Standard No.:	GB/T 47144-2026
English Name:	Requirements for development; validation and routine control of cleaning process for medical devices
Chinese Name:	医疗器械清洁过程的开发、确认和常规控制的要求
Professional Classification:	GB    National Standard
Source Content Issued by:	SAMR, SAC
Issued on:	2026-01-28
Implemented on:	2027-8-1
Status:	to be valid
Target Language:	English
File Format:	PDF
Word Count:	12500 words
Translation Price(USD):	375.0
Delivery:	via email in 1~5 business day

GB/T 47144-2026 Requirements for development; validation and routine control of cleaning process for medical devices English, Anglais, Englisch, Inglés, えいご This is a draft translation for reference among interesting stakeholders. The finalized translation (passing through draft translation, self-check, revision and verification) will be delivered upon being ordered. ICS 13.220.10 CCS H 57 National Standard of the People's Republic of China ‌GB/T 47144-2026 Requirements for development; validation and routine control of cleaning process for medical devices 医疗器械清洁过程的开发、确认和常规控制的要求 Issue date: 2026-01-28 Implementation date: 2027-02-01 Issued by the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China the Standardization Administration of the People's Republic of China Contents Foreword Introduction 1 Scope 2 Normative References 3 Terms and Definitions 4 Quality Management System Elements 5 Cleaning Agent Characteristics 6 Cleaning Process Characteristics and Equipment Characteristics 7 Product Requirements 8 Cleaning Process Requirements 9 Validation 10 Routine Control 11 Cleaned Product Release 12 Maintaining Process Effectiveness Annex A (Informative) Allocation of Process Control Responsibilities Annex B (Informative) Determination of Cleaning Effectiveness Bibliography Requirements for the Development, Validation, and Routine Control of Cleaning Processes for Medical Devices 1 Scope This document specifies the requirements for the development, validation, and routine control of cleaning processes for medical devices. This document applies to cleaning processes during the production and use phases of medical devices. Healthcare institutions, other medical products requiring cleaning, and manual cleaning processes may refer to this document for execution. This document does not apply to: —— Single-use medical devices supplied in a ready-to-use state intended for patients; —— Textiles used for sterile patient barrier systems or surgical gowns; or —— Devices that may be contaminated with viruses, for example, devices that may be contaminated with the transmissible spongiform encephalopathy (TSE) agent. 2 Normative References The following documents contain provisions which, through normative reference in this text, constitute essential provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition (including any amendments) applies. GB/T 16886.17 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents GB/T 19022 Measurement management systems - Requirements for measurement processes and measuring equipment GB/T 42061—2022 Medical devices - Quality management systems - Requirements for regulatory purposes GB 42125.11 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 11: Particular requirements for sterilizers and washer-disinfectors for processing medical materials 3 Terms and Definitions For the purposes of this document, the following terms and definitions apply. 3.1 chamber The part of the equipment that processes the load. [SOURCE: GB/T 19971—2026, 3.37, modified] 3.2 cleaning The removal of contaminants to the extent necessary for further processing or for intended use. [SOURCE: GB/T 19971—2026, 3.47] 3.3 cleaning agent A physical or chemical entity, or combination of entities, that achieves a cleaning effect on items. [SOURCE: GB/T 19971—2026, 3.48] 3.4 holding time The time during which a process parameter or cycle parameter is maintained within the specified permissible range for each phase of the cycle. [SOURCE: GB/T 19971—2026, 3.138] 3.5 installation qualification: IQ The process of obtaining objective evidence that the installation of process equipment and ancillary systems conforms to approved specifications. [SOURCE: GB/T 19971—2026, 3.247.2] 3.6 load The products, equipment, or materials processed together in one operational cycle. [SOURCE: GB/T 19971—2026, 3.172] 3.7 major repair Maintenance operations that go beyond the routine maintenance of the equipment and significantly affect its performance. EXAMPLE: Major repairs for a washer-disinfector include replacing the water pump, detergent supply system, heating system, control system, etc. [SOURCE: WS 310.3—2016, 3.4, modified] 3.8 operational qualification: OQ The process of obtaining and documenting evidence that installed equipment operates within predetermined limits when used in accordance with operational procedures. [SOURCE: GB/T 19971—2026, 3.247.3] 3.9 performance qualification: PQ The process of obtaining objective evidence that the process, under anticipated conditions, consistently produces product conforming to all predetermined requirements. [SOURCE: GB/T 19971—2026, 3.247.4] 3.10 process parameter A specified value for a process variable. NOTE: The specified value includes the process parameter and its tolerance. [SOURCE: GB/T 19971—2026, 3.235, modified] 3.11 process variable A chemical or physical attribute of a cleaning, disinfection, or packaging process whose change can affect effectiveness. EXAMPLE: Time, temperature, pressure, concentration, frequency, etc. [SOURCE: GB/T 19971—2026, 3.238, modified] 3.12 processing Preparation of a new or used medical device to meet requirements for its intended use. [SOURCE: GB/T 19971—2026, 3.240.1] 3.13 product The tangible result of a process. NOTE: For cleaning standards, product refers to items that can be contacted, encompassing raw materials, semi-finished goods, components, and medical devices.