GB/T 16886.11-1997
Replaced
T/CAMDI 134.4-2024
Active
Group standards
T/CAMDI 134.4-2024 Guidelines for Aging Tests of High-molecular-weight Materials and Packaging Materials for Medical Devices - Part 4: Methods for Selecting Accelerated Aging Temperatures
T/CAMDI 134.4-2024 Guidelines for Aging Tests of High-molecular-weight Materials and Packaging Materials for Medical Devices - Part 4: Methods for Selecting Accelerated Aging Temperatures
Price:
$ 20.00
Basic Information
Standard Code:
T/CAMDI 134.4-2024
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
-
ICS Name:
Integrated medical equipment
Publish Date:
2024-12-31
Implement Date:
2025-01-03
Scope
Main technical content: This document provides guidelines for selecting the temperature for accelerated aging of polymer materials and packaging materials used in medical devices. This document is applicable to polymer materials and packaging materials used in medical devices. Note: Medical devices made of polymer materials can refer to this document
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