GB/T 16886.11-1997
Replaced
T/NSSQ 049-2022
Active
Group standards
T/NSSQ 049-2022 The development, validation, and routine control requirements for cleaning processes for medical devices
T/NSSQ 049-2022 The development, validation, and routine control requirements for cleaning processes for medical devices
Price:
$ 20.00
Basic Information
Standard Code:
T/NSSQ 049-2022
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
-
ICS Name:
Integrated medical equipment
Publish Date:
2022-12-30
Implement Date:
2022-12-31
Scope
Scope: This document applies to the development, validation, and routine control of the cleaning process for medical devices during production and before their reuse in healthcare institutions. This document includes, but is not limited to, the following cleaning processes: a) Manual cleaning; b) Mechanical cleaning, including spray cleaning, pulsed vacuum cleaning, ultrasonic cleaning, etc. This document does not specify a quality management system for controlling all stages of medical device production. This document does not specify occupational safety requirements related to the design and operation of cleaning facilities. Main technical content: This document specifies the requirements for the development, validation, and routine control of the cleaning process for medical devices.
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