{"id":198363,"date":"2024-10-19T12:37:39","date_gmt":"2024-10-19T12:37:39","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-11135-2014\/"},"modified":"2024-10-25T05:10:43","modified_gmt":"2024-10-25T05:10:43","slug":"aami-11135-2014","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-11135-2014\/","title":{"rendered":"AAMI 11135 2014"},"content":{"rendered":"

Specifies requirements for the development, validation, and routine control of an ethylene oxide sterilization process for medical devices.<\/p>\n

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PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/ISO 11135:2014, Sterilization of health care products \u2014Ethylene oxide \u2014Requirements for development, validation and routine control of a sterilization process for medical devices <\/td>\n<\/tr>\n
2<\/td>\nObjectives and uses of AAMI standards and recommended practices <\/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 <\/td>\n<\/tr>\n
8<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
9<\/td>\nCommittee representation <\/td>\n<\/tr>\n
12<\/td>\nBackground of ANSI\/AAMI adoption of ISO 11135:2014 <\/td>\n<\/tr>\n
13<\/td>\nForeword <\/td>\n<\/tr>\n
14<\/td>\nIntroduction <\/td>\n<\/tr>\n
17<\/td>\n1 Scope
1.1 Inclusions
1.2 Exclusions <\/td>\n<\/tr>\n
18<\/td>\n2 Normative references <\/td>\n<\/tr>\n
19<\/td>\n3 Terms and definitions <\/td>\n<\/tr>\n
27<\/td>\n4 Quality management systems
4.1 Documentation
4.2 Management responsibility
4.3 Product realization
4.4 Measurement, analysis and improvement \u2014 Control of nonconforming product <\/td>\n<\/tr>\n
28<\/td>\n5 Sterilizing agent characterization
5.1 General
5.2 Sterilizing agent
5.3 Microbicidal effectiveness
5.4 Material effects
5.5 Safety and the environment
6 Process and equipment characterization
6.1 General <\/td>\n<\/tr>\n
29<\/td>\n6.2 Process characterization <\/td>\n<\/tr>\n
30<\/td>\n6.3 Equipment characterization <\/td>\n<\/tr>\n
31<\/td>\n7 Product definition
7.1 General
7.2 Product safety, quality and performance
7.3 Microbiological quality <\/td>\n<\/tr>\n
32<\/td>\n7.4 Documentation
8 Process definition <\/td>\n<\/tr>\n
33<\/td>\n9 Validation
9.1 General
9.2 Installation qualification, IQ
9.2.1 Equipment
9.2.2 Installation qualification <\/td>\n<\/tr>\n
34<\/td>\n9.3 Operational qualification, OQ
9.4 Performance qualification, PQ
9.4.1 General <\/td>\n<\/tr>\n
35<\/td>\n9.4.2 Performance qualification \u2014 Microbiological
9.4.3 Performance qualification \u2014 Physical <\/td>\n<\/tr>\n
36<\/td>\n9.5 Review and approval of validation <\/td>\n<\/tr>\n
38<\/td>\n10 Routine monitoring and control <\/td>\n<\/tr>\n
40<\/td>\n11 Product release from sterilization
12 Maintaining process effectiveness
12.1 General
12.2 Maintenance of equipment <\/td>\n<\/tr>\n
41<\/td>\n12.3 Requalification
12.4 Assessment of change
12.5 Assessment of equivalence
12.5.1 Process equivalence <\/td>\n<\/tr>\n
42<\/td>\n12.5.2 Product <\/td>\n<\/tr>\n
43<\/td>\nAnnex A: Determination of lethal rate of the sterilization process \u2014 Biological indicator\/bioburden approach
A.1 General
A.2 Procedure <\/td>\n<\/tr>\n
44<\/td>\nAnnex B: Conservative determination of lethal rate of the sterilization process \u2014 Overkill approach
B.1 General
B.2 Procedure <\/td>\n<\/tr>\n
46<\/td>\nAnnex C: Temperature sensors, RH sensors and biological indicator numbers
C.1 Temperature sensors
Table C.1 \u2014 Minimum recommended number of temperature sensors <\/td>\n<\/tr>\n
47<\/td>\nC.2 Humidity sensors
Table C.2 \u2014 Minimum recommended number of humidity sensors
C.3 Biological Indicators <\/td>\n<\/tr>\n
48<\/td>\nTable C.3 \u2014 Examples of minimum recommended number of BI\/PCDs <\/td>\n<\/tr>\n
49<\/td>\nAnnex D: Guidance on the application of the normative requirements
D.1 Scope
D.2 Normative references
D.3 Terms and definitions
D.4 Quality management systems
D.4.1 Documentation
D.4.2 Management responsibility <\/td>\n<\/tr>\n
