BS EN 13628-1:2002

Overview of BS EN 13628-1:2002

BS EN 13628-1:2002 is a crucial standard focused on the design and implementation of marking and packaging for sterile and non-sterile medical devices. This standard ensures compliance with essential safety requirements of the European Medical Device Directive while facilitating effective communication in packaging and distribution.

Key Features

• Standardization: Provides a framework for uniform packaging practices across Europe.
• Compliance: Ensures adherence to regulatory standards, enhancing legal conformity for manufacturers.
• Clarity: Establishes guidelines for clear and comprehensible labeling, improving product traceability.
• Safety: Focuses on minimizing the risk of contamination and damage to medical devices during transport.

Applications

BS EN 13628-1:2002 is applicable in various sectors, including:

• Manufacturers of medical equipment
• Healthcare providers distributing medical devices
• Regulatory bodies monitoring compliance with medical device regulations

Benefits of Compliance

Implementing BS EN 13628-1:2002 provides numerous advantages:

• Improved Quality Control: By following standardized packaging requirements, companies can enhance product integrity.
• Efficient Supply Chain Management: Proper labeling and packaging streamline logistics operations and reduce turnover times.
• Enhanced Market Access: Complying with this standard opens doors to major European markets and builds customer trust.

Conclusion

Investing in the BS EN 13628-1:2002 standard is instrumental for any organization involved in the medical device sector. For a price of £158.00, this standard equips stakeholders with the necessary guidelines to ensure quality, safety, and compliance in a competitive landscape.