{"id":198311,"date":"2024-10-19T12:37:28","date_gmt":"2024-10-19T12:37:28","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-20857-2010-ra-2015\/"},"modified":"2024-10-25T05:10:34","modified_gmt":"2024-10-25T05:10:34","slug":"aami-20857-2010-ra-2015","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-20857-2010-ra-2015\/","title":{"rendered":"AAMI 20857 2010 RA 2015"},"content":{"rendered":"

Specifies requirements for the development, validation and routine control of an industrial dry heat sterilization process for medical devices. Dry heat sterilization processes covered by this standard include but are not limited to forced air cycles and convection cycles. Although this standard primarily addresses dry heat sterilization, it also covers depyrogenation processes. The standard excludes processes that utilize infrared or microwaves as the heating medium.<\/p>\n

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PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/ISO 20857:2010\/(R)2015, Sterilization of health care products \u2014 Dry heat \u2014Requirements for 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
\n
Copyright information <\/td>\n<\/tr>\n
5<\/td>\nTable of contents
\n <\/td>\n<\/tr>\n
7<\/td>\nGlossary of equivalent standards
\n <\/td>\n<\/tr>\n
9<\/td>\nCommittee representation
\n <\/td>\n<\/tr>\n
11<\/td>\nBackground of ANSI\/AAMI adoption of ISO 20857:2010
\n <\/td>\n<\/tr>\n
12<\/td>\nForeword
\n <\/td>\n<\/tr>\n
13<\/td>\nIntroduction
\n <\/td>\n<\/tr>\n
15<\/td>\n1 Scope
1.1 Inclusions
1.2 Exclusions <\/td>\n<\/tr>\n
16<\/td>\n2 Normative references <\/td>\n<\/tr>\n
17<\/td>\n3 Terms and definitions <\/td>\n<\/tr>\n
25<\/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 nonconforming product <\/td>\n<\/tr>\n
26<\/td>\n5 Sterilizing agent characterization
5.1 Sterilizing agent
5.2 Microbicidal effectiveness
5.3 Material effects
5.4 Environmental considerations
6 Process and equipment characterization
6.1 Process characterization
6.2 Equipment characterization
6.2.1 Equipment specification
6.2.2 Identification <\/td>\n<\/tr>\n
27<\/td>\n6.2.3 Safety
6.2.4 Manuals and instructions
6.2.5 Utilities
6.2.6 Components
6.2.7 Accessories <\/td>\n<\/tr>\n
28<\/td>\n6.2.8 Control and recording systems
6.2.9 Control programs <\/td>\n<\/tr>\n
29<\/td>\n7 Product definition
7.1 General
7.2 Product safety and performance
7.3 Packaging considerations
7.4 Microbiological quality <\/td>\n<\/tr>\n
30<\/td>\n7.5 Product family
7.6 Biological safety
8 Process definition <\/td>\n<\/tr>\n
31<\/td>\n9 Validation
9.1 General
9.2 Installation qualification <\/td>\n<\/tr>\n
32<\/td>\n9.3 Operational qualification
9.4 Performance qualification
9.4.1 General <\/td>\n<\/tr>\n
33<\/td>\n9.4.2 Performance qualification\u00a0\u2014 Physical
9.4.3 Performance qualification\u00a0\u2014 Microbiological <\/td>\n<\/tr>\n
34<\/td>\n9.4.4 Performance qualification\u00a0\u2014 Depyrogenation
9.5 Additional sterilization systems
9.6 Review and approval of validation <\/td>\n<\/tr>\n
35<\/td>\n10 Routine monitoring and control
10.1 Routine control
10.2 Routine monitoring <\/td>\n<\/tr>\n
36<\/td>\n10.3 Process monitoring locations <\/td>\n<\/tr>\n
37<\/td>\n11 Product release from sterilization\/depyrogenation
12 Maintaining process effectiveness
12.1 General
12.2 Recalibration
12.3 Maintenance of equipment
12.4 Requalification <\/td>\n<\/tr>\n
38<\/td>\n12.5 Assessment of change <\/td>\n<\/tr>\n
39<\/td>\nAnnex A, Guidance on the application of this International Standard
\n
A.1 Scope
\n
A.1.1 Inclusions
\n
A.1.2 Exclusions
\n
A.2 Normative references
\n
A.3 Terms and definitions
\n <\/td>\n<\/tr>\n
40<\/td>\nA.4 Quality management systems
\n
A.4.1 Documentation
\n
