ISO 5840-1:2021 pdf download – Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements.
1 Scope This document is applicable to heart valve substitutes intended for implantation and provides general requirements. Subsequent parts of the ISO 5840 series provide specific requirements. This document is applicable to newly developed and modified heart valve substitutes and to the accessory devices, packaging, and labelling required for their implantation and for determining the appropriate size of the heart valve substitute to be implanted. ISO 5840-1 outlines an approach for verifying/validating 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 can include those to assess the physical, chemical, biological, and mechanical properties of heart valve substitutes and of their materials and components. The tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute. ISO 5840-1 defines operational conditions for heart valve substitutes. ISO 5840-1 furthermore defines terms that are also applicable to ISO 5840-2 and ISO 5840-3. ISO 5840-1 does not provide requirements specific to homografts, tissue engineered heart valves (e.g. valves intended to regenerate in vivo), and heart valve substitutes designed for implantation in circulatory support devices. Some of the provisions of ISO 5840-1 can be applied to valves made from human tissue that is rendered non-viable. NOTE A rationale for the provisions of ISO 5840-1 is given in Annex A .
2 Normative references The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 5840-2, Cardiovascular implants — Cardiac valve prostheses —Part 2: Surgically implanted heart valve substitutes ISO 5840-3, Cardiovascular implants — Cardiac valve prostheses —Part 3: Heart valve substitutes implanted by transcatheter techniques ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process ISO 11135, Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices ISO 11137 (all parts), Sterilization of health care products — Radiation ISO 11607 (all parts), Packaging for terminally sterilized medical devices ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes
ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice ISO 14160, Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, development, validation and routine control of a sterilization process for medical devices ISO 14630, Non-active surgical implants — General requirements ISO 14937, Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices ISO 14971, Medical devices — Application of risk management to medical devices ISO 15223-1, Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements ISO 22442 (all parts), Medical devices utilizing animal tissues and their derivatives IEC 62366 (all parts), Medical Devices — Application of usability engineering to medical devices
3.4 arterial end diastolic pressure minimum value of the arterial pressure during diastole 3.5 arterial peak systolic pressure maximum value of the arterial pressure during systole (3.68) 3.6 back pressure differential pressure across the valve during the closed phase 3.7 body surface area BSA total surface area (m ) of the human body Note 1 to entry: This can be calculated (Mosteller’s formula) as the square root of the product of the weight in kg and the height in cm divided by 3 600 (see Reference [ 26 ]). 3.8 cardiac output CO stroke volume (3.64) times heart rate 3.9 closing volume portion of the regurgitant volume (3.49) that is associated with the dynamics of valve closure during a single cycle (3.13) Note 1 to entry: See Figure 2 . Note 2 to entry: The volume of flow occurring between end of systole (3.23) and start of leakage (3.59) for aortic and pulmonary positions; between end of diastole (3.21) and start of leakage for mitral and tricuspid positions. 3.10 coating thin-film material that is applied to an element of a heart valve system (3.31) to modify its surface physical or chemical properties
