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AAMI/ISO TIR16775:2023 Packaging for terminally sterilized medical devices—Guidance on the application of ISO 11607-1 and ISO 11607-2, 2023
- AAMI/ISO TIR16775:2023; Packaging for terminally sterilized medical devices—Guidance on the application of ISO 11607-1 and ISO 11607-2
- Title page
- AAMI Technical Information Report
- Committee representation
- Background of AAMI adoption of ISO/TS 16775:2021
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Guidance on Clauses 1-4 of ISO 11607-1:2019 and ISO 11607-2:2019 [Go to Page]
- 4.1 Scope (ISO 11607-1:2019, Clause 1 and ISO 11607-2:2019, Clause 1) [Go to Page]
- 4.1.1 Intent
- 4.1.2 Guidance
- 4.2 Normative references (ISO 11607-1:2019, Clause 2 and ISO 11607-2:2019, Clause 2) [Go to Page]
- 4.2.1 Intent
- 4.2.2 Guidance
- 4.3 Terms and definitions (ISO 11607-1:2019, Clause 3 and ISO 11607-2:2019, Clause 3) [Go to Page]
- 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) [Go to Page]
- 4.4.1 Intent
- 4.4.2 Guidance [Go to Page]
- 4.4.2.1 Guidance on quality system requirements (4.1)
- 4.4.2.2 Guidance on risk management requirements (4.2)
- 4.5 Sampling (ISO 11607-1:2019, 4.3 and ISO 11607-2:2019, 4.3) [Go to Page]
- 4.5.1 Intent
- 4.5.2 Guidance
- 4.6 Test methods (ISO 11607-1:2019, 4.4 and ISO 11607-2:2019, 4.4) [Go to Page]
- 4.6.1 Intent
- 4.6.2 Guidance
- 4.7 Documentation (ISO 11607-1:2019, 4.5 and ISO 11607-2:2019, 4.5) [Go to Page]
- 4.7.1 Intent
- 4.7.2 Guidance
- 5 Guidance on Clauses 5-11 of ISO 11607-1:2019 [Go to Page]
- 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) [Go to Page]
- 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) [Go to Page]
- 5.2.1 Intent
- 5.2.2 Guidance
- 5.3 Source, history and traceability of materials (ISO 11607-1:2019, 5.1.5) [Go to Page]
- 5.3.1 Intent
- 5.3.2 Guidance
- 5.4 Properties to be evaluated (ISO 11607-1:2019, 5.1.6) [Go to Page]
- 5.4.1 Intent
- 5.4.2 Guidance
- 5.5 General performance requirements for materials (ISO 11607-1:2019, 5.1.7 and 5.1.8) [Go to Page]
- 5.5.1 Intent
- 5.5.2 Guidance [Go to Page]
- 5.5.2.1 Regarding requirements for leachables and odours [ISO 11607-1:2019, 5.1.7 a)]
- 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)
- 5.5.2.6 Regarding material chemical and toxicological characteristics (5.1.7 f) and 5.1.7 g) of ISO 11607-1:2019)
- 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) [Go to Page]
- 5.6.1 Intent
- 5.6.2 Guidance [Go to Page]
- 5.6.2.1 General
- 5.6.2.2 Seal strength
- 5.6.2.3 Bursting strength
- 5.7 Reusable sterile barrier systems (ISO 11607-1:2019, 5.1.10, 5.1.11 and 5.1.12) [Go to Page]
- 5.7.1 Intent
- 5.7.2 Guidance
- 5.8 Microbial barrier properties (ISO 11607-1:2019, 5.2) [Go to Page]
- 5.8.1 Intent
- 5.8.2 Guidance
- 5.9 Compatibility with the sterilization process (ISO 11607-1:2019, 5.3) [Go to Page]
- 5.9.1 Intent
- 5.9.2 Guidance
- 5.10 Labelling system (ISO 11607-1:2019, 5.4) [Go to Page]
- 5.10.1 Intent
- 5.10.2 Guidance [Go to Page]
- 5.10.2.1 Type of labelling
- 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
- 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) [Go to Page]
- 5.11.1 Intent
- 5.11.2 Guidance
- 5.12 Design and development (ISO 11607-1:2019, 6.1.1) [Go to Page]
- 5.12.1 Intent
- 5.12.2 Guidance
- 5.13 Aseptic presentation (ISO 11607-1:2019, 6.1.2) [Go to Page]
- 5.13.1 Intent
- 5.13.2 Guidance
- 5.14 Physical protection (ISO 11607-1:2019, 6.1.3 and 6.1.4) [Go to Page]
- 5.14.1 Intent
- 5.14.2 Guidance
- 5.15 Sterilization compatibility (ISO 11607-1:2019, 6.1.5) [Go to Page]
- 5.15.1 Intent
- 5.15.2 Guidance
- 5.16 Maintenance of Sterility (ISO 11607-1:2019, 6.1.6 and 6.1.7) [Go to Page]
- 5.16.1 Intent
- 5.16.2 Guidance [Go to Page]
- 5.16.2.1 Handling, distribution, and storage guidance
