GB/T 16886.11-1997
Replaced
WB/T 1115-2021
Active
Industry standards-Materials
WB/T 1115-2021 Specification for in vitro diagnostic reagent temperature control logistics service
WB/T 1115-2021 Specification for in vitro diagnostic reagent temperature control logistics service
Price:
$ 21.00
Basic Information
Standard Code:
WB/T 1115-2021
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Integrated medical equipment
Publish Date:
2021-05-31
Implement Date:
2021-07-01
Pages:
7 pages
Scope
This document specifies the basic requirements for temperature-controlled logistics services for in vitro diagnostic reagents, including personnel and training, facilities and equipment, logistics operations, temperature monitoring and control, traceability and application, and emergency response.
This document applies to temperature-controlled logistics services for in vitro diagnostic reagents that are subject to medical device management. This document does not apply to temperature-controlled logistics services for in vitro diagnostic reagents that are subject to drug management.
Development Information
Referenced Standards
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