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Figure A. If the device is intended to be sterilized by EO, steam, or oxidizing processes, the sterile barrier system has a permeable component to allow the steriliZing gases to enter, kill the microorganisms, and escape without significant residual concentrations. The manufacturer of a medical device chooses the appropriate sterilization processes for each device and their choice is dependent upon several factors. If the device is constructed of materials that are not irradiation stable, EO, steam, and oxidizing agents are typically used, Alternatively, if a device tends to retain high residual concentrations of the device manufacturer may choose irradiation.
The majority have a top-web, a bottom web, and a means to join the webs together. In the case where a peelable seal is required, a sealant layer is applied to allow heat-sealing of the two layers together.
The sealant layer, which is commonly known as coating, has traditionally been applied to the permeable web. Today, many films incorporate the sealant layer as a layer s in the film construction. Where a weld seal is required, compatibility of the webs is required to allow joining by heat, or other methods such as ultrasonic welding. The first type is the pre-formed rigid tray with a die-cut lid. The tray is usually preformed by a thermoforming or pressure-forming process. The die-cut lid can be permeable or impermeable and typically will have a sealant layer used to heat-seal the lid to the tray.
Rigid trays with die-cut lids are commonly used for large profile and heavy devices, such as orthopaedic implants and pacemakers, as well as surgical kits. A pouch is typically constructed of a film on one side and either film, paper, or nonwoven on the other.
Pouches are typically supplied as preformed sterile barrier systems where all the seals have been formed except for one typically at the bottom. This remains open so that the device can be placed inside and then the final seal applied prior to sterilization. Vast arrays of different medical devices use pouches as the sterile barrier system, due to their wide availability in a variety of sizes. These devices are typically low profile and lightweight.
Pouches can come with a variety of design features. For example, gussets may be included to allow for higher profile devices. A sterilization bag is constructed from a single web of porous medical-grade paper that has been folded to form a long tube with or without side gussets.
The tube is sealed along its length by a double line of adhesive. It is then cut to the required size and one end is sealed by one or more applications of adhesive. Additional folds may also be used to further strengthen the closure. The open end normally has either a lip or a thumb cut to facilitate ease of opening. Final closure of the bags is applied prior to sterilization. S The fourth type is the header bag.
The header bag is primarily a welded seal bag fabricated from two impermeable but compatible film webs. One of the webs is usually offset by several inches. Across this offset area, a permeable material, with adhesive, is heat-sealed. This permeable material can later be peeled off allowing access to the interior of the bag. Header bags are popular for bulky items such as kits. The sterile barrier systems that are manufactured via can look just like pouches, rigid trays with lids, or can have a flexible film bottom web that has been drawn or shaped.
The machine manufactures the sterile barrier system by forming the bottom web, filling the form with the device, and applying the top-web and sealing the sterile barrier system.
Most commonly it employs rotary sealing equipment to form the seal. In the 4SS process, the bottom and top webs are placed on the 4SS machine. The product is placed onto the bottom web.
The top web is applied above it and, finally, all four sides are sealed. Other constructions can be acceptable as sterile barrier systems. These may consist of caps, plugs, covers, or other device-specific closure designs. In these cases, the primary layer of product packaging may be represented by one of the four styles discussed above, but may not be required to provide a microbial barrier for the devices.
Instead of forming a heat or adhesive seal, the wrapping and folding process provides a tortuous path that maintains sterility. Devices are typically contained in organizing instrument trays prior to wrapping and subsequent sterilization.
These containers typically have matched tops and bottoms with a gasket that provides an impervious seal between the two parts. A venting system allows the sterilizing agent gasses to enter and escape from the container.
The vent design and materials used for providing microbial filtration vary widely. Devices sterilized in containers may require specific preconditioning or a longer exposure time to ensure that the sterilization process is complete.
This part of ISO provides minimum requirements for using packaging systems that provide appropriate sterile barrier systems.
Standardized test methods and procedures that may be used to demonstrate compliance with the requirements. The following documents contain provisions that may be used to demonstrate compliance with provisions of this International Standard.
For dated references, subsequent amendments to, or revisions of, any of these publications should be considered. Specific requirements for the use of test methods are found in 4. The criteria for inclusion of test methods and procedures in this annex are that they must be nominated for inclusion and commercially available from a standards development organization, trade association or national standards body.
Consequently, the Bibliography contains additional test methods that were published in the literature. This annex is not intended to be all-inclusive and the development of new test methods is known to be underway at the time of publication. Packaging materials and systems for medical devices which are to be sterilized Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN - Requirements and test methods.
Paper and board - Determination of air permeance and air resistance medium range - Part 5: Gurley method. Packaging materials and systems for medical devices which are to be sterilized Part 2: Sterilization wrap -Requirements and test methods Annex C: Method for the determination of the pore size.
ISO Paper, board and pulps - Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples. ASTM D Standard practice conditioning containers, packages or packaging components for testing.
ASTM F Standard test method for non-destructive detection of leaks in medical packaging which incorporates porous barrier material by CO2 tracer gas method. ASTM F Standard test method for detecting seal leaks in porous medical packaging by dye penetration.
