AAMI TIR16775 2023
$207.43
AAMI/ISO TIR16775:2023 Packaging for terminally sterilized medical devices—Guidance on the application of ISO 11607-1 and ISO 11607-2
| Published By | Publication Date | Number of Pages |
| AAMI | 2023 | 162 |
Provides guidance for the application of the requirements contained in ISO 11607-1 and ISO 11607-2.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | AAMI/ISO TIR16775:2023; Packaging for terminally sterilized medical devices—Guidance on the application of ISO 11607-1 and ISO 11607-2 |
| 3 | Title page |
| 5 | AAMI Technical Information Report |
| 7 | Committee representation |
| 11 | Background of AAMI adoption of ISO/TS 16775:2021 |
| 12 | Foreword |
| 13 | Introduction |
| 15 | 1 Scope 2 Normative references 3 Terms and definitions |
| 16 | 4 Guidance on Clauses 1-4 of ISO 11607-1:2019 and ISO 11607-2:2019 4.1 Scope (ISO 11607-1:2019, Clause 1 and ISO 11607-2:2019, Clause 1) 4.1.1 Intent 4.1.2 Guidance |
| 17 | 4.2 Normative references (ISO 11607-1:2019, Clause 2 and ISO 11607-2:2019, Clause 2) 4.2.1 Intent 4.2.2 Guidance |
| 18 | 4.3 Terms and definitions (ISO 11607-1:2019, Clause 3 and ISO 11607-2:2019, Clause 3) 4.3.1 Intent 4.3.2 Guidance 4.4 Quality and risk management (ISO 11607-1:2019, 4.1, 4.2 and ISO 11607-2:2019, 4.1, 4.2) 4.4.1 Intent 4.4.2 Guidance 4.4.2.1 Guidance on quality system requirements (4.1) 4.4.2.2 Guidance on risk management requirements (4.2) |
| 20 | 4.5 Sampling (ISO 11607-1:2019, 4.3 and ISO 11607-2:2019, 4.3) 4.5.1 Intent 4.5.2 Guidance |
| 21 | 4.6 Test methods (ISO 11607-1:2019, 4.4 and ISO 11607-2:2019, 4.4) 4.6.1 Intent 4.6.2 Guidance |
| 23 | 4.7 Documentation (ISO 11607-1:2019, 4.5 and ISO 11607-2:2019, 4.5) 4.7.1 Intent 4.7.2 Guidance |
| 24 | 5 Guidance on Clauses 5-11 of ISO 11607-1:2019 5.1 General requirements for materials, preformed sterile barrier systems and sterile barrier systems (ISO 11607-1:2019, 5.1.1 and 5.1.2) 5.1.1 Intent 5.1.2 Guidance 5.2 Conditions for production and handling (ISO 11607-1:2019, 5.1.3 and 5.1.4) 5.2.1 Intent 5.2.2 Guidance |
| 25 | 5.3 Source, history and traceability of materials (ISO 11607-1:2019, 5.1.5) 5.3.1 Intent 5.3.2 Guidance 5.4 Properties to be evaluated (ISO 11607-1:2019, 5.1.6) 5.4.1 Intent 5.4.2 Guidance |
| 26 | 5.5 General performance requirements for materials (ISO 11607-1:2019, 5.1.7 and 5.1.8) 5.5.1 Intent 5.5.2 Guidance 5.5.2.1 Regarding requirements for leachables and odours [ISO 11607-1:2019, 5.1.7 a)] |
| 27 | 5.5.2.2 Regarding requirements for visible material defects (5.1.7 b) of ISO 11607-1:2019) 5.5.2.3 Regarding material basis weight (5.1.7 c) of ISO 11607-1:2019) 5.5.2.4 Regarding material cleanliness (5.1.7 d) of ISO 11607-1:2019) 5.5.2.5 Regarding material physical properties (5.1.7 e) of ISO 11607-1:2019) |
| 28 | 5.5.2.6 Regarding material chemical and toxicological characteristics (5.1.7 f) and 5.1.7 g) of ISO 11607-1:2019) |
| 29 | 5.5.2.7 Regarding microbial barrier properties (ISO 11607-1:2019, 5.1.7 h)) 5.5.2.8 Regarding materials with adhesive coatings (ISO 11607-1:2019, 5.1.8) 5.6 Additional requirements for sterile barrier systems and preformed sterile barrier systems (ISO 11607-1:2019, 5.1.9) 5.6.1 Intent 5.6.2 Guidance 5.6.2.1 General |
| 30 | 5.6.2.2 Seal strength 5.6.2.3 Bursting strength |
