GB 9706.5-1992
Replaced
T/SXS 128-2023
Active
Group standards
T/SXS 128-2023 The requirements for the safety management of medical devices
T/SXS 128-2023 The requirements for the safety management of medical devices
Price:
$ 20.00
Basic Information
Standard Code:
T/SXS 128-2023
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
-
ICS Name:
Hospital equipment
Publish Date:
2023-11-30
Implement Date:
2023-11-30
Scope
Main technical content: This document stipulates the management requirements of the Medical Device Safety Management Requirements Standard, including personnel requirements, environmental and facility control, process control, safety and performance testing, and supplier management. This document is applicable to the Medical Device Safety Management Requirements Standard.
Development Information
Related Standards
GB 9706.6-1992
Replaced
GB 9706.6-1992 Particular requirements for the safety of microwave therapy equipment
GB/T 14710-1993
Replaced
GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment
GB 9706.7-1994
Replaced
GB 9706.7-1994 Medical electrical equipment—Particular requirements for the safety of ultrasonic therapy equipment
GB 12130-1995
Replaced
GB 12130-1995 Medical hyperbaric oxygen chamber
GB 9706.1-1995
Replaced