YY 0451-2023 in English

Background of Standard Revision and Technological Evolution

As the industry standard for non-electrically driven portable infusion pumps, YY 0451-2023 replaces the 2010 version and achieves three major upgrades: refined technical indicators (such as flow rate deviation tightened from ±20% to ±15%), comprehensive safety requirements (newly added particle pollution and chemical performance testing), and international integration (modification to adopt ISO 28620:2020). This standard is applicable to neural/vascular/subcutaneous continuous drug delivery scenarios, and explicitly excludes gravity infusion devices and implantable devices.

Comparison of core technical requirements

Analysis of key test methods

1. Flow measurement (Clause 6.2)

Adopt the dynamic weighing method, with the following requirements:
- Average flow deviation ≤±15% (adjustable ±20%)
- Instantaneous flow fluctuation within 80% of the nominal capacity period ≤±50%
The test must be carried out after completing the compression (150N/5s) and tensile (15N/15s) tests to simulate the actual usage conditions.

2. Validation of automatic liquid feeding system (clauses 6.7-6.8)

New models must pass triple validation:
- Standard trigger: liquid feeding volume ≤115% of nominal value
- Fast trigger (50% filling time): liquid feeding volume <75% of nominal value
- Full filling trigger: liquid feeding volume 50%-115% of nominal value

Implementation suggestions

Key points for corporate compliance

1. Material selection: materials that have passed the biocompatibility evaluation of GB/T 16886.1 are preferred
2. Connector design: must comply with the locking requirements of YY/T 0916.6/0916.7, and it is recommended to mark the connector type
3. Process validation: focus on monitoring the sterilization process (EO residue ≤10μg/g) and particulate contamination control (as per Appendix B)

Clinical use tips

According to the requirements of Chapter 8 of the standard, manufacturers must clearly state in the instructions:
- List of contraindicated drugs (such as incompatible chemotherapy drugs)
- Temperature effect coefficient on flow rate (rate of change per °C)
- Intravenous infusion warning label for neurological instruments