SIST EN 12342:2000/kprA1:2009

Overview

SIST EN 12342:2000/kprA1:2009 is a European standard specifying requirements for breathing tubes intended for use with anaesthetic apparatus and ventilators. Developed by the CEN Technical Committee (CEN/TC 215), this standard helps ensure safety, usability, and regulatory compliance in respiratory and anaesthetic medical devices. It supports essential requirements of the EU Directive 93/42/EEC on medical devices, promoting consistent quality and safety across member states.

The amendment (prA1:2009) introduces critical updates including labeling requirements for phthalates, instructions for use, single-use device risk disclosures, usability engineering, clinical evaluation, and biophysical modeling research. These enhancements reflect evolving regulatory and technical expectations for breathing tubes used in anaesthesia and ventilation.

Key Topics

• Labeling of Phthalates
  Devices containing phthalates, which may be carcinogenic or toxic to reproduction, must be clearly labeled to inform users and comply with safety regulations.

• Instructions for Use (IFU)
  Manufacturers are required to specify the date of issue or latest revision of IFU, ensuring clinicians have up-to-date guidance.

• Single-use Device Risks
  For single-use breathing tubes, risks associated with reuse must be disclosed either in the IFU or upon request to prevent unintended reuse and associated hazards.

• Manufacturer Identification
  If the manufacturer lacks a registered business in the EU, the name and address of an authorized representative must be provided on the device labeling.

• Usability Engineering
  Compliance with IEC 60601-1-6 and IEC 62366 standards for usability engineering must be documented to address risks related to poor usability.

• Clinical Evaluation
  A documented clinical evaluation is mandated, integrated within the risk management file, to demonstrate device safety and performance.

• Biophysical and Modelling Research
  When applicable, validated biophysical or modelling studies should be conducted and documented to support device design and risk assessments.

• Relationship to EU Directive 93/42/EEC
  This standard is harmonized under the Medical Devices Directive, providing a presumption of conformity with the directive’s Essential Requirements when implemented nationally.

Applications

SIST EN 12342:2000/kprA1:2009 applies primarily to breathing tubes used in conjunction with:

• Anaesthetic apparatus in hospitals and surgical settings
• Mechanical ventilators in critical care and emergency medicine
• Respiratory therapy devices requiring safe and reliable airway connection
• Single-use and reusable respiratory tubing for patient ventilation

By adhering to this standard, manufacturers ensure product safety, facilitate regulatory approval, and support effective clinical use. Healthcare providers benefit from clear labeling, risk information, and improved usability, enhancing patient safety during anaesthesia and ventilation procedures.

Related Standards

• IEC 60601-1-6 – Medical electrical equipment – Usability engineering
• IEC 62366 – Medical devices – Application of usability engineering to medical devices
• EU Directive 93/42/EEC – Concerning medical devices, including essential requirements for respiratory equipment
• Other CEN/TC 215 Standards – Respiratory and anaesthetic medical devices standards covering connectors, filters, and safety testing

These related standards support comprehensive quality management and regulatory compliance for medical breathing apparatus, underpinning the safe design, manufacture, and clinical use of respiratory tubing.

Keywords: EN 12342:1998, breathing tubes, anaesthetic apparatus, ventilators, medical devices, respiratory tubing, EU Directive 93/42/EEC, usability engineering, clinical evaluation, phthalates labeling, single-use medical devices, respiratory equipment standards.