ASTM F Standard test method for non-destructive detection of leaks in non-sealed and empty medical packaging trays by CO2 tracer gas method. Sterilization Sterile supply - Sterilization paper for bags and tube packings - test; subclause 2. Specification for paper for steam sterilization paper bags, pouches and reels for medical use Appendix C: Methods for determination of methylene blue particulate penetration.
Test method for evaluating the bacterial filtration efficiency BFE of medical face masks materials, using a biological aerosol of staphylococcus aureus. ISO 1 Complete, filled transport packages - General rules for the compilation of performance test schedules - Part 1: General principles. EN Packaging materials and systems for medical devices which are to be sterilized - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN - Requirements and test methods.
ASTM D Standard test method for impact resistance of plastic film by free-falling dart method. ASTM F Standard test method for slow rate penetration resistance of flexible barrier films and laminates. ASTM F Standard test methods for failure resistance of unrestrained and nonrigid packages for medical applications.
ASTM F Standard test method for burst testing of flexible package seals using internal air pressurization within restraining plates. Packaging materials and systems for medical devices which are to be sterilized - Part 5: Heat and self-sealable pouches and reels of paper and plastic film construction - Requirements and test methods. ASTM Standard test methods for propagation tear resistance of plastic film and thin sheeting by pendulum method.
ASTM Standard test method for tear-propagation resistance trouser tear of plastic film and thin sheeting by a single tear-method. Paper and board - Determination of tensile properties - Part 2: Constant rate of elongation method. ASTM Standard test method for determination of leaks in flexible packaging by bubble emission.
ASTM F Standard test method for determining integrity of seals for medical packaging by visual inspection. Packaging materials and systems for medical devices which are to be sterilized - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN Requirements and test methods. Standard test method for water resistance of paper, paperboard, and other sheet materials by dry indicator method.
Wet burst in wet condition ISO Paper and board - Determination of bursting strength after immersion in water. Test criterion: After not less than 1 h there shall be no visible movement of the cylinder, within the tolerance of 1 mm. Other methods for determining air permeance, such as the Schopper method for determination of air permeance, in accordance with ISO may be applicable.
Conversion factors for different types of apparatus used in various methods for determination of air permeance are given in ISO In quest of sterile packaging: Part 1; Approaches to package testing. In quest of sterile packaging: Part 2; Approaches to package testing. A potential method for the specification of microbial barrier properties. In: Pharm. Packaging 95, Copenhagen, Denmark. PDA J. Technik, 47 , pp.
Home Documents I. Match case Limit results 1 per page. Author: duongmien Post on Mar views. Category: Documents 18 download. I rish Standard I. EN ISO Table ZA. Adobe is a trademark of Adobe Systems Incorporated. ISO All rights reserved. ISO consists of the following parts, under the general title Packaging for terminally sterilized medical devices: Part 1: Requirements for materials, sterile barrier systems and packaging systems Part 2: Validation requirements for forming, sealing and assembly processes iv ISO - All rights reserved I.
ISO All rights reserved v I. EN ISO 1. ISO , Paper and board - Determination of air permeance and air resistance medium range -Part 5: Gurley method 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. NOTE 2 Repeatability conditions can include the following: the same measurement procedure; the same observer; the same measuring instrument, used under the same conditions; the same location; repetition over a short period of time.
EN ISO closeness of the agreement between the results of measurements of the same particular quantity subject to measurement measurand carried out under changed conditions of measurement NOTE 1 A valid statement of reproducibility requires specification of the conditions , ISO - All rights reserved 5 I. NOTE Annex 8 contains a list of suitable test methods. Sterilization effects on biocompatibility should be evaluated.
NOTE This may include visual inspection, other test methods and acceptance criteria for reuse. Evaluation of the microbial barrier properties of porous materials is typically conducted by challenging samples with an aerosol of bacterial spores or particulates, under a set of test conditions which specify the flow rate through the material, microbial challenge ISO - All rights reserved 9 loS.
EN ISO ISO E This can be accomplished by: a demonstrating retention of these characteristics under defined storage conditions, and b ensuring that storage conditions remain within specified limits. NOTE See also 6. NOTE For example, similarity could be established by different sizes of the same product.
Means, Inc. Active Only. Look Inside. ISO 2nd Edition, February Complete Document. Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes. Detail Summary View all details. Price USD. In Stock. Need it fast? Ask for rush delivery.
Most backordered items can be rushed in from the publisher in as little as 24 hours. Some rush fees may apply. Add to Cart. ISO , 2nd Edition, February - Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized.
These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems. It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized.
It does not cover all requirements for packaging medical devices that are manufactured aseptically. Complementary Documents and Links:. Active, Most Current Currently Viewing. ISO Complete Document. ISO Amendment Only. ISO Base Document. Browse Publishers. Top Sellers.
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It can be applied by suppliers of materials or of preformed sterile barrier systems, by medical device manufacturers or health care facilities. ISO describes the process development and validation requirements for forming, sealing and assembly processes and addresses controls during normal operations. WebAAMI ISO pdf download � Packaging for terminally sterilized medical devices. AAMI ISO pdf download - Packaging for terminally sterilized medical . WebDownload Download Iso Type: PDF Date: November Size: MB Author: Ilayaraja Boopathy This document was uploaded by user and they confirmed that they .