{"id":438809,"date":"2024-10-20T08:05:31","date_gmt":"2024-10-20T08:05:31","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-tir16775-2023\/"},"modified":"2024-10-26T15:09:52","modified_gmt":"2024-10-26T15:09:52","slug":"aami-tir16775-2023","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-tir16775-2023\/","title":{"rendered":"AAMI TIR16775 2023"},"content":{"rendered":"

Provides guidance for the application of the requirements contained in ISO 11607-1 and ISO 11607-2.<\/p>\n

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PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nAAMI\/ISO TIR16775:2023; Packaging for terminally sterilized medical devices\u2014Guidance on the application of ISO 11607-1 and ISO 11607-2 <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
5<\/td>\nAAMI Technical Information Report <\/td>\n<\/tr>\n
7<\/td>\nCommittee representation <\/td>\n<\/tr>\n
11<\/td>\nBackground of AAMI adoption of ISO\/TS 16775:2021 <\/td>\n<\/tr>\n
12<\/td>\nForeword <\/td>\n<\/tr>\n
13<\/td>\nIntroduction <\/td>\n<\/tr>\n
15<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
16<\/td>\n4 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 <\/td>\n<\/tr>\n
17<\/td>\n4.2 Normative references (ISO 11607-1:2019, Clause 2 and ISO 11607-2:2019, Clause 2)
4.2.1 Intent
4.2.2 Guidance <\/td>\n<\/tr>\n
18<\/td>\n4.3 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) <\/td>\n<\/tr>\n
20<\/td>\n4.5 Sampling (ISO 11607-1:2019, 4.3 and ISO 11607-2:2019, 4.3)
4.5.1 Intent
4.5.2 Guidance <\/td>\n<\/tr>\n
21<\/td>\n4.6 Test methods (ISO 11607-1:2019, 4.4 and ISO 11607-2:2019, 4.4)
4.6.1 Intent
4.6.2 Guidance <\/td>\n<\/tr>\n
23<\/td>\n4.7 Documentation (ISO 11607-1:2019, 4.5 and ISO 11607-2:2019, 4.5)
4.7.1 Intent
4.7.2 Guidance <\/td>\n<\/tr>\n
24<\/td>\n5 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 <\/td>\n<\/tr>\n
25<\/td>\n5.3 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 <\/td>\n<\/tr>\n
26<\/td>\n5.5 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)] <\/td>\n<\/tr>\n
27<\/td>\n5.5.2.2 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) <\/td>\n<\/tr>\n
28<\/td>\n5.5.2.6 Regarding material chemical and toxicological characteristics (5.1.7 f) and 5.1.7 g) of ISO 11607-1:2019) <\/td>\n<\/tr>\n
29<\/td>\n5.5.2.7 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 <\/td>\n<\/tr>\n
30<\/td>\n5.6.2.2 Seal strength
5.6.2.3 Bursting strength <\/td>\n<\/tr>\n
31<\/td>\n5.7 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 <\/td>\n<\/tr>\n
32<\/td>\n5.10 Labelling system (ISO 11607-1:2019, 5.4)
5.10.1 Intent
5.10.2 Guidance
5.10.2.1 Type of labelling <\/td>\n<\/tr>\n
33<\/td>\n5.10.2.2 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 <\/td>\n<\/tr>\n
34<\/td>\n5.10.2.6 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 <\/td>\n<\/tr>\n
35<\/td>\n5.12 Design and development (ISO 11607-1:2019, 6.1.1)
5.12.1 Intent
5.12.2 Guidance <\/td>\n<\/tr>\n
36<\/td>\n5.13 Aseptic presentation (ISO 11607-1:2019, 6.1.2)
5.13.1 Intent
5.13.2 Guidance <\/td>\n<\/tr>\n
37<\/td>\n5.14 Physical protection (ISO 11607-1:2019, 6.1.3 and 6.1.4)
5.14.1 Intent
5.14.2 Guidance <\/td>\n<\/tr>\n
38<\/td>\n5.15 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 <\/td>\n<\/tr>\n
39<\/td>\n5.17 Requirements for multi-layer packaging (ISO 11607-1:2019, 6.1.8)
5.17.1 Intent
5.17.2 Guidance <\/td>\n<\/tr>\n
40<\/td>\n5.18 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 <\/td>\n<\/tr>\n
41<\/td>\n5.18.2.3 Worst-case configuration \u2014 Medical devices
5.18.2.4 Worst-case \u2014 Sterile barrier system <\/td>\n<\/tr>\n
