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eLibrary > 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 >

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, 2014

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, 2014

ANSI/AAMI/ ISO TIR17665-3:2014, 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
Title page
Copyright information
AAMI Technical Information Report
ANSI Technical Report
Contents
Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of ISO/TS 17665-3:2013
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Classification [Go to Page]
4.1 General attributes [Go to Page]
Table 1 — General attributes
4.2 Detailed attributes [Go to Page]
4.2.1 Design [Go to Page]
Table 2 — Design
4.2.2 Material [Go to Page]
Table 3 — Materials
4.2.3 Weight [Go to Page]
Table 4 — Weight
4.2.4 Sterile barrier system and/or packaging system [Go to Page]
Table 5 — Sterile barrier system and/or packaging system
5 Product family (pf) [Go to Page]
5.1 Example 1 — pf 1
5.2 Example 2 — pf 24
5.3 Example 3 — pf 27 [Go to Page]
Table 6 — Product families
6 Processing category
7 Sterilization process parameters
8 Additional considerations [Go to Page]
8.1 Services
8.2 Process selection
Annex A: Process parameters [Go to Page]
Figure A.1 — Performance requirements: Small load test
Annex B: Characterization of a procedure set — Examples [Go to Page]
B.1 Assessment/extraction set (oral) [Go to Page]
B.1.1 General [Go to Page]
Figure B.1 — Assessment/extraction set
Table B.2 — Content of assessment/extraction set
Table B.3 — Analysis: assessment/extraction set
B.1.2 Product family [Go to Page]
Table B.4 — Product family — Classification based on estimates: Assessment/extraction set
B.2 Cystoscope, bridge and tap set [Go to Page]
B.2.1 General [Go to Page]
Figure B.2 — Cystoscope, bridge and tap set (22 FG)
Table B.5 — Content of cystoscope, bridge and tap set (22 FG)
Table B.6 — Analysis: cystoscope, bridge and tap set (22 FG)
B.2.2 Product family
Table B.7 — Product family — Classification based on estimates: Cystoscope, bridge and tap set (22 FG)
B.3 Cataract ophthalmic No. 6 set [Go to Page]
B.3.1 General [Go to Page]
Figure B.3 — Cataract ophthalmic No. 6 set
Table B.8 — Content of cataract ophthalmic No. 6 set
Table B.9 — Analysis: Cataract ophthalmic No. 6 set
B.3.2 Product family [Go to Page]
Table B.10 — Product family — Classification based on estimates: Cataract ophthalmic No. 6 set
B.4 General orthopaedic set [Go to Page]
B.4.1 General [Go to Page]
Figure B.4 — General orthopaedic set
Table B.11 — Content of general orthopaedic set
Table B.12 — Analysis -general orthopaedic set
B.4.2 Product family
B.5 General laparoscopy set [Go to Page]
B.5.1 General [Go to Page]
Figure B.5 — General laparoscopy set
Table B.14 — Content of general laparoscopy set
Table B.15 — General laparoscopy set
B.5.2 Product family [Go to Page]
Table B.16 — Product family — Classification based on estimates: General laparoscopy set
B.6 LCS knee set (1 of 6) [Go to Page]
B.6.1 General [Go to Page]
Figure B.6 — LCS knee (set 1 of 6)
Table B.17 — Contents: LCS knee (set 1 of 6)
Table B.18 — Product family — Classification based on estimates: LCS knee (set 1 of 6)
B.6.2 Product family [Go to Page]
Table B.19 — Product family — Classification based on estimates: LCS knee (set 1 of 6)
B.7 Femur repair and nail extraction set [Go to Page]
B.7.1 General [Go to Page]
Figure B.7 — Femur repair and nail extraction set
Table B.20 — Content: Femur repair and nail extraction set
Table B.21 — Analysis: Femur repair and nail extraction set
B.7.2 Product family
Annex C: Designating a processing category
Annex D: Processing categories — Examples [Go to Page]
D.1 General instruments [Go to Page]
Figure D.1 — Processing category: General instruments
D.1.1 Assessment of family member 1 [Go to Page]
Table D.1 — Content: Family member 1
Table D.2 — Analysis: Family member set 1
D.1.2 Product family [Go to Page]
Table D.3 — Product family — Classification based on estimates: Family member 1
D.1.3 Assessment of family member 2 [Go to Page]
Table D.4 — Content: Family member 2
Table D.5 — Analysis: Family member set 2
D.1.4 Product family [Go to Page]
Table D.6 — Product family classification based on estimates: family member 2
D.1.5 Assessment of family member 3 [Go to Page]
Table D.7 — Content: Family member 3
Table D.8 — Analysis: Family member set 3
D.1.6 Product family [Go to Page]
Table D.9 — Product family classification based on estimates: family member 3
D.1.7 Assessment of family member 4 [Go to Page]
Table D.10 — Content: Family member 4
Table D.11 — Analysis: Family member set 4
D.1.8 Product family [Go to Page]
Table D.12 — Product family — Classification based on estimates: Family member 4
D.1.9 Assessment of family member 5 [Go to Page]
Table D.13 — Content: Family member 5
Table D.14 — Analysis: Family member 5
D.1.10 Product family [Go to Page]
Table D.15 — Product family — Classification based on estimates: Family member 5
D.1.11 Master product [Go to Page]
Table D.16 — Content: Family member 6 (master product)
Table D.17 — Analysis — Family member set 6: Master product
D.1.12 Product family [Go to Page]
Table D.18 — Product family — Classification based on estimates — Master product: Family member set 6
D.2 Implant sets and complex orthopaedic sets [Go to Page]
Figure D.2 — Processing category: Implant sets
Table D.19 — Assessment — Family member 1: Tibial plates
Table D.20 — Assessment — Family member 2: Cannulated screw set
Table D.21 — Assessment — Family member 3: Bone screw and instrument set
Table D.22 — Assessment — Family member 4 — Master product: Fragment instruments, plates and screws set
Figure D.3 — Processing category – complex orthopaedic sets
Table D.23 — Assessment — Family member 1: ACL Instrument set
Table D.24 — Assessment — Family member 2: Revision reamers
Table D.25 — Assessment — Family member 3: Cup screw instrument set
Table D.26 — Assessment — Family member 4 — Master product: Hip core instrument set
Bibliography [Go to Page]

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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, 2014

To continue with accurate pricing,
please select your company type below: