BS EN ISO 595-2:1995

Overview

BS EN ISO 595-2:1995 specifies the design, performance requirements, and testing methods for reusable all-glass or metal-and-glass syringes intended for medical use. This standard is crucial for manufacturers, healthcare providers, and compliance professionals who seek to ensure that syringes meet stringent safety and performance criteria.

Key Requirements

• Design Specifications: The standard outlines specific design criteria that syringes must meet to ensure functionality and safety. This includes dimensions, materials, and construction methods.
• Performance Requirements: Syringes must demonstrate reliable performance under various conditions. This includes accuracy in dosage delivery, resistance to chemical interactions, and durability during repeated use.
• Testing Protocols: Comprehensive testing is mandated to verify compliance with the performance requirements. This includes tests for leakage, dimensional accuracy, and resistance to sterilisation processes.

Implementation Benefits

Adhering to BS EN ISO 595-2:1995 provides several benefits for manufacturers and healthcare facilities:

• Enhanced Safety: By following the design and performance criteria, manufacturers can produce syringes that are safer for patients and healthcare providers.
• Improved Quality Control: The standard's testing protocols help ensure that syringes consistently meet quality benchmarks, reducing the risk of product recalls and liability issues.
• Market Acceptance: Compliance with this standard can enhance a product's reputation in the marketplace, facilitating easier acceptance by healthcare institutions and regulatory bodies.

Compliance Value

Compliance with BS EN ISO 595-2:1995 is not merely a regulatory requirement; it is a commitment to quality and safety in healthcare technology. By adhering to this standard, organisations can:

• Meet Regulatory Requirements: Many regulatory bodies require compliance with international standards for medical devices. This standard helps organisations align with those requirements.
• Reduce Risk: Implementing the guidelines of this standard mitigates risks associated with syringe failure, which can lead to serious health consequences.
• Facilitate International Trade: Compliance with ISO standards can ease entry into international markets, as many countries recognise ISO certifications as a mark of quality.

In conclusion, BS EN ISO 595-2:1995 is an essential standard for the design and testing of reusable syringes in the healthcare sector. Its comprehensive guidelines ensure that syringes are safe, effective, and reliable, thereby enhancing patient care and safety.