It is important to ensure that this effect is considered during PQ and is commonly addressed during PQ by ensuring that the time of transfer specified in the PQ reflects the maximum time specification to be used for product transfer during routine sterilization.
When preconditioning is used, the product should be preconditioned within the specified time range. When preconditioning is not used, the temperature and relative humidity within the load should be within defined limits prior to the end of the conditioning phase of the cycle. The temperature and humidity profile within the sterilization load should be evaluated during the time that is needed for the sterilization load to attain the minimum predetermined temperature and humidity. For product, consideration should be given to locating humidity sensors in areas of the load that are most likely to experience variation in humidity, e.
These locations should take into account hot or cold spots located during OQ. The locations of hot and cold spots within a load can be significantly different than the locations in an empty chamber. During PQ, it is important to take into account the relationship between the load temperature and the chamber temperature in order to ensure adequate load temperature in the routine process. These sensors should also be functionally compatible with EO and with any diluent gases.
Parametric release is based upon a documented review of processing records rather than the testing of biological indicators or PCDs. The values and tolerances for both RH and EO concentration might need to be generated after review of a predefined number of routine cycles. The rationale for the number of runs selected should be justified and recorded.
This can be influenced by uniformity of the load, existing data, seasonal variations or frequency of sterilization. EO sterilizers used in health care facilities might not be adequately equipped to permit parametric release of product. If the product has been exposed to extreme temperatures, for example during transport, it might be necessary to store the product prior to preconditioning, or extend preconditioning time to allow the internal temperature and humidity to be within acceptable ranges.
Monitoring data for the operation of the preconditioning area should be reviewed in conjunction with other data for the release of product. The relative humidity value is then determined using the steam tables by a ratio of the partial pressure to the saturated vapour pressure for the actual cycle process temperature.
This will indicate the relative humidity value in the head space of the chamber and will be accurate until load or other reactions impact the actual water vapour content in the head space.
Consideration should be given to the amount of moisture introduced into the chamber with the load from preconditioning. See D. As EO concentration is a key variable affecting the efficacy of the sterilization process, it is considered essential that a separate second system be provided for documenting that the pressure rise is due to EO admission see AAMI TIR15[25] for more information. During EO injection and EO exposure phases of the sterilization process, EO is absorbed by product and packaging materials, which influences the correlation between the control measure pressure differential and the secondary measure i.
The purpose of external chemical indicators is to differentiate between processed and non-processed items. They do not establish whether the parameters for sterilization were achieved. Indicators should be of Class 1 specification in accordance with ISO Internal chemical indicators in health care facilities: a An internal chemical indicator can be used within each package to be sterilized. If used, the chemical indicator should be placed in that area of the package considered to be the least accessible to EO, heat, and humidity penetration; this might or might not be the centre of the pack.
While internal chemical indicators do not verify sterility, they allow detection of procedural errors and equipment malfunctions. The use of chemical indicators that respond to all the parameters of the EO process is beneficial. The user should be adequately trained and knowledgeable about the performance characteristics of the indicator in order to make an informed decision based on the result shown.
The complete unused package, including load identification and the chemical indicator, should be returned to the processing department for appropriate follow up. The results of the physical monitoring, chemical indicators elsewhere in the load, and the biological monitoring, should be reviewed, in order to reach a conclusion as to whether the entire load should be recalled or not. Records of this review should be retained.
A single non-responsive or inconclusive indicator should not be considered as evidence that the entire load is non-sterile. Chemical indicators can indicate problems associated with incorrect packaging, incorrect loading of the sterilizer, overloading of the sterilizer chamber, malfunctions of the sterilizer, incomplete delivery of the sterilization parameters, or inadequate preconditioning.
Therefore, data are gathered for additional processing parameters such as direct analysis of chamber relative humidity and EO concentration, in order to ensure that the sterilization process has met specification.
The requirement to measure temperature within the sterilizer from a minimum of two locations is established in order to ensure that an undetected fault in a temperature sensor does not lead to the inadvertent release of an improperly processed load. If there is a difference in the two temperature data points, the acceptable temperature difference should be defined within the processing specification. If either the controlling or the monitoring sensor do not meet specification and an investigation cannot determine the accuracy of the chamber readings, the load is rejected b Humidity measurement.
