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AAMI 11607 2 2019 A1 2023

Sun, 20 Oct 2024 10:41:46 +0000

This amendment adds Annex B on risk management and related modifications to the text.

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PDF Pages	PDF Title
1	ANSI/AAMI/ISO 11607-2:2019/A1:2023; Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes—Amendment 1: Application of risk management
3	Title page
4	AAMI Standard Copyright information
5	Contents
6	Committee representation
11	Background of ANSI/AAMI adoption of ISO 11607-2:2019/Amd 1:2023
12	Foreword
13	AMENDMENT 1: Application of risk management
15	Annex A (normative) Risk management A.1 General A.2 Application of the risk management process
16	A.3 Risk management plan A.3.1 General A.3.2 Criteria for risk acceptability
17	A.4 Specific hazards and hazardous situations to be addressed Table B.1 — Hazards and contributing factors A.5 Risk estimation A.6 Risk evaluation A.7 Risk control
18	A.8 Monitoring effectiveness of risk control measures

AAMI 11607 1 2019 A1 2023

Sun, 20 Oct 2024 10:41:46 +0000

This amendment adds Annexes F and G on risk management and related modifications to the text.

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PDF Pages	PDF Title
1	ANSI/AAMI/ISO 11607-1:2019/A1:2023; Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems—Amendment 1: Application of risk management
3	Title page
4	AAMI Standard Copyright information
5	Contents
6	Committee representation
11	Background of ANSI/AAMI adoption of ISO 11607-1:2019/Amd 1:2023
12	Foreword
13	AMENDMENT 1: Application of risk management
16	Annex A (normative) Risk management A.1 Risk management process A.2 Application of the risk management process
17	A.3 Risk management plan A.3.1 General A.3.2 Criteria for risk acceptability A.3.3 Similar packaging systems A.4 Specific hazards and hazardous situations to be addressed
18	Table F.1 — Hazards and potential relevant factors A.5 Risk estimation A.6 Risk evaluation A.7 Risk control
19	A.8 Monitoring effectiveness of risk control measures
20	Annex B (informative) Risk management for medical device packaging — Rationale for requirements B.1 Objective of risk management for medical devices B.2 Application of risk management for sterile medical device packaging B.2.1 General
21	Figure G.1 — Pictorial example of the relationship between hazard, sequence of events, hazardous situation and harm highlighting the focus of packaging risk management (from ISO/IEC Guide 63:2019, amended) B.2.2 Hazards to be addressed for medical packaging
22	B.2.3 Identification of sequences of events Figure G.2 — Example of sequence of events leading to contamination of a sterile device
23	B.2.4 Hazardous situations Table G.1 — Examples of relationship between hazards, foreseeable sequences of events and hazardous situations B.2.5 Risk estimation B.2.5.1 Estimating the probability of occurrence and severity of harm
24	Figure G.3 — Risk estimation using a criticality matrix B.2.5.2 Risk estimation applied to hazardous situations
25	Figure G.4 — Risk estimation using the risk priority number (RPN) method Table G.2 — Example of five qualitative severity levels
26	Table G.3 — Examples of quantitative severity levels with three levels Table G.4 — Example of semi-quantitative probability levels
27	Table G.5 — Example of a typical measurement scale for detectability B.2.6 Risk evaluation Table G.6 — Risk criticality zones and actions to be taken B.2.7 Risk control B.2.7.1 General B.2.7.2 Application of safe design principles B.2.7.3 Selection of suitable materials B.2.7.4 General requirements for design B.2.7.5 Process development B.2.8 Demonstrate the effectiveness of the risk control measures B.2.8.1 General
28	B.2.8.2 Usability for aseptic presentation Figure G.5 — Example of risk management for use-related hazards B.2.8.3 Addressing environmental conditions through performance and stability testing
29	B.2.8.4 Process validation B.2.9 Process control and monitoring B.2.10 Manage changes during the production phase B.2.11 Risk management applied to either preformed sterile barrier systems or materials, or both B.3 Documentation

AAMI 13408 1 2023

Sun, 20 Oct 2024 10:41:45 +0000

This document specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of aseptic processing of health care products. This document includes requirements and guidance relative to the overall topic of aseptic processing.

