Health Care Technology
Official British Standard
BS EN 61010-2-101:2017
Comprehensive healthcare technology standard BS EN 61010-2-101:2017. Ensures safety and compliance for medical devices and equipment. Detailed technical specifications and compliance benefits.
## BS EN 61010-2-101:2017 - Healthcare Technology StandardBS EN 61010-2-101:2017 is a critical standard for the healthcare industry, ensuring the safety and compliance of medical devices and equipment. This standard, identical to IEC 61010-2-101:2015, provides detailed technical specifications and requirements for the design, manufacture, and testing of a wide range of healthcare technology products.### Comprehensive Healthcare Technology CoverageThe scope of BS EN 61010-2-101:2017 is broad, covering a diverse range of healthcare technology, including:- Medical diagnostic and therapeutic equipment- Laboratory instrumentation- Surgical and treatment devices- Monitoring and control systems- Life support equipment- Dental equipment- Veterinary equipmentBy adhering to the requirements set forth in this standard, manufacturers can ensure their products meet the highest safety and performance standards, providing healthcare professionals and patients with the confidence they need.### Ensuring Patient and User SafetyAt the core of BS EN 61010-2-101:2017 is a focus on safeguarding the well-being of patients, healthcare workers, and other users. The standard outlines stringent requirements for:- Electrical safety- Mechanical safety- Thermal safety- Radiation safety- Chemical safety- Ergonomic designThese comprehensive safety measures help to minimize the risk of injury, electric shock, fire, and other hazards, ensuring the safe operation of healthcare technology in a variety of clinical settings.### Compliance and Regulatory BenefitsCompliance with BS EN 61010-2-101:2017 is not only a matter of safety but also a critical requirement for the commercialization and distribution of healthcare technology products. By meeting the standards set forth in this document, manufacturers can:- Demonstrate conformity with essential health and safety requirements- Gain access to European and global markets- Reduce the risk of regulatory non-compliance and associated penalties- Enhance the reputation and credibility of their products- Provide healthcare providers with the confidence they need to purchase and use the equipment### Detailed Technical SpecificationsBS EN 61010-2-101:2017 provides a comprehensive set of technical specifications and requirements, covering a wide range of design, construction, and testing considerations, including:- Electrical requirements- Mechanical requirements- Environmental conditions- Protective measures- Markings and documentation- Testing proceduresThese detailed technical specifications ensure that healthcare technology products are designed and manufactured to the highest standards, promoting reliability, durability, and consistent performance.By adhering to the requirements of BS EN 61010-2-101:2017, healthcare technology manufacturers can demonstrate their commitment to patient and user safety, regulatory compliance, and the delivery of high-quality, reliable products that meet the evolving needs of the healthcare industry.
Technical Information
Health Care Technology
BSI Group
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Specification Details
- Safety requirements for electrical equipment for measurement, control and laboratory use - Particular requirements for in vitro diagnostic (IVD) medical equipment
Official BSI Standard
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