ANSI/AAMI/ISO 5840-1:2015 pdf download.Cardiovascular implants— Cardiac valve prostheses— Part 1: General requirements.
This part of ISO 5840 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.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. 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 1 1 1 35, Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 1 1 1 37 (all parts), Sterilization of health care products — Radiation
ISO 1 1 607 (all parts), Packaging for terminally sterilized medical devices
ISO 1 41 55, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 1 41 60, 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 1 4630:2012, Non-active surgical implants — General requirements
ISO 1 4937, 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 1 4971, Medical devices — Application of risk management to medical devices
ISO 1 7665 (all parts), Sterilization of health care products — Moist heat
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1accessories
device-specific tools that are required to assist in the implantation of the heart valve substitute (3.28)
3.2adverse event
AEuntoward medical occurrence in a study subject which does not necessarily have to have a causal relationship with study treatment
Note 1 to entry: An AE can be an unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease, temporary or permanent, whether or not related to the prosthetic valve implantation or procedure.
3.3 actuarial methods
statistical technique for calculating event rates over time Note 1 to entry: Standard actuarial methods calculate the probability of freedom from events within pre-specified intervals of time.
When the intervals approach zero width, the methods are called Kaplan-Meier methods.ANSI/AAMI/ISO 5840-1 pdf download.