GB/T 16886.11-1997
Replaced
T/CSBME 022-2020
Active
Group standards
T/CSBME 022-2020 Plasma Freezer
T/CSBME 022-2020 Plasma Freezer
Price:
$ 20.00
Basic Information
Standard Code:
T/CSBME 022-2020
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medicine, health, and labor protection
ICS Name:
Integrated medical equipment
Publish Date:
2020-12-13
Implement Date:
2021-03-01
Scope
Scope: This document specifies the terms and definitions, requirements, test methods, marking, random documents, packaging, transportation, and storage of plasma quick-freezers. This document applies to plasma quick-freezers defined in 3.1 (hereinafter referred to as quick-freezers). This document does not apply to equipment that uses cold air circulation and heat convection to freeze plasma. Main technical content: This document specifies the terms and definitions of plasma quick-freezers, operating conditions, refrigeration performance, sliding performance, cold plate compression function, temperature control alerts, safety requirements, environmental test requirements and test methods, marking, random documents, packaging, transportation, and storage.
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