Health Care Technology Official British Standard

BS EN ISO 80601-2-13:2012+A2:2019

Comprehensive healthcare technology standard BS EN ISO 80601-2-13:2012+A2:2019. Ensures safety and performance of anaesthetic and respiratory equipment. Complies with latest ISO and EN regulations.

Comprehensive Healthcare Technology Standard

BS EN ISO 80601-2-13:2012+A2:2019 is a critical standard that ensures the safety and performance of anaesthetic and respiratory equipment used in healthcare settings. This standard, developed by the International Organization for Standardization (ISO) and the European Committee for Standardization (CEN), provides detailed requirements and test methods to verify the essential characteristics of these vital medical devices.

Compliance with Latest Regulations

This standard is the latest version, incorporating Amendment 2 published in 2019. It aligns with the most up-to-date ISO and EN regulations, ensuring that healthcare providers can confidently select and use equipment that meets the highest safety and performance standards.

Key Features and Benefits:

  • Comprehensive requirements for the design, construction, and performance of anaesthetic and respiratory equipment
  • Detailed test methods to verify essential characteristics such as flow, pressure, and volume measurement
  • Ensures the safety and reliability of equipment used in critical healthcare applications
  • Compliance with the latest ISO and EN regulations, including ISO 80601-2-13:2011/Amd 2:2018 and EN ISO 80601-2-13:2012/A2:2019
  • Applicable to a wide range of equipment, including anaesthetic workstations, ventilators, and gas delivery systems
  • Supports healthcare providers in selecting and using equipment that meets the highest standards of safety and performance

Ensuring Patient Safety and Reliable Performance

The BS EN ISO 80601-2-13:2012+A2:2019 standard is essential for healthcare organizations, medical device manufacturers, and regulatory bodies. It provides a comprehensive framework to ensure that anaesthetic and respiratory equipment used in critical care settings are designed, constructed, and tested to the highest standards.By complying with this standard, healthcare providers can be confident that the equipment they use will perform reliably and safely, protecting both patients and healthcare professionals. The detailed requirements and test methods outlined in the standard help to minimize the risk of equipment failure, ensuring that patients receive the necessary care without interruption.

Investing in Quality and Compliance

Purchasing the BS EN ISO 80601-2-13:2012+A2:2019 standard is an investment in the quality and safety of your healthcare organization's equipment. By staying up-to-date with the latest regulations and industry best practices, you can demonstrate your commitment to patient safety and ensure that your equipment meets the highest standards of performance and reliability.Whether you are a healthcare provider, medical device manufacturer, or regulatory body, this standard is an essential resource for ensuring the safe and effective use of anaesthetic and respiratory equipment in the healthcare sector.

Technical Information

Health Care Technology
BSI Group
978 0 580 95410 8
Specification Details
  • Medical electrical equipment - Particular requirements for basic safety and essential performance of an anaesthetic workstation
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