Health Care Technology Official British Standard

BS EN ISO 10079-1:2015+A1:2019

Comprehensive standard for health care suction units. Ensures safety, performance, and compliance for medical devices. Crucial for healthcare facilities and equipment manufacturers.

Comprehensive Standard for Health Care Suction Units

The BS EN ISO 10079-1:2015+A1:2019 is a crucial standard for the design, performance, and safety of health care suction units. This British Standard, which is identical to the international standard ISO 10079-1:2015/Amd 1:2018, provides detailed requirements and test methods to ensure the reliability and effectiveness of these essential medical devices.

Ensuring Safety and Performance in Medical Suction

Health care suction units play a vital role in various medical procedures, from clearing airways to wound management. This standard sets out the necessary specifications to guarantee the safety and performance of these devices, covering aspects such as:• Electrical safety and protection against electric shock• Mechanical safety, including protection against moving parts• Biocompatibility and resistance to cleaning agents• Suction capacity and flow rate• Noise and vibration levels• Labeling and user instructionsBy adhering to the requirements of BS EN ISO 10079-1:2015+A1:2019, manufacturers can ensure their health care suction units meet the highest standards of quality and safety, providing healthcare facilities with the confidence they need to deliver effective patient care.

Key Benefits of Compliance

Compliance with this standard offers several crucial benefits for healthcare providers and equipment manufacturers:• Ensures the safety and reliability of health care suction units, protecting both patients and medical staff• Facilitates the procurement and use of suction devices that meet international best practices• Supports the development of innovative suction technologies that adhere to global standards• Enables seamless integration of suction units into healthcare environments, streamlining operations• Demonstrates a commitment to quality and regulatory compliance, enhancing the reputation of manufacturers

Technical Specifications

The BS EN ISO 10079-1:2015+A1:2019 standard covers a comprehensive range of technical requirements, including:• Electrical safety and protection against electric shock• Mechanical safety, including protection against moving parts• Biocompatibility and resistance to cleaning agents• Suction capacity and flow rate• Noise and vibration levels• Labeling and user instructionsBy adhering to these detailed specifications, manufacturers can ensure their health care suction units are designed and manufactured to the highest standards, providing healthcare facilities with the confidence they need to deliver effective patient care.Overall, the BS EN ISO 10079-1:2015+A1:2019 standard is a critical resource for healthcare providers and equipment manufacturers, ensuring the safety, performance, and compliance of essential medical devices. Compliance with this standard is a must for any organization operating in the healthcare technology sector.

Technical Information

Health Care Technology
BSI Group
978 0 580 95563 1
Specification Details
  • Medical suction equipment - Electrically powered suction equipment
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