AAMI ISO TIR16775 pdf free download

AAMI ISO TIR16775 pdf free download.Packaging for terminally sterilized medical devices — Guidance on the application of ISO 1 1 607-1 and ISO 1 1 607-2.
3 Guidance for health care facilities IMPORTANT: Written instructions for use should be obtained from the packaging material and/or medical device manufacturer concerning their recommendations for sterilization and the subsequent maintenance of sterility of a sterile barrier system. 3.1 Test methods For guidance on the requirements for test methods contained in ISO 1 1 607-1 and ISO 1 1 607-2, see the health care annexes of this document. 3.2 Guidance for conformance to ISO 11607-1 3.2.1 General guidance for materials, preformed sterile barrier systems and sterile barrier systems 3.2.1.1 Preformed sterile barrier systems should be evaluated before purchase and use. Therefore, the supplier should consider providing a statement of compliance to the applicable sections of ISO 1 1 607-1 for the materials and/or preformed sterile barrier systems to be purchased. Before introducing associated components (e. g. labels, tapes, tray liners) into production, users should confirm that they will be suitable for use in their specific applications and conditions of use. 3.2.1.2 The key concepts that apply to all packaging materials and components are as follows: a) they should be made of known and traceable materials with processes capable of meeting the requirements of ISO 1 1 607-1 (see requirements in ISO 1 1 607-1 :2006, 5.1 .3, 5.1 .4 and 5.1 .5); b) they should be non-toxic, for guidance see A.3.3 (see requirement in ISO 11 607-1 :2006, 5.1 .6); NOTE 1 If the sterile barrier system or associated components contain natural rubber latex, the sterile barrier system should be labelled indicating natural rubber latex is present.c) there should be documented evidence that the ingress of microorganisms can be prevented when demonstrated under test conditions which consider sterilization process, handling, distribution, transport and storage (see requirement in ISO 1 1607-1:2006, 5.1 .6 and 5.2); d) they should have a demonstrated ability to meet the required physical properties for materials and closures (such as weight or grade, seal width and seal strength), resist tearing or puncture, be capable of opening or peeling in a continuous and homogenous manner, without delamination tearing (see requirements in ISO 1 1 607-1 :2006, 5.1 .7 and 5.1 .9); e) they should be compatible with the intended sterilization process and parameters capable of producing a sterile medical device (see requirement in ISO 1 1 607-1 :2006, 5.3); f) they should be compatible with the labelling system; if present, have color fast printing inks that do not degrade, fade or become illegible after exposure to the intended sterilization process (see requirement in ISO 1 1 607-1 :2006, 5.4); g) they should be protected from the effects of environmental conditions (e.g. relative humidity, direct sunlight or fluorescent light, temperature) during storage (see requirement in ISO 1 1 607-1 :2006, 5.5 and Clause 7); NOTE 2 Suggested storage conditions and shelf life should be provided by the material or preformed sterile barrier system manufacturer. If anticipated or actual storage is outside these conditions the manufacturer should be consulted. h) they should allow aseptic presentation. NOTE 3 Instructions for aseptic presentation should be provided by the manufacturer of the medical device and/or packaging system. NOTE 4 The internet is a useful tool for finding information on materials, see Annex N.3.2.2 Design and development guidance for packaging systems (ISO 11607-1:2006, 6.1 and 6.2) 3.2.2.1 Selection criteria When a health care facility determines which packaging system to use, the design and development guidance for those packaging systems should be considered (see requirements in ISO 1 1 607-1 :2006, 6.1 and 6.2). When a health care facility uses a contract packager or sterilizer additional considerations are necessary (see Annex P).AAMI ISO TIR16775 pdf download.