{"id":424603,"date":"2024-10-20T06:52:33","date_gmt":"2024-10-20T06:52:33","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-18472-2022\/"},"modified":"2024-10-26T12:55:51","modified_gmt":"2024-10-26T12:55:51","slug":"aami-18472-2022","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-18472-2022\/","title":{"rendered":"AAMI 18472 2022"},"content":{"rendered":"

Specifies requirements for test equipment to be used to test biological indicators for steam, ethylene oxide gas and dry heat sterilization processes for conformity to the requirements given in ISO 11138 series and test chemical indicators for steam, ethylene oxide gas, dry heat and vaporized hydrogen peroxide sterilization processes for conformity to the requirements given in ISO 11140-1:2014.<\/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\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/ISO 18472:2022; Sterilization of health care products\u2014Biological and chemical indicators\u2014Test equipment <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nAAMI Standard
Copyright information <\/td>\n<\/tr>\n
5<\/td>\nContents Page <\/td>\n<\/tr>\n
7<\/td>\nCommittee representation <\/td>\n<\/tr>\n
10<\/td>\nBackground of ANSI\/AAMI adoption of ISO 18472:2018 <\/td>\n<\/tr>\n
11<\/td>\nForeword <\/td>\n<\/tr>\n
12<\/td>\nIntroduction <\/td>\n<\/tr>\n
13<\/td>\n1 Scope
2 Normative references <\/td>\n<\/tr>\n
14<\/td>\n3 Terms and definitions <\/td>\n<\/tr>\n
16<\/td>\n4 Performance requirements for resistometers
4.1 Intended use
4.2 Test methods
4.3 Air leakage test <\/td>\n<\/tr>\n
17<\/td>\n4.4 Steam resistometer performance requirements
4.4.1 Measurement accuracy
Table 1\u2014Steam resistometer instrumentation requirements (measurement and recording)
4.4.2 Data
4.4.3 Process control <\/td>\n<\/tr>\n
18<\/td>\nTable 2\u2014Steam resistometer physical conditions
Figure 1\u2014Stabilization time for temperature for steam resistometer <\/td>\n<\/tr>\n
19<\/td>\n4.4.4 General steam resistometer requirements
4.4.5 Air leakage test
4.4.6 Operation of steam resistometer
4.5 Ethylene oxide gas resistometer performance requirements
4.5.1 Measurement accuracy <\/td>\n<\/tr>\n
20<\/td>\nTable 3\u2014EO gas resistometer instrumentation requirements (measurement and recording)
4.5.2 Data
4.5.3 Process control <\/td>\n<\/tr>\n
21<\/td>\nTable 4\u2014EO gas resistometer physical design\/control specifications
Figure 2\u2014Stabilization time for temperature for ethylene oxide gas resistometer <\/td>\n<\/tr>\n
22<\/td>\n4.5.4 General ethylene oxide gas resistometer requirements
4.5.5 Air leakage test
4.5.6 Operation of ethylene oxide gas resistometer
4.5.6.1 The chamber shall be designed such that the formation of condensate during any stage of the operating cycle does not adversely affect the required test conditions. In order to avoid condensation during the operating cycle it might be necessary…
4.5.6.2 Before initiating a test cycle, the inner surface of the chamber shall be heated to the test temperature.
4.5.6.3 The equipment shall be provided with a means of evacuating the chamber to less than the vacuum set point to permit adequate air removal prior to admission of water vapour and ethylene oxide gas.
4.5.6.4 Data from controlled values shall be provided at an interface to record with a minimum frequency of 1 s.
4.6 Dry heat (heated air) resistometer performance requirements
4.6.1 Measurement accuracy <\/td>\n<\/tr>\n
23<\/td>\nTable 5\u2014Dry heat resistometer instrumentation requirements (measurement and recording)
4.6.2 Data
4.6.3 Process control
Table 6\u2014Dry heat resistometer physical design\/control specifications <\/td>\n<\/tr>\n
24<\/td>\n4.6.4 General dry heat (heated air) resistometer requirements
4.6.5 Operation of dry heat (heated air) resistometer
4.7 Vaporized hydrogen peroxide resistometer performance requirements
4.7.1 Measurement accuracy <\/td>\n<\/tr>\n
25<\/td>\nTable 7\u2014Vaporized hydrogen peroxide resistometer instrumentation requirements (measurement and recording)
4.7.2 Recording interval
4.7.3 Process control <\/td>\n<\/tr>\n
27<\/td>\n4.7.4 General vaporized hydrogen peroxide resistometer requirements
4.7.5 Air leakage test
4.7.6 Operation of vaporized hydrogen peroxide resistometer
5 Calibration <\/td>\n<\/tr>\n
28<\/td>\nAnnex A (informative) Additional performance characterization\u2014Steam
A.1 General
Figure A.1\u2014Steam test sequence <\/td>\n<\/tr>\n
29<\/td>\nA.2 Chamber air removal
A.3 Vacuum\/pressurization rate
A.4 Range characterization
A.5 Indicator orientation <\/td>\n<\/tr>\n
30<\/td>\nAnnex B (informative) Additional performance characterization\u2014Ethylene oxide gas
B.1 General
Figure B.1\u2014Sequence of ethylene oxide gas resistometer used in ethylene oxide gas exposure processes <\/td>\n<\/tr>\n
31<\/td>\nB.2 Chamber air removal
B.3 Vacuum\/pressurization rate
B.4 Range characterization <\/td>\n<\/tr>\n
32<\/td>\nAnnex C (informative) Additional performance characterization\u2014Dry heat
C.1 General
C.2 Specific variable response
C.3 Range characterization <\/td>\n<\/tr>\n
33<\/td>\nFigure C.1\u2014Sequence of dry heat resistometer used in dry heat exposure processes <\/td>\n<\/tr>\n
34<\/td>\nAnnex D (informative) Resistometer documentation and derivations
D.1 General
D.2 Calculation of relative humidity concentration <\/td>\n<\/tr>\n
35<\/td>\nD.3 Calculation of ethylene oxide gas concentration
D.3.1 General <\/td>\n<\/tr>\n
36<\/td>\nD.3.2 Calculations <\/td>\n<\/tr>\n
37<\/td>\nTable D.1\u2014EO gas\/diluent constants, K
Table D.2\u2014Molecular mass
D.3.3 Example calculations\/Determining ethylene oxide gas concentration <\/td>\n<\/tr>\n
38<\/td>\nD.3.4 Derivation of Formula (D.4) <\/td>\n<\/tr>\n
39<\/td>\nTable D.3\u2014Gas constants, R
D.4 Documentation
D.4.1 General
D.4.2 Minimum information <\/td>\n<\/tr>\n
40<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 18472:2022, Sterilization of health care products\u2014Biological and chemical indicators\u2014Test equipment<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2022<\/td>\n41<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":424609,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-424603","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\/424603","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\/424609"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=424603"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=424603"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=424603"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}