The benefit of these methods is the real-time indication throughout the conditioning phase. Electronic sensors require periodic calibration to offset the effect of exposure to the EO gas and can require replacement after repeated exposures to EO due to irreversible deterioration of materials currently utilized as sensing elements. The frequency of analysis required to demonstrate that the minimum EO concentration is maintained throughout EO exposure should be established during the PQ studies.
Monitoring throughout the EO exposure dwell period should also be done as part of the validation, in order to determine how the EO concentration changes over time. The results of this analysis are specific to the product and load configuration being analysed. The analysis performed during the PQ study will result in documented specifications for how often direct analysis should be performed during the cycle.
It is recommended that when direct analysis of EO concentration is performed, at a minimum, direct analysis of EO concentration be performed during the first and last portions of EO exposure. Particular attention should be given to the measurement and documentation of humidity during conditioning and that of EO concentration during exposure. The EO sampling device providing direct EO concentration measurement using IR, GC, microwave, and other similar technologies should be positioned in a location to represent the EO gas concentration within the sterilizer chamber.
However, it is important to understand that this measurement provides an EO concentration at that position in the chamber throughout the entire exposure phase without any restrictions of reactivity effects or load impact. The reproducibility and accuracy of the results from direct analysis should be determined during PQ.
Routine cycle analysis should fall within the determined range for the cycle to be acceptable. It can be necessary to introduce an equilibration time at the start of the EO dwell phase of the cycle to allow the chamber concentration to stabilize as the EO gas is distributed throughout the chamber and penetrates into the void spaces in the load.
NOTE 1 An electronic sensor measures EO gas concentration at only one sample site, whereas the calculated EO gas concentration represents the mean EO gas concentration within the space volume available for EO gas molecules to reside. Due to several factors, such as EO sensor dynamic performance characteristics, placement of the EO sensor within the volume occupied by the EO gas molecules, potential stratification within the chamber especially when the sterilant is made up of both EO and diluent gas molecules, selective absorption and adsorption of EO in the load and the volume taken up by the load, the values obtained by calculating the mean EO gas concentration can differ considerably from the direct measured value.
NOTE 2 Health care facilities do not routinely use parametric release. If parametric release has been approved and used, product can be released based on compliance with specified process parameters. Routine release of a product following sterilization can be based on a review of electronic records in lieu of paper records.
Likewise, required signatures can be made electronically. The review of processing records and the decision to release should be performed by qualified individuals. This investigation should be documented and the subsequent handling of product should be in accordance with documented procedures. If a controlling or monitoring sensor has failed, the run should be rejected, unless a there is an assignable cause for the failure, and b data from the remaining sensors are within specification.
If the decision is to reprocess the load, the suitability of the product and its packaging system for re- sterilization should be established. Records of the original sterilization should be traceable from the re-sterilization records.
If the effect of repeated exposure on the packaging system is not known, product should be repackaged before resterilization. The use of a comprehensive product and process change control system is recommended. One parameter commonly monitored to ensure the continued ability to sterilize the load is the product bioburden. The bioburden should be monitored per ISO Decontaminated medical devices should be visually examined for cleanliness prior to terminal sterilization.
Medical devices that are not clean should not be sterilized. Policies and procedures should be in place to ensure that medical devices are adequately decontaminated prior to sterilization see ISO and the ISO series.
It is essential for health care facilities to obtain from the manufacturers detailed reprocessing instructions specific to the medical device, e. Policies and procedures should be in place to ensure that medical devices are decontaminated. The procedures should be documented, and maintenance personnel should be trained. If these data are used for product release, it could result in loads being released that have not been adequately sterilized. In order to do so, it is common practice to perform periodic requalification of equipment and should include: a review of IQ status of equipment; b assessment of trends in equipment performance; c temperature and relative humidity profiles of the preconditioning areas if used ; d chamber temperature profile; e temperature profile of the aeration areas if used.
These requalification exercises should indicate no significant changes in the performance of preconditioning if used , chamber or aeration areas since the previous re qualification. If equipment changes are necessary as a result of these exercises, requalification of OQ might need to be repeated.
NOTE For large preconditioning or aeration rooms containing multiple sterilization loads, the extent of requalification can be reduced if there have been no significant changes in equipment.
The rationale for reduced requalification is documented. Based on this review, the sterilization specialist should determine the extent of physical and microbiological requalification required. The review and decision should be documented. This can be required in certain situations, e. This would typically include, minimally, one fractional or half cycle exposure including load temperature and humidity measurements. Fractional cycles in a developmental chamber can also be used to support a requalification program, but requalification of the production chamber should be performed in the production chamber.
