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AAMI 11607 1 2019 A1 2023

AAMI 11607 1 2019 A1 2023

$99.13

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

Published By Publication Date Number of Pages
AAMI 2019 29
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This amendment adds Annexes F and G on risk management and related modifications to the text.

PDF Catalog

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

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AAMI 11607 1 2019 A1 2023
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