GB 18278-2000
Replaced
T/FDSA 0128-2026
Active
Group standards
T/FDSA 0128-2026 The evaluation of sterile inspection (testing) personnel's ability for medical devices
T/FDSA 0128-2026 The evaluation of sterile inspection (testing) personnel's ability for medical devices
Price:
$ 20.00
Basic Information
Standard Code:
T/FDSA 0128-2026
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Broadcasting and television transmission and reception equipment
ICS Name:
Integrated disinfection and sterilization
Publish Date:
2026-03-13
Implement Date:
2026-04-13
Scope
This document sets out the evaluation objects, evaluation subjects, evaluation indicators, evaluation processes, and basic requirements for the management of work positions for sterility testers of medical devices. It stipulates the basic process of sterility testing, the use of testing equipment, requirements for testing order, data statistics, report compilation requirements, environmental testing requirements, and describes the corresponding testing methods. This document is applicable to evaluating the basic competencies of sterility testers of medical devices.
Development Information
Related Standards
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