42<\/td>\n5.19 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 \u2014 medical device attributes <\/td>\n<\/tr>\n
43<\/td>\n5.20.2.3 Product attributes
5.20.2.4 Medical device protection guidance <\/td>\n<\/tr>\n
44<\/td>\n5.21 Sterile fluid path (ISO 11607-1:2019, 6.2.4, 6.2.5)
5.21.1 Intent
5.21.2 Guidance <\/td>\n<\/tr>\n
45<\/td>\nFigure 1 \u2014 Sterile fluid path symbol \u2014 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 <\/td>\n<\/tr>\n
46<\/td>\n5.23 Leveraging usability evaluations (ISO 11607-1:2019, 7.4)
5.23.1 Intent
5.23.2 Guidance <\/td>\n<\/tr>\n
47<\/td>\n5.24 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 <\/td>\n<\/tr>\n
48<\/td>\n5.24.3.2 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 <\/td>\n<\/tr>\n
49<\/td>\n5.25.2.2 Before testing
5.25.2.3 Separation of performance and stability testing
5.25.2.4 Different methods for integrity testing <\/td>\n<\/tr>\n
50<\/td>\n5.26 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 <\/td>\n<\/tr>\n
51<\/td>\n5.26.2.3 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 <\/td>\n<\/tr>\n
52<\/td>\n5.27.2.2 Establishing a stability test plan
5.27.2.3 Accelerated aging <\/td>\n<\/tr>\n
53<\/td>\n5.28 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 <\/td>\n<\/tr>\n
54<\/td>\n5.31 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 <\/td>\n<\/tr>\n
55<\/td>\n6 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 \u2013 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 <\/td>\n<\/tr>\n
56<\/td>\n6.4 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 <\/td>\n<\/tr>\n
57<\/td>\n6.4.2.2 Example No. 2
6.5 Installation qualification (ISO 11607-2:2019, 5.2)
6.5.1 Intent
6.5.2 Guidance <\/td>\n<\/tr>\n
58<\/td>\n6.6 Operational qualification (ISO 11607-2:2019, 5.3)
6.6.1 Intent
6.6.2 Guidance <\/td>\n<\/tr>\n
59<\/td>\n6.7 Performance qualification (ISO 11607-2:2019, 5.4)
6.7.1 Intent
6.7.2 Guidance <\/td>\n<\/tr>\n
60<\/td>\n6.8 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 <\/td>\n<\/tr>\n
61<\/td>\n6.10 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 <\/td>\n<\/tr>\n
62<\/td>\n6.11 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 <\/td>\n<\/tr>\n
63<\/td>\n6.11.2.4 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 <\/td>\n<\/tr>\n
65<\/td>\nAnnex A (informative) Design and development for packaging systems\u2014Guidance for industry
A.1 Design inputs
A.1.1 General
A.1.2 Manufacturing guidance
A.1.3 Marketing guidance <\/td>\n<\/tr>\n
66<\/td>\nA.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 <\/td>\n<\/tr>\n
67<\/td>\nA.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 \u2014 Typical material properties <\/td>\n<\/tr>\n
68<\/td>\nA.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 <\/td>\n<\/tr>\n
69<\/td>\nA.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 <\/td>\n<\/tr>\n
70<\/td>\nA.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 <\/td>\n<\/tr>\n
71<\/td>\nA.4.2 Packaging system design feasibility plan
A.4.3 Worst-case feasibility condition
A.4.4 Pass\/fail status of packaging system <\/td>\n<\/tr>\n
73<\/td>\nAnnex B (informative) Guidance on the application of the ISO 11607 series in healthcare facilities
B.1 Introduction <\/td>\n<\/tr>\n
74<\/td>\nB.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 <\/td>\n<\/tr>\n
75<\/td>\nB.3.3 Packaging design and selection considerations <\/td>\n<\/tr>\n
76<\/td>\nB.3.4 Sealing Equipment Considerations <\/td>\n<\/tr>\n
77<\/td>\nB.3.5 Assembly considerations <\/td>\n<\/tr>\n
78<\/td>\nB.4 Common choices for sterile barrier systems