Requalification can also include verification that if the sterilization process specification is changed, then requalification of the sterilization process should include confirmation that product meets allowable limits for EO residuals as specified in ISO In all of the above cases, it is important to document the decisions taken as well as the rationale for those decisions, and to define the plan for future review of requalification.
Figure D. Requalification can include verification that allowable product EO residuals as delineated in ISO are being met. It is important to formally assess the need for requalification of the sterilization process at least annually to ensure that inadvertent process changes have not occurred and to demonstrate that the original validation remains valid.
The requalification program should define acceptable ranges and levels of variability in performance that are necessary to maintain the validity of the original validation from year to year. The impact of the non-conformity on the validity of the requalification should be assessed and the rationale for the decision s reached should be documented. Further activities pertaining to the requalification should proceed with proper quality system oversight.
The study should demonstrate that product bioburden population or resistance has not increased to a level which might potentially invalidate the suitability of the internal PCD, or compromise achievement of the required product SAL. It does not require that the equipment be physically identical. Even if the parameters delivered by the equipment are not statistically identical, the processes delivered can still be equivalent if they are all capable of running the process within the defined, validated process limits see AAMI TIR 28[26].
Process equivalence among multiple pieces of equipment is intended to minimize the amount of testing required to qualify the process. The sterilization process should be validated in one chamber. Equivalence can also be used to reduce requalification of several pieces of equipment.
The equipment used to deliver a sterilization process commonly consists of a chamber or room and ancillary control systems. Sterilization process equipment might be located within a given processing facility or among several facilities.
This equipment can be used independently to deliver the same process conditions and could be exactly the same design or might differ in size or in the extent of ancillary equipment. Process equivalence can be established through analysis of process data in combination with a microbiological evaluation. The process data should demonstrate that the candidate equipment is performing within an acceptable range of control i.
The data analysis should confirm that the process operates within the defined tolerances for the validated parameters. The microbiological evaluation will demonstrate that the required SAL is achieved. The criteria to be met prior to the establishment of a process equivalence program are: a full validation of the sterilization process in at least one existing system according to the requirements of Clause 9; b performance of the IQ and OQ studies demonstrating and documenting that all equipment has been installed in accordance with engineering specification requirements and operates in accordance with those requirements; c definition of the process to include the tolerances allowed and documentation of all phases of the process; and d process data analysis associated with the validated tolerances for the candidate equipment and the original equipment.
Data obtained during the PQ on the process can also be used. The delivered parameters and tolerances should be those that were previously validated in the PQ of the sterilization process in the original equipment. The evaluation of equivalence involves performing a process analysis and evaluation as well as a microbiological evaluation. Process data should be collected from the candidate equipment.
These data should be compared with the parameter limits for that specific sterilization process and the results obtained in the PQ of the original equipment. The parameter limits are those established in the initial validation for the sterilization process including all process requirements identified in this International Standard in the existing equipment. The specifications, acceptance criteria, and pallet or load configuration should be the same as those defined for the initial PQ.
The actual parameters to be evaluated in the equivalence determination are generally a subset of the entire process specification. The parameters selected and the rationale for their selection should be documented. Statistical methods that evaluate both the central tendencies of the test data and the degree of variability of the data can be used in this evaluation.
If the process analysis and evaluation do not meet the established acceptance criteria, then it is not possible to demonstrate process equivalence.
An evaluation that compares the load temperature and humidity profiles within each environment should be performed. At a minimum, temperature and humidity uniformity within the load and the relationship of this uniformity with the corresponding set points and recorded control variables for the areas should be evaluated.
If the pieces of equipment use different set points or have different control limits, it might not be possible to declare that they are equivalent. Process equivalence for the preconditioning or aeration processes can be established if analysis of performance data concludes that conditions within the load meet the parameter limits e. The critical process and load parameters to be compared should be defined for the sterilization process before the evaluation is performed.
These parameters are unique for each sterilization process but can include the following: a Load parameters: 1 product temperatures — temperatures achieved and their distribution within the load during EO dwell; 2 product humidity — humidity achieved and its distribution within the load at the end of conditioning. This parameter can be measured directly or can be based on pressure rise due to steam injection; 2 chamber process temperature at selected times during the cycle e.
