SIST EN 1820:2005/kprA1:2009

Overview - EN 1820:2005/prA1 (Anaesthetic reservoir bags)

EN 1820:2005/prA1 is a CEN draft amendment to the European standard for anaesthetic reservoir bags (based on ISO 5362:2000, modified). Prepared by CEN/TC 215, this amendment clarifies and extends requirements for design, documentation and conformity assessment of anaesthetic reservoir bags used in respiratory and anaesthetic equipment. It supports essential requirements of the medical devices directive framework (see informative Annex ZA).

Key topics and technical requirements

The amendment adds and modifies specific clauses to strengthen safety, usability and regulatory traceability. Important points include:

• Usability engineering (new 4.7)

  • Manufacturers must address risks from poor usability in a usability engineering process (references IEC 60601-1-6 / IEC 62366).
  • Compliance is checked by inspection of the usability engineering file.

• Clinical evaluation (new 4.8)

  • A documented clinical evaluation is required and must be included in the risk management file.
  • Inspectors verify by reviewing the risk management file.

• Biophysical or modelling research (new 4.9)

  • Where appropriate, validated biophysical or modelling studies should be carried out and documented in the technical file.

• Single‑use device disclosure (modification to 7.3)

  • For single‑use devices, manufacturers must disclose risks associated with reuse in the instructions for use or upon request.

• Instructions for use and authorized representative (modification to 8)

  • If the manufacturer has no registered EU place of business, the authorized representative’s name and address must be provided.
  • The date of issue or latest revision of the instructions for use must be shown.

• Materials labelling - phthalates (modification to G.4)

  • Devices containing phthalates in parts that contact the patient (directly or indirectly) must be labelled accordingly. Attention is drawn to carcinogenic, mutagenic or repro-toxic substances.

• Regulatory mapping (Table ZA)

  • The amendment updates Table ZA to map these provisions to the essential requirements of Directive 93/42/EEC.

Practical applications and who uses this standard

• Medical device manufacturers of anaesthetic reservoir bags will use EN 1820:2005/prA1 to design, document and label products to meet European regulatory expectations.
• Regulatory affairs and quality managers will use it for conformity assessment, technical files, usability files and clinical evaluation documentation.
• Notified bodies and auditors will apply the specified checks (usability file, risk management file, technical file) during product assessment.
• Procurement teams and hospitals benefit indirectly through clearer labelling (phthalates, single‑use reuse risks) and improved safety documentation.

Related standards

• ISO 5362:2000 (base standard for anaesthetic reservoir bags)
• IEC 60601-1-6 / IEC 62366 (usability engineering / medical device usability)
• Directive 93/42/EEC (medical devices - referenced in Annex ZA)

Keywords: Anaesthetic reservoir bags, EN 1820:2005/prA1, ISO 5362, usability engineering, clinical evaluation, risk management, phthalates, single-use devices, instructions for use, CEN.