B.4.1 General
B.4.2 Sealable pouches and reels (preformed sterile barrier systems) <\/td>\n<\/tr>\n
79<\/td>\nB.4.3 SBS sterilization wrap
B.4.3.1 General <\/td>\n<\/tr>\n
80<\/td>\nB.4.3.2 General information about wrapping methods <\/td>\n<\/tr>\n
81<\/td>\nB.4.3.3 Envelope method
B.4.3.3.1 Simultaneous double envelope method
Figure B.1 \u2014 Simultaneous double envelope method steps 1 to 3
Figure B.2 \u2014 Simultaneous double envelope method steps 4 to 6 <\/td>\n<\/tr>\n
82<\/td>\nFigure B.3 \u2014 Aseptic opening of simultaneous double envelop wrapping
B.4.3.3.2 Sequential double envelope method <\/td>\n<\/tr>\n
83<\/td>\nFigure B.4 \u2014 Sequential double wrapping envelope method <\/td>\n<\/tr>\n
84<\/td>\nFigure B.5 \u2014 Aseptic opening of sequential double envelope wrapping by the non-sterile nurse
Figure B.6 \u2014 Aseptic opening of simultaneous double envelop wrapping by the sterile scrub nurse <\/td>\n<\/tr>\n
85<\/td>\nB.4.3.4 Square fold \/ parallel wrapping method
B.4.3.4.1 Simultaneous double square fold \/ parallel wrapping method
Figure B.7 \u2014 Simultaneous square fold \/ parallel wrapping steps 1 to 2
Figure B.8 \u2014 Simultaneous square fold \/ parallel wrapping steps 3 to 4 <\/td>\n<\/tr>\n
86<\/td>\nFigure B.9 \u2014 Simultaneous square fold \/ parallel wrapping steps 5 and 6
Figure B.10 \u2014 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 <\/td>\n<\/tr>\n
87<\/td>\nFigure B.11 \u2014 Square fold sequential double wrapping <\/td>\n<\/tr>\n
88<\/td>\nFigure B.12 \u2014 Aseptic opening of square fold sequential double wrapping by non-sterile nurse
Figure B.13 \u2014 Aseptic opening of square fold sequential double wrapping by sterile scrub nurse
B.4.4 Reusable containers <\/td>\n<\/tr>\n
89<\/td>\nB.4.5 Protective packaging <\/td>\n<\/tr>\n
90<\/td>\nFigure B.14 \u2014 Single Envelop Method for inner wrap \u2013 wrapping
Figure B.15 \u2014 Single Envelop Method for inner wrap \u2013Aseptic opening <\/td>\n<\/tr>\n
91<\/td>\nB.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) <\/td>\n<\/tr>\n
92<\/td>\nB.7 Allowing for aseptic presentation <\/td>\n<\/tr>\n
93<\/td>\nB.8 Validation requirements for forming, sealing and assembly processes
B.8.1 General <\/td>\n<\/tr>\n
94<\/td>\nB.8.2 Drafting of validation plan <\/td>\n<\/tr>\n
95<\/td>\nB.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 <\/td>\n<\/tr>\n
96<\/td>\nB.9.1.2 Operational Qualification <\/td>\n<\/tr>\n
97<\/td>\nB.9.1.3 Performance qualification <\/td>\n<\/tr>\n
98<\/td>\nB.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 <\/td>\n<\/tr>\n
99<\/td>\nB.9.3.2 Operational qualification
B.9.3.3 Performance Qualification <\/td>\n<\/tr>\n
100<\/td>\nB.9.3.4 Routine monitoring
B.9.4 Validation of the reusable container process (filling, closing and processing of reusable containers before use) <\/td>\n<\/tr>\n
101<\/td>\nB.9.4.1 Installation qualification
B.9.4.2 Operational qualification
B.9.4.3 Performance Qualification <\/td>\n<\/tr>\n
102<\/td>\nB.9.4.4 Routine monitoring of reusable container processes <\/td>\n<\/tr>\n
103<\/td>\nB.10 Process\/packaging changes and revalidation <\/td>\n<\/tr>\n
104<\/td>\nAnnex C (informative) Risk analysis tools\u2014Guidance for industry and healthcare facilities
C.1 Applications
C.1.1 Use\/applications\/system
C.1.2 Design
C.1.3 Process <\/td>\n<\/tr>\n
105<\/td>\nC.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) <\/td>\n<\/tr>\n
107<\/td>\nAnnex D (informative) Considerations for sampling plans\u2014Guidance for healthcare facilities <\/td>\n<\/tr>\n
