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AAMI 11607 2 2019 A1 2023

AAMI 11607 2 2019 A1 2023

$80.17

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

Published By Publication Date Number of Pages
AAMI 2019 18
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This amendment adds Annex B on risk management and related modifications to the text.

PDF Catalog

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

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AAMI 11607 2 2019 A1 2023
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