What does the cycle "from patient to patient" mean?
The term "from patient to patient" describes the idea that a medical device should be at least as safe to use after each reprocessing cycle as it was before use. Every stage in the cycle contributes to this – and can jeopardize the entire process if not performed correctly.
A simplified overview:
- Product development & material selection:
It is already determined at this stage whether a product can be meaningfully cleaned, disinfected and sterilized – including biocompatibility and material resistance to cleaning and sterilization processes. - Production & Cleanliness:
During manufacturing, purity, bioburden, and, if applicable, sterility requirements must be met. Tests such as bioburden (ISO 11737-1), sterility (ISO 11737-2), and TOC analyses serve as the basis for process development, batch control, and risk assessment. - Packaging & sterile barrier
Packaging systems must form a reliable sterile barrier and be validated – e.g. according to ISO 11607-2, supplemented by EN 868 6 and ASTM F1608 for materials and microbiological barrier testing. - Sterilization
processes (e.g. steam according to ISO 17665-1, small/large sterilizers according to EN 13060 / EN 285) are developed, qualified and monitored. - Clinical Use:
In patient care, risk management, instructions for use, and clinical procedures are intertwined. Errors or deviations can have consequences along the process chain, for example, if cleaning steps are not performed according to the instructions for use. - Return transport & pre-cleaning:
Transport, intermediate storage and pre-treatment (e.g. pre-rinsing, soaking) influence the initial conditions for machine processing and must be compatible with the IFU. - Cleaning & Disinfection (RDG):
Washer-disinfection devices are type-tested and validated according to ISO 15883. Methods for cleaning evaluation are described, among others, in ISO 15883-5 and ANSI/AAMI ST98. These define how, for example, protein, hemoglobin, or TOC can be used as cleaning markers. - Cleanliness verification & implant cleanliness:
For many products, especially implants, quantitative cleanliness criteria must be met – e.g., according to ISO 19227. TOC measurements and other parameters are used here as sum and marker values. - End-of-Life / Durability under Repeated Reprocessing:
Repeated washer-disinfector cycles and sterilization processes put stress on materials, coatings, surfaces, and functional mechanisms. End-of-life tests simulate this multiple stress – e.g., using cyclic steam exposure (ISO 17665-1), accelerated aging (ASTM F1980), material resistance (ISO 21530), particulate cleanliness (AAMI TIR42), and microbiological parameters (ISO 11737).
This allows for an assessment of whether a medical device can be safely reprocessed throughout its entire lifespan. - Release for reuse
At the end of the reprocessing process, the medical device is documented and released for use – this release is only valid if all previous steps have been validated and monitored within a quality management system.
Your testing modules along the medical device lifecycle
The following service areas together form a complete testing offering for the validation of reprocessing processes and life cycle aspects of your medical device – from cleanliness verification to washer-disinfector and sterilization validation to packaging and microbiology testing.
ISO 17664 – Validation of manufacturer's specifications
Check the validatability of the reprocessing processes
ISO 17664 specifies the process steps manufacturers must indicate for reprocessing. HygCen Germany conducts neutral testing to verify that these described procedures – cleaning, disinfection, packaging, and sterilization – are technically feasible and can be validated according to the standard . This is not IFU consulting, but rather purely accredited testing for effectiveness and reproducibility.
ISO 15883 – Validation of the cleaning and disinfection of medical devices
Safely validate cleaning and disinfection devices
The ISO 15883 series defines requirements for washer-disinfectors (WDs) and their validation. HygCen Germany conducts type testing as well as process and revalidation – including cleaning verification according to ISO 15883-5 and ANSI/AAMI ST98 (protein, hemoglobin, TOC). Suitable for both operators and equipment manufacturers.
ISO 17665-1 / EN 13060 / EN 285 – Sterilization validation
Ensure steam sterilization processes comply with standards.
We validate sterilization processes in small and large sterilizers according to ISO 17665-1, EN 13060 and EN 285 – including performance qualification, load studies and routine monitoring. Alternative methods such as formaldehyde and H₂O₂/plasma are also considered.
Cleanliness verification & cleaning validation (TOC, protein, hemoglobin, ISO 19227)
Quantitatively demonstrate cleaning performance
Cleanliness is a prerequisite for successful reprocessing: We test hygiene and implant cleanliness using TOC, protein, and hemoglobin. For implants, ISO 19227 also applies. These tests complement washer-disinfector validations according to EN ISO 15883-5 and ANSI/AAMI ST98 and support the validation of the processes described by the manufacturer.
End of Life / Material & Functional Durability
Stress tests throughout the entire reprocessing cycle
Repeated cleaning, disinfection, and sterilization affect materials, surfaces, and functionality. HygCen Germany tests durability and functional reliability over defined reprocessing cycles – including steam/plasma exposure, material changes, aging (ASTM F1980), and particulate cleanliness (AAMI TIR42).