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PDF Pages	PDF Title
1	ANSI/AAMI/ISO 13408-1:2023; Aseptic processing of health care products—Part 1: General requirements
2	Blank Page
3	Title page
4	AAMI Standard Copyright information
5	Contents
6	Committee representation
10	Background of ANSI/AAMI adoption of ISO 13408-1:2023
11	Foreword
13	Introduction
15	Figure 1 — Relationship between the ISO 13408 series and ISO 18362
17	1 Scope 2 Normative references 3 Terms and definitions
25	4 General 5 Principles of aseptic processing 5.1 General
26	Figure 2 — Key activities in the development and operation of an aseptic process and their relationships 5.2 Use of an aseptic process
27	5.3 Core elements
28	5.4 Aseptic processing zones 5.4.1 General 5.4.2 Critical processing zone 5.4.3 Direct support zones
29	5.4.4 Indirect support zones 6 Process design, development and risk management 6.1 General
31	6.2 Process design 6.3 Risk assessment 6.4 Identification of critical control points and process parameters
32	6.5 Handling and processing 6.6 Environment and air handling
33	6.7 Materials 6.8 Personnel 6.8.1 General 6.8.2 Training
34	6.8.3 Health 6.8.4 Interventions
35	6.8.5 Service personnel 6.8.6 Cleanroom clothing systems
36	6.9 Aseptic processing equipment 6.9.1 General 6.9.2 Automated processes and robotics 6.9.3 Single use systems and connecting devices 6.9.4 Auxiliary equipment and utilities
37	6.10 Components 6.11 Product related safety requirements 6.12 Aseptic final packaging process
38	6.13 Flow management 6.13.1 Containment 6.13.2 Cross contamination 6.13.3 Item introduction
39	6.13.4 Egress 6.13.5 Waste management 6.14 Manufacturing process duration 7 Contamination control strategy (CCS) 7.1 General
40	7.2 Cleaning and disinfection programs 7.2.1 General 7.2.2 Cleaning
41	7.2.3 Disinfection 7.2.4 Equipment used for cleaning and disinfection in APA
42	7.2.5 Cleaning process validation 7.2.6 Disinfection process validation 7.2.7 Cleaning and disinfection of equipment
43	7.2.8 Cleaning and disinfection procedures 7.3 Sterilization 7.3.1 General 7.3.2 Sterilization processes 7.3.3 Sterilization equipment
44	7.3.4 Sterilization procedures 7.3.5 Post aseptic lethal treatments 7.3.6 Endotoxin control
45	7.3.7 Depyrogenation process 7.4 Maintenance of sterility
47	7.5 Maintenance and calibration programs 7.5.1 Service personnel
48	7.5.2 Planned maintenance activities 7.5.3 Unplanned maintenance 7.5.4 Calibration of equipment
49	7.6 Environmental monitoring 7.6.1 General 7.6.2 Sampling for non-viable particulate monitoring
50	7.6.3 Sampling for microbiological environmental monitoring 7.7 Containment of highly potent or toxic substances
51	8 Demonstration of the effectiveness 8.1 Equipment qualification and validation 8.1.1 General 8.1.2 User requirements specification 8.1.3 Design qualification 8.1.4 Installation qualification (IQ)
52	8.1.5 Operational qualification (OQ) 8.1.6 Performance qualification (PQ) 8.1.7 Requalification 8.2 Aseptic process validation 8.2.1 General 8.2.2 Establishment and management of interventions
53	8.2.3 Process simulation 8.2.3.1 General 8.2.3.2 Media selection and growth support
54	8.2.3.3 Simulation procedures
55	8.2.3.4 Incubation and inspection of media filled units 8.2.4 Initial aseptic qualification 8.2.5 Periodic performance requalification 8.2.5.1 General
56	8.2.5.2 Numbers to be processed 8.2.5.3 Acceptance criteria 8.2.6 Repeat of initial aseptic qualification
57	8.2.7 Documentation of process simulations
58	8.2.8 Disposition of filled product 8.2.9 Aseptic process lifecycle considerations 8.3 Maintenance of process 8.3.1 General 8.3.2 Review of the manufacturing process
59	8.3.3 Changes or developments to the manufacturing process 9 Product release 9.1 General 9.2 Testing for sterility
60	9.3 Testing for bacterial endotoxins 9.4 Testing for mycoplasma 9.5 Rapid and alternative microbiological methods
61	Annex A (informative) Aseptic processing — Typical elements
62	Annex B (informative) Risk management B.1 General B.2 Quality risk-management process B.2.1 Risk assessment B.2.2 Risk control
63	B.2.3 Risk communication B.2.4 Risk review Figure B.1 — Overview of a typical quality risk management process (reference ICH Q9)
64	B.3 Risk assessment tools B.3.1 General B.3.2 Failure mode and effects analysis (FMEA) Table B.1 — Sample FMEA for aseptic connection of single-use processing equipment
65	B.3.3 Fault tree analysis (FTA)
66	Figure B.2 — Example FTA diagram B.3.4 Hazard and operability analysis (HAZOP)
67	B.3.5 Hazard analysis and critical control points (HACCP) B.3.6 Simplified risk assessment
69	Annex C (informative) Typical processing zones C.1 General Figure C.1 — Critical processing zone and support zone
70	Table C.1 — APA system
71	C.2 Aseptic processing area (APA) example set-up Figure C.2 — Example of an aseptic processing area (APA) configuration using a RABS or biological safety cabinet
72	Figure C.3 — Example of an aseptic processing area (APA) configuration using a closed system
73	Annex D (informative) Comparison of classification of cleanrooms and filters Table D.1 — Classification systems
75	Table D.2 — Comparison of HEPA and ULPA filters
77	Annex E (informative) Example of an aseptic process flow chart Figure E.1 — Example of an aseptic process divided into unit operations
78	Annex F (informative) Closed systems and robotics F.1 General F.2 Single use systems as closed systems within an aseptic process Figure F.1 — Overview of a filling system including multiple connections and disconnections
79	Figure F.2 — Example of a single sterile manifold system F.3 Robotics
81	Annex G (informative) Sterile cleanroom clothing system qualification G.1 General G.2 Design qualification G.2.1 General G.2.2 Material qualifications
82	G.2.3 Performance testing G.2.3.1 General G.2.3.2 Simulated use of cleanroom clothing system G.2.3.3 Cleanroom clothing system performance supported by historical data from actual use G.2.4 Stability testing of sterile cleanroom garments and accessories G.2.4.1 General G.2.4.2 Sterile disposable garments G.2.4.3 Reusable garments G.2.5 Usability evaluation
83	G.3 Installation qualification (IQ) G.4 Operational qualification (OQ)
84	G.5 Performance qualification (PQ)
85	Annex H (informative) Rapid and alternative microbiological methods
87	Bibliography

