GB/T 16886.11-1997
Replaced
T/ZZB 0397-2018
Active
Group standards
T/ZZB 0397-2018 Infant Incubator
T/ZZB 0397-2018 Infant Incubator
Price:
$ 20.00
Basic Information
Standard Code:
T/ZZB 0397-2018
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical electronic instruments and equipment
ICS Name:
Integrated medical equipment
Publish Date:
2018-07-20
Implement Date:
2018-08-31
Scope
Main technical content: This standard specifies the terms and definitions, product classification, basic requirements, technical requirements, test methods, inspection rules, marking, instruction manuals, packaging, transportation and storage, and quality commitments for infant incubators (hereinafter referred to as "incubators"). This standard applies to infant incubators defined in GB 11243-2008, 2.1.101. This standard does not apply to transfer incubators used for transporting infants.
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