GB/T 16886.11-1997
Replaced
T/CSBME 033-2021
Active
Group standards
T/CSBME 033-2021 Failure Mode Effects and Criticality Analysis (FMECA) method for medical electrical equipment
T/CSBME 033-2021 Failure Mode Effects and Criticality Analysis (FMECA) method for medical electrical equipment
Price:
$ 20.00
Basic Information
Standard Code:
T/CSBME 033-2021
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Integrated medical equipment
Publish Date:
2021-01-16
Implement Date:
2021-03-01
Scope
Scope: This document specifies the procedures and methods for systematically conducting failure mode, effects, and criticality analysis (FMECA) of medical electrical equipment (ME equipment) and medical electrical systems (ME systems). This document is applicable to the failure mode, effects, and criticality analysis process of all types of ME equipment and ME systems. Main technical content: This document specifies the procedures and methods for systematically conducting failure mode, effects, and criticality analysis (FMECA) of medical electrical equipment (ME equipment) and medical electrical systems (ME systems).
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