BS EN ISO 80601-2-56:2017+A1:2020
Medical electrical equipment Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
Standard number: | BS EN ISO 80601-2-56:2017+A1:2020 |
Pages: | 68 |
Released: | 2020-05-12 |
ISBN: | 978 0 580 52252 9 |
Status: | Standard |
BS EN ISO 80601-2-56:2017+A1:2020
Medical Electrical Equipment: Essential Safety and Performance Standards for Clinical Thermometers
In the ever-evolving world of medical technology, ensuring the safety and performance of medical devices is paramount. The BS EN ISO 80601-2-56:2017+A1:2020 standard is a critical document that outlines the specific requirements for the basic safety and essential performance of clinical thermometers used for body temperature measurement. This standard is indispensable for manufacturers, healthcare providers, and regulatory bodies who are committed to maintaining the highest standards of patient care and safety.
Key Features of the Standard
- Standard Number: BS EN ISO 80601-2-56:2017+A1:2020
- Pages: 68
- Release Date: 12th May 2020
- ISBN: 978 0 580 52252 9
- Status: Standard
Comprehensive Coverage
This standard provides a comprehensive framework for the design, testing, and performance evaluation of clinical thermometers. It ensures that these devices meet stringent safety and performance criteria, which are crucial for accurate and reliable body temperature measurement. The document covers various aspects, including:
- Electrical safety requirements
- Performance standards for accuracy and reliability
- Environmental considerations for device operation
- Guidelines for user interface and usability
Why This Standard Matters
Clinical thermometers are essential tools in medical diagnostics, providing critical data that can influence treatment decisions. The BS EN ISO 80601-2-56:2017+A1:2020 standard ensures that these devices are not only safe to use but also deliver precise measurements. This is particularly important in clinical settings where even minor inaccuracies can lead to significant consequences.
Global Relevance
As a part of the ISO 80601 series, this standard is recognized internationally, making it a vital reference for global manufacturers and healthcare institutions. Compliance with this standard facilitates international trade and ensures that products meet the expectations of diverse healthcare systems worldwide.
For Whom Is This Standard Intended?
This standard is designed for a wide range of stakeholders in the healthcare and medical device industries, including:
- Medical device manufacturers seeking to ensure their products meet international safety and performance standards
- Healthcare providers who rely on accurate and reliable thermometers for patient care
- Regulatory bodies responsible for the approval and oversight of medical devices
- Quality assurance professionals focused on maintaining high standards in medical equipment
Enhancing Patient Safety
By adhering to the BS EN ISO 80601-2-56:2017+A1:2020 standard, manufacturers can significantly enhance the safety and effectiveness of clinical thermometers. This not only protects patients but also builds trust in healthcare systems and medical technologies.
Conclusion
The BS EN ISO 80601-2-56:2017+A1:2020 standard is an essential document for anyone involved in the design, production, or use of clinical thermometers. Its comprehensive guidelines ensure that these critical devices meet the highest standards of safety and performance, ultimately contributing to better patient outcomes and advancing the field of medical technology.
For those committed to excellence in healthcare, this standard is an invaluable resource that supports the development and deployment of reliable, high-quality medical devices.
BS EN ISO 80601-2-56:2017+A1:2020
This standard BS EN ISO 80601-2-56:2017+A1:2020 Medical electrical equipment is classified in these ICS categories:
- 11.040.55 Diagnostic equipment
IEC 60601‑1:2005+A1:2012, Clause 1 applies, except as follows:
201.1.1 Scope
Replacement:
This document applies to the basic safety and essential performance of a clinical thermometer in combination with its accessories, hereafter referred to as me equipment. This document specifies the general and technical requirements for electrical clinical thermometers. This document applies to all electrical clinical thermometers that are used for measuring the body temperature of patients.
Clinical thermometers can be equipped with interfaces to accommodate secondary indicators, printing equipment, and other auxiliary equipment to create me systems. This document does not apply to auxiliary equipment.
Me equipment that measures and displays a body temperature is inside the scope of this document.
EXAMPLE 1 Me equipment using accessories such as a pulmonary artery catheter for the determination of cardiac output by thermodilution is in the scope of this document if it displays a body temperature.
EXAMPLE 2 Me equipment using accessories such as a Foley catheter that includes a temperature probe is in the scope of this document.
This document does not specify the requirements for screening thermographs intended to be used for the individual non-invasive human febrile temperature screening of groups of individual humans under indoor environmental conditions, which are given in IEC 80601‑2‑59[4].
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 IEC 60601‑1:2005+A1:2012, 7.2.13 and 8.4.1.
NOTE Additional information can be found in IEC 60601‑1:2005+A1:2012, 4.2.
201.1.2 Object
Replacement:
The object of this particular document is to establish particular basic safety and essential performance requirements for a clinical thermometer, as defined in 201.3.206, and its accessories.
NOTE Accessories are included because the combination of the clinical thermometer and the accessories needs to be safe and effective. Accessories can have a significant impact on the basic safety and essential performance of a clinical thermometer.
201.1.3 Collateral standards
Addition:
This document refers to those applicable collateral standards that are listed in IEC 60601‑1:2005+A1:2012, Clause 2, as well as 201.2 of this document.
IEC 60601‑1‑2, IEC 60601‑1‑6, IEC 60601‑1‑8, IEC 60601‑1‑11 and IEC 60601‑1‑12 apply as modified in Clauses 202, 206, 208, 211 and 212, respectively. IEC 60601‑1‑3[5] does 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 as appropriate for the particular me equipment under consideration, and may add other basic safety and essential performance requirements.
A requirement of a document takes priority over IEC 60601‑1 and its collateral standards.
For brevity, IEC 60601‑1:2005+A1:2012 is referred to in this document as the general standard. Collateral standards are referred to by their document number.
The numbering of sections, clauses and subclauses of this document 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 document addresses the content of Clause 4 of the 60601-1-2 collateral standard, 203.4 in this document addresses the content of Clause 4 of the 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 IEC 60601‑1 or applicable collateral standard is replaced completely by the text of this particular document.
“Addition” means that the text of this document is additional to the requirements of the IEC 60601‑1 or applicable collateral standard.
“Amendment” means that the clause or subclause of the IEC 60601‑1 or applicable collateral standard is amended as indicated by the text of this document.
Subclauses or figures which are additional to those of the general standard are numbered starting from 201.101, Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
Subclauses or figures 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 IEC 60601‑1:2005+A1:2012, any applicable collateral standards and this document taken together.
Where there is no corresponding section, clause or subclause in this document, the section, clause or subclause of the IEC 60601‑1 or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of the IEC 60601‑1 or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this document.