(Combined revision of ANSI/AAMI/ISO and ANSI/AAMI/ISO TIR). Sterilization echecs16.info PREVIEW. ANSI/AAMI/ISO “Sterilization of health care products – Ethylene oxide -. Part 1: Requirements for the development, validation and routine control . ISO. First edition. Corrected version Details of the software products used to create this PDF file can be found in the General Info relative.
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ISO (E). PDF disclaimer. This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file. ISO. Second edition. Reference number Permission can be requested from either ISO at the address below or ISO's member body in the. ISO specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both.
EN ISO Biological indicators to test sterilization processes Part I General requirements Part II for ethylene oxide sterilization strips and self-contained Part III for moist heat sterilization strips and self-contained Part IV for dry heat sterilization Part V for low-temperature-steam-formaldehyde sterilization Part VI for hydrogen peroxide vapour sterilization processes Draft EN ISO Guidance for the selection, use and interpretation of results for the validation and routine monitoring of the sterilization of medical products with biological indicators 3. Part III Human waste containers bed pan WD Part IV Thermo-labile re-usable instruments including endoscopes Part V Test soils and methods for demonstrating cleaning efficacy Part VI Requirements and tests for general purpose washer-disinfectors employing thermal disinfection Part VII Requirements and tests for general purpose washer-disinfectors employing chemical disinfection for bedframes, bedside tables, transport carts, containers, surgical tables, furnishings and surgical clogs 7.
Vacuum is again applied, and after inserting filtered air once again, the procedure is repeated 7 times consecutively. For ventilation, 1 additional smaller cycle, to 0. Validation of each particular sterilization process Conformity Tests: During the process of loading the autoclave, as routine control, 24 packs of pre designed tubes containing nX different bacteria and spores are placed in 24 positions in the autoclave, according to pre determined positions.
These spores are tested for efficiency of sterilization. Results are obtained after 48 hours. Results are obtained after 14 days. In addition to microbial tests, 24 chemical detectors, as part of the biological indicator that are marked on it to show efficiency of the gas. Per litter. Preparation for Validation process: 2. The 35 sensors are introduced into the chamber through a 38mm opening in the side of the chamber, - see attached photograph.
Each container is approximately cm wide, cm deep and cm height and the distance between each pallet is minimum 5cm to permit air ventilation. Temperature pre validated sensor no. Distance between each pallet minimum 5 cm. The packs were placed into the pallets according to the attached diagram.
One biological indicator from same lot was placed outside the chamber. The same lot of samples were marked and placed in the chamber for sterilization. Process and results 3. The temperature stabilized at temperature of C to C for rest time of acclimatization. During this time the inner pressure was reduced to 0. A dual element temperature probe can be used to meet this need. To prevent this from happening, it is general practice to have redundant sensors for many critical process parameters.
The common options for utilizing these redundant sensors include: Product definition for a medical device includes the medical device itself, the sterile barrier system containing the device, and any accessories, instructions, or other items included in the packaging system. It also includes a description of the intended functionality of the medical device, and the available manufacturing and sterilization processes.
The product definition process should also consider whether this is a new design, or whether it is part of an existing product family. The following should be considered as part of product definition: The construction and configuration of the new or modified product should be carefully examined for any features that could present obstacles to the penetration of EO, heat or humidity.
For medical device manufacturers, this comparison should also involve an examination of factors that could affect the initial bioburden on the product, including the location of the manufacturing facilities, the types of raw material used, the sources of these materials and production methods. For modified reusable products, this comparison should include the evaluation of the cleaning efficacy for the product.
If a new or modified product is demonstrated to be equivalent to an existing medical device or PCD for which sterilization characteristics are already known, the new or modified product might be considered to be part of a product family or a processing category.
As part of the technical review the following questions should be considered. During sterilization, the sterile barrier system needs to be able to withstand the process conditions and to remain intact to ensure product quality. When selecting a packaging system for a product that is to be sterilized, certain major design and manufacturing factors are considered with respect to the particular sterilization process.
To ensure EO penetration, the permeability of the packaging to the particular sterilizing environment is of utmost importance.
As air removal is part of the EO sterilization process the packaging system should also allow gases to vent into, and out of, the package during pressure changes during gas injections and evacuations without damage to, or rupture of, the seal integrity. The ability of the sterile barrier system SBS to protect product during customary handling and distribution should be demonstrated.
Evidence should also be generated to show that the SBS can withstand the sterilization process without losing its ability to protect the product. Packaging considerations are addressed in more detail in the ISO? The load configuration is to be defined during the validation to ensure adequate product temperature, humidity and EO penetration and EO removal during processing.
