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Sterility and Microbial Limit Testing/
ISO 14644-7 Separative Devices (Clean Air Hoods, Gloveboxes, etc.)ISO 14644-7 Separative Devices (Clean Air Hoods, Gloveboxes, etc.) Laboratory Testing Service Provided by Eurolab
Standard-Related Information
ISO 14644-7 is a standard that defines the requirements for testing and certification of separative devices, also known as clean air hoods or gloveboxes. These devices are used in various industries to provide a controlled environment for processing sensitive materials, equipment, or products.
The standard is developed by the International Organization for Standardization (ISO) and is based on international best practices. The current version, ISO 14644-7:2018, was published in August 2018 and supersedes the previous version, ISO 14644-7:2004.
International Standards
National Standards
Standard Development Organizations
The International Organization for Standardization (ISO) is responsible for developing and publishing international standards. The American Society for Testing and Materials (ASTM) and the German Institute for Standardisation (DIN) are also involved in standard development.
Evolution of Standards
Standards evolve through a collaborative process between industry experts, regulatory bodies, and other stakeholders. New versions of standards are published to reflect changes in technology, best practices, or regulatory requirements.
Standard Numbers and Scope
Specifies the requirements for testing and certification of separative devices
Defines the classification system for air cleanliness
Describes the test methods for verifying the designated classification
Industry-Specific Requirements
These industries require strict control over environmental conditions, including cleanroom standards, to ensure product quality and safety.
Consequences of Not Performing This Test
Failure to perform this test can result in:
Test Conditions and Methodology
The testing process involves a series of steps, including:
1. Sample preparation
2. Testing equipment calibration
3. Test setup and execution
4. Data analysis and reporting
Test Reporting and Documentation
Test results are documented in a comprehensive report that includes:
The report is typically presented in a standard format, with specific sections and headings.
Why This Test Should Be Performed
This test provides numerous benefits, including:
Why Eurolab Should Provide This Service
Eurolab offers a comprehensive testing service for separative devices, including:
Conclusion
ISO 14644-7 Separative Devices (Clean Air Hoods, Gloveboxes, etc.) laboratory testing service provided by Eurolab is a comprehensive solution for industries requiring strict control over environmental conditions. By following this guide, companies can ensure compliance with industry standards and regulations, prevent product contamination or defects, and maintain a competitive advantage.
References
Appendix
Table 1: ISO 14644-7 Classification System
Class Airborne Particle Concentration
--- ---
1 <0.1 particles/m³
2 <100 particles/m³
3 <10,000 particles/m³
Additional Resources
For more information on Eurolabs testing services or to schedule a test, please contact us at:
Email: infoeurolab.com(mailto:infoeurolab.com)
Phone: 1 (800) 123-4567
Address: 123 Main St, Anytown, USA
We look forward to serving your testing needs!