BS EN ISO 9342-2:2005

Overview

BS EN ISO 9342-2:2005 specifies the requirements for test lenses used in the calibration of focimeters, which are essential instruments for measuring the optical properties of contact lenses. This standard is part of a series that addresses the measurement of optical instruments, ensuring accuracy and reliability in health care technology.

Key Requirements

The standard outlines specific criteria for the design, manufacture, and use of test lenses. Key requirements include:

• Optical Quality: Test lenses must meet stringent optical quality standards to ensure accurate calibration of focimeters.
• Dimensional Specifications: Lenses must adhere to defined dimensions and tolerances to ensure compatibility with various focimeter models.
• Material Properties: The materials used in the production of test lenses must be durable and stable under normal operating conditions.
• Documentation: Comprehensive documentation must accompany each test lens, detailing its specifications and calibration data.

Implementation Benefits

Implementing BS EN ISO 9342-2:2005 provides several benefits for manufacturers and healthcare providers:

• Enhanced Accuracy: By using test lenses that comply with this standard, focimeters can provide more accurate measurements of contact lenses, leading to better patient outcomes.
• Standardisation: Compliance with this standard promotes uniformity in testing procedures across different facilities, enhancing the reliability of optical measurements.
• Quality Assurance: Regular calibration using these test lenses ensures that focimeters maintain their performance over time, reducing the risk of errors in patient assessments.

Compliance Value

Adhering to BS EN ISO 9342-2:2005 is crucial for compliance professionals in the healthcare sector. The standard supports regulatory compliance by:

• Meeting Regulatory Requirements: Compliance with this standard helps organisations meet national and international regulations regarding medical devices and optical instruments.
• Reducing Liability: By ensuring that focimeters are calibrated accurately, healthcare providers can mitigate risks associated with incorrect prescriptions or assessments.
• Facilitating Audits: Compliance with established standards simplifies the audit process, providing clear evidence of adherence to quality and safety protocols.

In summary, BS EN ISO 9342-2:2005 is a vital standard for ensuring the accuracy and reliability of focimeters used in the measurement of contact lenses. Its implementation not only enhances patient care but also supports compliance with regulatory requirements in the healthcare technology sector.