BS EN ISO 10555-4:2023
Intravascular catheters. Sterile and single-use catheters Balloon dilatation catheters
| Standard number: | BS EN ISO 10555-4:2023 |
| Pages: | 26 |
| Released: | 2023-12-04 |
| ISBN: | 978 0 539 20328 8 |
| Status: | Standard |
BS EN ISO 10555-4:2023 Intravascular Catheters - Sterile and Single-Use Balloon Dilatation Catheters
Introducing the latest standard in medical technology, the BS EN ISO 10555-4:2023. This comprehensive document sets the benchmark for intravascular catheters, specifically focusing on sterile and single-use balloon dilatation catheters. Released on December 4, 2023, this standard is an essential resource for healthcare professionals, medical device manufacturers, and regulatory bodies.
Key Features and Benefits
The BS EN ISO 10555-4:2023 standard is meticulously designed to ensure the highest quality and safety of balloon dilatation catheters. Here are some of the key features and benefits:
- Comprehensive Guidelines: This 26-page document provides detailed guidelines on the design, performance, and safety requirements for balloon dilatation catheters.
- Up-to-Date Information: Released in December 2023, this standard incorporates the latest advancements and best practices in the field of intravascular catheters.
- Global Recognition: As an ISO standard, it is recognized and respected worldwide, ensuring that your products meet international quality and safety standards.
- Enhanced Patient Safety: By adhering to this standard, manufacturers can ensure that their catheters are safe and effective, thereby enhancing patient safety and outcomes.
- Regulatory Compliance: Compliance with this standard can help manufacturers meet regulatory requirements in various regions, facilitating market access and reducing the risk of non-compliance penalties.
Detailed Specifications
Here are the detailed specifications of the BS EN ISO 10555-4:2023 standard:
| Standard Number | BS EN ISO 10555-4:2023 |
|---|---|
| Pages | 26 |
| Released | 2023-12-04 |
| ISBN | 978 0 539 20328 8 |
| Name | Intravascular catheters. Sterile and single-use catheters Balloon dilatation catheters |
| Status | Standard |
Why Choose BS EN ISO 10555-4:2023?
Choosing the BS EN ISO 10555-4:2023 standard offers numerous advantages:
1. Quality Assurance
Adhering to this standard ensures that your balloon dilatation catheters are manufactured to the highest quality standards. This not only enhances the performance and reliability of your products but also builds trust with healthcare providers and patients.
2. Safety and Efficacy
Patient safety is paramount in the medical field. This standard provides stringent guidelines to ensure that balloon dilatation catheters are safe and effective, minimizing the risk of complications during medical procedures.
3. International Acceptance
As an ISO standard, BS EN ISO 10555-4:2023 is recognized globally. This facilitates international trade and ensures that your products are accepted in various markets, expanding your business opportunities.
4. Regulatory Compliance
Compliance with this standard helps manufacturers meet regulatory requirements in different regions. This not only speeds up the approval process but also reduces the risk of non-compliance penalties, saving time and resources.
5. Competitive Advantage
In a competitive market, adhering to recognized standards can give your products a significant edge. It demonstrates your commitment to quality and safety, making your products more attractive to healthcare providers and patients.
Who Should Use This Standard?
The BS EN ISO 10555-4:2023 standard is an invaluable resource for a wide range of stakeholders in the medical field, including:
- Medical Device Manufacturers: Ensure that your balloon dilatation catheters meet the highest quality and safety standards.
- Healthcare Providers: Gain confidence in the safety and efficacy of the catheters you use in medical procedures.
- Regulatory Bodies: Use this standard as a benchmark for evaluating the compliance of balloon dilatation catheters.
- Quality Assurance Professionals: Implement best practices and ensure that your products meet international standards.
Conclusion
The BS EN ISO 10555-4:2023 standard is a critical resource for anyone involved in the design, manufacture, or use of balloon dilatation catheters. By adhering to this standard, you can ensure that your products meet the highest quality and safety standards, enhancing patient outcomes and building trust in your brand.
Don't miss out on this essential resource. Ensure that your balloon dilatation catheters are compliant with the latest international standards by adopting the BS EN ISO 10555-4:2023 standard today.
ISBN: 978 0 539 20328 8
Released: December 4, 2023
Pages: 26
BS EN ISO 10555-4:2023
This standard BS EN ISO 10555-4:2023 Intravascular catheters. Sterile and single-use catheters is classified in these ICS categories:
- 11.040.25 Syringes, needles and catheters