| 31 | 5.7 Reusable sterile barrier systems (ISO 11607-1:2019, 5.1.10, 5.1.11 and 5.1.12) 5.7.1 Intent 5.7.2 Guidance 5.8 Microbial barrier properties (ISO 11607-1:2019, 5.2) 5.8.1 Intent 5.8.2 Guidance 5.9 Compatibility with the sterilization process (ISO 11607-1:2019, 5.3) 5.9.1 Intent 5.9.2 Guidance |
| 32 | 5.10 Labelling system (ISO 11607-1:2019, 5.4) 5.10.1 Intent 5.10.2 Guidance 5.10.2.1 Type of labelling |
| 33 | 5.10.2.2 Placement of labelling 5.10.2.3 Ability to remain attached and intact 5.10.2.4 Legibility 5.10.2.5 Compatibility of labelling with sterilization process |
| 34 | 5.10.2.6 Protection of sterile barrier system and contents 5.11 Storage and transport of materials and preformed sterile barrier systems (ISO 11607-1:2019, 5.5) 5.11.1 Intent 5.11.2 Guidance |
| 35 | 5.12 Design and development (ISO 11607-1:2019, 6.1.1) 5.12.1 Intent 5.12.2 Guidance |
| 36 | 5.13 Aseptic presentation (ISO 11607-1:2019, 6.1.2) 5.13.1 Intent 5.13.2 Guidance |
| 37 | 5.14 Physical protection (ISO 11607-1:2019, 6.1.3 and 6.1.4) 5.14.1 Intent 5.14.2 Guidance |
| 38 | 5.15 Sterilization compatibility (ISO 11607-1:2019, 6.1.5) 5.15.1 Intent 5.15.2 Guidance 5.16 Maintenance of Sterility (ISO 11607-1:2019, 6.1.6 and 6.1.7) 5.16.1 Intent 5.16.2 Guidance 5.16.2.1 Handling, distribution, and storage guidance |
| 39 | 5.17 Requirements for multi-layer packaging (ISO 11607-1:2019, 6.1.8) 5.17.1 Intent 5.17.2 Guidance |
| 40 | 5.18 Packaging families (ISO 11607-1:2019, 6.1.9) 5.18.1 Intent 5.18.2 Guidance 5.18.2.1 General 5.18.2.2 Packaging family considerations for healthcare facilities |
| 41 | 5.18.2.3 Worst-case configuration — Medical devices 5.18.2.4 Worst-case — Sterile barrier system |
| 42 | 5.19 Design process (ISO 11607-1:2019, 6.2.1) 5.19.1 Intent 5.19.2 Guidance 5.20 Design inputs (ISO 11607-1:2019, 6.2.2 and 6.2.3) 5.20.1 Intent 5.20.2 Guidance 5.20.2.1 General 5.20.2.2 Design inputs — medical device attributes |
| 43 | 5.20.2.3 Product attributes 5.20.2.4 Medical device protection guidance |
| 44 | 5.21 Sterile fluid path (ISO 11607-1:2019, 6.2.4, 6.2.5) 5.21.1 Intent 5.21.2 Guidance |
| 45 | Figure 1 — Sterile fluid path symbol — ISO 7000-3084 5.22 Usability evaluation for aseptic presentation (ISO 11607-1:2019, 7.1, 7.2 and 7.3) 5.22.1 Intent 5.22.2 Guidance |
| 46 | 5.23 Leveraging usability evaluations (ISO 11607-1:2019, 7.4) 5.23.1 Intent 5.23.2 Guidance |
| 47 | 5.24 Usability evaluation failures (ISO 11607-1:2019, 7.5) 5.24.1 Intent 5.24.2 Guidance 5.24.3 Guidance on formative and summative studies 5.24.3.1 Formative studies |
| 48 | 5.24.3.2 Summative studies 5.25 Packaging system performance and stability (ISO 11607-1:2019, 8.1) 5.25.1 Intent 5.25.2 Guidance 5.25.2.1 Significance of integrity testing |
| 49 | 5.25.2.2 Before testing 5.25.2.3 Separation of performance and stability testing 5.25.2.4 Different methods for integrity testing |
| 50 | 5.26 Packaging system performance testing (ISO 11607-1:2019, 8.2) 5.26.1 Intent 5.26.2 Guidance 5.26.2.1 Establishing a performance test plan 5.26.2.2 Define the distribution environment |
| 51 | 5.26.2.3 Environmental challenging 5.27 Stability testing (ISO 11607-1:2019, 8.3) 5.27.1 Intent 5.27.2 Guidance 5.27.2.1 Aging time practicalities and requirements |
| 52 | 5.27.2.2 Establishing a stability test plan 5.27.2.3 Accelerated aging |
| 53 | 5.28 Packaging system validation and changes (ISO 11607-1:2019, 9.1) 5.28.1 Intent 5.28.2 Guidance 5.29 Change control (ISO 11607-1:2019, 9.2) 5.29.1 Intent 5.29.2 Guidance 5.30 Revalidations (ISO 11607-1:2019, 9.3, 9.4, and 9.5) 5.30.1 Intent 5.30.2 Guidance |