AAMI TIR28:2016 R 2024

Sun, 20 Oct 2024 10:41:44 +0000

This technical information report provides guidance for the adoption of new or modified products into an existing validated sterilization process and for the determination of equivalence of a sterilization process as conducted with different equipment. Guidance is intended to augment the ANSI/AAMI/ISO 11135 series in the areas of product adoption and process equivalence.

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PDF Pages	PDF Title
2	Blank Page
3	Title page
4	AAMI Technical Information Report Copyright information
5	Contents Page
6	Glossary of equivalent standards
7	Committee representation
9	Foreword
11	1 Scope 2 Terms and definitions
12	3 Product adoption 3.1 Establishment of an EO product family
13	3.2 Establishment of an EO processing category 3.3 Evaluation for product adoption 3.3.1 Determination of adverse effects 3.3.2 Determination of product design effects 3.3.3 Determination of product material and characteristics effects
14	3.3.4 Determination of sterile barrier system effects 3.3.5 Determination of load configuration effects 3.4 Conclusions of product adoption evaluation 3.4.1 Comparative resistance study
15	3.4.2 Temperature and humidity distribution study 3.4.3 Residual study 3.5 Maintenance of EO product adoption 3.6 Documentation
16	4 Process equivalence 4.1 General 4.2 Requirements of process equivalence 4.3 Determination of process equivalence 4.3.1 Process analysis and evaluation
17	4.3.1.1 Evaluation of preconditioning or aeration areas 4.3.1.2 Evaluation of sterilization chamber performance
18	4.3.2 Microbiological evaluation 4.3.3 Results evaluation 4.4 Process requalification and maintenance of equivalence 4.5 Documentation
20	Annex A Guide for evaluation of a product for adoption into an EO product family or EO processing category
22	Bibliography

AAMI TIR15:2016 R 2024

Sun, 20 Oct 2024 10:41:44 +0000

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.

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PDF Pages	PDF Title
1	AAMI TIR15:2016/(R)2024; Physical aspects of ethylene oxide sterilization
2	Blank Page
3	Title page
4	AAMI Technical Information Report Copyright information
5	Contents
6	Glossary of equivalent standards
7	Committee representation
10	Foreword
11	1 Scope 2 Definitions
12	3 EO sterilization processing equipment 3.1 General 3.2 Preconditioning area (outside sterilizer chamber)
13	3.3 Sterilizer system
15	3.4 Aeration system
16	3.5 EO handling, storage, and dispensing 3.6 Calibration and maintenance
18	3.7 Safety 4 Determination of minimum product temperature prior to preconditioning 4.1 General 4.2 Simulation of anticipated process conditions
19	4.3 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)
20	5.1.2.2 Deep vacuum processes 5.2 Dynamic conditioning 5.2.1 Process definition
21	5.2.2 Design of a dynamic conditioning phase 5.2.2.1 Operational pressure during dynamic conditioning 5.2.2.2 PSI—Process description and setup 5.2.2.3 CSI—Process description and setup
22	5.2.3 Equipment concerns—Dynamic 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 — List of constants and molecular weights of some common EO/Diluent combinations
23	Table 2 — Gas constants (R)* 6.2 Definition of variables 6.3 Ideal Gas Law
24	6.4 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—Partial pressure method 6.5.1.2 Example 2—EO weight method
25	6.5.2 EO and diluent molecular blend 6.5.2.1 Example 3—Partial pressure method of a 20 % EO and 80 % CO2 sterilant gas with values of K in Table 1
26	6.5.2.2 Example 4—Sterilant weight method
27	6.6 EO absorption 7 Calculations for use of flammability curve
29	Figure 1 — EO Cycle Flammability Diagram
31	Table 4 — Flammability review, partial pressures, and volume percentage
32	8 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
33	8.2.2 Calculation of Ppk 8.2.3 Normality test
34	8.2.4 Data interpretation 8.2.5 Worked Ppk, Pp example
35	8.3 Other statistical methods
36	Bibliography

AAMI TIR14:2016 R 2024

Sun, 20 Oct 2024 10:41:43 +0000

This technical information report provides additional guidance to augment the ANSI/AAMI/IS0 11135 series both for medical manufacturers that use contract sterilization facilities and for contract sterilization operations. It addresses how ANSI/AAMI/ISO 11135:2014 applies to ethylene oxide sterilization operations for devices marketed in the United States. Ethylene oxide sterilization guidance for health care facilities is not specifically covered.

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PDF Pages	PDF Title
1	AAMI TIR14:2016/(R)2024, Contract sterilization using ethylene oxide
3	Title page
4	AAMI Technical Information Report Copyright information
5	Contents Page
6	Glossary of equivalent standards
7	Committee representation
9	Foreword
11	1 Scope 2 Definitions 3 Selection of sterilization facility
12	4 Written agreement between product manufacturer and contract sterilizer
14	5 Validation program 5.1 General 5.2 Responsibilities 5.3 EO product families and EO processing groups 6 Handling of BIs, PCDs, and product samples
15	7 Sterilization processing documentation 7.1 Validation documentation
16	7.2 Routine processing documentation
17	8 Controls for routine processing 8.1 Product load configuration 8.2 Shipment and receipt of product for processing 8.3 Process control 8.4 Process documentation review
18	8.5 Indicators and test samples 8.6 Change controls and process deviations 8.7 Resterilization 8.8 Shipment of product following processing
19	Bibliography

AAMI TIR56:2013 R 2024

Sun, 20 Oct 2024 10:41:40 +0000

This AAMI Technical Information Report (TIR) provides information to be considered during the development, validation, and routine control of EO sterilization processes that are performed using gas diffusion within individually sealed flexible sterilization bags.