An analysis of the process data are used to indicate that the processes are or are not equivalent in their ability to meet the existing process parameter limits and any additional acceptance criteria. The data generated should be analysed and compiled in a format that will allow for its use in future process equivalence determinations. NOTE If the run used during process analysis was a fractional or half cycle and included microbiological monitoring, then the data can also be used for this evaluation.
In addition to the delivery of the specified product SAL, additional factors that should be evaluated include any changes to the sterilization location or manufacturing location that might have an impact on the bioburden level of the product as presented for sterilization. Increased distances between the manufacturing facility and sterilization site might result in higher bioburden levels, especially if the product will support microbial growth.
Differences in manufacturing environments might lead to the manufacture of product with higher or more resistant bioburden levels than previously qualified, even if the product does not support microbiological growth.
Another issue to be evaluated when shipping product between sites is the difference in shipping conditions, such as time in transit and seasonal effects e. If the different pieces or sets of equipment are equivalent, then the requirement for a reduced MPQ has been satisfied through the testing that was already performed and no further qualification would be necessary.
This review should be conducted before changes are made and should be part of the change control process. If any process fails the periodic equivalence review, then it should be removed from the equivalence list and requalified on its own. At a minimum, this documentation package should include: a The complete specification for the candidate equipment, which fully describes the equipment, operating specifications, and tolerances, and which refers to or provides a list of applicable operating procedures, calibration procedures, and maintenance schedules.
This specification should include or reference the current IQ per this International Standard. The evidence or assessment should include or reference the current OQ. This comparison should clearly demonstrate that all major systems and critical parameters were assessed, including statistical analysis if used. This conclusion should include or reference any additional tests performed to supplement the existing validation study and any further testing performed for confirmation or qualification for routine release of product from the existing validated cycle e.
Although product families can be used for other reasons EO residuals, bioburden, or biocompatibility for EO sterilization a product family usually refers to products that have been grouped together for the purposes of determining that the required SAL has been delivered to the products during the MPQ.
An EO product family can consist of various combinations of similar products. For example, a product family might contain a series of catheters that differ only in their sizes or a variety of products that are made in the same environment with the same material. When products are grouped into families it is important that they are grouped based on a rationale that is appropriate for the EO sterilization process.
The use of product families makes the validation process simpler since all products in the family would be determined to represent an equivalent or lesser challenge to the sterilization process than the representative product or internal PCD. In addition to product families, processing categories can also be used in EO sterilization routinely once the PQ has been completed.
A processing category is a collection of EO product families that can be dissimilar in the details used to establish the product family, such as material of construction or packaging, or manufacturers, but each of the EO product families within a processing category should be qualified in a common sterilization process. For example, a collection of products intravenous sets might constitute a product family and might be placed in a processing category that includes a separate collection of products e.
The commonality within the processing category might be the PCD that represents the microbial challenge for those products in that group. All products within this processing category should present an equivalent or lesser challenge to the sterilization process when compared with the worst-case product, representative member, or internal PCD which is placed within the product sterile barrier system.
The review for product equivalence can be conducted within each product family or processing category. Alternatively, a worst-case product or representative member can be selected for the qualification study. In the following paragraphs, several aspects of product evaluation are addressed. A system to evaluate these aspects should be addressed by the design or change control process.
Consideration should be given to functionality, integrity, stability, biocompatibility, and residuals, with special consideration given to determining the effect that the sterilization process might have on drugs that could be included in devices or components. For products that contain certain types of finished components e. The EO process for which the product will be tested should constitute a representative challenge to the product and its packaging system.
Documentation should address how the challenge process differs from the nominal process, and the product qualification should demonstrate that these parameters are acceptable for product acceptance.
The candidate product and its packaging should be evaluated to determine the effect on product EO residual levels, and any changes to either should be evaluated for the impact on product release. ISO should be used as guidance for making this evaluation.
Examples of possible changes include longer lumens, the addition of closures, or a larger number of mated surfaces or product density.
This AAMI resource keeps you up to date with standards-related activities:. Download PDF. Information is available here. Registration for the event will be available soon. If you would like to comment on one of the draft documents listed below, contact the individual indicated by e-mail to receive a PDF copy of the draft. These copies are free. Comments due August 16, This includes information for processing prior to use or reuse of the medical device.
Applicable for medical devices that are intended for invasive or other direct patient contact or that otherwise present the risk of transmission of infectious agents. Processing instructions are not defined in this standard. Rather, this International Standard specifies requirements to assist manufacturers of medical devices in providing detailed instructions for processing that consists of the following activities where applicable: pre-treatment at the point of use; preparation, cleaning, disinfection; drying; inspection, maintenance and testing; packaging; sterilization; storage; transportation.
