Proficiency testing program according EN13727 and EN13624

Proficiency testing program according EN13727 and EN13624

We have opened the registration time for participation in the intercomparison until 4th August 2023

Take the opportunity and check your technical competence in the new EN13624:2021 updating changes

Both standars (EN13727 & EN13624) apply to products that are used in the medical area in the fields of hygienic handrub, hygienic handwash, surgical handdrub, surgical handwash, instrument disinfection by immersion, and surface disinfection by wiping, spraying, flooding or other means.

The objectives of this trail are:

  • COMPLY with the accreditation requirements according to EN ISO/IEC 17025, which stablish the requirement of perform proficiency testing programs regularly to ensure the technical competence of your laboratory according your accreditation scope.
  • IDENTIFY problems in your laboratory and help to initiate correction actions.
  • ESTABLISH the efficacy of the assay method
  • ADICIONAL CONFIDENCE for your clients through our participation’s certificate
  • VALIDATE the declared uncertainty estimates.
  • Performance CONTROL monitoring

Proficiency testing programs of 2023 year refers to chemical disinfectants and antiseptics to according to EN 13727 & EN 13624 requirements.

This proficiency test is intended for laboratories:

  • Accredited to EN ISO/IEC 17025, in the process of accreditation or not accredited.
  • Laboratories which are preparing for accreditation according to EN ISO/IEC 17025.
  • Laboratories that want to perform continuous performance monitoring.

SHAPYPRO’s commitment

Organisation and processing of results in concordance with the current standards (ISO/IEC 17043, ISO 5725 and ISO/IEC Guide 35).

Entity(ies) tested:

  • The product to be tested that will be supplied by SHAPYPRO is a disinfectant product and its active ingredient is benzyl C12-C16 alkyldimethylammonium chloride.
  • The strain tested will be
  1. EN 13727. Pseudomona aeruginosa, ATCC 15442
  2. EN 13624. Aspergillus brasiliensis ATCC 16404

Test method:

The technical requirements of EN 13727 and EN 13624 test standards shall be respected. After sending the samples SHAPYPRO will provide the detailed protocol with the test conditions (contact time, temperature, cleaning conditions, etc.).

The test will consist of two stages;

  • Stage 1. Determination of the effective concentration
  • Step 2. Determination of the reduction rate of the three prescribed conditions of the product.

EN13727 and EN13624 test general conditions

Table 1 – Test General Conditions

  EN13727 EN13624
Test condition Bactericidal activity Fungicidal activity
Minimum strains of test microorganisms Enterococcus hirae

Escherichia coli K12

Pseudomonas eruginosa

Staphylococcues aureus

E. faecium (Tª ≥40°C)

Aspergillus brasiliensis

Candida albicans

Additional Any relevant test organims Any relevant test organims
Test temperature Between 4°C to 70°C intervals Between 4°C to 60°C intervals
Contact time Between 1 min to 60 min (at 1 min intervals from 1 min to 5 min and at 5 min intervals from 5 min to 60 min)
Interfering substance
Clean conditions 0.3 g/l of bovine albumin solution
Soiled conditions 3.0 g/l of bovine albumin solution plus 3,0 ml/l erythrocytes
Additional Any relevant interfering substance
Decimal logarithmic reduction ≥ 5 log ≥ 4 log

Schedule (dd.mm.yyyy):

  • Registration end date: 04.08.2023
  • Sample shipment: 07.08.2023
    • Phase I commencement: 04.09.2023
      • Results collection phase I: 27.10.2023
    • Phase II commencement: 27.10.2023
      • Results collection phase II: 22.12.2023
    • Final SHAPYPRO´s report: 31.01.2024

Final report

All results will be statistically processed and a final report will be sent to the participants. This will contain the results of all participants (returned with coding to respect anonymity), a descriptive analysis, tests for outliers, evaluation of participant performance and all other elements useful for interpretation.

🤍image thanks to Storyset🤍

if you want to join us feel free to contact with us at anytime
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