{"id":198109,"date":"2024-10-19T12:36:43","date_gmt":"2024-10-19T12:36:43","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-tir15-2016\/"},"modified":"2024-10-25T05:09:55","modified_gmt":"2024-10-25T05:09:55","slug":"aami-tir15-2016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-tir15-2016\/","title":{"rendered":"AAMI TIR15 2016"},"content":{"rendered":"

This technical information report (TIR) provides additional guidance to augment the ANSI\/AAMI\/ISO 11135 series. Topics covered in this TIR are sterilization equipment, considerations for preconditioning, calculations for relative humidity, calculations of ethylene oxide concentration, and flammability.<\/p>\n

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nAAMI TIR15:2016; Physical aspects of ethylene oxide sterilization <\/td>\n<\/tr>\n
2<\/td>\nBlank Page <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nAAMI Technical Information Report
Copyright information <\/td>\n<\/tr>\n
5<\/td>\nContents <\/td>\n<\/tr>\n
6<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
7<\/td>\nCommittee representation <\/td>\n<\/tr>\n
10<\/td>\nForeword <\/td>\n<\/tr>\n
11<\/td>\n1 Scope
2 Definitions <\/td>\n<\/tr>\n
12<\/td>\n3 EO sterilization processing equipment
3.1 General
3.2 Preconditioning area (outside sterilizer chamber) <\/td>\n<\/tr>\n
13<\/td>\n3.3 Sterilizer system <\/td>\n<\/tr>\n
15<\/td>\n3.4 Aeration system <\/td>\n<\/tr>\n
16<\/td>\n3.5 EO handling, storage, and dispensing
3.6 Calibration and maintenance <\/td>\n<\/tr>\n
18<\/td>\n3.7 Safety
4 Determination of minimum product temperature prior to preconditioning
4.1 General
4.2 Simulation of anticipated process conditions <\/td>\n<\/tr>\n
19<\/td>\n4.3 Special situations
4.4 Other considerations
5 Calculation of moisture content
5.1 Static humidification
5.1.1 Process definition
5.1.2 Designing a static humidification process
5.1.2.1 Shallow vacuum processes (nitrogen soft cycles) <\/td>\n<\/tr>\n
20<\/td>\n5.1.2.2 Deep vacuum processes
5.2 Dynamic conditioning
5.2.1 Process definition <\/td>\n<\/tr>\n
21<\/td>\n5.2.2 Design of a dynamic conditioning phase
5.2.2.1 Operational pressure during dynamic conditioning
5.2.2.2 PSI\u2014Process description and setup
5.2.2.3 CSI\u2014Process description and setup <\/td>\n<\/tr>\n
22<\/td>\n5.2.3 Equipment concerns\u2014Dynamic conditioning
5.2.3.1 Vacuum system
5.2.3.2 Steam supply
5.2.3.3 Control systems
6 Calculation of EO concentration
6.1 Calculation tables
Table 1 \u2014 List of constants and molecular weights of some common EO\/Diluent combinations <\/td>\n<\/tr>\n
23<\/td>\nTable 2 \u2014 Gas constants (R)*
6.2 Definition of variables
6.3 Ideal Gas Law <\/td>\n<\/tr>\n
24<\/td>\n6.4 Calculations
6.5 Method of determining EO gas concentration based on physical laws of perfect gas behavior
6.5.1 100 % EO sterilant
6.5.1.1 Example 1\u2014Partial pressure method
6.5.1.2 Example 2\u2014EO weight method <\/td>\n<\/tr>\n
25<\/td>\n6.5.2 EO and diluent molecular blend
6.5.2.1 Example 3\u2014Partial pressure method of a 20 % EO and 80 % CO2 sterilant gas with values of K in Table 1 <\/td>\n<\/tr>\n
26<\/td>\n6.5.2.2 Example 4\u2014Sterilant weight method <\/td>\n<\/tr>\n
27<\/td>\n6.6 EO absorption
7 Calculations for use of flammability curve <\/td>\n<\/tr>\n
29<\/td>\nFigure 1 \u2014 EO Cycle Flammability Diagram <\/td>\n<\/tr>\n
31<\/td>\nTable 4 \u2014 Flammability review, partial pressures, and volume percentage <\/td>\n<\/tr>\n
32<\/td>\n8 Guide for statistical comparison to determine process equivalence
8.1 General
8.2 Equations for Pp, Ppk or for Cp, Cpk
8.2.1 Calculation of Pp <\/td>\n<\/tr>\n
33<\/td>\n8.2.2 Calculation of Ppk
8.2.3 Normality test <\/td>\n<\/tr>\n
34<\/td>\n8.2.4 Data interpretation
8.2.5 Worked Ppk, Pp example <\/td>\n<\/tr>\n
35<\/td>\n8.3 Other statistical methods <\/td>\n<\/tr>\n
36<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

AAMI TIR15:2016 – Physical aspects of ethylene oxide sterilization<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2016<\/td>\n37<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198112,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198109","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-aami","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/198109","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/198112"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198109"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198109"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198109"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}