BS EN 80601-2-58:2015+A1:2019

Medical Electrical Equipment: Essential Safety and Performance for Ophthalmic Surgery Devices

In the ever-evolving field of ophthalmic surgery, ensuring the safety and performance of medical electrical equipment is paramount. The BS EN 80601-2-58:2015+A1:2019 standard is a comprehensive guideline that addresses the particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices used in ophthalmic surgery. This standard is an indispensable resource for manufacturers, healthcare professionals, and regulatory bodies involved in the design, production, and use of these critical medical devices.

Key Features of the Standard

• Standard Number: BS EN 80601-2-58:2015+A1:2019
• Pages: 40
• Released: September 2, 2019
• ISBN: 978 0 580 90617 6
• Status: Standard

Comprehensive Coverage

This standard provides detailed requirements that ensure the safety and performance of lens removal and vitrectomy devices. It covers a wide range of aspects, including electrical safety, mechanical safety, and performance criteria, ensuring that these devices meet the highest standards of quality and reliability.

Why This Standard is Essential

Ophthalmic surgery is a delicate and precise field that requires the utmost care and precision. Devices used in these procedures must adhere to stringent safety and performance standards to prevent any risk to patients. The BS EN 80601-2-58:2015+A1:2019 standard provides a framework that helps manufacturers design devices that are not only effective but also safe for use in surgical environments.

Ensuring Patient Safety

Patient safety is the top priority in any medical procedure. This standard outlines the necessary precautions and performance benchmarks that devices must meet to ensure they do not pose any harm to patients. By adhering to these guidelines, manufacturers can produce equipment that minimizes risks and enhances the overall safety of ophthalmic surgeries.

Enhancing Device Performance

In addition to safety, the performance of medical devices is crucial for successful surgical outcomes. The standard specifies performance requirements that ensure devices operate effectively and efficiently. This includes criteria for precision, reliability, and durability, which are essential for the demanding environment of ophthalmic surgery.

Regulatory Compliance

Compliance with international standards is often a prerequisite for market entry and acceptance. The BS EN 80601-2-58:2015+A1:2019 standard is recognized globally, making it a critical component for manufacturers aiming to distribute their products internationally. Adhering to this standard not only facilitates regulatory approval but also enhances the credibility and reputation of the manufacturer.

Who Should Use This Standard?

This standard is designed for a wide range of stakeholders in the medical device industry, including:

• Manufacturers: To ensure their products meet safety and performance requirements.
• Healthcare Professionals: To understand the standards that devices must meet for safe use.
• Regulatory Bodies: To assess compliance and approve devices for market entry.

Conclusion

The BS EN 80601-2-58:2015+A1:2019 standard is an essential document for anyone involved in the development, regulation, or use of lens removal and vitrectomy devices in ophthalmic surgery. By providing a comprehensive set of guidelines for safety and performance, this standard plays a crucial role in advancing the quality and reliability of medical devices, ultimately contributing to better patient outcomes and enhanced surgical practices.

BS EN 80601-2-58:2015+A1:2019

This standard BS EN 80601-2-58:2015+A1:2019 Medical electrical equipment is classified in these ICS categories:

• 11.040.70 Ophthalmic equipment

Clause 1 of the general standard¹ applies, except as follows:

201.1.1 * Scope

Replacement:

This International Standard applies to the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery (as defined in 201.3.208 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 standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.

NOTE See also 4.2 of the general standard.

201.1.2 Object

Replacement:

The object of this particular standard is to establish particular basic safety and essential performance requirements for lens removal devices and vitrectomy devices for ophthalmic surgery (as defined in 201.3.208 and 201.3.217) and associated accessories that can be connected to the me equipment and are to be tested together or individually.

201.1.3

* Collateral standards

Addition:

This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 201.2 of this particular standard.

IEC 60601‑1‑2 applies as modified in Clause 202. IEC 60601‑1‑3, IEC 60601‑1‑10, IEC 60601‑1‑11, and IEC 60601‑1‑12 do not apply.

201.1.4 Particular standards

Replacement:

In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the general standard and collateral standards as appropriate for the particular me equipment under consideration, and may add other basic safety and essential performance requirements.

A requirement of a particular standard takes priority over the general standard.

For brevity, IEC 60601‑1 is referred to in this particular standard as the “general standard”. Collateral standards are referred to by their document number.

The numbering of clauses and subclauses of this particular standard corresponds to that of the general standard with the prefix “201” (e.g. 201.1 in this standard addresses the content of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x” where × is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular standard addresses the content of Clause 4 of the IEC 60601‑1‑2 collateral standard, 203.4 in this particular standard addresses the content of Clause 4 of the IEC 60601‑1‑3 collateral standard, etc.). The changes to the text of the general standard are specified by the use of the following words:

”Replacement” means that the clause or subclause of the general standard or applicable collateral standard is replaced completely by the text of this particular standard.

“Addition” means that the text of this particular standard is additional to the requirements of the general standard or applicable collateral standard.

“Amendment” means that the clause or subclause of the general standard or applicable collateral standard is amended as indicated by the text of this particular standard.

Subclauses, figures or tables which are additional to those of the general standard are numbered starting from 201.101. However, due to the fact that definitions in the general standard are numbered 3.1 through 3.139, additional definitions in this standard are numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.

Subclauses, figures or tables which are additional to those of a collateral standard are numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601‑1‑2, 203 for IEC 60601‑1‑3, etc.

The term “this standard” is used to make reference to the general standard, any applicable collateral standards and this particular standard taken together.

Where there is no corresponding clause or subclause in this particular standard, the clause or subclause of the general standard or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of the general standard or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard.