EN 13544-2:2002/prA1

Overview

EN 13544-2:2002/prA1 is a CEN draft amendment addressing respiratory therapy equipment - Part 2: tubing and connectors. The amendment updates the original EN 13544-2:2002 to strengthen safety, usability and regulatory documentation for tubing and connector components used in respiratory and anaesthetic devices. The draft was prepared by CEN/TC 215 and links to Essential Requirements of EU Directive 93/42/EEC (medical devices). Note: the extracted document is a prA1 draft (January 2009) and was distributed for review.

Key topics and requirements

• Scope: Tubing and connectors used in respiratory therapy equipment (medical device components that come into direct or indirect contact with the patient).
• Labeling of phthalates: If phthalates are incorporated into parts contacting the patient, the device must be labelled. For devices used on children, pregnant or nursing women, residual risks must be stated in the instructions for use. (NOTE: attention to carcinogenic, mutagenic or reproductive toxic substances.)
• Manufacturer and representative details: Where the manufacturer has no registered business in the European Community, the name and address of an authorized representative must be provided.
• Instructions for use: Must include the date of issue or latest revision. For single‑use devices, manufacturers must disclose the risks associated with reusing the device (in instructions or on request).
• Usability (new Clause 8): Manufacturers must address usability risks through a usability engineering process in line with IEC/EN usability standards. Compliance is verified by inspection of the usability engineering file.
• Clinical evaluation (new Clause 9): A clinical evaluation is required and must be documented within the risk management file; compliance is checked via that file.
• Regulatory alignment (Annex ZA): The amendment clarifies the relationship between the standard and EU Directive 93/42/EEC, listing Essential Requirements that the standard helps satisfy.

Practical applications and users

This amendment is practical for:

• Manufacturers and designers of respiratory tubing and connectors (product design, labelling, and risk disclosure).
• Regulatory affairs and quality teams preparing technical documentation, instructions for use, and compliance evidence for CE marking.
• Usability engineers and human factors specialists creating usability engineering files and validating safe device operation.
• Clinical evaluators and risk managers documenting clinical evaluation and risk management files.
• Notified bodies and conformity assessors reviewing technical files for compliance with EN 13544-2 and Directive 93/42/EEC.

Related standards

• EN 13544-2:2002 (original standard)
• EN 60601-1-6 / IEC 60601-1-6 (medical electrical equipment - usability collateral)
• EN 62366 (application of usability engineering to medical devices)
• EU Directive 93/42/EEC (medical devices)

Keywords: EN 13544-2, respiratory therapy tubing, medical device connectors, usability engineering, clinical evaluation, phthalates labelling, risk management, single-use devices.