Examples of ways to develop PCDs for use in the demonstration of equivalence include, but are not limited to a placement of a microbiological challenge between rings, lands, grommets or ribs of a syringe stopper, c placement of a microbiological challenge in an interface, b placement of a microbiological challenge in the middle of the lumen of a tube that is then reconnected using a solvent bond agent or a connector to restore product integrity, d placement of a microbiological challenge in a series of envelopes or packages.
Several PCD designs have been recommended for use in health care facilities.
See also D. To prepare the internal PCD, the microbiological challenge can be inoculated on the product either directly or indirectly. Direct inoculation is accomplished by applying a liquid suspension of the spores Licensed to: Listed below are various ways to prepare a PCD.
The simulated product consists of portions of a medical device or a combination of components that are known to represent the greatest challenge to the process while still adequately representing all products within a product family. NOTE Direct inoculation with a spore suspension can result in variable resistance of the inoculated product because of surface phenomena, other environmental factors and the occlusion of the spores on or in the product. Therefore, it is important to provide scientific rationale or validation for this practice to ensure that the resistance of the inoculated product is reasonably correlated to the routine product.
The inoculum recovery should also be validated if resistance is measured by plate count techniques. Equivalence studies should compare the new or modified product to the internal PCD used to validate the process. Properties of materials required to satisfy requirements for product performance, such as physical strength, permeability, physical dimensions and resilience, are evaluated after sterilization to ensure that the materials are still acceptable for use.
Degradation effects due to exposure to the sterilization process, such as crazing and embrittlement may need to be considered. Where applicable, the effects of exposure to multiple sterilization processes may also need to be evaluated. Demonstration that the specified sterilization process does not affect the correct functioning of the product can be accomplished by performing functionality tests, or other appropriate tests, on the medical device and its packaging system.
These tests can be performed after exposure in the sterilizer or other environmental chambers that simulate the specified process and can range from a simple visual inspection to a battery of specialized tests.
Elements that could affect safety, quality or performance include: Medical devices containing a potential source of ignition e.
The effect of repeated sterilization and any necessary pre-treatment on the materials, functionality and safety of the product should be evaluated. The instructions should include the recommended sterilization parameters for the process and the limits to the number of sterilization cycles to which the reusable medical device can be exposed. If applicable, testing and inspection should be performed to assess functionality of the reusable medical device following sterilization. A system should be in place which will provide notification if the maximum number of cycles is reached.
NOTE D. Consideration should be given to the placement of the residual product test samples within the load, taking into account the most challenging positions for EO removal.
Local environment, health and safety regulations can require extra worker exposure precautions when handling EO sterilized products even when product residuals are in compliance with ISO?
For health care facilities: If information regarding aeration for a medical device is not available from the manufacturer, the health care facility should establish the aeration process for that device using either data or knowledge of the product and its material and design.
The aeration process should be established based upon the most difficult-to-aerate product or product family. When using the bioburden approach see Annex? A bioburden testing should be performed at least quarterly. The period of monitoring can be extended following a documented risk analysis that considers the following: The specification should also include or reference the required SAL, as well as evidence for, or assessment of, the compatibility of the product with the process.
This result should clearly demonstrate that product complexity, materials, packaging and load configuration were assessed. This documentation should be approved, retained and retrievable. The following should be taken into account: The sterilization process parameters to be established include: A and B provide requirements for determination of cycle lethality. For health care facilities, for reusable medical devices that will be reprocessed in the health care facility, the manufacturer is expected to provide validated reprocessing instructions, which are based in part on the process definition.
See also ISO? If the medical device or packaging manufacturer supplies instructions for reprocessing that are not specific enough or not appropriate e. If the health care facility is not able to validate the product or assess the appropriateness of its own reprocessing method, it should not reprocess the medical device. Using a developmental chamber does not preclude confirmation of PQ in a production chamber.
A determination should be made as to which variables will have the greatest impact, and those should be assessed. Data supporting this activity can be collected from alternative studies, e. Alternatively, data can be generated from a specific challenge cycle s in a developmental or production chamber. Approach 1 D. This approach is to use the rationale that most of the microorganisms found on product present a lesser challenge than the reference microorganism.
In this approach, bioburden trending data should be available and should demonstrate the consistency of the bioburden regarding the number and types of microorganisms.
Manufacturing processes and product contact materials should also be evaluated to ensure that potential sources of bioburden are identified and controlled.