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PDF Pages	PDF Title
1	AAMI TIR56:2013/(R)2024, Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices
2	Blank Page
3	Title page
4	AAMI Technical Information Report Copyright information
5	Contents
7	Glossary of equivalent standards
8	Committee representation
12	Foreword
13	Introduction
15	1 Scope 2 Terms and definitions
17	3 Process descriptions 3.1 Type 1 – Gas injection systems
18	3.2 Type 2 – EO cartridge based systems utilizing permeable flexible sterilization bags
19	3.3 Type 3 – EO cartridge based systems utilizing effectively impermeable flexible sterilization bags
20	4 Quality management systems 5 Sterilizing agent characterization 5.1 General 5.2 Sterilizing agent 5.3 Microbicidal effectiveness 5.4 Material effects 5.5 Safety and the environment
21	6 Process and Equipment Characterization 6.1 Process characterization
22	6.2 Equipment characterization
23	7 Product definition 7.1 General
24	7.2 Demonstration of equivalence 7.3 Product safety and performance
25	7.4 Microbiological quality 7.5 Documentation
26	8 Process definition
27	9 Validation 9.1 Installation qualification 9.2 Operational qualification
29	9.3 Performance qualification 9.3.1 General 9.3.2 Performance qualification—Microbiological
30	9.3.3 Performance qualification — Physical
31	9.4 Varying load configurations 9.5 Review and approval of validation
33	10 Routine Monitoring and Control
34	11 Product Release from Sterilization 12 Maintaining Process Effectiveness 12.1 General 12.2 Calibration 12.3 Maintenance of equipment
35	12.4 Requalification 12.5 Assessment of change
36	12.6 Assessment of equivalence
37	Annex A: Microbial Validation Using an Augmented Overkill Approach
39	Annex B: Microbial Validation Using Reduced EO Concentration
40	Bibliography

AAMI 20417 2021:2024 Edition

Sun, 20 Oct 2024 10:31:18 +0000

Specifies the requirements for information supplied by the manufacturer for a medical device or by the manufacturer for an accessory. This document includes the generally applicable requirements for identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information.

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PDF Pages	PDF Title
1	ANSI/AAMI/ISO 20417:2021; Medical devices—Information to be supplied by the manufacturer
3	Title page
4	AAMI Standard Copyright information
5	Contents
6	Committee representation
8	Background of ANSI/AAMI adoption of ISO 20417:2021
9	Foreword
10	Introduction
11	1 Scope 2 Normative references
12	3 Terms and definitions
13	Figure 1 — Relationship of terms used to describe information supplied by the manufacturer
14	Figure 2 — Relationship of terms used to describe distinct product identification
20	4 General considerations 5 Information elements to be established 5.1 Units of measurement
21	5.2 Graphical information 5.3 Language and country identifiers 5.3.1 Language identifiers
22	5.3.2 Country identifiers 5.4 Dates 5.5 Full address
23	5.6 Commercial product name 5.7 Model number 5.8 Catalogue number 5.9 Production controls 5.10 Unique device identifier
24	5.11 Types of use/reuse 5.12 Sterile 6 Requirements for accompanying information 6.1 Requirements for information to be supplied on the label 6.1.1 Minimum requirements for the label
25	6.1.2 Identification of the manufacturer 6.1.3 Identification of the medical device or accessory
28	6.1.4 Other label requirements
30	6.1.5 Consult instructions for use 6.1.6 Safety signs
31	6.2 Identification requirements for detachable components of a medical device or accessory
32	6.3 Legibility of the label 6.4 Durability of markings 6.5 Information to be provided on the packaging 6.5.1 General information
34	6.5.2 Packaging for the lay user
35	6.5.3 Special conditions indicated on the packaging
36	6.6 Requirements for information in the instructions for use and technical description 6.6.1 General
37	6.6.2 Requirements for instructions for use
42	6.6.3 Additional requirements for the instructions for use for a lay user
43	6.6.4 Requirements for technical description
45	6.6.5 Requirements for e-documentation
46	7 Other information that is required to be supplied with the medical device or accessory 7.1 Importer 7.2 Distributor
47	7.3 Repackaging 7.4 Translation
48	7.5 Regulatory identification
49	Annex A (informative) Particular guidance and rationale A.1 General guidance A.2 General
52	Annex B (informative) Example test method for assessing clearly legible requirements
53	Annex C (informative) Example test method for assessing durability
54	Annex D (informative) Cross reference between the document and the requirements considered Table D.1 — Correspondence between this document and the requirements considered
74	Annex E (informative) Reference to the IMDRF essential principles and labelling guidances Table E.1 — Correspondence between this document and the essential principles
75	Table E.2 — Correspondence between this document and the labelling principles
78	Annex F (informative) Reference to the essential principles Table F.1 — Correspondence between the essential principles for non-IVD medical devices and this document
80	Table F.2 — Correspondence between the essential principles for IVD medical devices and this document
82	Annex G (informative) Reference to the general safety and performance requirements for medical devices Table G.1 — Correspondence between this document and the general safety and performance requirements for medical devices
86	Annex H (informative) Reference to the general safety and performance requirements for IVD medical devices Table H.1 — Correspondence between this document and the general safety and performance requirements for IVD medical devices
90	Annex I (informative) Terminology — Alphabetized index of defined terms
93	Bibliography

