SIST EN 1282-2:2005/kprA1:2009

Overview

EN 1282-2:2005/prA1 is a CEN draft amendment to the European standard for tracheostomy tubes - Part 2: Paediatric tubes (based on ISO 5366-3:2001, modified). Prepared by CEN/TC 215, this amendment updates requirements for design, labeling and documentation of paediatric tracheostomy tubes and clarifies conformity with EU medical device rules. It is intended to support manufacturers, conformity assessment bodies and regulators working with paediatric airway devices.

Key topics and technical requirements

• Phthalates labeling: If phthalates are present in parts that come into direct or indirect contact with the patient, the device must be labelled accordingly. (Note: attention is drawn to carcinogenic, mutagenic or reproductive toxins.)
• Usability engineering: Manufacturers must address risks from poor usability through a usability engineering process (referenced standards: IEC 60601-1-6 / IEC 62366). Compliance is checked by inspection of the usability engineering file.
• Clinical evaluation: A documented clinical evaluation is required and must be recorded in the risk management file; inspectors verify this by reviewing the risk management documentation.
• Biophysical / modelling research: Where appropriate, validated biophysical or modelling studies should be carried out and documented in the technical file.
• Single-use devices: For single-use paediatric tracheostomy tubes, instructions for use (IFU) must disclose the risks associated with reuse, either in the IFU or upon request.
• Traceability and representation: Label/data requirements expanded to include the name and address of the authorized representative if the manufacturer has no registered business in the EU. Manufacturers are also reminded to use consistent single-use indications across the Community.
• Regulatory linkage: Annex ZA modifications explicitly map clauses to Essential Requirements of EU Directive 93/42/EEC for medical devices, supporting conformity assessment.

Applications and who uses this standard

• Manufacturers and design engineers - ensure compliance in device design, labeling, usability engineering and technical documentation for paediatric tracheostomy tubes.
• Regulatory affairs and quality teams - prepare and maintain risk management files, clinical evaluations and technical files to demonstrate conformity with EU requirements.
• Notified bodies and conformity assessors - use the standard to assess compliance during audits and conformity reviews.
• Clinicians and purchasing - understand labeling, single-use risks and material information (e.g., phthalates) to inform safe clinical use and procurement decisions.

Related standards

• ISO 5366-3:2001 (Paediatric tracheostomy tubes) - base international standard
• IEC 60601-1-6 / ISO 62366 - usability engineering for medical devices
• EU Directive 93/42/EEC - Essential Requirements for medical devices

Keywords: tracheostomy tubes, paediatric tracheostomy tubes standard, medical device risk management, usability engineering for medical devices, phthalates labeling, single-use tracheostomy tubes.