Quantitative suspension test for the evaluation of bactericidal and yeasticidal activity of chemical disinfectants and antiseptics used medical areas according to EN13727:2012+A:2015 and EN13624:2021
This test considers the practical conditions of application of the product, including contact time, temperature, test organisms and interfering substances, i.e., conditions that may influence its action in practical situations.
Both standards apply to products that are used in the medical area in the fields of hygienic and surgical handrub and handwash, instrument disinfection by inmersion, and surface disinfection by wiping, spraying, flooding or other means were medically used are indicated.
Proficiency testing program EN13727 and EN13624
The test protocol shall specify a test method and minimum requirements for the bactericidal activity of chemical antiseptics and disinfectants (test sample) that form a homogeneous, physically stable preparation when diluted with hard water.
Our Proficiency Testing Programs
Interlaboratory comparisons are widely used for a number of purposes and their use is increasing internationally:
- to evaluate the performance of laboratories in carrying out specific tests or measurements and to monitor the ongoing performance of laboratories.
- identify problems in laboratories and initiate actions for improvement.
- establish the effectiveness and comparability of test or measurement methods.
- provide additional confidence to customers of the laboratories.
- identify differences between laboratories.
- instruct analysts participating laboratories because of the results of these comparisons.
- validate reported uncertainty estimates.
- evaluating the performance characteristics of a method – often described as collaborative trials.
- assigning values to reference materials and assessing their suitability for use in specific test or measurement procedures.
- support statements of equivalence of measurements by international bodies “key comparisons” or “ring trials”.
Proficiency testing involves the use of interlaboratory comparisons for the determination of laboratory performance as described in points a) through g). Proficiency tests do not normally address purposes h), i) and j), because these applications assume that laboratories are competent. However, these applications may be used to provide independent demonstrations of the competence of laboratories. The requirements of International Standard ISO/IEC 17043:2023 can be applied to many of the operational and technical planning activities for purposes h), i) and j).
ISO/IEC 17025:2017 assurance of the validity of results
One of the most important requirements of the ISO/IEC 17025:2017 for the activity accreditation it must ensure the validity of its results.
The resulting data should be recorded in such a way that trends are detectable and where possible, statistical techniques should be applied to review the results. This service is offered by SHAPYPRO for our clients.
This monitoring should be planned and reviewed and include, where appropriate.
EN13727 and EN13624 test general conditions
Table 1 – Test General Conditions
|Test condition||Bactericidal activity||Fungicidal activity|
|Minimum strains of test microorganisms||Enterococcus hirae
Escherichia coli K12
E. faecium (Tª ≥40°C)
|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)|
|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|
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