AAMI ST24 2024

Sun, 20 Oct 2024 10:31:18 +0000

This standard covers minimum labeling, safety, performance, and testing requirements for ethylene oxide sterilizers that are intended for general-purpose use in health care facilities and that have automatic controls. It also covers labeling, product composition, and container requirements for ethylene oxide sterilant sources, as well as labeling, performance, safety, and installation requirements for ethylene oxide emission control systems.

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PDF Pages	PDF Title
1	ANSI/AAMI ST24:2024; General-purpose ethylene oxide sterilizers with automated process control and ethylene oxide sterilant sources intended for use in health care facilities
3	Title page
4	AAMI Standard Copyright information
5	Contents
6	Committee representation
9	Foreword
10	Introduction
11	1 Scope 1.1 General 1.2 Inclusions 1.3 Exclusions 2 Normative references
12	3 Terms and definitions 4 Requirements 4.1 Requirements for EO sterilizers 4.1.1 Labeling
13	4.1.1.1 Device markings 4.1.1.2 Information manual 4.1.1.3 Service manual
14	4.1.1.4 User training program 4.1.2 Sterilizer construction, components, and accessories 4.1.2.1 Pressure requirements 4.1.2.2 Electrical components 4.1.2.3 Corrosion resistance 4.1.2.4 Air filters 4.1.3 Sterilizer safety 4.1.3.1 Prevention of worker exposure to EO
15	4.1.3.2 Prevention of thermal hazards 4.1.3.3 Sterilizer controls for aborting cycles 4.1.4 Process monitoring devices 4.1.4.1 Temperature measurement 4.1.4.2 Pressure measurement 4.1.4.3 Exposure time 4.1.5 Physical performance of sterilizers 4.1.5.1 Control of temperature 4.1.5.2 Control of exposure time 4.1.5.3 Control of relative humidity 4.1.5.4 Control of EO delivery 4.1.6 Biological performance of sterilizers
16	4.1.7 Certification and recordkeeping 4.2 Requirements for EO sterilant sources 4.2.1 Registration 4.2.2 Labeling 4.2.3 Container safety 4.2.4 Product composition 4.2.5 Shipping 4.3 Requirements for EO emission control systems 4.3.1 Labeling 4.3.1.1 Device markings 4.3.1.2 Information/service manuals
17	4.3.1.3 User training program 4.3.2 Performance requirements 4.3.3 Safety requirements 4.3.4 Installation requirements 5 Tests 5.1 Methods of verifying conformance with the requirements for EO sterilizers 5.1.1 Labeling 5.1.2 Sterilizer construction, components, and accessories 5.1.2.1 Pressure requirements 5.1.2.2 Electrical components 5.1.2.3 Corrosion resistance 5.1.2.4 Air filters
18	5.1.3 Sterilizer safety 5.1.3.1 Prevention of worker exposure to EO 5.1.3.2 Prevention of thermal hazards 5.1.3.3 Sterilizer controls for aborting cycles 5.1.4 Process monitoring devices 5.1.5 Physical performance of sterilizers 5.1.5.1 Temperature control 5.1.5.2 Control of exposure time 5.1.5.3 Control of relative humidity 5.1.5.4 Control of EO delivery 5.1.6 Biological performance of sterilizers
20	Figure 1—Preparation of the PCD (routine BI test pack) (drawing not to scale) Figure 2—Placement of BI in syringe
21	Figure 3—Some components of the PCD (challenge BI test pack) Figure 4—Placement of components in PCD (challenge BI test pack)
