BS EN IEC 80601-2-60:2020 - Medical Electrical Equipment Standard

In the ever-evolving world of dental technology, ensuring the safety and performance of medical electrical equipment is paramount. The BS EN IEC 80601-2-60:2020 standard is a comprehensive guide that sets out the particular requirements for the basic safety and essential performance of dental equipment. Released on April 6, 2020, this standard is an indispensable resource for manufacturers, healthcare professionals, and regulatory bodies involved in the dental industry.

Key Features of the Standard

• Standard Number: BS EN IEC 80601-2-60:2020
• Pages: 50
• Release Date: 2020-04-06
• ISBN: 978 0 580 93041 6
• Status: Standard

Why This Standard is Essential

The BS EN IEC 80601-2-60:2020 standard is crucial for ensuring that dental equipment meets the highest safety and performance criteria. It provides detailed guidelines that help manufacturers design and produce equipment that is not only effective but also safe for both patients and healthcare providers. By adhering to this standard, manufacturers can ensure that their products are compliant with international safety regulations, thereby enhancing their credibility and marketability.

Ensuring Patient Safety

Patient safety is the cornerstone of any medical practice, and dental care is no exception. This standard outlines the necessary safety measures that must be incorporated into the design and manufacturing of dental equipment. It addresses potential risks and provides solutions to mitigate them, ensuring that the equipment operates safely under all conditions.

Enhancing Equipment Performance

In addition to safety, the performance of dental equipment is a critical factor in delivering high-quality care. The BS EN IEC 80601-2-60:2020 standard specifies the essential performance requirements that equipment must meet. This ensures that dental practitioners can rely on their tools to function optimally, leading to better patient outcomes and increased efficiency in dental procedures.

Comprehensive Coverage

With 50 pages of detailed information, this standard provides a thorough overview of the requirements for dental equipment. It covers a wide range of topics, including electrical safety, mechanical safety, and environmental considerations. This comprehensive approach ensures that all aspects of equipment safety and performance are addressed, leaving no stone unturned.

Global Relevance

As a part of the IEC 80601 series, this standard is recognized internationally, making it relevant for dental equipment manufacturers and healthcare providers around the world. By complying with this standard, companies can ensure that their products are accepted in global markets, facilitating international trade and collaboration.

Who Should Use This Standard?

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

• Manufacturers: To ensure their products meet international safety and performance standards.
• Healthcare Providers: To select equipment that is safe and reliable for patient care.
• Regulatory Bodies: To establish guidelines and regulations for dental equipment safety and performance.
• Quality Assurance Professionals: To implement and maintain compliance with safety standards.

Conclusion

The BS EN IEC 80601-2-60:2020 standard is an essential tool for anyone involved in the design, manufacture, or use of dental equipment. By providing clear and comprehensive guidelines for safety and performance, it helps ensure that dental equipment is both effective and safe. Whether you are a manufacturer looking to enhance your product's marketability, a healthcare provider seeking reliable equipment, or a regulatory body setting industry standards, this document is an invaluable resource.

Invest in the safety and performance of your dental equipment by adhering to the BS EN IEC 80601-2-60:2020 standard. With its global recognition and comprehensive coverage, it is the benchmark for excellence in the dental industry.

BS EN IEC 80601-2-60:2020

This standard BS EN IEC 80601-2-60:2020 Medical electrical equipment is classified in these ICS categories:

• 11.040.01 Medical equipment in general

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

201.1.1 Scope

Replacement:

This part of IEC 80601 applies to the basic safety and essential performance of dental units, dental patient chairs, dental handpieces and dental operating lights, hereafter referred to as dental 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 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 basic safety and essential performance requirements for dental equipment (as defined in 201.3.202.)

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 60601‑1‑3 and IEC 60601‑1‑10 do not apply. All other published collateral standards in the IEC 60601‑1 series apply as published.

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 60601‑1:2005 and IEC 60601‑1:2005/AMD1:2012 are 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 document addresses the content of Clause 1 of the general standard) or applicable collateral standard with the prefix “20x” where x 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 3.147, additional definitions in this document 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 document" 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.