1、ANSI/AAMI/ISO TIR16775: 2014Technical Information ReportPackaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2An ANSI Technical Information Report prepared by AAMI ANSI/AAMI/ISO TIR16775:2014 (Revision of AAMI TIR22:2007) Packaging for terminal
2、ly sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2 Approved 28 July 2014 by Association for the Advancement of Medical Instrumentation Approved 27 July 2014 by American National Standards Institute Abstract: This technical report contains guidance on the applica
3、tion of ISO 11607-1:2006, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems and ISO 11607-2:2006, Packaging for terminally sterilized medical device - Part 2: Validation requirements for forming, sealing, and assem
4、bly processes. Possible options for compliance with the requirements of Parts 1 and 2 will be addressed as special concerns that may require attention due to regional or local conditions, practices or regulations. Keywords: sterile barrier systems, packaging systems, terminally sterilized Published
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8、ontact AAMI at 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Phone: (703) 525-4890; Fax: (703) 525-1067. Printed in the United States of America ISBN 1-57020-559-0 AAMI Technical Information Report A technical information report (TIR) is a publication of the Association for the Advance
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20、 301, Arlington, VA 22203-1633. Contents Page Glossary of equivalent standards . vii Committee representation viii Background of AAMI adoption of ISO/TS 16775:2014 x Foreword xi Introduction xii 1 Scope 1 2 Terms and definitions 1 3 Guidance for health care facilities . 2 3.1 Test methods . 2 3.2 Gu
21、idance for conformance to ISO 11607-1 2 3.3 Guidance on conformance to ISO 11607-2, Validation requirements for forming, sealing and assembly processes 10 3.4 Quality system . 18 4 Guidance for industry 18 4.1 General guidance . 18 4.2 Design inputs . 19 4.3 Selection and evaluation of materials 19
22、4.4 Sterile barrier system and protective packaging design (packaging system development) 20 4.5 Packaging process feasibility evaluation 22 4.6 Sterile barrier system design feasibility evaluation 22 4.7 Validation of sterile barrier system manufacturing process 24 4.8 Packaging system design valid
23、ation . 25 4.9 Revalidation . 27 Annex A (informative) Selection, evaluation and testing of packaging materials and sterile barrier systems Guidance for industry and health care facilities . 28 Annex B (informative) Sterilization considerations Guidance for industry and health care facilities 35 Ann
24、ex C (informative) Examples of wrapping methods Guidance for health care facilities . 42 Annex D (informative) Validation plan documents Guidance for health care facilities 49 Annex E (informative) Installation qualification documentation Guidance for health care facilities 65 Annex F (informative)
25、Operational qualification documentation Guidance for health care facilities . 70 Annex G (informative) Performance qualification documentation Guidance for health care facilities 76 Annex H (informative) Addressing worst-case requirements Guidance for industry and health care facilities 82 Annex I (
26、informative) Generating a final packaging system validation protocol Guidance for industry 84 Annex J (informative) Design inputs Medical device attributes Guidance for industry 87 Annex K (informative) Risk analysis tools Guidance for industry and health care facilities . 91 Annex L (informative) C
27、onsiderations for sampling plans Guidance for health care facilities . 93 Annex M (informative) Stability testing (ISO 11607-1:2006, 6.4) Guidance for industry 95 Annex N (informative) Use of the Internet Guidance for industry and health care facilities . 96 Annex O (informative) Test method validat
28、ion Guidance for industry 97 Annex P (informative) Use of contract packagers Guidance for industry and health care facilities 98 Annex Q (informative) Guidance on establishing process parameters Guidance for industry . 99 Annex R (informative) Investigation failure Guidance for industry and health c
29、are facilities . 105 Annex S (informative) Packaging manufacturing process and packaging system design feasibility evaluation Guidance for industry 108 Bibliography . 111 Glossary of equivalent standards International Standards adopted in the United States may include normative references to other I
30、nternational Standards. AAMI maintains a current list of each International Standard that has been adopted by AAMI (and ANSI). Available on the AAMI website at the address below, this list gives the corresponding U.S. designation and level of equivalency to the International Standard. www.aami.org/s
