GB/T 16886.11-1997
Replaced
T/ZHYL 011-2024
Active
Group standards
T/ZHYL 011-2024 Technical requirements and test methods for surface coating of pipette tips used in in vitro diagnostic medical devices
T/ZHYL 011-2024 Technical requirements and test methods for surface coating of pipette tips used in in vitro diagnostic medical devices
Price:
$ 20.00
Basic Information
Standard Code:
T/ZHYL 011-2024
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
-
ICS Name:
Integrated medical equipment
Publish Date:
2024-12-04
Implement Date:
2025-06-05
Scope
Scope: This document specifies the technical requirements, test methods, inspection rules, transportation, and storage for the surface coatings of pipette needles used in in vitro diagnostic medical devices. This document applies to the design, production, testing, and acceptance of surface coatings for pipette needles used in in vitro diagnostic medical devices (with requirements for medium transfer and dispensing volumes ≥ 1 μL). Main technical contents: -
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