CARDIAC VALVES , CHEMICAL PROPERTIES , ENDURANCE TESTS , MARKING , MEDICAL TECHNOLOGY , PACKAGES , PHYSICAL PROPERTIES , PROSTHETIC DEVICES , SURGICAL IMPLANTS , TESTING , MEDICINE , PACKING
被代替标准
2002-01-01
适用范围
This National Standard of Canada is equivalent to International Standard ISO 5840:1996. 1 Scope 1.1 This International Standard specifies tests to be performed and
requirements for test apparatus to be used in determining the physical,
biological and mechanical properties of heart valve substitutes of all types,
and of the materials and components of which they are made. 1.2 Requirements are provided for preclinical in vivo evaluation, for clinical
evaluation, and for reporting the results of all types of testing and
evaluation covered in this International Standard. These requirements do not
purport to comprise a complete test programme. 1.3 Specifications are also given for packaging and labelling of heart valve
substitutes. 1.4 This international Standard is not applicable to heart valve substitutes
comprised in whole or in part of human tissue. NOTE - A rationale for the provisions of this International Standard is given in annex A.