Standards, guidelines, validation and routine control
Standards
General information on national, European and international standards for the reprocessing of medical equipment
A standard is a technical specification that describes how different objects must be defined in an unambiguous way, for example measurements and weight, or that describes work methods, for example quality management in a process.
Both routine control and validation of washing processes and sterilization processes are regulated by standards.
There are national, European and international standards that describe both how equipment such as autoclaves and washing machines/laundry decontaminators should function, be tested and validated.
The name of the standard is preceded by a prefix that shows whether the standard is applicable nationally, Europeanly or internationally. The national prefix for Norwegian standards is "NS" - Norsk Standard. European standards have the abbreviation "EN" - European standard. European standards apply to all countries that are members of the EU, as well as Norway, Iceland and Switzerland.
ISO standards are internationally applicable, and are prepared by committee members from the various countries' national standards committees.
Important standards for routine control and validation of sterilizers
EN ISO 17665
Describes requirements for development, validation and routine control of steam sterilization processes.
EN 285
Describes requirements for large autoclaves with a chamber size over 54 litres.
EN ISO 15883
The standards group defines general requirements, test methods and validation of laundry decontaminators.
EN ISO 11140-4
Alternative Bowie&Dick test for testing vapor penetration. Alternative to the original 7 kg Bowie&Dick test package described in EN ISO 11140-3.
EN 867-5
Standard describing a test system for hollow instruments. A test system consists of a PCD (Process challenge device) and a chemical indicator type 2. The standard will be replaced and included in the upcoming EN ISO 11140-6.
Quick reference various standards
Norwegian guidelines and recommendations
Here you will find information on recommendations and guidelines that deal with the validation of reprocessing machines in Norway.
The rights to the individual document belong to the issuing body, and all reproduced material is freely available on the internet.
Statement from the Norwegian Medicines Agency regarding the obligation to have the machine park process validated:
In May 2021, a new MDR was introduced in which some equipment that was previously not defined as medical equipment is now precisely defined as such. Equipment for disinfection, washing and sterilization is mentioned. This means that there is no longer any doubt that this is medical equipment.
This follows that the Handling Regulations shall. (Regulations on the handling of medical equipment - Statutory data) This account of training, maintenance, etc. of electromedical equipment used in the health service (as well as a little about equipment outside the health service - e.g. veterinary clinics etc.) The handling regulations are aimed at the health service/health establishment at department director (while the Health Personnel Act is aimed at the individual professional). The department director is obliged to have a quality system. The handling regulations state that the instructions for use must be followed (also what the instructions for use must contain information about validation). If the Handling Regulations are not followed, we are talking about not providing proper health care, and the Health Personnel Act will apply.
Quick reference various standards
Validation
A validation is clear evidence that processes, equipment, materials, procedures or systems lead to expected results. The results are published in a validation report and include comments that are later used to optimize the validated processes.
Annual validation of washing and sterilization processes in the healthcare and dental services is a central part of any infection control work, as it is only such process validation that can give clear answers as to whether the instruments actually become clean and sterile. Cross-contamination and instrument-borne infection is a real challenge for everyone who works with patient care, and the highest possible patient safety can only be achieved by following current standards and best practice in the area.
When washing, disinfecting and sterilizing reprocessable instruments, it is the course of the processes and thus their expected results that are validated.
A validation includes:
Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ).IQ (installation qualification)
Verification that the equipment has been installed according to the manufacturer's specifications, and that, among other things, the following are in place:
User manual
Correct supply of process media (power, water, etc.)
Other conditions related to surroundings
OQ (operational qualification)
Verification that the equipment actually functions as specified when used in accordance with the work procedures. Includes, among other things:
Test with empty chamber
Test load
An assessment is also made here of the quality of the clinic/sterilisation centre's internal procedures, as well as whether these are known and followed as they should be. Feedback in the form of deviations and suggestions for improvement gives the sterilization center the opportunity to work concretely with continuous improvement.
PQ (performance qualification)
A method of providing evidence that the equipment (when installed and operated as prescribed) functions consistently and in line with the specified criteria, and that the processes meet the specifications. Includes, among other things:
Documentation of IQ and OQ
Knowledge of the instruments to be reprocessed
"Worst case" load
Preparations
Packing
Routine control
The routine check is a test that is carried out regularly to check the performance of the equipment in question. You thus get confirmation that the equipment's performance is in line with the validation. The frequency of routine checks depends on the type of unit and process.
Rutinekontroll stor autoklave
Traditionally, the 7-kilos Bowie&Dick-package is central to the routine control of large autoclaves. Ebro has developed an electronic version that provides simple and efficient handling, exact and verifiable results as well as secure storage of test reports.