BS EN 60601-1-10:2008+A2:2021 - Medical Electrical Equipment Standard

In the ever-evolving world of medical technology, ensuring the safety and performance of medical electrical equipment is paramount. The BS EN 60601-1-10:2008+A2:2021 standard is a crucial document that provides comprehensive guidelines for the development of physiologic closed-loop controllers, which are integral to modern medical devices.

Overview

This standard, officially titled Medical electrical equipment - General requirements for basic safety and essential performance. Collateral Standard: Requirements for the development of physiologic closed-loop controllers, is a vital resource for manufacturers, engineers, and healthcare professionals involved in the design and implementation of medical electrical equipment. Released on August 16, 2021, this document is the latest update, incorporating amendments to ensure it meets current technological and safety standards.

Key Features

• Standard Number: BS EN 60601-1-10:2008+A2:2021
• Pages: 52
• ISBN: 978 0 580 97597 4
• Status: Standard

Importance of the Standard

The BS EN 60601-1-10:2008+A2:2021 standard is essential for ensuring that medical electrical equipment is designed with the highest levels of safety and performance. It provides a framework for the development of physiologic closed-loop controllers, which are systems that automatically adjust the operation of medical devices based on real-time physiological data from patients. This capability is crucial for devices such as ventilators, infusion pumps, and other life-supporting equipment.

Ensuring Patient Safety

Patient safety is the foremost priority in the healthcare industry. This standard outlines the necessary requirements to minimize risks associated with the use of medical electrical equipment. By adhering to these guidelines, manufacturers can ensure that their products are safe for use in clinical settings, thereby protecting patients from potential harm.

Enhancing Device Performance

In addition to safety, the standard emphasizes the importance of essential performance. Medical devices must not only be safe but also perform their intended functions effectively. The guidelines provided in this standard help manufacturers design devices that meet these performance criteria, ensuring that they deliver reliable and accurate results in medical applications.

Who Should Use This Standard?

The BS EN 60601-1-10:2008+A2:2021 standard is indispensable for a wide range of professionals in the medical device industry, including:

• Medical Device Manufacturers: To ensure their products comply with international safety and performance standards.
• Biomedical Engineers: To design and develop advanced medical equipment with closed-loop control systems.
• Regulatory Affairs Specialists: To understand the compliance requirements for medical devices.
• Healthcare Providers: To ensure the equipment used in their facilities meets the highest safety standards.

Benefits of Compliance

Compliance with the BS EN 60601-1-10:2008+A2:2021 standard offers numerous benefits, including:

• Improved Safety: Reducing the risk of device-related injuries and adverse events.
• Regulatory Approval: Facilitating the approval process for medical devices in various markets.
• Market Competitiveness: Enhancing the reputation of manufacturers as providers of high-quality, safe medical equipment.
• Innovation: Encouraging the development of cutting-edge technologies in medical device design.

Conclusion

The BS EN 60601-1-10:2008+A2:2021 standard is a cornerstone document for the medical device industry, providing essential guidelines for the development of physiologic closed-loop controllers. By adhering to this standard, manufacturers can ensure their products are safe, effective, and compliant with international regulations. This not only protects patients but also enhances the credibility and marketability of medical devices.

For those involved in the design, manufacture, or regulation of medical electrical equipment, this standard is an invaluable resource that supports the creation of innovative and reliable medical technologies.

BS EN 60601-1-10:2008+A2:2021

This standard BS EN 60601-1-10:2008+A2:2021 Medical electrical equipment is classified in these ICS categories:

• 11.040.01 Medical equipment in general
• 11.040.10 Anaesthetic, respiratory and reanimation equipment

1.1 * Scope

This International Standard applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems, hereafter referred to as me equipment and me systems.

This collateral standard specifies requirements for the development (analysis, design, verification and validation) of a physiologic closed-loop controller (pclc) as part of a physiologic closed-loop control system (pclcs) to control at least one patient variable (i.e. a physiologic variable) in me equipment and me systems.

EXAMPLE A patient variable can be a measure of body chemistry (e.g. electrolytes or blood glucose value), a physical property (e.g. body temperature, electrophysiologic characteristic, hemodynamic quantity), or a pharmaceutical concentration.

This collateral standard applies to various types of pclc, e.g. linear and non-linear, adaptive, fuzzy, neural networks.

This collateral standard does not specify:

• additional mechanical requirements; or

• additional electrical requirements.

This collateral standard applies to a closed-loop controller (see Figure 1) that sets the controller output variable in order to adjust (i.e., change or maintain) the measured physiologic variable by relating it to the reference variable.

A closed-loop controller that maintains a physical or chemical variable, using feedback that is not measured from a patient, is outside the scope of this standard.

1.2 Object

The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards.

1.3 Related standards

1.3.1 IEC 60601‑1

For me equipment and me systems, this collateral standard complements IEC 60601‑1.

When referring to IEC 60601‑1 or to this collateral standard, either individually or in combination, the following conventions are used:

• "the general standard" designates IEC 60601‑1 alone, including any amendments;

• "this collateral standard" designates IEC 60601‑1‑10 alone, including any amendments;

• "this standard" designates the combination of the general standard and this collateral standard.

1.3.2 Particular standards

A requirement in a particular standard takes priority over the corresponding requirement in this collateral standard.