GB/T 16886.11-1997
Replaced
DB14/T 2254-2020
Active
Shanxi ProvinceLocal standards
DB14/T 2254-2020 The standard for the refrigerated and frozen management of clinical in vitro diagnostic reagents in medical institutions
DB14/T 2254-2020 The standard for the refrigerated and frozen management of clinical in vitro diagnostic reagents in medical institutions
Basic Information
Standard Code:
DB14/T 2254-2020
Standard Type:
Local standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Integrated medical equipment
Publish Date:
2020-12-25
Implement Date:
2021-02-25
Pages:
9 pages
Scope
This document stipulates the terms and definitions, basic principles, management systems, configuration requirements, operational management, and evaluation and improvement for the refrigeration and freezing management of clinical in vitro diagnostic reagents in medical institutions. This document is applicable to all medical institutions that control in vitro diagnostic reagents with temperature control requirements according to medical device management, but it is not applicable to in vitro diagnostic reagents such as blood screening and radioisotope labeling that are managed according to drug management regulations.
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