- 5.17 Requirements for multi-layer packaging (ISO 11607-1:2019, 6.1.8) [Go to Page]
- 5.17.1 Intent
- 5.17.2 Guidance
- 5.18 Packaging families (ISO 11607-1:2019, 6.1.9) [Go to Page]
- 5.18.1 Intent
- 5.18.2 Guidance [Go to Page]
- 5.18.2.1 General
- 5.18.2.2 Packaging family considerations for healthcare facilities
- 5.18.2.3 Worst-case configuration — Medical devices
- 5.18.2.4 Worst-case — Sterile barrier system
- 5.19 Design process (ISO 11607-1:2019, 6.2.1) [Go to Page]
- 5.19.1 Intent
- 5.19.2 Guidance
- 5.20 Design inputs (ISO 11607-1:2019, 6.2.2 and 6.2.3) [Go to Page]
- 5.20.1 Intent
- 5.20.2 Guidance [Go to Page]
- 5.20.2.1 General
- 5.20.2.2 Design inputs — medical device attributes
- 5.20.2.3 Product attributes
- 5.20.2.4 Medical device protection guidance
- 5.21 Sterile fluid path (ISO 11607-1:2019, 6.2.4, 6.2.5) [Go to Page]
- 5.21.1 Intent
- 5.21.2 Guidance [Go to Page]
- 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) [Go to Page]
- 5.22.1 Intent
- 5.22.2 Guidance
- 5.23 Leveraging usability evaluations (ISO 11607-1:2019, 7.4) [Go to Page]
- 5.23.1 Intent
- 5.23.2 Guidance
- 5.24 Usability evaluation failures (ISO 11607-1:2019, 7.5) [Go to Page]
- 5.24.1 Intent
- 5.24.2 Guidance
- 5.24.3 Guidance on formative and summative studies [Go to Page]
- 5.24.3.1 Formative studies
- 5.24.3.2 Summative studies
- 5.25 Packaging system performance and stability (ISO 11607-1:2019, 8.1) [Go to Page]
- 5.25.1 Intent
- 5.25.2 Guidance [Go to Page]
- 5.25.2.1 Significance of integrity testing
- 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
- 5.26 Packaging system performance testing (ISO 11607-1:2019, 8.2) [Go to Page]
- 5.26.1 Intent
- 5.26.2 Guidance [Go to Page]
- 5.26.2.1 Establishing a performance test plan
- 5.26.2.2 Define the distribution environment
- 5.26.2.3 Environmental challenging
- 5.27 Stability testing (ISO 11607-1:2019, 8.3) [Go to Page]
- 5.27.1 Intent
- 5.27.2 Guidance [Go to Page]
- 5.27.2.1 Aging time practicalities and requirements
- 5.27.2.2 Establishing a stability test plan
- 5.27.2.3 Accelerated aging
- 5.28 Packaging system validation and changes (ISO 11607-1:2019, 9.1) [Go to Page]
- 5.28.1 Intent
- 5.28.2 Guidance
- 5.29 Change control (ISO 11607-1:2019, 9.2) [Go to Page]
- 5.29.1 Intent
- 5.29.2 Guidance
- 5.30 Revalidations (ISO 11607-1:2019, 9.3, 9.4, and 9.5) [Go to Page]
- 5.30.1 Intent
- 5.30.2 Guidance
- 5.31 Inspection immediately prior to aseptic presentation (ISO 11607-1:2019, Clause 10) [Go to Page]
- 5.31.1 Intent
- 5.31.2 Guidance
- 5.32 Information to be provided (ISO 11607-1:2019, Clause 11) [Go to Page]
- 5.32.1 Intent
- 5.32.2 Guidance
- 6 Guidance on Clauses 5-8 of ISO 11607-2:2019 [Go to Page]
- 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) [Go to Page]
- 6.2.1 Intent
- 6.2.2 Guidance
- 6.3 Process specification (ISO 11607-2:2019, 5.1.3) [Go to Page]
- 6.3.1 Intent
- 6.3.2 Guidance
- 6.4 Process validation of packaging families (ISO 11607-2:2019, 5.1.4) [Go to Page]
- 6.4.1 Intent
- 6.4.2 Guidance [Go to Page]
- 6.4.2.1 Example No. 1
- 6.4.2.2 Example No. 2
- 6.5 Installation qualification (ISO 11607-2:2019, 5.2) [Go to Page]
- 6.5.1 Intent
- 6.5.2 Guidance
- 6.6 Operational qualification (ISO 11607-2:2019, 5.3) [Go to Page]
- 6.6.1 Intent
- 6.6.2 Guidance
- 6.7 Performance qualification (ISO 11607-2:2019, 5.4) [Go to Page]
- 6.7.1 Intent
- 6.7.2 Guidance
- 6.8 Formal approval of the process validation (ISO 11607-2:2019, 5.5) [Go to Page]
- 6.8.1 Intent
- 6.8.2 Guidance
- 6.9 Process control and monitoring (ISO 11607-2:2019, 5.6) [Go to Page]
- 6.9.1 Intent
- 6.9.2 Guidance
- 6.10 Process changes and revalidation (ISO 11607-2:2019, 5.7) [Go to Page]
- 6.10.1 Intent
- 6.10.2 Guidance [Go to Page]
- 6.10.2.1 General
