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GB/T 47144-2026: Requirements for development, validation and routine control of cleaning process for medical devices
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Requirements for development, validation and routine control of cleaning process for medical devices
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Basic data | Standard ID | GB/T 47144-2026 (GB/T47144-2026) | | Description (Translated English) | Requirements for development, validation and routine control of cleaning process for medical devices | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C47 | | Classification of International Standard | 11.080.01 | | Word Count Estimation | 22,233 | | Date of Issue | 2026-01-28 | | Date of Implementation | 2027-08-01 | | Issuing agency(ies) | State Administration for Market Regulation, Standardization Administration of China | GB/T 47144-2026: Requirements for development, validation and routine control of cleaning process for medical devices
---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 11.080.01
CCSC47
National Standards of the People's Republic of China
Development, validation, and standardization of medical device cleaning processes
Control requirements
Published on 2026-01-28
Implemented on August 1, 2027
State Administration for Market Regulation
The State Administration for Standardization issued a statement.
Table of contents
Preface III
Introduction IV
1.Scope 1
2 Normative References 1
3.Terms and Definitions 1
4.Elements of a Quality Management System
5.Characteristics of cleaning agents 4
6.Cleaning process characteristics and equipment characteristics 5.
7 Product Requirements
8.Cleaning process requirements
9 Confirmed 8
10 Routine Controls 10
11 Cleaning products released.
12 Maintain process effectiveness 11
Appendix A (Informative) Process Control Responsibility Allocation 13
Appendix B (Informative) Cleaning Effectiveness Assessment 14
References 16
Foreword
This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents".
Drafting.
Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents.
This document was proposed by the National Medical Products Administration.
This document is under the jurisdiction of the National Technical Committee on Standardization of Disinfection Technology and Equipment (SAC/TC200).
This document was drafted by. Shandong Xinhua Medical Instrument Co., Ltd., Guangdong Provincial Institute of Medical Device Quality Supervision and Inspection, and the Chinese Academy of Medical Sciences.
The college, Peking Union Medical College Hospital, Changshu Rongrui Sterilization Technology Co., Ltd., Zhongguancun International Medical Testing and Certification Technology Co., Ltd., and Chongqing Medical Device...
Medical Device Quality Inspection Center, Diekang (Shanghai) Trading Co., Ltd., Mairun Medical Technology (Shaoxing) Co., Ltd., and Beiliman Medical Equipment (Shanghai) Co., Ltd.
Limited Liability Company, Stereo (Shanghai) Trading Co., Ltd., Maikewei Medical Equipment (Suzhou) Co., Ltd., Hebei Rongfeng Disinfection Equipment Co., Ltd.
Olympus (Beijing) Sales & Service Co., Ltd. Shanghai Branch, Shandong Ande Medical Supplies Co., Ltd., Xinhua Surgical Instruments Co., Ltd.
company.
The main drafters of this document are. Zhang Longlong, Lin Manting, Tu Rong, Hu Changming, Zhang Qing, Zhou Ping, Su Yuxin, Guo Jing, Zhu Yibing, Wu Shaohai, and Zhou Zhilong.
Xu Weixiong, Wang Yimin, Zhang Jie, Wang Yizhen, Zhang Liwen, Chen Huahua, Chen Jiansheng, Wang Kui, Sun Mingqiang, Huang Yanhong.
Introduction
Medical device manufacturers are responsible for the cleanability of the devices they produce that require cleaning, and must guarantee that the devices have reliable and repeatable cleaning capabilities.
Cleaning method.
Cleaning is typically considered a critical or special process in medical device manufacturing. The purpose of cleaning is to remove...
Medical devices are susceptible to surface contaminants, processing aids, and certain microorganisms during the manufacturing process, which must be addressed to ensure the smooth operation of the medical devices.
Further processing is required to ensure the safety and effectiveness of the product upon delivery. The effectiveness of the cleaning process is assessed by evaluating cleaning process parameters (such as cleaning time).
The composition, concentration, and temperature of the chemical agents (such as time and temperature) are confirmed, and the performance and cleaning effect of the cleaning equipment are confirmed and monitored regularly.
For reusable medical devices, manufacturers must provide validated cleaning process instructions. More importantly, the cleaning process must be validated.
Organizations handling medical devices can effectively clean them before sterilization and/or disinfection (if applicable).
This document aims to provide medical device manufacturers with requirements for the development, validation, and routine control of medical device cleaning processes. Furthermore, this document...
It also provides information for developing cleaning plans, selecting test contaminants, and determining acceptance criteria.
Therefore, the requirements described in this document apply to cleaning processes intended for removing contaminants attached to medical devices to ensure cleaning results.
Reliable and reproducible.
The development, validation, and routine control of the cleaning process involves several disjointed but related activities, such as calibration, maintenance, product definition, and process control.
The process includes definition, installation qualification, operational qualification, and performance qualification. Individuals or organizations can selectively implement these as needed; Appendix A provides details for each activity.
The party responsible for the action.
Development, validation, and standardization of medical device cleaning processes
Control requirements
1 Scope
This document specifies the requirements for the development, validation, and routine control of cleaning processes for medical devices.
This document applies to the cleaning process during the production and use of medical devices, medical institutions, other medical products requiring cleaning, and manual cleaning.
Follow the cleaning process as a reference.
This document does not apply to.
---Disposable medical devices supplied to patients in a ready-to-use state;
---Textiles used in patient sterile hood systems or surgical gowns; or
---Instruments that may come into contact with prions, such as instruments that may be contaminated with infectious spongiform encephalopathy (TSE) virus.
2 Normative references
The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included.
For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies.
This document.
GB/T 16886.17 Biological evaluation of medical devices - Part 17.Toxicological risk assessment of medical device components
GB/T 19022 Measurement Management System - Requirements for Measurement Processes and Measuring Equipment
GB/T 42061-2022 Medical Device Quality Management System - Regulatory Requirements
GB 42125.11 Safety requirements for electrical equipment for measuring, controlling and laboratory use - Part 11.Sterilization of medical materials
Special requirements for cleaning and sterilizing equipment
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
chamber
The part of the equipment that is under processing load.
[Source. GB/T 19971-2026, 3.37, with modifications]
3.2
cleaning
Remove contaminants to the extent necessary for further processing or intended use.
[Source. GB/T 19971-2026, 3.47]
3.3
Cleaning agent
A physical or chemical entity, or a combination of entities, that enables an item to achieve a cleaning effect.
[Source. GB/T 19971-2026, 3.48]
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