GB/T 16886.11-1997
Replaced
T/GDMDMA 0036-2024
Active
Group standards
T/GDMDMA 0036-2024 Clinical medical device rental service specifications
T/GDMDMA 0036-2024 Clinical medical device rental service specifications
Price:
$ 20.00
Basic Information
Standard Code:
T/GDMDMA 0036-2024
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
-
ICS Name:
Integrated medical equipment
Publish Date:
2024-11-26
Implement Date:
2024-12-01
Scope
Scope: This document specifies the terms and definitions, basic principles, requirements for lessors, information disclosure to lessees, service processes, and service evaluations for clinical medical device leasing services. This document applies to clinical medical device leasing services. This document does not apply to single-use medical device products and medical devices used inside the human body (implantable devices). Main technical content: It mainly stipulates the general principles of clinical medical device leasing services, requirements for lessors, information disclosure to lessees, service processes, and service evaluations.
Development Information
Related Standards
GB/T 16886.3-1997
Replaced
GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.6-1997
Replaced
GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation
GB/T 16886.1-2001
Replaced
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.13-2001
Replaced
GB/T 16886.13-2001 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices
GB/T 16886.7-2001
Replaced