BS EN IEC 80601-2-58:2024
Medical electrical equipment Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
| Standard number: | BS EN IEC 80601-2-58:2024 |
| Pages: | 46 |
| Released: | 2024-10-25 |
| ISBN: | 978 0 539 17212 6 |
| Status: | Standard |
BS EN IEC 80601-2-58:2024 - Medical Electrical Equipment Standard
Introducing the BS EN IEC 80601-2-58:2024, a comprehensive standard that sets the benchmark for the basic safety and essential performance of lens removal devices and vitrectomy devices used in ophthalmic surgery. This standard is an essential resource for manufacturers, healthcare professionals, and regulatory bodies involved in the design, production, and use of medical electrical equipment in the field of ophthalmology.
Overview
The BS EN IEC 80601-2-58:2024 standard is meticulously crafted to ensure that lens removal and vitrectomy devices meet the highest safety and performance criteria. Released on September 26, 2024, this standard is the latest in a series of updates that reflect the evolving technological advancements and regulatory requirements in medical electrical equipment.
Key Features
- Standard Number: BS EN IEC 80601-2-58:2024
- Pages: 46
- ISBN: 978 0 539 17212 6
- Status: Standard
Why Choose This Standard?
The BS EN IEC 80601-2-58:2024 standard is indispensable for ensuring that ophthalmic surgical devices are safe and effective. It provides detailed guidelines on the design and testing of these devices, ensuring they meet rigorous safety and performance standards. By adhering to this standard, manufacturers can demonstrate their commitment to quality and safety, thereby gaining the trust of healthcare providers and patients alike.
Ensuring Patient Safety
Patient safety is paramount in any medical procedure, and ophthalmic surgery is no exception. This standard outlines the essential safety requirements that lens removal and vitrectomy devices must meet to minimize risks during surgery. By following these guidelines, manufacturers can help ensure that their devices do not pose unnecessary risks to patients.
Enhancing Device Performance
In addition to safety, the BS EN IEC 80601-2-58:2024 standard emphasizes the importance of device performance. It provides a framework for evaluating the essential performance characteristics of ophthalmic surgical devices, ensuring they function as intended and deliver optimal results. This focus on performance helps healthcare professionals achieve better surgical outcomes and enhances patient satisfaction.
Who Should Use This Standard?
This standard is a valuable resource for a wide range of stakeholders in the medical device industry, including:
- Manufacturers: Ensure your products meet the latest safety and performance standards.
- Regulatory Bodies: Use this standard as a benchmark for evaluating the compliance of ophthalmic surgical devices.
- Healthcare Professionals: Gain confidence in the safety and efficacy of the devices you use in surgery.
Conclusion
The BS EN IEC 80601-2-58:2024 standard is an essential tool for anyone involved in the design, production, or use of lens removal and vitrectomy devices for ophthalmic surgery. By adhering to this standard, you can ensure that your devices meet the highest safety and performance criteria, ultimately leading to better patient outcomes and increased trust in your products.
Stay ahead in the field of ophthalmic surgery by integrating the BS EN IEC 80601-2-58:2024 standard into your processes. With its comprehensive guidelines and focus on safety and performance, this standard is your key to success in the ever-evolving world of medical electrical equipment.
BS EN IEC 80601-2-58:2024
This standard BS EN IEC 80601-2-58:2024 Medical electrical equipment is classified in these ICS categories:
- 11.040.70 Ophthalmic equipment
IEC 80601-2-58:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery (as defined in 201.3.209 and 201.3.217) and associated ACCESSORIES that can be connected to this MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 7.2.13 of IEC 60601-1:2005 and IEC 60601 1:2005/AMD2:2020 and 8.4.1 of IEC 60601-1:2005. IEC 80601-2-58:2024 cancels and replaces the second edition published in 2014 and its Amendment 1:2016. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) the alignment of this particular standard based on the amendment of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020; b) updating collateral, particular and IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 references to align with amendments to IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and other collateral standards; c) updated normative references; d) added new requirement for particulate matter from APPLIED PARTS in 201.9.5.101; e) adding the shadow light method in 201.12.1.101.7; f) clarify test conditions for EMC requirements in 202.7.1.2; g) updated Table D.4 references to include specific IEC references to the symbols and delete “Annex AA, 201.7.6.101”; h) include a new annex to address the relevant general safety and performance requirements of European regulation (EU) 2017/745 (Annex BB); i) remove all references of the LIQUEFACTION FRAGMENTATION LENS REMOVAL method.