Bioburden & Sterility – ISO 11737-1/-2
Microbiological basis for safe processing
Bioburden and sterility tests according to ISO 11737-1/-2 show whether products can be provided clean-ready or sterile, or sterilized. HygCen Germany performs quantitative bioburden determinations, method validations, and sterility tests for development, process, and routine applications.
Supplementary testing services for processing equipment
These services are aimed at manufacturers and operators of reprocessing equipment. HygCen Germany tests the basic performance and compliance of washer-disinfectors, sterilizers, sealing devices and other equipment in accordance with the applicable European and international standards.
Type testing of processing equipment
Equipment testing according to EN standards
We test cleaning and disinfection equipment, sterilizers, sealing devices, drying cabinets and other reprocessing equipment in accordance with the applicable standards – e.g. ISO 15883-1/-2, EN 13060, EN 285, EN 11607-2, EN 14180 and EN 14937. The type test assesses the basic performance of the device regardless of its place of use.
Why HygCen?
- independent, DAkkS-accredited testing laboratory
- 30 years of expertise in reprocessing validation
- Strictly neutral role (no IFU advice)
- QES signed reports
- Complete coverage of all standard components (RDG, sterilization, packaging, microbiology, implant cleanliness)
- Referral to external processing/regulatory consultants possible
HygCen is a neutrally accredited testing laboratory and performs tests and validations according to the relevant standards. We do not design or formulate Inspection Function Reports (IFUs) and do not provide process selection advice. External consultants develop the reprocessing strategy and IFU content; we verify whether the described processes are validatable under standard conditions and deliver the corresponding test reports.
Not necessarily. Often a step-by-step approach is advisable: for example, first washer-disinfector validation and cleanliness verification, then sterilization and packaging validation, and finally microbiological testing. The crucial point is that a consistent overall picture emerges that meets the requirements of ISO 17664, MDR, and relevant guidelines (e.g., KRINKO/BfArM, DGKH guidelines).
- If you are a manufacturer and have already designed an IFU, the ISO 17664 page is the best starting point.
- If you are an operator or a CSSD/AEMP, the page ISO 15883 (RDG) or Sterilization Validation will usually lead you to the quickest answers to your questions.
- If cleanliness, implant cleanliness or complaints are the focus, the page Cleanliness Proof & Cleaning Validation is a good starting point.
Yes, in many cases it is efficient to combine washer-disinfector, sterilization, and packaging validation in a coordinated program. This allows for consistent documentation of reprocessing procedures and leverages synergies with samples, loads, and test specimens. However, the results typically remain assigned to individual standard blocks to ensure traceability during audits.
These recommendations specify the reprocessing and validation requirements in the German healthcare system and supplement the standards. HygCen considers such guidelines when interpreting testing requirements, without itself providing regulatory advice. The actual implementation in hygiene concepts, SOPs, and IFUs is the responsibility of the operators and external consultants .
The easiest way is to send us a brief description of your product, the existing processing procedures, and the target standards (e.g., ISO 15883, ISO 17665-1, ISO 19227). Based on this information, we can then prepare a structured testing proposal for you.
Typically, this includes: product type, materials, type and duration of contact, planned reprocessing procedures, relevant standards, and target markets (EU, USA, etc.). The more precise the preliminary information, the more effectively we can plan the testing program.
No. HygCen is accredited to perform all relevant tests along the reprocessing cycle – including cleaning validation (including TOC, protein, hemoglobin), washer-disinfector validation according to ISO 15883, sterilization validation (ISO 17665-1, EN 13060, EN 285), packaging and barrier testing (ISO 11607-2, EN 868-6, ASTM F1608), and bioburden and sterility testing according to ISO 11737-1/-2.
For process and IFU consulting, HygCen collaborates with independent partners and remains strictly neutral in all testing.
Yes. If you need support with creating or revising IFUs, process design, or regulatory questions regarding the MDR, we can, upon request, put you in touch with experienced, independent medical device consultants. HygCen itself does not offer consulting services and focuses entirely on the neutral, accredited auditing of reprocessing procedures.
Further links
ISO 17664 - Validation of manufacturer's specifications, ISO 15883 - Waste Disposal Device Validation, ISO 17665-1 / EN 13060 / EN 285 - Sterilization Validation, Cleanliness Verification - TOC / Protein / Hemoglobin / ISO 19227, End of Life - Material and Functional Durability, Bioburden & Sterility - ISO 11737-1/-2, Type Testing of Reprocessing Equipment, Packaging & sterile barrier – ISO11607-2