Anaesthetic and respiratory equipment standards ensure that medical equipment is safe and reliable. This is essential for patient safety and quality of care in anaesthesia and respiratory medicine. Anaesthetic and respiratory equipment standards cover the production of a wide variety of standards in relation to anaesthetic machines, lung ventilators and medical gas supply and breathing systems.
Facilitating safety and reliability for patients and operators
Learn how standards ensure the quality of anaesthetic and respiratory equipment
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Achieving respiratory safety with standards
The prevalence of respiratory diseases will continue to rise as the global population continues to age and the incidence of chronic diseases, such as asthma, increases exponentially. As a result, respiratory diseases, breathing issues, and other medical conditions require special care and often an array of medical equipment. Respiratory equipment can include medical devices intended to provide breathing support for patients, promote the removal of carbon dioxide, and provision of therapy to reduce disuse atrophy of abdominal wall muscles. The importance of quality and safety in the provision of this respiratory equipment was evident by the mass surge in respiratory concerns experienced by the population, caused by the COVID-19 pandemic, which resulted in a massive increase in demand for respiratory equipment. Meeting Demand for Respiratory Equipment in the COVID-19 Crisis: A Case Study
The recent pandemic challenged manufacturers across the globe to adapt to the problems caused by the COVID-19 virus. In the United Kingdom (UK), one major concern was the potential impact on the National Health Service (NHS) caused by the influx of patients requiring admission into intensive care wards/high dependency wards and requiring access to ventilators and other respiratory equipment to support patient breathing. It was evident that the NHS did not have enough ventilators to support the ever-growing patient population which in turn led to a global increase in demand, which meant that UK manufacturers were going to have to find a way to produce them domestically. There are some smaller-scale manufacturers of ventilators in the UK, such as Penlon and Smiths Medical, and it became clear that part of the solution lay in the increase of manufacturing capacity of the manufacturers' ventilators. The ability to do this lay in achieving excellence in collaboration, and it is this development that will give rise to several opportunities for manufacturers in future years, even when COVID-19 is no longer defined as a pandemic. Supply chains that can react and adapt to rapidly changing circumstances will be able to compete effectively, and manufacturers need to be able to put those good collaborative practices into place now in order to be part of that exciting future. To achieve supply chain resilience, manufacturers of respiratory medical devices need to ensure the products being developed are of the highest quality and meet all safety requirements. This is where standards can be of benefit. To learn more about how the industry overcame these supply chain challenges, read our article 'Supply chain resilience standards: Responding to COVID-19'. The Key Standards for Respiratory Equipment Our catalogue of respiratory standards specifies minimum requirements for respiratory devices. They also feature information on testing and marking equipment. BS EN ISO 13485:2016+A11:2021 Medical devices. Quality management systems. Requirements for regulatory purposes BS EN ISO 13485:2016+A11:2021 is the recognized quality management system (QMS) standard for the medical device industry. The standard specifies requirements for a QMS for those organizations involved in one or more stages of the life cycle of a medical device. The standard provides the framework for design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices and the design and development or provision of associated activities (e.g. technical support). BS ISO 18190:2016 Anaesthetic and respiratory equipment - General requirements for airways and related equipment BS ISO 18190:2016 provides the general requirements for basic safety and performance for the design, packaging, marking and labelling that is generally applicable to all airways and related equipment. It aims to serve as a central catalogue of these common requirements, allowing each device-specific standard to more concisely focus on the unique safety and essential requirements for the equipment. BS EN ISO 5367:2014 Anaesthetic and respiratory equipment - Breathing sets and connectors BS EN ISO 5367:2014 specifies basic requirements for breathing sets and breathing tubes intended to be used with anaesthetic breathing systems, ventilator breathing systems, humidifiers or nebulizers. It applies to breathing sets and breathing tubes and patient end adaptors supplied already assembled and to those supplied as components and assembled in accordance with the manufacturer's instructions. The standard is applicable to breathing sets which include special components (e.g. water traps) between the patient end and machine end which are supplied already assembled. This standard; however, does not apply to breathing sets and breathing tubes for special purposes. BS EN ISO 4135:2022 Anaesthetic and respiratory equipment - Vocabulary BS EN ISO 4135:2022 establishes a vocabulary of terms used in connection with anaesthetic and respiratory equipment and supplies, related devices and supply systems. BS EN ISO 5356-1:2015 Anaesthetic and respiratory equipment - Conical connectors. Part 1: Cones and sockets In clinical practice, several breathing attachments used in anaesthetic and respiratory equipment may have to be joined together to provide a suitable breathing system. Items of medical equipment, such as a humidifier or a spirometer, are often incorporated into the breathing system which might also be connected to an anaesthetic gas scavenging system. Connections for these purposes are usually cone and socket joints, and a lack of standardization of these connections has given rise to problems of interchangeability when connecting equipment made by different manufacturers. BS EN ISO 5356-1:2015 specifies the requirements and dimensions for cones and sockets used in anaesthetic and respiratory equipment. BS EN ISO 5366:2016 Anaesthetic and respiratory equipment -Tracheostomy tubes and connectors BS EN ISO 5366:2016 provides the essential requirements for the design of cuffed and uncuffed tracheostomy tubes and connectors. These devices are intended to be inserted through a stoma in the trachea to convey gases and vapours to and from the trachea. Cuffed devices are designed to seal and protect the trachea from aspiration and to provide an unobstructed airway in patients during spontaneous, assisted or controlled ventilation for short or prolonged durations. Specialized tubes with walls reinforced with metal or nylon, tubes with shoulders, tapering tubes, tubes with provision for suctioning or monitoring or delivery of drugs or other gases and the many other types of tracheostomy tubes devised for specialized applications are included in this specification. BS EN ISO 23328-2:2009 Breathing system filters for anaesthetic and respiratory use. Part 2: Non-filtration aspects BS EN ISO 23328-2:2009 specifies requirements for non-filtration aspects of breathing system filters (BSF) intended for anaesthetic and respiratory use, and addresses connection ports, leakage, resistance to flow, packaging, marking and information supplied. The test method is intended for BSF used with a clinical breathing system. It is not applicable to other types of filters, e.g. those designed to protect vacuum sources or gas sample lines, to filter compressed gases, or to protect test equipment for physiological respiratory measurements. In your safety-critical industry, ensure you are meeting the industry standards. A BSI Knowledge subscription gives you instant access to the resources you need to improve the safe design, manufacture and use of respiratory equipment. The flexibility and visibility it provides of the best practices guidance enables you to get the most from your healthcare equipment standards. Build your own custom collection of standards, or opt for access to over 4,800 documents in our GBM05 Sciences & Healthcare module and keep up-to-date with any relevant changes to your standards strategy. Request to learn more. Ensure your respiratory equipment comply with regulations, are safe and manufactured to the highest quality by adding these standards to your collection today.Read more
Key Anaesthetic and Respiratory Equipment Standards
