BS EN ISO 5840-1:2015
Cardiovascular implants. Cardiac valve prostheses-General requirements
standard by British Standard / European Standard / International Organization for Standardization , 10/31/2015
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About This Item
Full Description
BS EN ISO 5840-1:2015 is applicable to heart valve substitutes intended for human implantation and
provides general requirements. Subsequent parts of the ISO 5840-series provide specific requirements.
This part of ISO 5840 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.
This part of ISO 5840 outlines an approach for qualifying the design and manufacture of a heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests may include those to assess the physical, chemical, biological, and mechanical properties of heart valve substitutes and of their materials and components. The tests may also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.
This part of ISO 5840 defines operational conditions for heart valve substitutes.
This part of ISO 5840 excludes homografts.
NOTE A rationale for the provisions of this part of ISO 5840 is given in Annex A.
Cross References:
ISO 5840-2
ISO 5840-3
ISO 11135
ISO 11137
ISO 11607
ISO 14155
ISO 14160
ISO 14630:2012
ISO 14937
ISO 14971
ISO 17665
ISO 532:1975
ISO/TS 11139:2006
ISO/TS 12417:2011
ISO 13485
ISO 16061
ISO 22442-1
ISO 22442-2
ISO 22442-3
ISO 25539-1:2003
ISO/IEC 17025
IEC 60651:1973
IEC 62366
ASTM F2052
ASTM F2119
ASTM F2182
ASTM F2213
ASTM F2503
All current amendments available at time of purchase are included with the purchase of this document.
This part of ISO 5840 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.
This part of ISO 5840 outlines an approach for qualifying the design and manufacture of a heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests may include those to assess the physical, chemical, biological, and mechanical properties of heart valve substitutes and of their materials and components. The tests may also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.
This part of ISO 5840 defines operational conditions for heart valve substitutes.
This part of ISO 5840 excludes homografts.
NOTE A rationale for the provisions of this part of ISO 5840 is given in Annex A.
Cross References:
ISO 5840-2
ISO 5840-3
ISO 11135
ISO 11137
ISO 11607
ISO 14155
ISO 14160
ISO 14630:2012
ISO 14937
ISO 14971
ISO 17665
ISO 532:1975
ISO/TS 11139:2006
ISO/TS 12417:2011
ISO 13485
ISO 16061
ISO 22442-1
ISO 22442-2
ISO 22442-3
ISO 25539-1:2003
ISO/IEC 17025
IEC 60651:1973
IEC 62366
ASTM F2052
ASTM F2119
ASTM F2182
ASTM F2213
ASTM F2503
All current amendments available at time of purchase are included with the purchase of this document.
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