GB/T 13339-1991
Abolished
T/ZJPA 002-2023
Active
Group standards
T/ZJPA 002-2023 Injection packaging tightness check: Microbial challenge: In-immersion exposure test requirements
T/ZJPA 002-2023 Injection packaging tightness check: Microbial challenge: In-immersion exposure test requirements
Price:
$ 20.00
Basic Information
Standard Code:
T/ZJPA 002-2023
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
-
ICS Name:
Quality management and quality assurance
Publish Date:
2024-01-23
Implement Date:
2024-02-01
Pages:
17 pages
Scope
Main technical content: 1. Scope 2. Normative reference documents 3. Terms and definitions 4. Quality management system 5. Methodological principles 6. Challenge containers 7. Challenge microorganisms, culture media, and selection of culture conditions 8. Sample preparation 9. Sampling principles 10. Preparation of challenge suspensions 11. Exposure test conditions 12. Overview of test procedures 13. Acceptable standards and result determination Appendix A (informative) – Method sensitivity verification test Appendix B (informative) – Sample testing and method sensitivity test flowchart example
Development Information
Related Standards
GB/T 13340-1991
Abolished
GB/T 13340-1991 Methods for determination and calculation of quality grading rate of products
GB/T 13341-1991
Abolished
GB/T 13341-1991 Methods for determination and accounting of quality failure rate
GB/T 19004.3-1994
Abolished
GB/T 19004.3-1994 Quality management and quality system elements—Part 3:Guidelines for processed materials
GB/T 19004.2-1994
Abolished
GB/T 19004.2-1994 Quality management and quality system element—Part 2:Guidelines for services
GB/T 19000.4-1995
Abolished