Chirurgické implantáty

Oblast zaměření: Chirurgické implantáty
Komise : CEN/CLC/JTC 16 (CEN/CENELEC Joint Working Group on Active Implantable Medical Devices)
Původce: CEN
K připomínkám do: 2.03.2019
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This document specifies requirements for safety and performance of active implantable circulatory support devices, including type tests, animal studies and clinical evaluation requirements.

NOTE          The device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify main requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device.

The tests that are specified in document are type tests and are to be carried out on a sample of a device to assess device behavioural responses and are not intended to be used for the routine testing of manufactured products.

Included within the scope of this document are:

—    ventricular assist devices (VAD), left or right heart support;

—    total artificial hearts (TAH);

—    biventricular assist devices (biVAD);

—    percutaneous assist devices;

—    paediatric assist devices.

Oblast zaměření: Chirurgické implantáty
Komise : CEN/TC 285 (Non-active surgical implants)
Původce: CEN
K připomínkám do: 8.03.2019
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This part of ISO 5840 is applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization. See Annex E for examples of surgical heart valve substitutes and their components.

This part of ISO 5840 is applicable to both newly developed and modified surgical heart valve substitutes and to the accessory devices, packaging, and labelling required for their implantation and for determining the appropriate size of the surgical heart valve substitute to be implanted.

This part of ISO 5840 outlines an approach for verifying/ validating the design and manufacture of a surgical 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 surgical heart valve substitutes and of their materials and components. The tests can also include those for pre-clinical in vivo evaluation and clinical evaluation of the finished surgical heart valve substitute.

This part of ISO 5840 defines operational conditions and performance requirements for surgical heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.

For novel surgical heart valve substitutes, e.g. sutureless, the requirements of both this International Standard and ISO 5840‑3 might be relevant and shall be considered as applicable to the specific device design and shall be based on the results of the risk analysis.

Oblast zaměření: Chirurgické implantáty
Komise : CEN/TC 285 (Non-active surgical implants)
Původce: CEN
K připomínkám do: 8.03.2019
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This part of ISO 5840 is applicable to all devices intended for implantation as a transcatheter heart valve substitute (see Annex A for examples).

This part of ISO 5840 is applicable to both newly developed and modified transcatheter heart valve substitutes and to the accessory devices, packaging and labelling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted. 

This part of ISO 5840 outlines an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management. The selection of appropriate verification/validation tests and methods are to be 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 can 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 and performance requirements for transcatheter heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.

This part of ISO 5840 includes considerations for implantation of a transcatheter heart valve substitute inside a pre-existing prosthetic device (e.g. valve-in-valve and valve-in-ring configurations).

Oblast zaměření: Chirurgické implantáty
Komise : CEN/TC 285 (Non-active surgical implants)
Původce: CEN
K připomínkám do: 8.03.2019
Zobraz více Zobraz méně
 

This part of ISO 5840 is applicable to heart valve substitutes intended for implantation and provides general requirements. Subsequent parts of the ISO 5840 series provide specific requirements.

ISO 5840 is applicable to: newly developed and modified heart valve substitutes; 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 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 may 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 defines operational conditions for heart valve substitutes.

ISO 5840 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.

NOTE:         A rationale for the provisions of ISO 5840 is given in Annex A.