AAMI TIR17665 3 2014 RA 2016
$140.32
AAMI/ISO TIR17665-3:2014/(R)2016 – Sterilization of health care products-Moist Heat-Guidance on the designation of a medical product to a product family and processing category for steam sterilization
| Published By | Publication Date | Number of Pages |
| AAMI | 2014 | 65 |
This Technical Specification provides guidance about the attributes of a medical device to be considered by the user when assigning a medical device to a product family for the purpose of identifying and aligning it to a processing category for a specific moist heat sterilization process.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ ISO TIR17665-3:2014, Sterilization of health care products โ Moist Heat โ Guidance on the designation of a medical product to a product family and processing category for steam sterilization |
| 3 | Title page |
| 4 | Copyright information |
| 5 | AAMI Technical Information Report ANSI Technical Report |
| 6 | Contents |
| 8 | Glossary of equivalent standards |
| 9 | Committee representation |
| 12 | Background of ANSI/AAMI adoption of ISO/TS 17665-3:2013 |
| 13 | Foreword |
| 14 | Introduction |
| 15 | 1 Scope 2 Normative references 3 Terms and definitions |
| 16 | 4 Classification 4.1 General attributes Table 1 โ General attributes 4.2 Detailed attributes |
| 17 | 4.2.1 Design Table 2 โ Design 4.2.2 Material |
| 18 | Table 3 โ Materials 4.2.3 Weight Table 4 โ Weight |
| 19 | 4.2.4 Sterile barrier system and/or packaging system Table 5 โ Sterile barrier system and/or packaging system 5 Product family (pf) |
| 20 | 5.1 Example 1 โ pf 1 5.2 Example 2 โ pf 24 |
| 21 | 5.3 Example 3 โ pf 27 |
| 22 | Table 6 โ Product families |
| 23 | 6 Processing category 7 Sterilization process parameters 8 Additional considerations 8.1 Services 8.2 Process selection |
| 25 | Annex A: Process parameters Figure A.1 โ Performance requirements: Small load test |
| 27 | Annex B: Characterization of a procedure set โ Examples B.1 Assessment/extraction set (oral) B.1.1 General Figure B.1 โ Assessment/extraction set |
| 28 | Table B.2 โ Content of assessment/extraction set Table B.3 โ Analysis: assessment/extraction set |
| 29 | B.1.2 Product family Table B.4 โ Product family โ Classification based on estimates: Assessment/extraction set B.2 Cystoscope, bridge and tap set B.2.1 General |
| 30 | Figure B.2 โ Cystoscope, bridge and tap set (22 FG) Table B.5 โ Content of cystoscope, bridge and tap set (22 FG) Table B.6 โ Analysis: cystoscope, bridge and tap set (22 FG) |
| 31 | B.2.2 Product family Table B.7 โ Product family โ Classification based on estimates: Cystoscope, bridge and tap set (22 FG) B.3 Cataract ophthalmic No. 6 set B.3.1 General |
| 32 | Figure B.3 โ Cataract ophthalmic No. 6 set Table B.8 โ Content of cataract ophthalmic No. 6 set |
| 33 | Table B.9 โ Analysis: Cataract ophthalmic No. 6 set B.3.2 Product family Table B.10 โ Product family โ Classification based on estimates: Cataract ophthalmic No. 6 set B.4 General orthopaedic set B.4.1 General |
| 34 | Figure B.4 โ General orthopaedic set Table B.11 โ Content of general orthopaedic set |
| 35 | Table B.12 โ Analysis -general orthopaedic set B.4.2 Product family |
| 36 | B.5 General laparoscopy set B.5.1 General |
| 37 | Figure B.5 โ General laparoscopy set Table B.14 โ Content of general laparoscopy set |
| 38 | Table B.15 โ General laparoscopy set B.5.2 Product family Table B.16 โ Product family โ Classification based on estimates: General laparoscopy set |
| 39 | B.6 LCS knee set (1 of 6) B.6.1 General Figure B.6 โ LCS knee (set 1 of 6) |
| 40 | Table B.17 โ Contents: LCS knee (set 1 of 6) Table B.18 โ Product family โ Classification based on estimates: LCS knee (set 1 of 6) |
| 41 | B.6.2 Product family Table B.19 โ Product family โ Classification based on estimates: LCS knee (set 1 of 6) B.7 Femur repair and nail extraction set B.7.1 General |
| 42 | Figure B.7 โ Femur repair and nail extraction set Table B.20 โ Content: Femur repair and nail extraction set |
| 43 | Table B.21 โ Analysis: Femur repair and nail extraction set B.7.2 Product family |
| 45 | Annex C: Designating a processing category |
| 47 | Annex D: Processing categories โ Examples D.1 General instruments Figure D.1 โ Processing category: General instruments D.1.1 Assessment of family member 1 |
| 48 | Table D.1 โ Content: Family member 1 Table D.2 โ Analysis: Family member set 1 D.1.2 Product family |
| 49 | Table D.3 โ Product family โ Classification based on estimates: Family member 1 D.1.3 Assessment of family member 2 Table D.4 โ Content: Family member 2 |
| 50 | Table D.5 โ Analysis: Family member set 2 D.1.4 Product family Table D.6 โ Product family classification based on estimates: family member 2 D.1.5 Assessment of family member 3 |
| 51 | Table D.7 โ Content: Family member 3 Table D.8 โ Analysis: Family member set 3 D.1.6 Product family |
| 52 | Table D.9 โ Product family classification based on estimates: family member 3 D.1.7 Assessment of family member 4 Table D.10 โ Content: Family member 4 Table D.11 โ Analysis: Family member set 4 |
| 53 | D.1.8 Product family Table D.12 โ Product family โ Classification based on estimates: Family member 4 D.1.9 Assessment of family member 5 |
| 54 | Table D.13 โ Content: Family member 5 Table D.14 โ Analysis: Family member 5 D.1.10 Product family Table D.15 โ Product family โ Classification based on estimates: Family member 5 |
| 55 | D.1.11 Master product Table D.16 โ Content: Family member 6 (master product) Table D.17 โ Analysis โ Family member set 6: Master product |
| 56 | D.1.12 Product family Table D.18 โ Product family โ Classification based on estimates โ Master product: Family member set 6 D.2 Implant sets and complex orthopaedic sets |
| 57 | Figure D.2 โ Processing category: Implant sets Table D.19 โ Assessment โ Family member 1: Tibial plates |
| 58 | Table D.20 โ Assessment โ Family member 2: Cannulated screw set Table D.21 โ Assessment โ Family member 3: Bone screw and instrument set |
| 59 | Table D.22 โ Assessment โ Family member 4 โ Master product: Fragment instruments, plates and screws set Figure D.3 โ Processing category โ complex orthopaedic sets |
| 60 | Table D.23 โ Assessment โ Family member 1: ACL Instrument set Table D.24 โ Assessment โ Family member 2: Revision reamers |
| 61 | Table D.25 โ Assessment โ Family member 3: Cup screw instrument set |
| 62 | Table D.26 โ Assessment โ Family member 4 โ Master product: Hip core instrument set |
| 63 | Bibliography |