- 6.10.2.2 Process change examples: new sealing heating element in a sealing equipment
- 6.11 Assembly (ISO 11607-2:2019, Clause 6) [Go to Page]
- 6.11.1 Intent
- 6.11.2 Guidance [Go to Page]
- 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
- 6.11.2.4 Assembly instructions
- 6.12 Use of reusable sterile barrier systems (ISO 11607-2:2019, Clause 7) [Go to Page]
- 6.12.1 Intent
- 6.12.2 Guidance
- 6.13 Sterile fluid path packaging (ISO 11607-2:2019, Clause 8) [Go to Page]
- 6.13.1 Intent
- 6.13.2 Guidance
- Annex A (informative) Design and development for packaging systems—Guidance for industry [Go to Page]
- A.1 Design inputs [Go to Page]
- A.1.1 General
- A.1.2 Manufacturing guidance
- A.1.3 Marketing guidance
- A.1.4 Budget guidance
- A.1.5 Regulatory guidance
- A.2 Sterile barrier system and protective packaging design (packaging system development) [Go to Page]
- A.2.1 Key elements in the design
- A.2.2 Selection and evaluation of materials [Go to Page]
- 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 [Go to Page]
- Table A.1 — Typical material properties
- 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 [Go to Page]
- A.2.3.1 Design the sterile barrier system
- 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
- A.3 Packaging process feasibility evaluation [Go to Page]
- 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 [Go to Page]
- A.4.1 General considerations
- A.4.2 Packaging system design feasibility plan
- A.4.3 Worst-case feasibility condition
- A.4.4 Pass/fail status of packaging system
- Annex B (informative) Guidance on the application of the ISO 11607 series in healthcare facilities [Go to Page]
- B.1 Introduction
- B.2 General requirements
- B.3 Design and development guidance for packaging systems (ISO 11607-1:2019, Clause 6) [Go to Page]
- B.3.1 Design and development planning
- B.3.2 Design and development inputs
- B.3.3 Packaging design and selection considerations
- B.3.4 Sealing Equipment Considerations
- B.3.5 Assembly considerations
- B.4 Common choices for sterile barrier systems [Go to Page]
- B.4.1 General
- B.4.2 Sealable pouches and reels (preformed sterile barrier systems)
- B.4.3 SBS sterilization wrap [Go to Page]
- B.4.3.1 General
- B.4.3.2 General information about wrapping methods
- B.4.3.3 Envelope method [Go to Page]
- B.4.3.3.1 Simultaneous double envelope method [Go to Page]
- Figure B.1 — Simultaneous double envelope method steps 1 to 3
- Figure B.2 — Simultaneous double envelope method steps 4 to 6
- Figure B.3 — Aseptic opening of simultaneous double envelop wrapping
- B.4.3.3.2 Sequential double envelope method [Go to Page]
- Figure B.4 — Sequential double wrapping envelope method
- 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
- B.4.3.4 Square fold / parallel wrapping method [Go to Page]
- B.4.3.4.1 Simultaneous double square fold / parallel wrapping method [Go to Page]
- Figure B.7 — Simultaneous square fold / parallel wrapping steps 1 to 2
- Figure B.8 — Simultaneous square fold / parallel wrapping steps 3 to 4
- 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 [Go to Page]
- Figure B.11 — Square fold sequential double wrapping
- 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
- B.4.5 Protective packaging [Go to Page]
- Figure B.14 — Single Envelop Method for inner wrap – wrapping
- Figure B.15 — Single Envelop Method for inner wrap –Aseptic opening
- 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)
- B.7 Allowing for aseptic presentation
- B.8 Validation requirements for forming, sealing and assembly processes [Go to Page]
- B.8.1 General
- B.8.2 Drafting of validation plan
- 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 [Go to Page]
- B.9.1 Validation of the sealing process (pouch, reel or bag forming and sealing) of preformed sterile barrier systems [Go to Page]
- B.9.1.1 Installation Qualification
- B.9.1.2 Operational Qualification
- B.9.1.3 Performance qualification
- 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) [Go to Page]
- B.9.3.1 Installation qualification
- B.9.3.2 Operational qualification
- B.9.3.3 Performance Qualification
- B.9.3.4 Routine monitoring
- B.9.4 Validation of the reusable container process (filling, closing and processing of reusable containers before use) [Go to Page]
- B.9.4.1 Installation qualification
- B.9.4.2 Operational qualification
- B.9.4.3 Performance Qualification
- B.9.4.4 Routine monitoring of reusable container processes
- B.10 Process/packaging changes and revalidation
- Annex C (informative) Risk analysis tools—Guidance for industry and healthcare facilities [Go to Page]
- C.1 Applications [Go to Page]
- C.1.1 Use/applications/system
- C.1.2 Design
- C.1.3 Process
- C.2 Risk analysis tools [Go to Page]
- 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)
- Annex D (informative) Considerations for sampling plans—Guidance for healthcare facilities
- Annex E (informative) Guidance on establishing process parameters—Guidance for industry [Go to Page]
- E.1 General
- E.2 Example of forming and lidding a tray [Go to Page]
- E.2.1 FMEA (failure modes and effects analysis) [Go to Page]
- Table E.1 — FMEA example
- E.2.2 Design of experiment (DOE)
- E.2.3 Heat seal curve analysis (process range assessment) [Go to Page]
- Figure E.1 — Heat seal curve for optimum process parameters
- E.2.4 Visual scoring method for heat seals [Go to Page]
- 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 [Go to Page]
- Figure E.2 — Seal strength and visual seal quality vs. temperature
- E.2.6 Determination of process capability [Go to Page]
- Table E.4 — CpK value example
- Annex F (informative) Sterilization considerations—Guidance for industry and healthcare facilities [Go to Page]
- F.1 Overview
- F.2 Ethylene oxide
- F.3 Gamma irradiation
- F.4 Electron beam sterilization (E-beam)
- F.5 X-ray sterilization
- F.6 Moist heat (steam) sterilization
- F.7 Sterilization using moist heat and non-porous plastic bags
- F.8 Dry heat
- F.9 Vaporized hydrogen peroxide sterilization (VH2O2)
- F.10 Chlorine dioxide (ClO2 or CD)
- Annex G (informative) Use of contract packagers—Guidance for industry and healthcare facilities [Go to Page]
- G.1 General
- G.2 Functions performed by contract packagers
- G.3 Responsibilities
- Annex H (informative) Example of a handling, distribution and storage checklist—Guidance for healthcare facilities for selecting a sterile barrier system
- Annex I (informative) Investigating failure—Guidance for industry and healthcare facilities [Go to Page]
- I.1 Evaluating failure
- I.2 Determining the source of the defect
- I.3 Chemical and mechanical causes
- I.4 Other tools
- I.5 Problem solving approach
- Annex J (informative) Validation summary—Guidance for healthcare facilities [Go to Page]
- Table J.1 — Number of process validations
- Table J.2 — Responsibilities
- Table J.3 — Work area
- Table J.4 — Summary approval of the validation
- Annex K (informative) Validation for wrapping process—Guidance for healthcare facilities [Go to Page]
- Table K.1 — Wrapping process validation
- Annex L (informative) Validation for reusable container process—Guidance for healthcare facilities [Go to Page]
- Table L.1 — Validation reusable container process
- Annex M (informative) Validation for heat sealing process for preformed sterile barrier systems (PSBS)—Guidance for healthcare facilities [Go to Page]
- Table M.1 — Heat sealing process validation
- Annex N (informative) Evaluation of sterile packaging by end users—Guidance for healthcare facilities [Go to Page]
- Table N.1 — Evaluation of sterile packaging by end users
- Bibliography [Go to Page]
