BS EN 61010-2-061:2015

# BS EN 61010-2-061:2015 - Healthcare Technology Standard## OverviewBS EN 61010-2-061:2015 is a critical healthcare technology standard that ensures the safety and compliance of medical equipment and devices. This standard, which is identical to IEC 61010-2-061:2015, provides essential requirements and test methods for the design, manufacture, and operation of healthcare technology products.## Key Features and Benefits- **Comprehensive Safety Requirements**: BS EN 61010-2-061:2015 outlines detailed safety requirements for a wide range of healthcare technology, including equipment used for in-vitro diagnostics, laboratory use, and medical applications.- **Compliance and Regulatory Alignment**: By adhering to this standard, healthcare technology manufacturers can demonstrate compliance with relevant regulations and directives, such as the EU Medical Device Regulation (MDR).- **Patient and User Safety**: The standard's rigorous safety requirements help to minimize the risk of injury or harm to patients, healthcare professionals, and other users of medical equipment.- **Quality Assurance**: Implementing the testing methods and procedures outlined in BS EN 61010-2-061:2015 can help to ensure the consistent quality and reliability of healthcare technology products.- **Global Harmonization**: As an identical adoption of the IEC 61010-2-061:2015 standard, BS EN 61010-2-061:2015 aligns with international best practices and facilitates global market access for healthcare technology products.## Technical SpecificationsBS EN 61010-2-061:2015 covers the following key technical requirements and test methods:### General Safety Requirements- Electrical safety- Mechanical safety- Fire and thermal safety- Radiation safety- Chemical safety- Ergonomic design### Specific Requirements for In-Vitro Diagnostic (IVD) Equipment- Sample handling and processing- Reagent and consumable safety- Instrument performance and reliability### Specific Requirements for Laboratory Equipment- Hazardous substance containment- Ventilation and fume extraction- Electrical and mechanical safety for laboratory applications### Specific Requirements for Medical Equipment- Patient safety and protection- Usability and human factors- Electromagnetic compatibility (EMC)## Compliance and CertificationAdhering to the requirements of BS EN 61010-2-061:2015 is essential for healthcare technology manufacturers and suppliers to demonstrate compliance with relevant regulations and directives, such as the EU Medical Device Regulation (MDR). Certification to this standard can also help to build trust and confidence with healthcare providers, regulatory authorities, and end-users.By implementing the safety and quality assurance measures outlined in BS EN 61010-2-061:2015, healthcare technology companies can ensure the safe and reliable performance of their products, ultimately contributing to improved patient outcomes and enhanced healthcare delivery.