GB/T 47144-2026
Pending
National standards
GB/T 47144-2026 Requirements for development,validation and routine control of cleaning process for medical devices
GB/T 47144-2026 Requirements for development,validation and routine control of cleaning process for medical devices
Price:
$ 50.00
Basic Information
Standard Code:
GB/T 47144-2026
Standard Type:
National standards
Standard Status:
Pending
is_force_gb:
no
CCS Name:
Public medical equipment
ICS Name:
Integrated disinfection and sterilization
Publish Date:
2026-01-28
Implement Date:
2027-08-01
Pages:
24 pages
Scope
This document specifies the requirements for the development, validation, and routine control of the cleaning process for medical devices.
This document applies to the cleaning process during the production and use of medical devices, and medical institutions and other medical products requiring cleaning may refer to it for implementation.
This document does not apply to:
— Disposable medical devices supplied in a ready-to-use state for patient use;
— Textiles used in patient sterile drape systems or surgical gowns; or
— Devices that may come into contact with prions, such as devices that may be contaminated with the transmissible spongiform encephalopathy (TSE) virus.
Development Information
Referenced Standards
GB/T 16886.17-2005 Biological evaluation of medical devices—Part 17:Establishment of allowable limits for leachable substances
GB/T 16886.17-2025 Biological evaluation of medical devices—Part 17:Toxicological risk assessment of medical device constituents
GB/T 19022-2003 Measurement management systems—Requirements for measurement processes and measuring equipment
GB/T 19022.2-2000 Quality assurance for measuring equipment—Part 2:Guidelines for control of measurement processes
GB/T 42061-2022 Medical devices—Quality management systems—Requirements for regulatory purposes
GB 42125.11-2025 Safety requirements for electrical equipment for measurement,control and laboratory use—Part 11:Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
Related Standards
GB 18278-2000
Replaced
GB 18281.1-2000
Replaced
GB 18281.1-2000 Sterilization of health care products—Biological indicators—Part 1:General
GB 18281.2-2000
Replaced
GB 18281.2-2000 Sterilization of health care products—Biological indicators—Part 2:Biological indicators for ethylene oxide sterilization
GB 18281.3-2000
Replaced
GB 18281.3-2000 Sterilization of health care products—Biological indicators—Part 3:Biological indicators for moist heat sterilization
GB 18282.1-2000
Replaced
GB 18282.1-2000 Sterilization of health care products—Chemical indicators—Part 1:General requirements
YY/T 0567.2-2005
Replaced