| 54 | 5.31 Inspection immediately prior to aseptic presentation (ISO 11607-1:2019, Clause 10) 5.31.1 Intent 5.31.2 Guidance 5.32 Information to be provided (ISO 11607-1:2019, Clause 11) 5.32.1 Intent 5.32.2 Guidance |
| 55 | 6 Guidance on Clauses 5-8 of ISO 11607-2:2019 6.1 General Clauses 1-4 of ISO 11607-2:2019 6.2 Validation of packaging processes – general requirements (ISO 11607-2:2019, 5.1.1 and 5.1.2) 6.2.1 Intent 6.2.2 Guidance 6.3 Process specification (ISO 11607-2:2019, 5.1.3) 6.3.1 Intent 6.3.2 Guidance |
| 56 | 6.4 Process validation of packaging families (ISO 11607-2:2019, 5.1.4) 6.4.1 Intent 6.4.2 Guidance 6.4.2.1 Example No. 1 |
| 57 | 6.4.2.2 Example No. 2 6.5 Installation qualification (ISO 11607-2:2019, 5.2) 6.5.1 Intent 6.5.2 Guidance |
| 58 | 6.6 Operational qualification (ISO 11607-2:2019, 5.3) 6.6.1 Intent 6.6.2 Guidance |
| 59 | 6.7 Performance qualification (ISO 11607-2:2019, 5.4) 6.7.1 Intent 6.7.2 Guidance |
| 60 | 6.8 Formal approval of the process validation (ISO 11607-2:2019, 5.5) 6.8.1 Intent 6.8.2 Guidance 6.9 Process control and monitoring (ISO 11607-2:2019, 5.6) 6.9.1 Intent 6.9.2 Guidance |
| 61 | 6.10 Process changes and revalidation (ISO 11607-2:2019, 5.7) 6.10.1 Intent 6.10.2 Guidance 6.10.2.1 General 6.10.2.2 Process change examples: new sealing heating element in a sealing equipment |
| 62 | 6.11 Assembly (ISO 11607-2:2019, Clause 6) 6.11.1 Intent 6.11.2 Guidance 6.11.2.1 General 6.11.2.2 Environmental conditions for forming, sealing and assembly processes 6.11.2.3 Labelling and processing procedures |
| 63 | 6.11.2.4 Assembly instructions 6.12 Use of reusable sterile barrier systems (ISO 11607-2:2019, Clause 7) 6.12.1 Intent 6.12.2 Guidance 6.13 Sterile fluid path packaging (ISO 11607-2:2019, Clause 8) 6.13.1 Intent 6.13.2 Guidance |
| 65 | Annex A (informative) Design and development for packaging systems—Guidance for industry A.1 Design inputs A.1.1 General A.1.2 Manufacturing guidance A.1.3 Marketing guidance |
| 66 | A.1.4 Budget guidance A.1.5 Regulatory guidance A.2 Sterile barrier system and protective packaging design (packaging system development) A.2.1 Key elements in the design |
| 67 | A.2.2 Selection and evaluation of materials A.2.2.1 General A.2.2.2 Guidance on sterilization requirements (ISO 11607-1:2019, 5.1.6 e) and 5.3) A.2.2.3 Material physical properties Table A.1 — Typical material properties |
| 68 | A.2.2.4 Guidance on optical requirements of materials A.2.2.5 Material processing guidance A.2.3 Steps in packaging system design A.2.3.1 Design the sterile barrier system |
| 69 | A.2.3.2 Design the protective packaging A.2.3.3 Prototype the packaging system A.2.3.4 Labelling considerations for the packaging system design |
| 70 | A.3 Packaging process feasibility evaluation A.3.1 General A.3.2 Sterile barrier system manufacturing process A.3.3 Equipment installation qualification guidance A.3.4 Trial run with Prototypes A.4 Packaging system design feasibility evaluation A.4.1 General considerations |
| 71 | A.4.2 Packaging system design feasibility plan A.4.3 Worst-case feasibility condition A.4.4 Pass/fail status of packaging system |
| 73 | Annex B (informative) Guidance on the application of the ISO 11607 series in healthcare facilities B.1 Introduction |
