Not every surface needs the same disinfectant. Romanian Ministry of Health Order no. 1761/2021 defines three levels of disinfection, according to the microorganisms destroyed, and links them to the transmission risk of devices and surfaces. Choosing correctly protects patients and avoids the unnecessary use of aggressive products.
In short
- High level: vegetative bacteria, fungi, viruses, mycobacteria and most spores; mandatory, as a minimum, for semi-critical devices.
- Intermediate level: bacteria, fungi, mycobacteria and viruses, with no action on spores.
- Low level: most bacteria, some fungi and some viruses; sufficient for non-critical devices, after cleaning.
Definitions in Order 1761/2021
| Level | Microorganisms destroyed | No action on |
|---|---|---|
| High | Vegetative bacteria, fungi, viruses, mycobacteria and most bacterial spores | Cannot replace sterilisation |
| Intermediate | Vegetative bacteria, fungi, mycobacteria, viruses | Bacterial spores |
| Low | Most vegetative bacteria, some fungi, some viruses | Mycobacteria, spores, non-enveloped viruses, moulds |
Device classification: critical, semi-critical, non-critical
The Order follows the principle of the Spaulding classification: the risk depends on the tissue the device comes into contact with.
| Category | Contact | Minimum requirement | Examples |
|---|---|---|---|
| Critical | Enter sterile tissue or the vascular system | Sterilisation | Surgical instruments, needles, vascular catheters |
| Semi-critical | Intact mucous membranes, without penetrating the skin barrier | At least high-level disinfection | Flexible endoscopes, endocavity ultrasound probes, anaesthesia accessories |
| Non-critical | Intact skin or minimal contact | Cleaning and at least low-level disinfection | Blood pressure cuffs, stethoscopes, beds, furniture, floors |
How to read a disinfectant’s spectrum
The disinfection level does not appear as such in the authorisation: it results from the spectrum demonstrated by tests to European standards, at a given concentration and contact time. The terms on the label have a precise meaning:
| Term | What it demonstrates | Common standards |
|---|---|---|
| Bactericidal | Destroys vegetative bacteria | EN 13727, EN 13697, EN 1276 |
| Yeasticidal / fungicidal | Destroys yeasts (Candida albicans) / and moulds (Aspergillus brasiliensis) | EN 13624, EN 13697, EN 1650 |
| Tuberculocidal / mycobactericidal | Destroys Mycobacterium terrae / and Mycobacterium avium | EN 14348 |
| Virucidal against enveloped viruses | Active against viruses with a lipid envelope (tested on Vaccinia virus) | EN 14476, EN 16777 |
| Virucidal | Also active against the more resistant non-enveloped viruses (poliovirus, adenovirus, murine norovirus) | EN 14476 |
| Sporicidal | Destroys bacterial spores, including Clostridioides difficile | EN 13704, EN 17126 |
Examples from the GM 2000 range
| Product | Spectrum according to the authorisation | Concentration and time |
|---|---|---|
| Clorom | Bactericidal, yeasticidal, fungicidal, tuberculocidal, mycobactericidal, virucidal (including poliovirus, adenovirus, murine norovirus), sporicidal | 1 tablet / 3 L water, 60 minutes; bactericidal effect in 5 minutes |
| Bionet A15 | Bactericidal, yeasticidal, fungicidal, virucidal, mycobactericidal, tuberculocidal | From 1% / 5 minutes (bactericidal, yeasticidal) to 2% / 90 minutes (mycobactericidal) |
| Hexy Spray | Bactericidal, yeasticidal, mycobactericidal/tuberculocidal, virucidal against enveloped viruses; fungicidal | Undiluted, 1 minute; fungicidal in 5 minutes |
These data are indicative; the authorisation of each product, available on the product sheet, remains the reference document.
Common mistakes
- Using a low-level disinfectant on a semi-critical device.
- Considering a product “virucidal” when the authorisation only covers enveloped viruses.
- Immersing devices in a high-level solution beyond its period of use: the Order limits use of the solution to a maximum of 24 hours or 30 cycles, in covered containers, recorded in a register.
- No records: for high-level disinfection, the Order requires a register with the product, concentration, time of preparation, start and end of the cycle, the list of devices and the signature of the person in charge.
Frequently asked questions
Can high-level disinfection replace sterilisation?
No. Romanian MoH Order 1761/2021 states that high-level disinfection cannot substitute sterilisation. Critical devices must be sterilised.
What level of disinfection is needed for floors and furniture?
They are non-critical surfaces: cleaning and at least low-level disinfection. In high-risk areas or during an outbreak, choose a broader spectrum, according to the facility’s procedure.
What does “enveloped viruses” mean on a disinfectant label?
The product was tested on Vaccinia virus, considered representative of viruses with a lipid envelope (influenza, coronavirus, hepatitis B and C viruses, HIV). It does not cover non-enveloped viruses such as norovirus or adenovirus.
GM 2000 products for this application
Full spectrum, including sporicidal, for surfaces and objects in healthcare facilities.
View product sheet →Concentrate for surfaces, from 0.25% to 5% depending on the intended effect.
View product sheet →References
- Romanian Ministry of Health Order no. 1761/2021 approving the Technical Rules on cleaning, disinfection and sterilisation in public and private healthcare facilities, Annex 1.
- EN 14885: application of European Standards for chemical disinfectants and antiseptics.
- Authorisations of the products cited, available on the product sheets.
Article reviewed by the GM 2000 technical team. Last updated: 22.10.2026. Product information is taken from the authorisations issued by the Romanian Ministry of Health; for other applications, refer to the label and the technical data sheet.
Use biocides safely. Always read the label and product information before use.
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