BS EN ISO 18778:2022
Respiratory equipment. Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors
| Standard number: | BS EN ISO 18778:2022 |
| Pages: | 68 |
| Released: | 2022-11-01 |
| ISBN: | 978 0 539 12988 5 |
| Status: | Standard |
BS EN ISO 18778:2022 Respiratory Equipment - Essential Safety and Performance for Infant Cardiorespiratory Monitors
Ensure the highest level of safety and performance for infant cardiorespiratory monitors with the BS EN ISO 18778:2022 standard. This comprehensive document sets out the particular requirements for the basic safety and essential performance of these critical medical devices, providing a robust framework for manufacturers, healthcare providers, and regulatory bodies.
Key Features and Benefits
The BS EN ISO 18778:2022 standard is an indispensable resource for anyone involved in the design, production, and use of infant cardiorespiratory monitors. Here are some of the key features and benefits:
- Comprehensive Coverage: Spanning 68 pages, this standard provides detailed guidelines and requirements to ensure the safety and performance of infant cardiorespiratory monitors.
- Up-to-Date Information: Released on November 1, 2022, this standard reflects the latest advancements and best practices in the field of respiratory equipment.
- International Recognition: As an ISO standard, it is recognized and respected globally, ensuring that your products meet international safety and performance benchmarks.
- ISBN: 978 0 539 12988 5 - Easily reference and cite this standard in your documentation and compliance materials.
Why Choose BS EN ISO 18778:2022?
Infant cardiorespiratory monitors are vital in neonatal care, providing continuous monitoring of an infant's heart rate and respiratory rate. The BS EN ISO 18778:2022 standard ensures that these devices meet stringent safety and performance criteria, which is crucial for the following reasons:
- Patient Safety: The standard outlines essential safety requirements to protect the most vulnerable patients - infants. It addresses potential risks and provides guidelines to mitigate them.
- Device Reliability: By adhering to this standard, manufacturers can ensure that their devices perform reliably under various conditions, providing accurate and consistent monitoring.
- Regulatory Compliance: Compliance with this standard helps manufacturers meet regulatory requirements, facilitating market access and acceptance.
- Quality Assurance: The standard promotes high-quality manufacturing practices, ensuring that the devices are built to last and function as intended.
Detailed Content
The BS EN ISO 18778:2022 standard covers a wide range of topics essential for the safety and performance of infant cardiorespiratory monitors, including:
- General requirements for safety and performance
- Specific requirements for electrical safety
- Guidelines for mechanical safety
- Performance criteria for monitoring accuracy
- Environmental considerations and testing
- Instructions for use and labeling requirements
- Maintenance and servicing guidelines
Who Should Use This Standard?
The BS EN ISO 18778:2022 standard is designed for a wide range of stakeholders in the healthcare and medical device industries, including:
- Manufacturers: Ensure that your infant cardiorespiratory monitors meet the highest safety and performance standards.
- Healthcare Providers: Select and use devices that comply with international safety and performance criteria, ensuring the best care for your patients.
- Regulatory Bodies: Reference this standard when evaluating and approving infant cardiorespiratory monitors for market entry.
- Quality Assurance Professionals: Use this standard to develop and implement quality control processes that ensure compliance and reliability.
Conclusion
The BS EN ISO 18778:2022 standard is an essential tool for anyone involved in the design, production, and use of infant cardiorespiratory monitors. By adhering to this standard, you can ensure that your devices meet the highest safety and performance criteria, providing peace of mind for healthcare providers and the best possible care for infants.
Invest in the BS EN ISO 18778:2022 standard today and take a significant step towards ensuring the safety and reliability of your infant cardiorespiratory monitors.
Product Details
| Standard Number | BS EN ISO 18778:2022 |
|---|---|
| Pages | 68 |
| Released | 2022-11-01 |
| ISBN | 978 0 539 12988 5 |
| Name | Respiratory equipment. Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors |
| Status | Standard |
BS EN ISO 18778:2022
This standard BS EN ISO 18778:2022 Respiratory equipment. Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors is classified in these ICS categories:
- 11.040.10 Anaesthetic, respiratory and reanimation equipment
- 11.040.55 Diagnostic equipment