| 74 | B.2 General requirements B.3 Design and development guidance for packaging systems (ISO 11607-1:2019, Clause 6) B.3.1 Design and development planning B.3.2 Design and development inputs |
| 75 | B.3.3 Packaging design and selection considerations |
| 76 | B.3.4 Sealing Equipment Considerations |
| 77 | B.3.5 Assembly considerations |
| 78 | B.4 Common choices for sterile barrier systems B.4.1 General B.4.2 Sealable pouches and reels (preformed sterile barrier systems) |
| 79 | B.4.3 SBS sterilization wrap B.4.3.1 General |
| 80 | B.4.3.2 General information about wrapping methods |
| 81 | B.4.3.3 Envelope method B.4.3.3.1 Simultaneous double envelope method Figure B.1 — Simultaneous double envelope method steps 1 to 3 Figure B.2 — Simultaneous double envelope method steps 4 to 6 |
| 82 | Figure B.3 — Aseptic opening of simultaneous double envelop wrapping B.4.3.3.2 Sequential double envelope method |
| 83 | Figure B.4 — Sequential double wrapping envelope method |
| 84 | Figure B.5 — Aseptic opening of sequential double envelope wrapping by the non-sterile nurse Figure B.6 — Aseptic opening of simultaneous double envelop wrapping by the sterile scrub nurse |
| 85 | B.4.3.4 Square fold / parallel wrapping method B.4.3.4.1 Simultaneous double square fold / parallel wrapping method Figure B.7 — Simultaneous square fold / parallel wrapping steps 1 to 2 Figure B.8 — Simultaneous square fold / parallel wrapping steps 3 to 4 |
| 86 | Figure B.9 — Simultaneous square fold / parallel wrapping steps 5 and 6 Figure B.10 — Aseptic opening of square fold simultaneous double wrapping by the non-sterile nurse B.4.3.4.2 Sequential double square fold / parallel wrapping method |
| 87 | Figure B.11 — Square fold sequential double wrapping |
| 88 | Figure B.12 — Aseptic opening of square fold sequential double wrapping by non-sterile nurse Figure B.13 — Aseptic opening of square fold sequential double wrapping by sterile scrub nurse B.4.4 Reusable containers |
| 89 | B.4.5 Protective packaging |
| 90 | Figure B.14 — Single Envelop Method for inner wrap – wrapping Figure B.15 — Single Envelop Method for inner wrap –Aseptic opening |
| 91 | B.5 Packaging system performance testing (ISO 11607-1:2019, 8.2) B.6 Sterile barrier system stability evaluation (shelf life) (ISO 11607-1:2019, 8.3) |
| 92 | B.7 Allowing for aseptic presentation |
| 93 | B.8 Validation requirements for forming, sealing and assembly processes B.8.1 General |
| 94 | B.8.2 Drafting of validation plan |
| 95 | B.8.3 Implementation of validation B.8.4 Validation approval B.8.5 Process control and routine monitoring B.9 Validation of common sterile barrier systems use in healthcare facilities B.9.1 Validation of the sealing process (pouch, reel or bag forming and sealing) of preformed sterile barrier systems B.9.1.1 Installation Qualification |
| 96 | B.9.1.2 Operational Qualification |
| 97 | B.9.1.3 Performance qualification |
| 98 | B.9.1.4 Routine monitoring B.9.2 Self-sealing or taped pouches B.9.3 Validation of the wrapping process (folding and closing of sterilization wraps) B.9.3.1 Installation qualification |
| 99 | B.9.3.2 Operational qualification B.9.3.3 Performance Qualification |
| 100 | B.9.3.4 Routine monitoring B.9.4 Validation of the reusable container process (filling, closing and processing of reusable containers before use) |
| 101 | B.9.4.1 Installation qualification B.9.4.2 Operational qualification B.9.4.3 Performance Qualification |