A.4.2 Management responsibility
\n
A.4.3 Product realization
\n
A.4.4 Measurement, analysis and improvement — Control of nonconforming product
\n <\/td>\n<\/tr>\n
41<\/td>\nA.5 Sterilizing agent characterization
\n
A.5.1 Sterilizing agent
\n
A.5.2 Microbicidal effectiveness
\n
A.5.3 Material effects
\n
A.6 Process and equipment characterization
\n
A.6.1 Process characterization
\n <\/td>\n<\/tr>\n
43<\/td>\nA.6.2 Equipment characterization
\n
A.6.2.1 Equipment specification
\n <\/td>\n<\/tr>\n
44<\/td>\nA.6.2.2 Identification
\n
A.6.2.3 Safety
\n
A.6.2.4 Manuals and instructions
\n <\/td>\n<\/tr>\n
45<\/td>\nA.6.2.5 Utilities
\n
A.6.2.6 Components
\n <\/td>\n<\/tr>\n
46<\/td>\nA.6.2.7 Accessories
\n
A.6.2.8 Control and recording systems
\n <\/td>\n<\/tr>\n
47<\/td>\nA.6.2.9 Control programs
\n
A.7 Product definition
\n
A.7.1 General
\n <\/td>\n<\/tr>\n
48<\/td>\nA.7.2 Product safety and performance
\n
A.7.3 Packaging considerations
\n
A.7.4 Microbiological quality
\n <\/td>\n<\/tr>\n
49<\/td>\nA.7.5 Product family
\n
A.7.6 Biological safety
\n
A.8 Process definition
\n <\/td>\n<\/tr>\n
51<\/td>\nA.9 Validation
\n
A.9.1 General
\n <\/td>\n<\/tr>\n
52<\/td>\nA.9.2 Installation qualification
\n <\/td>\n<\/tr>\n
53<\/td>\nA.9.3 Operational qualification
\n <\/td>\n<\/tr>\n
54<\/td>\nA.9.4 Performance qualification
\n
A.9.4.1 General
\n
A.9.4.2 Performance qualification — Physical
\n <\/td>\n<\/tr>\n
55<\/td>\nA.9.4.3 Performance qualification — Microbiological
\n
A.9.4.4 Performance qualification — Depyrogenation
\n <\/td>\n<\/tr>\n
56<\/td>\nA.9.5 Additional sterilization systems
\n <\/td>\n<\/tr>\n
58<\/td>\nA.9.6 Review and approval of validation
\n <\/td>\n<\/tr>\n
59<\/td>\nA.10 Routine monitoring and control
\n
A.10.1 Routine control
\n <\/td>\n<\/tr>\n
60<\/td>\nA.10.2 Routine monitoring
\n
A.10.3 Process monitoring locations
\n
A.11 Product release from sterilization\/depyrogenation
\n <\/td>\n<\/tr>\n
61<\/td>\nA.12 Maintaining process effectiveness
\n
A.12.1 General
\n
A.12.2 Recalibration
\n
A.12.3
\nMaintenance of equipment <\/td>\n<\/tr>\n
62<\/td>\nA.12.4 Requalification
\n <\/td>\n<\/tr>\n
63<\/td>\nA.12.5 Assessment of change
\n <\/td>\n<\/tr>\n
64<\/td>\n\nAnnex B, Process definition based on inactivation of the microbial population in its natural state (bioburden-based approach)
B.1 General
\n
B.2 Product selection
\n
B.3 Procedure
\n <\/td>\n<\/tr>\n
65<\/td>\nB.4 Maintaining process effectiveness <\/td>\n<\/tr>\n
66<\/td>\nAnnex C, Process definition based on the inactivation of reference microorganisms and knowledge of bioburden (combined bioburden\/biological indicator approach)
\n
C.1 General
\n
C.2 Procedure
\n <\/td>\n<\/tr>\n
67<\/td>\nC.3 Process lethality determination
\n
C.3.1 Direct enumeration
\n
C.3.2 Fraction-negative method using Holcomb-Spearman-Karber approach (HSKP)
\n <\/td>\n<\/tr>\n
68<\/td>\nC.3 Fraction-negative method using Stumbo Murphy Cochran Procedure (SMCP)
\n <\/td>\n<\/tr>\n
69<\/td>\nAnnex D, Conservative process definition based on inactivation of reference microorganisms (overkill method)
\n
D.1 General
\n <\/td>\n<\/tr>\n
70<\/td>\nD.2 Product selection
\n
D.3 Procedure
\n
D.4 Partial cycle approach
\n <\/td>\n<\/tr>\n
71<\/td>\nD.5 Full cycle approach
\n <\/td>\n<\/tr>\n
72<\/td>\nAnnex E, Process development
\n
E.1 Process development — Biological methods
\n <\/td>\n<\/tr>\n
73<\/td>\nE.2 Process development — Physical methods
\n <\/td>\n<\/tr>\n
75<\/td>\nBibliography
\n <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 20857:2010\/(R)2015 – Sterilization of health care products-Dry heat: Requirements for 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
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