BS EN IEC 61010-2-040:2021
Safety requirements for electrical equipment for measurement, control, and laboratory use Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
| Standard number: | BS EN IEC 61010-2-040:2021 |
| Pages: | 46 |
| Released: | 2021-12-07 |
| ISBN: | 978 0 539 05209 1 |
| Status: | Standard |
BS EN IEC 61010-2-040:2021 Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use
Particular Requirements for Sterilizers and Washer-Disinfectors Used to Treat Medical Materials
Standard Number: BS EN IEC 61010-2-040:2021
Pages: 46
Released: 2021-12-07
ISBN: 978 0 539 05209 1
Status: Standard
Overview
The BS EN IEC 61010-2-040:2021 standard is an essential document for professionals in the field of medical equipment, particularly those involved in the design, manufacture, and maintenance of sterilizers and washer-disinfectors. This standard outlines the safety requirements for electrical equipment used in measurement, control, and laboratory settings, with a specific focus on devices used to treat medical materials.
Why This Standard is Crucial
Ensuring the safety and reliability of medical sterilizers and washer-disinfectors is paramount. These devices play a critical role in maintaining the sterility of medical instruments and materials, which is essential for patient safety and infection control. The BS EN IEC 61010-2-040:2021 standard provides comprehensive guidelines to ensure that these devices meet stringent safety requirements, thereby minimizing risks associated with their use.
Key Features
- Comprehensive Safety Guidelines: The standard covers a wide range of safety aspects, including electrical safety, mechanical safety, and environmental considerations.
- Specific Focus on Medical Applications: Tailored requirements for sterilizers and washer-disinfectors ensure that these devices are safe and effective for medical use.
- Up-to-Date Information: Released on 2021-12-07, this standard reflects the latest advancements and best practices in the field.
- Detailed Documentation: With 46 pages of in-depth information, the standard provides thorough guidance for compliance.
Who Should Use This Standard?
This standard is indispensable for a variety of professionals, including:
- Medical Device Manufacturers: Ensure that your products meet the highest safety standards.
- Quality Assurance Teams: Verify that sterilizers and washer-disinfectors comply with regulatory requirements.
- Healthcare Facilities: Maintain the safety and effectiveness of your sterilization equipment.
- Regulatory Bodies: Reference this standard when evaluating the safety of medical devices.
Benefits of Compliance
Adhering to the BS EN IEC 61010-2-040:2021 standard offers numerous benefits, including:
- Enhanced Safety: Reduce the risk of accidents and equipment failures.
- Regulatory Compliance: Meet national and international safety regulations.
- Improved Reliability: Ensure consistent performance of sterilizers and washer-disinfectors.
- Increased Trust: Gain the confidence of healthcare providers and patients.
Detailed Content
The standard is divided into several sections, each addressing different aspects of safety and performance. Key sections include:
- General Requirements: Basic safety principles applicable to all electrical equipment for measurement, control, and laboratory use.
- Specific Requirements for Sterilizers: Detailed guidelines for the design, construction, and testing of sterilizers used in medical settings.
- Specific Requirements for Washer-Disinfectors: Comprehensive requirements for washer-disinfectors, ensuring they effectively clean and disinfect medical materials.
- Testing and Verification: Procedures for testing and verifying compliance with the standard.
- Documentation and Labeling: Requirements for proper documentation and labeling to ensure traceability and user safety.
Conclusion
The BS EN IEC 61010-2-040:2021 standard is a vital resource for anyone involved in the design, manufacture, or maintenance of medical sterilizers and washer-disinfectors. By adhering to this standard, you can ensure that your equipment meets the highest safety and performance standards, thereby protecting both healthcare providers and patients. With its comprehensive guidelines and up-to-date information, this standard is an indispensable tool for achieving excellence in the field of medical device safety.
BS EN IEC 61010-2-040:2021
This standard BS EN IEC 61010-2-040:2021 Safety requirements for electrical equipment for measurement, control, and laboratory use is classified in these ICS categories:
- 11.080.10 Sterilizing equipment
- 19.080 Electrical and electronic testing
- 71.040.10 Chemical laboratories. Laboratory equipment
IEC 61010-2-040:2020 specifies safety requirements for electrical equipment intended for sterilization, washing, and disinfection of medical materials in the medical, veterinary, pharmaceutical and laboratory fields, when used under the environmental conditions of 1.4. Examples of such equipment include the following: - sterilizers and disinfectors using steam and/or hot water as the sterilant; - sterilizers and disinfectors using toxic gas, toxic aerosol or toxic vapour as the sterilant; - sterilizers and disinfectors using hot air or hot inert gas as the sterilant; and - washer-disinfectors. This third edition cancels and replaces the second edition published in 2015. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: - it is established on the basis of the third edition (2010) of IEC 61010?1 and its Amendment 1 (2016); - added tolerance for stability of a.c. voltage test equipment to 6.8.3.1; - the status of a Group Safety Publication has been removed (this does not change the technical requirements in the document).