Approach 2 This approach is to use a test of sterility of the product and PCD, following a fractional cycle. The results of this study should provide a means of lethality comparison using survival data from the tests of sterility for the product and PCD.
Approach 3 This approach can be applied in cases where a the product bioburden challenge is equal to or greater than the challenge of the BI within the PCD, b the product bioburden contains highly resistant microorganisms, or c where a BI with a lower population than required by ISO?
If any of the above changes are made, it is important to verify the effectiveness of the changes. Product design might not allow a BI to be positioned in the most difficult-to-sterilize location of the product. In this circumstance it might be appropriate to place the BI in a location to which the relationship with the most difficult-to-sterilize location can be established. Additionally, in many medical devices the most difficult-to sterilize location contains a low number of microorganisms, and therefore the challenge population may be more closely linked to the bioburden of the product.
Different types of PCDs are described in D. Methods similar to those used for determining the appropriateness of the BI can be used for determining the appropriateness of the PCD. A PCD located within the confines of the product, in the product shipper or product shipper case is an internal PCD, whereas a PCD located between shipper cases or on the exterior surfaces of the sterilization load is an external PCD.
Internal PCDs can be used for routine product release; however, external PCDs are usually used as they are easier to recover after completion of the sterilization process. Studies conducted in a development chamber can be used to demonstrate the comparative lethality challenge of the internal and external PCDs; however, consideration should be given to the effects of load volume and production sterilizer performance when performing these studies.
If the development chamber is not capable of duplicating the production process then the comparative lethality challenge studies should be conducted in the production chamber. The comparative lethality challenge of the internal versus external PCDs can be assessed using concurrent exposure s in a fractional cycle s.
The resulting data can be used for: There can be instances when it is desirable to compare the lethality challenge of one PCD to another without comparing both to the challenge of the product. This is often used when an internal PCD has been proven to be appropriate and an external PCD is being introduced for monitoring routine production cycles for conventional release or when it is desirable to change to another external PCD.
In this case, a method of evaluating the appropriateness of the PCD is to demonstrate that the external PCD presents an equal or greater lethality challenge when compared to the internal PCD. Typically this is done by performing a single fractional cycle that compares the fraction-negative results of the internal and external PCDs. If the lethality challenge of the external PCD is less than the lethality challenge of the internal PCD not more than 20?
NOTE It is not uncommon to find an external PCD in a less difficult-to-sterilize configuration presenting a greater lethality challenge than an internal PCD in a more difficult-to-sterilize configuration. It is theorized that this occurs because the EO is removed more rapidly from the external PCD than the internal PCD, resulting in less gas exposure time to the microbiological challenge. Product sterilized in the validated process should be shown to meet predetermined specifications and quality characteristics related to product functionality and safety i.
Validation of the sterilization process should be performed according to an approved written document e. This document should be reviewed by a sterilization specialist s. In a health care facility, IQ and OQ are typically performed by the sterilizer manufacturer, although they can be performed by any qualified personnel. MPQ data might be available from the sterilizer manufacturer for general loads.
For health care facilities, this means describing and documenting the following: Examples of relevant documents include design specifications, the original download order, user requirements specifications and functional design specifications.
The following are examples of equipment components that should be qualified to ensure that the equipment was installed according to the applicable specifications and requirements: ISO — All rights reserved D. To protect the health and the safety of personnel, equipment that detects atmospheric levels of EO or gas mixtures should be installed near the sterilizer and anywhere else where potential exposure could occur.
EO safety is achieved and maintained through a combination of factors that include: In healthcare facilities IQ is generally the responsibility of the sterilizer manufacturer, while in industrial facilities it is often performed by site personnel in conjunction with a factory representative.
If the IQ is performed by the manufacturer, or by a third party, the facility is responsible for retention and management of documents and records relating to the download, installation of the equipment. Drawings and parts lists for the equipment should include: This range of parameters and operating limits should include the initial sterilization process that has been defined in process definition see Clause?
OQ should also determine the performance of associated ancillary systems. For example, the capability of the EO vaporizer to achieve a minimum EO input temperature. OQ can include the following when using a predefined cycle: The user is responsible for assuring the software is validated. This can be performed by smoke tests in combination with calculation of air change rates and anemometric determinations.
The temperature and humidity in a number of locations distributed throughout the preconditioning area should be determined. The remaining temperature sensors should be distributed evenly throughout the usable chamber volume. When the OQ exercise is carried out using a loaded chamber, then the? The study should characterize the temperature profile for comparison on a periodic basis to ensure the system continues to operate effectively.
