SIST EN 1782:2000/kprA1:2009

Overview

EN 1782:1998/prA1 (CEN draft amendment, Jan 2009) covers tracheal tubes and connectors used in anaesthetic, respiratory and reanimation equipment. Prepared by CEN/TC 215, this amendment to EN 1782:1998 introduces additional safety, usability and regulatory requirements for manufacturers and those assessing conformity. The draft amendment links the standard to the Essential Requirements of EC Directive 93/42/EEC and adds labelling, clinical evaluation and documentation expectations.

Key topics and requirements

• Scope: Tracheal tubes and connecting pieces (patient airway devices).
• Phthalate labelling: If phthalates are present in parts that come (directly or indirectly) into contact with the patient, the device must be labelled accordingly. (Note draws attention to carcinogenic, mutagenic or reprotoxic substances.)
• Usability engineering (new 4.8): Manufacturers must address usability risks via a usability engineering process and keep a usability engineering file. Compliance may be checked by inspection. Relevant standards referenced: IEC 60601-1-6 and IEC 62366.
• Clinical evaluation (new 4.9): A documented clinical evaluation is required and must be recorded in the device risk management file.
• Biophysical or modelling research (new 4.10): Where appropriate, validated biophysical modelling studies should be carried out and included in the technical file.
• Regulatory and labelling changes (Clause 7):
  • If the manufacturer has no registered place of business in the EU, the authorized representative’s name and address must be provided.
  • For single-use devices, manufacturers must disclose risks associated with reuse in the instructions for use or upon request.
• Annex ZA updates: Clarifies how compliance with this standard confers a presumption of conformity with specified Essential Requirements of Directive 93/42/EEC (medical devices directive) within the standard’s scope.

Practical applications and who uses it

• Manufacturers of tracheal tubes and connectors - to design, document and label products in line with EU requirements.
• Regulatory affairs and quality teams - to prepare technical files, risk management files, usability documentation and clinical evaluations for conformity assessment.
• Notified bodies and auditors - to inspect usability files, clinical evaluation records and technical files during conformity assessment.
• Procurement and clinical engineers - to understand labelling (e.g., phthalates, single-use indications) and safety implications for device selection and reprocessing policies.
• Researchers and designers - to plan validated biophysical or modelling studies that support device performance and safety claims.

Related standards and keywords

• Related standards: IEC 60601-1-6, IEC 62366 (usability/medical device software and ergonomics).
• Relevant keywords: tracheal tubes, connectors, EN 1782, CEN, medical devices, usability engineering, clinical evaluation, risk management, phthalates, single-use devices, Directive 93/42/EEC.