What is BS EN ISO 10079-3:2019 ?

Title: What is EN ISO 10079-3:2019 and EN ISO 10079-6:2021? A Comprehensive Guide

Suction equipment is an essential tool for healthcare professionals to perform various medical procedures effectively and safely. However, the use of suction equipment can pose risks to patient health and the quality of care. To address these concerns, international organizations like the International Organization for Standardization (ISO) develop and publish technical standards for medical suction equipment. Two such standards are EN ISO 10079-3:2019 and EN ISO 10079-6:202In this article, we will provide a comprehensive guide to these two important standards, including their significance, requirements, and implications for medical supply unit manufacturers.

What is EN ISO 10079-3:2019?

EN ISO 10079-3:2019, also known as "Medical Suction Equipment, " is a technical standard developed by the ISO to provide guidelines and specifications for the safe and effective use of suction equipment in medical settings. This standard is part of a series of medical suction equipment standards and is designed to minimize the risk of complications associated with the use of suction devices while maintaining high standards of quality and effectiveness in medical procedures.

Key Principles and Requirements

EN ISO 10079-3:2019 is based on several key principles and requirements that manufacturers must adhere to. These requirements are essential for ensuring the safety and reliability of medical suction equipment. Key among them are:

Medical Performance

The standard specifies the medical performance requirements for suction equipment, which are intended to ensure that the equipment is capable of meeting the requirements of relevant medical procedures. These requirements are based on the principles of good practice and are designed to minimize the risk of complications associated with the use of suction devices.

Safety

EN ISO 10079-3:2019 places a significant emphasis on safety, including the prevention of electrical hazards, fires, and other incidents that could compromise patient safety. The standard outlines the safety requirements for medical suction equipment, such as the use of appropriate materials for electrical components, the installation of electrical isolation barriers, and the provision of adequate electrical safety training for equipment users.

Traceability

The standard requires manufacturers to provide traceability for medical suction equipment, which is essential for ensuring that equipment is properly designed, manufactured, and tested. This helps to minimize the risk of counterfeit or defective equipment entering the market.

Integration

EN ISO 10079-3:2019 also specifies the integration requirements for medical suction equipment, which are intended to ensure that the equipment is seamlessly integrated into medical procedures and systems. These requirements take into account the specific needs of different medical settings and the requirements of relevant medical procedures.

Documentation

The standard requires manufacturers to provide comprehensive documentation for medical suction equipment, including user manuals, maintenance manuals, and electrical diagrams. This documentation is essential for ensuring that equipment is properly used and maintained, which helps to minimize the risk of complications associated with the use of suction devices.

EN ISO 10079-6:2021

EN ISO 10079-6:2021 is a technical standard developed by the ISO to address the electrical safety requirements for medical supply units, specifically with regard to their electrical safety. This standard is an essential tool for ensuring the safety and reliability of medical supply units, which are used in hospitals, clinics, and other healthcare settings to provide power supply and support to various critical medical equipment.

Key Principles and Requirements

EN ISO 10079-6:2021 is based on several key principles and requirements that medical supply unit manufacturers must adhere to.