Standards › Standard 31 › Standard operating procedures (SOPs)
Standard operating procedure (SOP) · DEN-SOP-001 · Version 1.0 · Approved by the ASF Expert Committee
Supports: 31.1
At a glance
- Only instruments processed in a validated cycle are used (DEN-REG-001).
- Instruments are packed in sealed sterile-barrier packs and dated.
- Every cycle is monitored with the indicators named in this procedure (DEN-REG-001).
- A failed indicator quarantines the load and triggers action.
- Stop and get help straight away if: a load is released for use with a failed indicator, or with no cycle record.
1. Purpose
To make sure every reusable instrument is sterile before it reaches a patient, and that each cycle can be proved (31.1, 31.2).
2. Scope
| Applies to | Clinical and support staff in the hospital |
| Locations | All wards, clinics and departments of the facility |
| When | Whenever the activity described is carried out |
| Does not apply to | Activities covered by another document listed in section 15 |
3. Definitions
| Term | Meaning |
|---|---|
| Clinical lead | The doctor or nurse in charge of the area at the time |
4. Background
Dental instruments that are not properly sterilised carry blood and infection from one patient to the next. A validated process, applied to every instrument, is what makes them safe to reuse.
5. Responsibilities
| Role | Responsibility | Competence |
|---|---|---|
| Infection prevention lead | Owns the validated cycles and the monitoring schedule | Clinician or manager |
| Decontamination operator | Processes instruments and records each cycle | Infection prevention lead |
6. Materials and equipment
| Item | Requirement | Condition |
|---|---|---|
| Records and forms named in this document | Current version | Checked before use |
7. Safety
- Stop and call for help if a patient is at immediate risk. Do not delay urgent care to complete paperwork.
8. Before you start
- Confirm the forms and equipment named in this document are available and current.
9. Procedure
Step 1. Clean and dry.
- Clean each instrument by the manufacturer’s method before packing.
- Dry fully so the sterilising agent can reach all surfaces.
Key point: Clean and dry.
Step 2. Pack and load.
- Pack instruments in sealed sterile-barrier packs with a date.
- Load the chamber within the validated load pattern.
Key point: Packed and loaded.
Step 3. Run and monitor.
- Run the validated cycle for the instrument type.
- Record the chemical and biological indicator results (DEN-REG-001).
Key point: Cycle recorded.
10. Decision points
- No decision points in this procedure.
11. Special situations
| Situation | Action |
|---|---|
| Out of hours | Follow the same steps. Use the on-call contact on the wall of the area. |
12. Escalation
- Any serious problem goes to the duty clinical lead at once and to the clinical director the same day.
13. Monitoring
| Measure | Target | Frequency | Owner | If not met |
|---|---|---|---|---|
| Cycles with complete indicator records | 100% | Weekly | Infection prevention lead | Quarantine the loads and escalate to the clinical director |
14. Records
| Record | Kept in | Retention |
|---|---|---|
| Record named in this document | Patient record or the area file | the period set by the facility’s records policy years |
15. Training
- Staff are trained in this document at induction and refreshed each year, with a recorded competency check.
16. Related documents
| ID | Title | Use |
|---|---|---|
| DEN-REG-001 | Sterilisation cycle and load register | Register |
| DEN-SOP-002 | Dental unit waterline management | Procedure |
17. Evidence
| Reference | Note |
|---|---|
| E-009 | Based on the CDC guidelines for infection control in dental health-care settings (Kohn et al., 2003), ISO 17665 for moist-heat sterilisation, the Minamata Convention on Mercury (2013), IAEA Specific Safety Guide SSG-46 (2018), Council Directive 2013/59/Euratom, and the ADA guidelines on sedation (2016). |
| E-006 | ASF Policy Framework v1.2. Adapted. |
| E-009 | ASF Expert Committee consensus. |
18. Change history
| Version | Date | What changed | Approval |
|---|---|---|---|
| 1.0 | the date of approval | First version | set Expert Committee approval |
E-learning for this document
References
- Accréditation Sans Frontières (2026). ASF Policy Framework v1.2. (E-006)
- Accréditation Sans Frontières (2026). ASF Expert Committee consensus on Standard 1. (E-009)