31、tandards/glossary.pdf 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO TIR16775:2014 vii Committee representation Association for the Advancement of Medical Instrumentation AAMI/ST/WG 07, Packaging Working Group The adoption of ISO/TS 16775:2014 as a Technical Report and
32、 revision of existing AAMI TIR22:2007 was initiated by the AAMI Packaging Working Group, which serves as the U.S. TAG (technical advisory group) for ISO/TC 198/WG 7. U.S. representatives played an active role in developing the ISO TR. Committee approval of the standard does not necessarily imply tha
33、t all committee members voted for its approval. At the time this document was published, the AAMI Packaging Working Group had the following members: Chairs: David W. Johnson, Kimberly-Clark Corporation Jackie Daly Johnson, Flexible Packing Association Members: Edward Arscott, NAMSA Donald S. Barcan,
34、 DBI Inc (Donbar Industries Inc) Jennifer Neid Benolken, CPP, St Jude Medical Inc Bradley J. Bushman, Standard Textile Co Inc Brian Buxton, Bausch b) they should be non-toxic, for guidance see A.3.3 (see requirement in ISO 11607-1:2006, 5.1.6); NOTE 1 If the sterile barrier system or associated comp
35、onents contain natural rubber latex, the sterile barrier system should be labelled indicating natural rubber latex is present. 2 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO TIR16775:2014 c) there should be documented evidence that the ingress of microorganisms can b
36、e prevented when demonstrated under test conditions which consider sterilization process, handling, distribution, transport and storage (see requirement in ISO 11607-1:2006, 5.1.6 and 5.2); d) they should have a demonstrated ability to meet the required physical properties for materials and closures
37、 (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 11607-1:2006, 5.1.7 and 5.1.9); e) they should be compatible with the intended steriliza
38、tion process and parameters capable of producing a sterile medical device (see requirement in ISO 11607-1:2006, 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 sterili
39、zation process (see requirement in ISO 11607-1:2006, 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 11607-1:2006, 5.5 and Clause 7); NOTE 2 Suggested sto
40、rage 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 presentati
41、on 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
42、 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 11607-1:2006, 6.1 and 6.2). When a health care facility uses a contract packager or sterilizer additional considerations are
43、 necessary (see Annex P). The materials and systems chosen should: a) be intended for use in medical packaging applications, as stated by the manufacturer; b) be supported by technical information from the manufacturer confirming that it meets the requirements of ISO 11607-1 that relate to materials
44、; c) provide adequate protection for the medical device(s) during specified intended storage and transportation conditions to the point of use; d) allow for and be compatible with the intended sterilization process, and have the ability to withstand conditions of the chosen process; NOTE Not all mat
45、erials are appropriate for all sterilization processes. Information on compatibility with a given sterilization process is typically provided by the manufacturer of the medical device and/or packaging system. For further explanation of challenges of common sterilization processes see Annex B. e) mai
46、ntain sterile barrier integrity until its time of use; f) ensure aseptic presentation at the point of use; g) allow a method of closure that is tamper evident; h) allow for ease of identification of contents. The user of the packaging materials should ensure that the sterile barrier system or packag
47、ing system complies with ISO 11607-1, that requirements concerning product compatibility are met and that processes for packaging, sterilization, storage and distribution are validated and controlled. 2014 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 16775:2014 3 3.2.2.2
48、Selection considerations The selection process at the health care facility should include an evaluation of the ability of both the sterile barrier system and protective packaging (if required) utilized to maintain the integrity of that sterile barrier system until its time of use and permit aseptic
49、presentation at the point of use. The choice of packaging components will be dependent on the risk associated with the medical device, its conditions of use, the storage and transport requirements and health care procedures practiced at the facility. These risks should be analyzed by the health care facility and procedures put in place to mitigate/control those risks (see Annex K). To choose the most appropriate material for the sterile barrier system and/or packaging system, the following should be considered: a) Duration and cond