50<\/td>\nD.4.3 Product realization
D.4.4 Measurement, analysis and improvement \u2014 Control of non-conforming product
D.5 Sterilizing agent characterization
D.5.1 General <\/td>\n<\/tr>\n
51<\/td>\nD.5.2 Sterilizing agent
D.5.3 Microbicidal effectiveness
D.5.4 Material effects
D.5.5 Safety and the environment <\/td>\n<\/tr>\n
52<\/td>\nD.6 Process and equipment characterization
D.6.1 General
D.6.2 Process characterization <\/td>\n<\/tr>\n
54<\/td>\nD.6.3 Equipment characterization <\/td>\n<\/tr>\n
56<\/td>\nD.7 Product definition
D.7.1 General <\/td>\n<\/tr>\n
59<\/td>\nD.7.2 Product safety, quality and performance <\/td>\n<\/tr>\n
61<\/td>\nD.7.3 Microbiological quality
D.7.4 Documentation
D.8 Process definition <\/td>\n<\/tr>\n
65<\/td>\nD.9 Validation
D.9.1 General
D.9.2 Installation qualification
D.9.2.1 Equipment <\/td>\n<\/tr>\n
66<\/td>\nD.9.2.2 Installation qualification <\/td>\n<\/tr>\n
67<\/td>\nD.9.3 Operational qualification <\/td>\n<\/tr>\n
69<\/td>\nD.9.4 Performance qualification
D.9.4.1 General <\/td>\n<\/tr>\n
70<\/td>\nD.9.4.2 Performance qualification \u2014 Microbiological <\/td>\n<\/tr>\n
71<\/td>\nD.9.4.3 Performance qualification \u2014 Physical <\/td>\n<\/tr>\n
72<\/td>\nD.9.4.4 Review and approval of validation <\/td>\n<\/tr>\n
73<\/td>\nD.10 Routine monitoring and control <\/td>\n<\/tr>\n
76<\/td>\nD.11 Product release from sterilization
D.12 Maintaining process effectiveness
D.12.1 General <\/td>\n<\/tr>\n
77<\/td>\nD.12.2 Maintenance of equipment <\/td>\n<\/tr>\n
78<\/td>\nD.12.3 Requalification <\/td>\n<\/tr>\n
80<\/td>\nFigure D.1 \u2014 Requalification decision tree
D.12.4 Assessment of change <\/td>\n<\/tr>\n
81<\/td>\nD.12.5 Assessment of equivalence1F**
D.12.5.1 Process equivalence
D.12.5.2 Criteria for process equivalence <\/td>\n<\/tr>\n
82<\/td>\nD.12.5.3 Determination of process equivalence
D.12.5.4 Process analysis and evaluation
D.12.5.5 Evaluation of preconditioning or aeration areas
D.12.5.6 Evaluation of sterilization chamber performance <\/td>\n<\/tr>\n
83<\/td>\nD.12.5.7 Microbiological evaluation
D.12.5.8 Results evaluation <\/td>\n<\/tr>\n
84<\/td>\nD.12.5.9 Maintenance of equivalence
D.12.5.10 Documentation
D.12.5.11 Product
D.12.5.11.1 Product family <\/td>\n<\/tr>\n
85<\/td>\nD.12.5.11.2 Determination of adverse effects to product
D.12.5.11.3 Determination of product design effects <\/td>\n<\/tr>\n
86<\/td>\nD.12.5.11.4 Determination of product material and characteristics effects
D.12.5.11.5 Determination of sterile barrier system effects
D.12.5.11.6 Determination of load configuration effects
D.12.5.11.7 Conclusions of product adoption evaluation
D.13 Guidance on Annex A \u2014 Determination of lethal rate of the sterilization process \u2014 Biological indicator\/bioburden approach
D.13.1 [A.1] General <\/td>\n<\/tr>\n
88<\/td>\nD.13.2 [A.2] Procedure <\/td>\n<\/tr>\n
89<\/td>\nD.14 Guidance on Annex B \u2014 Conservative determination of lethal rate of the sterilization process \u2014 Overkill approach
D.14.1 [B.1] General <\/td>\n<\/tr>\n
90<\/td>\nD.14.2 [B.2] Procedure <\/td>\n<\/tr>\n
91<\/td>\nAnnex E: Single Lot Release
E.1 General
E.2 Procedure <\/td>\n<\/tr>\n
93<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 11135:2014 – Sterilization of health care products-Ethylene oxide-Requirements for development, validation and routine control of a sterilization process for medical devices<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2014<\/td>\n95<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198364,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198363","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\/198363","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\/198364"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198363"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198363"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198363"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}