{"id":198172,"date":"2024-10-19T12:36:55","date_gmt":"2024-10-19T12:36:55","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-14937-2009-ra-2013\/"},"modified":"2024-10-25T05:10:06","modified_gmt":"2024-10-25T05:10:06","slug":"aami-14937-2009-ra-2013","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-14937-2009-ra-2013\/","title":{"rendered":"AAMI 14937 2009 RA 2013"},"content":{"rendered":"

Specifies general requirements for the characterization of a sterilizing agent and for the development, validation and routine monitoring and control of a sterilization process for medical devices. Applies to sterilization processes in which microorganisms are inactivated by physical and\/or chemical means. Intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of products to be sterilized and organizations responsible for sterilizing medical devices.<\/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 14937:2009\/(R)2013, Sterilization of health care products – General requirements for characterization of a sterilizing agent and the 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
7<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
9<\/td>\nCommittee Representation <\/td>\n<\/tr>\n
11<\/td>\nBackground of AAMI adoption of ANSI\/AAMI\/ISO 14937 <\/td>\n<\/tr>\n
12<\/td>\nForeword <\/td>\n<\/tr>\n
13<\/td>\nIntroduction <\/td>\n<\/tr>\n
15<\/td>\n1 Scope
1.1 Inclusions
1.2 Exclusions <\/td>\n<\/tr>\n
16<\/td>\n2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
22<\/td>\n4 Quality management system elements
4.1 Documentation
4.2 Management responsibility
4.3 Product realization
4.4 Measurement, analysis and improvement\u00a0\u2014 Control of non-conforming product
5 Sterilizing agent characterization
5.1 General <\/td>\n<\/tr>\n
23<\/td>\n5.2 Sterilizing agent
5.3 Microbicidal effectiveness
5.4 Effects on materials
5.5 Safety and the environment <\/td>\n<\/tr>\n
24<\/td>\n6 Process and equipment characterization
6.1 General
6.2 Process characterization
6.3 Equipment characterization <\/td>\n<\/tr>\n
25<\/td>\n7 Product definition
8 Process definition <\/td>\n<\/tr>\n
26<\/td>\n9 Validation
9.1 General <\/td>\n<\/tr>\n
27<\/td>\n9.2 Installation qualification
9.2.1 Equipment
9.2.2 Installation
9.3 Operational qualification <\/td>\n<\/tr>\n
28<\/td>\n9.4 Performance qualification <\/td>\n<\/tr>\n
29<\/td>\n9.5 Review and approval of validation
10 Routine monitoring and control
11 Product release from sterilization <\/td>\n<\/tr>\n
30<\/td>\n12 Maintaining process effectiveness
12.1 General
12.2 Recalibration
12.3 Maintenance of equipment
12.4 Requalification
12.5 Assessment of change <\/td>\n<\/tr>\n
31<\/td>\nAnnex A Factors to be considered in selection of microorganisms for demonstrating microbicidal effectiveness
A.1 General
A.2 Identification of reference microorganism
A.3 Selection of microorganisms <\/td>\n<\/tr>\n
33<\/td>\nAnnex B Approach 1 \u2014 Process definition based on inactivation of the microbial population in its natural state
B.1 General
B.2 Product selection
B.3 Procedure
B.4 Maintaining process effectiveness <\/td>\n<\/tr>\n
34<\/td>\nAnnex C Approach 2 \u2014 Process definition based on inactivation of reference microorganisms and knowledge of bioburden
C.1 General
C.2 Procedure <\/td>\n<\/tr>\n
35<\/td>\nAnnex D Approach 3 \u2014 Conservative process definition based on inactivation of reference microorganisms
D.1 General
D.2 Procedure <\/td>\n<\/tr>\n
37<\/td>\nAnnex E Guidance on application of this International Standard
E.1 Scope
E.2 Normative references
E.3 Terms and definitions
E.4 Quality management system elements
E.4.1 Documentation
E.4.2 Management responsibility <\/td>\n<\/tr>\n
41<\/td>\nE.4.3 Product realization
E.4.4 Measurement, analysis and improvement \u2014 Control of non-conforming product
E.5 Sterilizing agent characterization
E.5.1 General
E.5.2 Sterilizing agent
E.5.3 Microbicidal effectiveness <\/td>\n<\/tr>\n
44<\/td>\nE.5.4 Effects on materials
E.5.5 Safety and the environment
E.6 Process and equipment characterization
E.7 Product definition <\/td>\n<\/tr>\n
45<\/td>\nE.8 Process definition <\/td>\n<\/tr>\n
47<\/td>\nE.9 Validation
E.9.1 General
E.9.2 Installation qualification (IQ)
E.9.3 Operational qualification (OQ)
E.9.4 Performance qualification (PQ) <\/td>\n<\/tr>\n
48<\/td>\nE.9.5 Review and approval of validation
E.10 Routine monitoring and control <\/td>\n<\/tr>\n
49<\/td>\nE.11 Product release from sterilization
E.12 Maintaining process effectiveness
E.12.1 General <\/td>\n<\/tr>\n
50<\/td>\nE.12.2 Recalibration
E.12.3 Maintenance of equipment
E.12.4 Requalification
E.12.5 Assessment of change <\/td>\n<\/tr>\n
52<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 14937:2009\/(R) 2013 – Sterilization of health care products-General requirements for characterization of a sterilizing agent and the 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>\n2009<\/td>\n53<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198175,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198172","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\/198172","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\/198175"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198172"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198172"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198172"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}