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GB/T 45635-2025 English PDF

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US$539.00 · In stock
Delivery: <= 5 days. True-PDF full-copy in English will be manually translated and delivered via email.
GB/T 45635-2025: Specifications for the control of biosafety risks in the operation and use of entry-exit special products
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 45635-2025	539	Add to Cart	5 days	Specifications for the control of biosafety risks in the operation and use of entry-exit special products	Valid

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Basic data

Standard ID: GB/T 45635-2025 (GB/T45635-2025)
Description (Translated English): Specifications for the control of biosafety risks in the operation and use of entry-exit special products
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: C62
Classification of International Standard: 11.020
Word Count Estimation: 26,285
Date of Issue: 2025-04-25
Date of Implementation: 2025-11-01
Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration

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

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11.020 CCSC62 National Standard of the People's Republic of China Biosafety in the operation and use of special items entering and leaving the country Risk Control Specifications 2025-11-01 Implementation State Administration for Market Regulation The National Standardization Administration issued

Preface III 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Object 2 5 Biosafety Management 2 5.1 General Requirements 2 5.2 Responsibilities 2 5.3 System establishment 2 5.4 Implementation Requirement 3 5.5 Personnel Position Competence 3 5.6 Rating 3 6 Risk Identification 4 6.1 Risk Factors 4 6.2 Risk Information Collection Methods 4 6.3 Risk information transmission and notification channels 4 6.4 Risk classification 5 7 Risk Assessment 5 7.1 Trigger Conditions 5 7.2 Principle 5 7.3 Procedures and methods 5 7.4 Content 5 7.5 Risk Conclusion 7 8 Risk Control 7 8.1 Principle 7 8.2 Source safety 7 8.3 Packaging safety 7 8.4 Label Security 8 8.5 Transportation Safety 8 8.6 Biosafety during use 8 8.7 Safe disposal of biological waste 9 8.8 Storage safety 9 8.9 Emergency Response 9 9 Records and Reports10 9.1 Records Management10 9.2 Recording Scope 10 9.3 Record content 11 9.4 Report Contents 11 Appendix A (Informative) List of infectious substances classified as Class A in transport packaging12 Appendix B (Normative) Requirements for packaging systems for Category A infectious substances and Category B infectious substances 15 B.1 Packaging requirements for Category A infectious substances (UN Nos. UN2814 and UN2900) 15 B.2 Packaging requirements for Category B infectious substances (UN No. UN3373) 16 B.3 Basic three-layer packaging requirements 16 Reference 18

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents" Drafting. Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents. This document is issued by the General Administration of Customs of the People's Republic of China. This document is under the jurisdiction of the National Technical Committee on Health and Quarantine Standardization (SAC/TC582). This document was drafted by. General Administration of Customs of the People's Republic of China, Shanghai Customs of the People's Republic of China, China Institute of Inspection and Quarantine, Beijing Customs of the People's Republic of China, Hangzhou Customs of the People's Republic of China, Shanghai International Travel Health Care Center, Fudan University, Shanghai Institute of Infectious Diseases and Biosafety. The main drafters of this document are. Xu Feng, Lou Yating, Liu Lijuan, Liang Libo, Feng Gang, Tian Zhenggan, Liu Mei, Qi Runzi, Xu Wenyan, Lu Ye, Yi Zaijong, Xu Hefei, Lu Yan, Hu Kongxin, Chen Leiqiong, Chen Haijing, Qu Di, Xie Youhua. Biosafety in the operation and use of special items entering and leaving the country Risk Control Specifications

1 Scope

This document specifies the biosafety risk control requirements for the operation and use of special items entering and leaving the country, including biosafety management, risk identification, classification, risk assessment, risk control, records and reports, etc. This document is applicable to entities that operate and use special items for entry and exit or their entrusted entities to manage and use special items during the period of customs supervision for entry and exit. Biosafety risk control management in packaging, storage, transportation, use, and disposal.

2 Normative references

The contents of the following documents constitute essential clauses of this document through normative references in this document. For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to This document. GB 19489 General requirements for laboratory biosafety GB/T 27921 Risk management risk assessment technology GB/T 43429 General requirements for the preservation of pathogenic microorganisms and samples of human infections HJ1284 Technical Specifications for Operation and Management of Medical Waste Disinfection and Treatment Facilities SN/T 4707 Biosafety Risk Grading Management Procedures for Special Articles Entering and Leaving the Country

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 Special items special product Goods or articles related to public health and safety. Note. Special items include human tissues such as blood, pathogenic microorganisms, biological products, etc., but do not include those that have been included in the management of medicines, veterinary drugs, and medical devices. 3.2 Special items contain or may contain pathogenic microorganisms, toxins and other biological factors, which may cause potential threats to the ecological environment and human health. 3.3 According to the risk factors such as pathogenicity, pathogenicity, preparation process, use and controllability of biosafety risks of special items and relevant national The competent authorities shall control and require, follow the risk management principles, and classify special items into different biosafety risk levels. [Source. SN/T 4707-2016, 3.3, modified] ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of GB/T 45635-2025_English be delivered?

Answer: Upon your order, we will start to translate GB/T 45635-2025_English as soon as possible, and keep you informed of the progress. The lead time is typically 3 ~ 5 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of GB/T 45635-2025_English with my colleagues?

Answer: Yes. The purchased PDF of GB/T 45635-2025_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.