| 102 | B.9.4.4 Routine monitoring of reusable container processes |
| 103 | B.10 Process/packaging changes and revalidation |
| 104 | Annex C (informative) Risk analysis tools—Guidance for industry and healthcare facilities C.1 Applications C.1.1 Use/applications/system C.1.2 Design C.1.3 Process |
| 105 | C.2 Risk analysis tools C.2.1 Failure modes and effects analysis (FMEA) C.2.2 Fault tree analysis (FTA) C.2.3 Hazard analysis and critical control points (HACCP) |
| 107 | Annex D (informative) Considerations for sampling plans—Guidance for healthcare facilities |
| 109 | Annex E (informative) Guidance on establishing process parameters—Guidance for industry E.1 General E.2 Example of forming and lidding a tray E.2.1 FMEA (failure modes and effects analysis) |
| 110 | Table E.1 — FMEA example E.2.2 Design of experiment (DOE) |
| 111 | E.2.3 Heat seal curve analysis (process range assessment) Figure E.1 — Heat seal curve for optimum process parameters |
| 112 | E.2.4 Visual scoring method for heat seals |
| 113 | Table E.2 — Lower end of sealing range Table E.3 — Upper end of sealing range E.2.5 Combining heat seal curve analysis and visual scoring |
| 114 | Figure E.2 — Seal strength and visual seal quality vs. temperature E.2.6 Determination of process capability |
| 115 | Table E.4 — CpK value example |
| 116 | Annex F (informative) Sterilization considerations—Guidance for industry and healthcare facilities F.1 Overview F.2 Ethylene oxide |
| 117 | F.3 Gamma irradiation |
| 118 | F.4 Electron beam sterilization (E-beam) |
| 119 | F.5 X-ray sterilization |
| 120 | F.6 Moist heat (steam) sterilization F.7 Sterilization using moist heat and non-porous plastic bags |
| 121 | F.8 Dry heat F.9 Vaporized hydrogen peroxide sterilization (VH2O2) |
| 122 | F.10 Chlorine dioxide (ClO2 or CD) |
| 124 | Annex G (informative) Use of contract packagers—Guidance for industry and healthcare facilities G.1 General G.2 Functions performed by contract packagers G.3 Responsibilities |
| 125 | Annex H (informative) Example of a handling, distribution and storage checklist—Guidance for healthcare facilities for selecting a sterile barrier system |
| 128 | Annex I (informative) Investigating failure—Guidance for industry and healthcare facilities I.1 Evaluating failure I.2 Determining the source of the defect |
| 129 | I.3 Chemical and mechanical causes |
| 130 | I.4 Other tools I.5 Problem solving approach |
| 131 | Annex J (informative) Validation summary—Guidance for healthcare facilities Table J.1 — Number of process validations Table J.2 — Responsibilities |
| 132 | Table J.3 — Work area Table J.4 — Summary approval of the validation |
| 133 | Annex K (informative) Validation for wrapping process—Guidance for healthcare facilities Table K.1 — Wrapping process validation |
| 140 | Annex L (informative) Validation for reusable container process—Guidance for healthcare facilities Table L.1 — Validation reusable container process |
| 147 | Annex M (informative) Validation for heat sealing process for preformed sterile barrier systems (PSBS)—Guidance for healthcare facilities Table M.1 — Heat sealing process validation |
| 156 | Annex N (informative) Evaluation of sterile packaging by end users—Guidance for healthcare facilities Table N.1 — Evaluation of sterile packaging by end users |
| 157 | Bibliography |
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