45635-2025 Active National standards

GB/T 45635-2025 Specifications for the control of biosafety risks in the operation and use of entry-exit special products

Publish Date: 2025-04-25 Implement Date: 2025-11-01 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 45635-2025

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Sanitary quarantine

ICS Name: Integrated medical science and healthcare devices

Publish Date: 2025-04-25

Implement Date: 2025-11-01

Pages: 28 pages

Scope

This document stipulates the requirements for biosafety risk control of the operation and use of special goods entering and leaving the country, including biosafety management, risk identification, risk assessment, risk control, record keeping, and reporting, etc.
This document applies to units operating and using special goods entering and leaving the country, or their entrusted units, in the management of biosafety risk control during the customs supervision period for special goods in terms of packaging, storage, transportation, use, and disposal of such goods.

Development Information

Word Count: 36 Thousand words Pages: 28 pages

Referenced Standards

GB 19489-2004 Laboratories—General requirements for biosafety GB 19489-2008 Laboratories—General requirements for biosafety GB/T 27921-2011 Risk management—Risk assessment techniques GB/T 27921-2023 Risk management—Risk assessment techniques GB/T 43429-2023 General requirements for preservation of human pathogenic microorganisms and samples HJ 1284-2023 Disinfection and treatment facility operation and management technical specifications for medical waste SN/T 4707-2016 SN/T 4707-2016 Inbound and outbound biosafety risk classification management regulations for special substances and materials

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