109<\/td>\nAnnex E (informative) Guidance on establishing process parameters\u2014Guidance for industry
E.1 General
E.2 Example of forming and lidding a tray
E.2.1 FMEA (failure modes and effects analysis) <\/td>\n<\/tr>\n
110<\/td>\nTable E.1 \u2014 FMEA example
E.2.2 Design of experiment (DOE) <\/td>\n<\/tr>\n
111<\/td>\nE.2.3 Heat seal curve analysis (process range assessment)
Figure E.1 \u2014 Heat seal curve for optimum process parameters <\/td>\n<\/tr>\n
112<\/td>\nE.2.4 Visual scoring method for heat seals <\/td>\n<\/tr>\n
113<\/td>\nTable E.2 \u2014 Lower end of sealing range
Table E.3 \u2014 Upper end of sealing range
E.2.5 Combining heat seal curve analysis and visual scoring <\/td>\n<\/tr>\n
114<\/td>\nFigure E.2 \u2014 Seal strength and visual seal quality vs. temperature
E.2.6 Determination of process capability <\/td>\n<\/tr>\n
115<\/td>\nTable E.4 \u2014 CpK value example <\/td>\n<\/tr>\n
116<\/td>\nAnnex F (informative) Sterilization considerations\u2014Guidance for industry and healthcare facilities
F.1 Overview
F.2 Ethylene oxide <\/td>\n<\/tr>\n
117<\/td>\nF.3 Gamma irradiation <\/td>\n<\/tr>\n
118<\/td>\nF.4 Electron beam sterilization (E-beam) <\/td>\n<\/tr>\n
119<\/td>\nF.5 X-ray sterilization <\/td>\n<\/tr>\n
120<\/td>\nF.6 Moist heat (steam) sterilization
F.7 Sterilization using moist heat and non-porous plastic bags <\/td>\n<\/tr>\n
121<\/td>\nF.8 Dry heat
F.9 Vaporized hydrogen peroxide sterilization (VH2O2) <\/td>\n<\/tr>\n
122<\/td>\nF.10 Chlorine dioxide (ClO2 or CD) <\/td>\n<\/tr>\n
124<\/td>\nAnnex G (informative) Use of contract packagers\u2014Guidance for industry and healthcare facilities
G.1 General
G.2 Functions performed by contract packagers
G.3 Responsibilities <\/td>\n<\/tr>\n
125<\/td>\nAnnex H (informative) Example of a handling, distribution and storage checklist\u2014Guidance for healthcare facilities for selecting a sterile barrier system <\/td>\n<\/tr>\n
128<\/td>\nAnnex I (informative) Investigating failure\u2014Guidance for industry and healthcare facilities
I.1 Evaluating failure
I.2 Determining the source of the defect <\/td>\n<\/tr>\n
129<\/td>\nI.3 Chemical and mechanical causes <\/td>\n<\/tr>\n
130<\/td>\nI.4 Other tools
I.5 Problem solving approach <\/td>\n<\/tr>\n
131<\/td>\nAnnex J (informative) Validation summary\u2014Guidance for healthcare facilities
Table J.1 \u2014 Number of process validations
Table J.2 \u2014 Responsibilities <\/td>\n<\/tr>\n
132<\/td>\nTable J.3 \u2014 Work area
Table J.4 \u2014 Summary approval of the validation <\/td>\n<\/tr>\n
133<\/td>\nAnnex K (informative) Validation for wrapping process\u2014Guidance for healthcare facilities
Table K.1 \u2014 Wrapping process validation <\/td>\n<\/tr>\n
140<\/td>\nAnnex L (informative) Validation for reusable container process\u2014Guidance for healthcare facilities
Table L.1 \u2014 Validation reusable container process <\/td>\n<\/tr>\n
147<\/td>\nAnnex M (informative) Validation for heat sealing process for preformed sterile barrier systems (PSBS)\u2014Guidance for healthcare facilities
Table M.1 \u2014 Heat sealing process validation <\/td>\n<\/tr>\n
156<\/td>\nAnnex N (informative) Evaluation of sterile packaging by end users\u2014Guidance for healthcare facilities
Table N.1 \u2014 Evaluation of sterile packaging by end users <\/td>\n<\/tr>\n
157<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

AAMI\/ISO TIR16775:2023 Packaging for terminally sterilized medical devices\u2014Guidance on the application of ISO 11607-1 and ISO 11607-2<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
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