EN ISO 5361:2023/A1:2026

EN ISO 5361:2023/A1:2026 is the CEN (European Committee for Standardization) amendment to EN ISO 5361:2023 for anaesthetic and respiratory equipment. It reinstates the third edition S1 dimensions for tracheal tubes and connectors by replacing Table 1 in clause 6.3.1.6. Manufacturers, test labs, and procurement teams use it to apply the updated tube dimensions when specifying or checking tracheal tubes.

What does EN ISO 5361:2023/A1:2026 specify?

EN ISO 5361:2023/A1:2026 is a technical amendment to EN ISO 5361:2023. The amendment text is the CEN adoption of ISO 5361:2023/Amd 1:2026 without modification.

The document is organized around the European foreword, the endorsement notice, and the technical change in clause 6.3.1.6. That clause replaces Table 1, which is the dimensional schedule for tracheal tubes.

The amendment is focused on the reinstatement of the third edition S1 dimensions. In practice, it updates the size and geometry data that designers, manufacturers, and test personnel use for tracheal tubes.

What are the key requirements of EN ISO 5361:2023/A1:2026?

EN ISO 5361:2023/A1:2026 changes one main technical point: clause 6.3.1.6 now points to a replaced Table 1 of basic tracheal tube dimensions. That table is the core of the amendment, so anyone making or checking tubes needs to use the revised dimensional schedule.

Table 1: basic tube dimensions

• The table gives basic dimensions of tracheal tubes in millimetres by designated size. This is the reference used for drawing control, inspection, and product comparison.
• It covers designated sizes from 2.0 to 11.0. That matters because the allowable geometry changes across the tube size range.
• Dimension A is the minimum length of the tube. In practice, this is the length check used to confirm the tube is long enough for its intended use.
• Dimension C is the maximum distance from the patient end to the machine end of the inflatable cuff for tracheal tubes designed for a general patient population. This controls cuff location on the finished tube.
• The table also gives a corresponding cuff-position dimension for tracheal tubes designed specifically for neonatal and paediatric patients. This is important because small-patient tubes need different geometry.
• Dimension S1 is the minimum distance from the patient end to the point where the inflating tube separates. The amendment reinstates the third edition S1 values, so drawings and gauges should use the restored separation distances.
• The table note says a shorter Dimension C can reduce the likelihood of endobronchial intubation in paediatric patients, with the rationale given in Annex A.7 of the base standard. In practice, this links the tube geometry to a known clinical risk.
• The dimensions are tied to Figure 1. That means users should read the measurements as geometric requirements on the tube, not as clinical procedure steps.

What terms does EN ISO 5361:2023/A1:2026 define?

EN ISO 5361:2023/A1:2026 uses a few key terms that matter for reading Table 1 correctly.

• Tracheal tube - an airway tube used in anaesthetic and respiratory care.
• Connector - the part that joins the tracheal tube to breathing equipment.
• Designated size - the size marking used to identify which row of Table 1 applies.
• Dimension A - the minimum tube length.
• Dimension C - the maximum distance from the patient end to the machine end of the inflatable cuff.
• Dimension S1 - the minimum distance from the patient end to the point where the inflating tube separates.
• Endobronchial intubation - unintended placement of the tube into a bronchus, which the table note links to cuff-length design in paediatric use.

Who uses EN ISO 5361:2023/A1:2026?

EN ISO 5361:2023/A1:2026 is used by manufacturers of anaesthetic and respiratory equipment, especially makers of tracheal tubes and related connectors. They use it to set product dimensions and to keep production consistent with the revised table.

Quality managers, design engineers, and test laboratories use EN ISO 5361:2023/A1:2026 to verify tube length, cuff position, and inflating-tube separation against the specified sizes. Procurement and regulatory teams use it when they need to compare products or confirm that a supplier is working to the current dimensional basis.

What changed in EN ISO 5361:2023/A1:2026 from the previous edition?

EN ISO 5361:2023/A1:2026 is Amendment 1 to EN ISO 5361:2023. It reinstates the third edition S1 dimensions by replacing Table 1 in clause 6.3.1.6, and the CEN text was approved without modification from ISO 5361:2023/Amd 1:2026.

Which standards are used with EN ISO 5361:2023/A1:2026?

EN ISO 5361:2023/A1:2026 is used together with EN ISO 5361:2023, which it modifies. It is also the CEN version of ISO 5361:2023/Amd 1:2026, so the European text follows the same technical content as the ISO amendment.

What does the EN ISO 5361:2023/A1:2026 document contain?

EN ISO 5361:2023/A1:2026 contains the European foreword, the endorsement notice, and one technical replacement in clause 6.3.1.6. The replaced Table 1 gives the basic dimensions of tracheal tubes and links them to Figure 1.

The table is used for design control, dimensional inspection, and product verification. Its note points readers to Annex A and Annex B of the base standard for clinical context, and the table rationale is identified in Annex A.7.