Legal Requirements & Overview
The reprocessing of medical instruments is regulated by law. It is based on the IfSG, MPBetreibV and the KRINKO/BfArM recommendations for maximum patient safety.
Instrument preparation according to RKI
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Proper Pre-Cleaning
After use, coarse contamination is removed immediately. This ensures the subsequent disinfection remains effective and hygienically safe.
Cleaning and Disinfection
Residues are removed manually or mechanically using validated agents. Temperature, dosage and contact time ensure successful results.
Instrument Care
Regular care protects function and service life. Joints and hinges are treated with special care oils.
Instrument Packaging
Sterile barrier packaging protects instruments until use. Each batch is sealed in a germ-tight manner and clearly labelled.
Sterilization in the Autoclave
Sterilization is carried out under controlled pressure, temperature and time. Only validated processes guarantee complete elimination of microorganisms.
Release & Documentation
Every sterilization cycle is checked and released. Complete documentation ensures seamless traceability.
Storage of Sterile Instruments
Clean, dry storage maintains sterility. Storage duration depends on packaging and environmental conditions.
Labelling After Sterilization
Each batch is documented with sterilization date, expiry date and the responsible person – using a colour-change indicator.
Documentation After Patient Use
Every instrument is assigned to a patient – for legally compliant traceability and quality assurance.
Hygiene Room per KRINKO
The hygiene room separates clean and contaminated areas. Equipment and workflows follow the KRINKO requirements.
Initial Validation of a Klasse B Autoclave
Before use, it is verified that the autoclave sterilizes reliably. Only validated equipment is RKI-compliant.
Frequently Asked Questions
Real questions from practices, clinics and studios — clearly answered.
Am I required to reprocess my instruments according to RKI guidelines?
Anyone using reusable medical devices on patients must reprocess them – the legal basis is MPBetreibV § 8 and the KRINKO/BfArM recommendation. This is mandatory whenever critical instruments that come into contact with blood or mucous membranes are used. Those who exclusively use non-critical products are generally not affected.
What do the RKI risk classes non-critical, semi-critical and critical mean?
The classification is based on patient contact: non-critical = intact skin only, semi-critical = mucous membranes, critical = penetrates skin/mucous membranes (blood contact). Semi-critical and critical are further subdivided into A/B (critical also C). The class determines the required depth of reprocessing.
Which instruments must I sterilize in packaging?
Critical instruments are sterilized in packaging to maintain their sterility until use. Non-critical and semi-critical instruments may be reprocessed without packaging; mixed loads are possible.
Do I need a Klasse B autoclave?
For wrapped, hollow and porous (critical) instruments, a steam sterilizer of Klasse B with fractionated vacuum is the prescribed standard (DIN EN 13060), because it fully evacuates even narrow lumens. Class S devices cover only a limited range of applications.
Is a washer-disinfector (WD) sufficient, or do I also need an autoclave?
A WD/washer-disinfector handles cleaning and disinfection but does not replace sterilization. Critical instruments must subsequently be sterilized in a Klasse B autoclave.
What type of water does the autoclave require?
Distilled or demineralized/deionized water (conductivity preferably below 15–20 µS/cm). Tap water is unsuitable and can damage the device; a water treatment system ensures consistent quality.
When do I label the batch and how do I document the release?
Labelling takes place after sterilization; at a minimum, the batch number, sterilization date and use-by date must appear on the packaging. Release is carried out by trained personnel after visual inspection and complete documentation (KRINKO 2.2.7/2.2.8, MPBetreibV).
How long does sterilized material remain sterile and how should I store it?
Store dry, dust-protected and separated from non-sterile material (max. approx. 60 % relative humidity). Guidelines: unprotected max. 48 hours, protected up to 6 months (DIN 58953), following the first-in-first-out principle. Damaged or moist packaging is considered non-sterile.
Does my autoclave need to be validated – and how often?
Yes, reprocessing must be performed using validated processes (MPBetreibV § 8). After the initial validation at commissioning, regular revalidation follows – typically every 24 months or after 1,000 cycles; large devices or heavy utilization may require shorter intervals.
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Frequently Asked Questions
Instrument preparation according to RKI – key questions answered clearly.