BS EN ISO 7864:2016

Comprehensive Standard for Sterile Hypodermic Needles

BS EN ISO 7864:2016 is the essential standard for healthcare professionals and organizations working with sterile hypodermic needles. This British Standard, identical to ISO 7864:2016, provides detailed technical specifications and requirements to ensure the safety, quality, and compliance of these critical medical devices.

Ensuring Patient and User Safety

At the core of this standard is a commitment to safeguarding the wellbeing of patients and healthcare workers. BS EN ISO 7864:2016 specifies design, manufacturing, and performance criteria that minimize the risks associated with hypodermic needle use, including:

• Strict sterility requirements to prevent infection
• Robust construction to prevent needle breakage or bending
• Smooth, sharp tips to ensure comfortable and painless injection
• Precise dimensional tolerances for consistent, reliable performance

Comprehensive Technical Specifications

This standard provides exhaustive technical details to ensure the quality and consistency of sterile hypodermic needles, covering:

• Materials: Stainless steel, silicone, and other biocompatible materials that meet stringent purity and safety requirements
• Dimensions: Precise measurements for needle length, diameter, bevel, and other critical features
• Packaging: Sterile, tamper-evident packaging to maintain cleanliness and integrity
• Performance: Rigorous testing for strength, sharpness, and other functional characteristics

Ensuring Compliance and Regulatory Alignment

Compliance with BS EN ISO 7864:2016 is essential for healthcare providers, manufacturers, and distributors to meet strict regulatory requirements and industry best practices. Key benefits include:

• Alignment with the latest ISO standards for sterile hypodermic needles
• Demonstration of due diligence in product safety and quality
• Reduced risk of non-compliance penalties or product recalls
• Confidence that products meet the highest international standards

Comprehensive Guidance for Healthcare Professionals

Whether you're a manufacturer, distributor, or healthcare provider, BS EN ISO 7864:2016 is an essential resource for ensuring the safety and quality of sterile hypodermic needles. With its detailed technical specifications, rigorous testing requirements, and alignment with international standards, this British Standard is a critical tool for maintaining compliance and delivering the highest level of patient care.