Biocidal Product Efficacy
Ensuring disinfectants and sanitisers meet international antimicrobial performance standards.
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ISO Standards for Biocide Testing
A scientific and regulatory overview of international standards governing the evaluation of disinfectants, antiseptics, preservatives, and antimicrobial-treated products in microbiology.
Scientific Context and Purpose
ISO and harmonised EN standards provide validated, reproducible methodologies for assessing the antimicrobial efficacy of biocidal products. These methods form the technical basis for efficacy claims, formulation optimisation, and regulatory submissions across healthcare, cosmetics, veterinary, industrial, and environmental sectors.
Biocide Test Phases and Methodological Design
Biocide efficacy testing is structured into sequential phases, each addressing increasing levels of practical relevance:
- Phase 1: Preliminary suspension tests demonstrating intrinsic antimicrobial activity (non-claim).
- Phase 2, Step 1: Quantitative suspension tests under defined clean and dirty conditions.
- Phase 2, Step 2: Quantitative surface or carrier tests simulating practical application.
- Phase 3: Field or in-use studies (product- and application-specific).
Key ISO and EN Standards
| Standard | Scope | Target Microorganisms | Typical Performance Criterion |
|---|---|---|---|
| EN ISO 1276 | Bactericidal activity, quantitative suspension test | E. coli, S. aureus, P. aeruginosa, Enterococcus spp. | ≥ 5 log10 reduction |
| EN ISO 13727 | Bactericidal activity for medical and hygienic applications | Healthcare-relevant bacterial strains | ≥ 5 log10 reduction |
| EN ISO 1650 | Fungicidal and yeasticidal activity, suspension test | Candida albicans, Aspergillus brasiliensis | ≥ 4 log10 reduction |
| EN ISO 13697 | Non-porous surface test under simulated practical conditions | Bacteria and fungi (surface-associated) | ≥ 4 log10 (bacteria) ; ≥ 3 log10 (fungi) |
| ISO 11930 | Evaluation of antimicrobial preservation of cosmetic products | Bacteria, yeasts, and moulds | Time-dependent criteria |
Test Parameters and Critical Controls
ISO biocide standards rigorously define experimental parameters to ensure scientific validity and inter-laboratory comparability. These include:
- Defined inoculum concentrations and physiological state of test organisms.
- Use of interfering substances to simulate clean and soiled conditions.
- Validated neutralisation procedures to prevent residual biocidal activity.
- Specified contact times and temperatures aligned with intended product use.
Robust neutralisation validation is essential to avoid false-positive efficacy results caused by antimicrobial carry-over during microbial recovery.
Regulatory and Quality Alignment
Data generated under ISO and EN standards support efficacy claims under regulatory frameworks such as the EU Biocidal Products Regulation (BPR) and cosmetic regulations. Testing is commonly conducted under controlled quality systems, with full traceability, method validation, and statistical integrity.