EN ISO 18465 Norovirus Detection in Frozen Shellfish Laboratory Testing Service: A Comprehensive Guide
EN ISO 18465 is a international standard that provides guidelines for the detection of noroviruses in frozen shellfish. This standard is developed by the International Organization for Standardization (ISO) and is published as a European Standard (EN). The standard is applicable to laboratories that conduct testing on frozen shellfish samples for the presence of noroviruses.
1.1 Legal and Regulatory Framework
The legal and regulatory framework surrounding EN ISO 18465 Norovirus Detection in Frozen Shellfish testing is primarily governed by international standards, national regulations, and industry-specific guidelines. Some key regulations include:
1.2 Standard Development Organizations
Standard development organizations play a crucial role in the development and maintenance of international standards like EN ISO 18465. Some key organizations include:
1.3 Standard Evolution and Updates
Standards evolve over time to reflect changes in technology, regulations, or industry practices. The EN ISO 18465 standard has undergone several updates since its initial publication. These updates ensure that the standard remains relevant and effective in guiding laboratory testing.
1.4 Standard Numbers and Scope
The current version of the EN ISO 18465 standard is 2020. This standard provides guidelines for the detection of noroviruses in frozen shellfish using molecular biology techniques, such as polymerase chain reaction (PCR).
1.5 Compliance Requirements
Compliance with EN ISO 18465 is mandatory for laboratories that conduct testing on frozen shellfish samples. Laboratories must demonstrate their competence to perform this test by meeting specific requirements, including:
EN ISO 18465 Norovirus Detection in Frozen Shellfish testing is required for several reasons:
2.1 Business and Technical Reasons
Businesses that import or export frozen shellfish must demonstrate compliance with regulatory requirements. Laboratories that fail to perform EN ISO 18465 Norovirus Detection in Frozen Shellfish testing may face:
2.2 Consequences of Not Performing this Test
Failure to detect noroviruses in frozen shellfish can have serious consequences:
EN ISO 18465 Norovirus Detection in Frozen Shellfish testing is conducted using molecular biology techniques, such as PCR. The test involves the following steps:
3.1 Testing Equipment and Instruments
Laboratories must calibrate and validate equipment, such as PCR machines, thermocyclers, and DNA sequencers, to ensure accuracy and reliability.
3.2 Sample Preparation Procedures
Sample preparation procedures involve:
3.3 Testing Parameters and Conditions
The test involves:
Test results are reported in accordance with EN ISO 18465 guidelines:
5. Conclusion
EN ISO 18465 Norovirus Detection in Frozen Shellfish testing is a critical component of ensuring product safety and regulatory compliance. Laboratories that fail to perform this test may face serious consequences, including foodborne illness outbreaks or costly product recalls.
6. References