The air flow rates and air flow patterns through the area should also be determined. Acceptance criteria should include conformance with the specifications for the sterilization process parameters and microbiological challenge. PQ activities should be clearly defined in a written document e. Where elements of the PQ are carried out by separate parties, those parties should approve the relevant documentation. See 4. Typical load parameters to be defined might include stacking configuration, overall density, dimensions, material composition, and use and type of pallet wrap.
Load configuration should be documented for each sterilizer. Product placement should also be specified. In a large industrial sterilizer, this would refer to the positioning of cases in a pallet or tote. For smaller sterilizers, as used by health care facilities, this refers to the positioning of baskets, packs and rigid containers on a sterilization carriage or carrier.
The product and load used during PQ should be at least as difficult to sterilize as the most challenging load expected during normal production. The load can consist of product or materials that have characteristics similar to those of a load to be sterilized routinely. Changes in the load configuration can affect the lethality of a sterilization process. It is important that the acceptable load configurations be specified. If multiple load configurations are allowed, the load configuration used in the PQ studies should represent the most difficult-to-sterilize configuration, or should have a known relationship to the most difficult-to-sterilize configuration.
Some variations in the load size might be justified as having no significant impact.
During PQ, two types of load can be chosen: Products or surrogate product materials utilized in validation loads should represent those that typically present? Consideration should be given to include load material with substantially varying characteristics such as: After repeated use, the suitability of the load should be considered.
Aeration between exposures will ensure that EO residues in the load do not affect the biological indicator. If equilibration time is insufficient, the load could be warmer than the normal ambient conditions, or the load humidity could be much lower than the normal ambient load conditions. Either of these situations produce data that are not representative of normal production. Too high a starting temperature produces an unrealistically rapid kill rate. Too low a humidity, where test spores become desiccated, produces an unrealistically low kill rate.
Exposure time isJoe theMr. Other parameters can be adjusted as necessary to provide assurance that the MPQ delivers less lethality than the normal production process. This would provide assurance that any observed values within the specified range will produce acceptable lethality. MPQ should be conducted using product that is at or below the minimum temperature specified for product to enter the preconditioning area.
If it is anticipated that initial product temperature could vary, for example because of transport for sterilization at a remote facility, the design of the qualification testing should reflect this possibility.
For fractional cycles sub-lethal or half cycle , it might also be necessary to shorten the post-exposure phases of the cycle or to remove BIs prior to the aeration phase or after an abbreviated aeration phase. When shortening the post-exposure phases of the cycle, factors such as operator safety should be taken into account.
NOTE Attention is drawn to the existence of statutory regulations existing in some countries on personnel exposure to EO. To achieve this objective, it is common to use PCDs or a worst case product to represent EO product families. PCDs should be placed within the product case and evenly distributed in the sterilization load, but distribution should include those locations where sterilization conditions are the most difficult to achieve.
The locations used should include those selected for temperature monitoring. For loads that are palletized, these locations should also include the top and bottom of the pallets to ensure that all potential stratification within the chamber is assessed. For guidance on sample numbers, see Table? The development of the microbial inactivation curves is not always possible in production chambers because of the size of the chamber and the time required to inject and remove EO in the chamber.
These long injection and vacuum times limit the ability to obtain the required fractional recovery of indicator organisms. These inactivation curves can be developed in a developmental chamber that can deliver equivalent parameters especially EO concentration used in the production chamber.
Methods for demonstrating a relationship between the data developed in the developmental chamber and a production chamber involve a physical profile comparison and load density comparison. The sterilization conditions delivered in the developmental chamber should be compared with the physical profile obtained in a production chamber.
Comparison of the lethality obtained in the development chamber and production chamber should take into account the differences in EO gas injection and evacuation times of the two chambers. During the development of the sterilization process in a developmental chamber, it is important to place PCDs inside the finished product case or in the routine configuration to provide a relationship of the dynamics of the products within the case against the PCD during process development.
If process parameters cannot be maintained within the defined limits, an investigation should be conducted. If modifications are made, additional runs might be necessary. For large preconditioning areas where a small load will not have a significant effect on the area dynamics, it is not necessary and indeed might be impractical to perform the studies with the preconditioning area in various loading states. The guidance on PPQ of preconditioning also applies to the performance qualification of conditioning i.
See Table? 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.
Requirements for the development, validation and routine control of a sterilization process for medical devices. Sterilization of health-care products. July Sterilization of health care products. Guidance on the application of ISO June Sterilization of health care products.
Requirements for development, validation and routine control of a sterilization process for medical devices. October Sterilization of medical devices.