22	Table 1—Test pack number and location for empty-chamber testing Table 2—Number of test packs for simulated-load testing 5.1.7 Certification and recordkeeping 5.2 Methods of verifying conformance with the requirements for EO sterilant sources 5.2.1 Registration 5.2.2 Labeling 5.2.3 Container safety 5.2.4 Product composition 5.2.5 Shipping
23	5.3 Methods of verifying compliance with the requirements for EO emission control systems 5.3.1 System approvals 5.3.2 Labeling 5.3.2.1 Device markings 5.3.2.2 Information/service manuals 5.3.2.3 User training program 5.3.3 Performance requirements 5.3.4 Safety requirements 5.3.5 Installation requirements
24	Annex A (informative) Rationale for the development and provisions of this standard A.1 Introduction A.1.1 Historical background and scope of the standard A.1.2 Need for the standard A.2 Normative references
25	A.3 Terms and definitions A.4 Rationale for the specific provisions of the standard A.4.1 Requirements for EO sterilizers A.4.1.1 Labeling A.4.1.2 Sterilizer construction, components, and accessories A.4.1.2.1 Pressure requirements A.4.1.2.2 Electrical components A.4.1.2.3 Corrosion resistance A.4.1.3 Sterilizer safety A.4.1.3.1 Prevention of worker exposure to EO A.4.1.3.2 Prevention of thermal hazards A.4.1.3.3 Sterilizer controls for aborting cycles A.4.1.4 Process monitoring devices
26	Annex B (informative) Calculating chamber relative humidity B.1 Calculations Table B.1—Temperature versus saturation pressure of water vapor B.2 Graphic representation of relative humidity versus pressure
27	Figure B.1—Relative humidity versus partial pressure for two common sterilization temperatures
28	Annex C (informative) Calculating chamber ethylene oxide concentration C.1 Introduction C.2 Calculations
29	Table C.1—EO constant and molecular weight Table C.2—Gas constants (R =PV/nt)* C.3 Example calculations C.3.1 Determining EO concentration in pounds per cubic foot (lbs/ft3) C.3.2 Determining EO concentration in milligrams/liter (mg/L)
31	Bibliography

AAMI CR513 2024

Sun, 20 Oct 2024 10:31:17 +0000

This consensus report provides guidance on simplified approaches for validation and routine control of single-use systems used for pharmaceutical and biopharmaceutical manufacturing sterilized by radiation.

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PDF Pages	PDF Title
1	AAMI CR513:2024; Guidance on radiation sterilization validation and routine control of single-use systems used for pharmaceutical and biopharmaceutical manufacturing
3	Title page
4	AAMI Consensus Report
5	Copyright information Contents
6	Task Group representation
9	1 Purpose 1.1 Scope 2 References and resources
10	3 Terms and definitions 4 Definition and maintenance of product families for dose establishment and dose auditing 4.1 Representative product 4.1.1 Master product
11	4.1.2 Equivalent product 4.1.3 Simulated product 5 Selection and testing of product for establishing the sterilization dose 5.1 Selection of product to be tested 5.2 Sample item portion (SIP)
12	6 Sterile claim 7 Transfer of dose between radiation types 8 Application of dose 8.1 Application of verification dose to SUSs 8.2 Application of sterilization dose to SUSs
13	9 Risk assessment 9.1 Risk assessment for SAL 9.2 Risk assessment for simplification of SUSs for testing 10 Guidance on release and independent verification for the user 10.1 SUS release information
14	10.2 SUS user information 11 Regulatory aspects