{"id":465654,"date":"2024-10-20T10:41:46","date_gmt":"2024-10-20T10:41:46","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-11607-1-2019-a1-2023\/"},"modified":"2024-10-26T19:43:04","modified_gmt":"2024-10-26T19:43:04","slug":"aami-11607-1-2019-a1-2023","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-11607-1-2019-a1-2023\/","title":{"rendered":"AAMI 11607 1 2019 A1 2023"},"content":{"rendered":"

This amendment adds Annexes F and G on risk management and related modifications to the text.<\/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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/ISO 11607-1:2019\/A1:2023; Packaging for terminally sterilized medical devices\u2014Part 1: Requirements for materials, sterile barrier systems and packaging systems\u2014Amendment 1: Application of risk management <\/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
6<\/td>\nCommittee representation <\/td>\n<\/tr>\n
11<\/td>\nBackground of ANSI\/AAMI adoption of ISO 11607-1:2019\/Amd 1:2023 <\/td>\n<\/tr>\n
12<\/td>\nForeword <\/td>\n<\/tr>\n
13<\/td>\nAMENDMENT 1: Application of risk management <\/td>\n<\/tr>\n
16<\/td>\nAnnex A (normative) Risk management
A.1 Risk management process
A.2 Application of the risk management process <\/td>\n<\/tr>\n
17<\/td>\nA.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 <\/td>\n<\/tr>\n
18<\/td>\nTable F.1 \u2014 Hazards and potential relevant factors
A.5 Risk estimation
A.6 Risk evaluation
A.7 Risk control <\/td>\n<\/tr>\n
19<\/td>\nA.8 Monitoring effectiveness of risk control measures <\/td>\n<\/tr>\n
20<\/td>\nAnnex B (informative) Risk management for medical device packaging \u2014 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 <\/td>\n<\/tr>\n
21<\/td>\nFigure G.1 \u2014 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 <\/td>\n<\/tr>\n
22<\/td>\nB.2.3 Identification of sequences of events
Figure G.2 \u2014 Example of sequence of events leading to contamination of a sterile device <\/td>\n<\/tr>\n
23<\/td>\nB.2.4 Hazardous situations
Table G.1 \u2014 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 <\/td>\n<\/tr>\n
24<\/td>\nFigure G.3 \u2014 Risk estimation using a criticality matrix
B.2.5.2 Risk estimation applied to hazardous situations <\/td>\n<\/tr>\n
25<\/td>\nFigure G.4 \u2014 Risk estimation using the risk priority number (RPN) method
Table G.2 \u2014 Example of five qualitative severity levels <\/td>\n<\/tr>\n
26<\/td>\nTable G.3 \u2014 Examples of quantitative severity levels with three levels
Table G.4 \u2014 Example of semi-quantitative probability levels <\/td>\n<\/tr>\n
27<\/td>\nTable G.5 \u2014 Example of a typical measurement scale for detectability
B.2.6 Risk evaluation
Table G.6 \u2014 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 <\/td>\n<\/tr>\n
28<\/td>\nB.2.8.2 Usability for aseptic presentation
Figure G.5 \u2014 Example of risk management for use-related hazards
B.2.8.3 Addressing environmental conditions through performance and stability testing <\/td>\n<\/tr>\n
29<\/td>\nB.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 <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 11607-1:2019\/A1:2023 Packaging for terminally sterilized medical devices\u2014Part 1: Requirements for materials, sterile barrier systems and packaging systems Amendment 1: Application of risk management<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2019<\/td>\n29<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":465661,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-465654","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\/465654","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\/465661"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=465654"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=465654"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=465654"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}