Contact: Amanda Benedict. Contact: Colleen Elliott. This standard seeks to provide a recommended framework for new or established education programs in health care technology management HTM.
Contact: Ovidiu Munteanu. The committee is seeking user, regulatory and general interest members to participate in the development of TIR Regulatory Science. Digital Transformation. Transitional Periods. Contact Us. Johner-Institut Product Development And more Content overview 1. Introduction » 2. Regulatory requirements » 3. The ISO standard » 4. Eight practical tips » 5. Implementation support » 6. Conclusion, summary ». Introduction to the world of ISO a Definition of terms.
The standard does not add any notes for this definition. While this probability can be reduced to a very low number, it can never be reduced to zero. All three are considered processing. In terms microorganisms, a distinction is made between: Bacteria, e.
A lot of the devices named in this section do not fall within the scope of ISO It does not apply to: Non-critical medical devices Textiles e.
The standard defines the criticality categories in the informative Annex C: Device criticality Definition: Devices Example Not critical … come into contact with intact skin or are devices that are not intended for direct patient contact Blood pressure cuffs, bedpans, crutches and surrounding surfaces Semi-critical … come into contact with mucous membranes or non-intact skin Anesthesia systems, ventilators Critical … usually penetrate sterile parts of the human body Surgical instruments, implants, invasive medical devices The standard only takes responsibility for single-use devices that are only processed, i.
Annex I, paragraph Further information Read more on the biocompatibility and ISO here. The ISO standard: a Structure of the standard The standard is relatively slim at just 36 pages and the fourth and fifth sections together only take up a single page. The informative annexes, which together are 10 pages long, are very helpful. The standard does not specify how manufacturers should carry out this validation.
Manufacturers must factor all the typical processing steps see below into this risk analysis. They must then determine the information that needs to be provided based on this analysis. Provide information The information to be provided must include the elements specified in section 6 for all processing steps. A typical processing procedure contains several steps see Fig.
Eight practical tips for implementing ISO Tip 1: Think about processing even in the design stage Manufacturers should already be keeping an eye on processing even in the development stage. They should pay particular attention to the: Choice of geometry Areas that are hard to reach must be avoided so that cleaning, disinfection and sterilization can be performed more easily.
This affects, for example, cavities bag lumens, thin lumens , open mechanisms and transitions edges, seams.
Requirements resulting from processing If there are areas that cannot passively be reached by detergents and disinfectants, these areas must be actively rinsed e.
Choice of materials Choosing the right materials in crucial in two ways: Firstly, they must easy to process. Secondly, they must be able to survive a lot of processing cycles without compromising mechanical or biological safety. For example, materials that become porous are more difficult to clean, disinfect and sterilize. Choice of processing procedure A lot of developers design their devices based on its intended purpose in order to optimize its benefits.
The choice of processing procedure takes a back seat. In general, mechanical processing is always preferable. Mechanical processing can have consequences for the design of the device. Notified bodies are increasingly asking how it is ensured that no production residues e. If the process chemicals were defined and controlled more precisely, this would be less of a problem or even not a problem at all.
Risk management file Tip 4: Work with device families rather than individual devices Medical device manufacturers should make use of the option to take the whole device family into account rather than each individual device. Worst case scenarios have been proven to be successful. If no EU declaration of conformity has been issued, the declaration is incomplete or technically not documented, the medical device can be uso as officially non-compliant.
This ensures that the medical device is free from any viable microorganisms when reused. Request a quote from us — by phone or via online request. In the future, only these specially designated bodies will be able to carry out conformity assessments for high-risk products.
Take the next step How can we help you? Rights as a patient Recycled medical devices must be as safe for the patient as first or single used. This means that the products must not be microbially contaminated or functionally impaired. To ensure this, the preparers have to: You will receive a test report incl. As a manufacturer, you are required to recommend a validated reprocessing process. Check instructions for use. This particularly applies to Class I medical devices which must be sterilized before use and which have not yet been subject to inspection by a Notified Body prior to market approval.
The Medical Device Regulation combines two independent medical device directives. If the does not deliver then, it may violate the medical device law. To the reprocessing of disposable products. The classification includes an overall assessment and, if applicable, a rating in accordance with EN ISO as well as other standards and acceptance criteria.
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