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About This Item
Full Description
ISO 5840-1:2021 is applicable to heart valve substitutes intended for human implantation and provides general requirements. Subsequent parts of the ISO 5840 series provide specific requirements.
ISO 5840-1:2021 is applicable to both newly developed and modified heart valve substitutes and to the accessories, packaging, and labelling required for their implantation and for determining the appropriate size of the heart valve substitute to be implanted.
Document History
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ISO 5840-1:2021 Plus Redline
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements- Historical Version
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ISO 5840-1:2021
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Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements- Most Recent
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ISO 5840-1:2015
Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements- Historical Version