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//ISO 5840-3:2021/Amd 1:2025

ISO 5840-3:2021/Amd 1:2025

Name: ISO 5840-3:2021/Amd 1:2025 — Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques — Amendment 1
SKU: ISO 5840-3:2021/Amd 1:2025
Price: 5400 RUB
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Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques — Amendment 1

Название (английский):

Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques — Amendment 1

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 3
Дата публикации:: 4 марта 2025 г.
Издание:: ISO IS 5840 edition 2 version 1
ICS:: 11.040.40

Тип поставки:

Full version5 400 ₽Read online 24h1 200 ₽Read online 72h1 800 ₽

Язык документа:

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Срок поставки:1 раб. дн. (перевод)

Цена:5 400 ₽

Abstract

Overview

ISO 5840-3:2021/Amd 1:2025 is an important amendment to the ISO 5840-3:2021 international standard, which focuses on cardiovascular implants specifically cardiac valve prostheses delivered by transcatheter techniques. This amendment updates regulatory and technical requirements for . It addresses performance, safety, and compatibility of these advanced cardiac devices, their delivery systems, accessories, packaging, and labelling.

Key Topics

Scope Expansion: Applies to both newly developed and modified transcatheter heart valve substitutes, delivery systems, accessory devices, packaging, and labelling. This ensures comprehensive coverage of all components involved in the implantation process.
Intended Performance Requirements:
- Safe and accurate loading of valves onto delivery systems.
- Reliable deployment and potential retrieval or repositioning.
- Structural and functional integrity durability throughout the expected device lifetime.
- Anatomical conformity to cardiac structures like coronary ostia, mitral leaflet, conduction system, and interactions with previously implanted devices.
- Efficient forward blood flow with minimal pressure difference.
- Prevention of retrograde flow and paravalvular leakage.
- Resistance to migration, embolization, haemolysis, and thrombus formation.
- Maintenance of biocompatibility and sterility.
- Reproducibility of functionality and shelf life stability.
Testing and Measurement Enhancements:
- Defined accuracy criteria for pressure and flow measurements during hydrodynamic testing to ensure device performance matches clinical conditions.
- Updated testing protocols for pressure cycles, cardiac output, and differential pressure across closed valves, including hypotensive and hypertensive scenarios.
- Clear metrics for regurgitant volume and differential pressure, critical for valve efficacy evaluation.
Safety and Adverse Event Categorization:
- Adverse device effects (ADEs) categorized into serious (SADE) and non-serious types following ISO 14155.
- Classification into anticipated or unanticipated consequences enhances vigilance during clinical use.

Applications

ISO 5840-3:2021/Amd 1:2025 applies broadly to manufacturers, healthcare providers, regulatory bodies, and quality assurance professionals involved in the design, testing, approval, and clinical application of transcatheter heart valve prostheses. Key applications include:

Device Development: Guiding engineering teams on performance and compatibility requirements for next-generation transcatheter valves and delivery systems.
Regulatory Compliance: Supporting conformant documentation and testing protocols for market authorization and post-market surveillance.
Clinical Practice: Assisting cardiovascular surgeons and interventional cardiologists in selecting suitable devices with validated safety and efficiency.
Quality Control: Enhancing manufacturing and packaging standards to ensure device sterility and longevity.
Safety Monitoring: Aiding in the reporting and classification of adverse events related to implanted transcatheter valve substitutes.

Related Standards

ISO 5840 Series: Covers comprehensive standards related to cardiac valve prostheses, including surgical valve substitutes and test methods.
ISO 14155: Specifies clinical investigation standards for medical devices, particularly regarding adverse event categorization.
ISO/IEC Directives: Provides guidelines on the development, drafting, and maintenance of ISO standards.

For more details and updated information, stakeholders should consult the official ISO website at www.iso.org and national standards bodies. Implementers are encouraged to verify related patent rights and ensure adherence to the regulatory framework driving transcatheter cardiovascular devices.

Keywords: ISO 5840-3 amendment, transcatheter heart valve prostheses, cardiovascular implants, cardiac valve substitutes, valve delivery systems, implant safety standards, hydrodynamic testing, adverse device effects, valve implantation protocols, biocompatibility standards, heart valve regulations.

Технические детали

Технический комитет: ISO/TC 150/SC 2 - Cardiovascular implants and extracorporeal systems
SKU: ISO 5840-3:2021/Amd 1:2025

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ISO 5840-3:2021

Действующий

Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcathet…

Overview ISO 5840-3:2021 - Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques - is the international standard that defines engi…

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102 600 ₽

BS EN ISO 14155:2026-TC

Действующий

Tracked Changes. Clinical investigation of medical devices for human subjects. Good clinical practice.

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ISO 5840-2:2021/Amd 1:2025

Действующий

Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes — A…

Overview ISO 5840-2:2021/Amd 1:2025 is an important International Standard amendment that addresses updates to the requirements for cardiovascular implants-specifically, surgically implanted heart va…

2 · PDF

3 600 ₽

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ISO 5840-3:2021/Amd 1:2025

Abstract

Overview

Похожие стандарты

Key Topics

Applications

Related Standards

Технические детали

ISO 5840-3:2021

Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcathet…

BS EN ISO 14155:2026-TC

Tracked Changes. Clinical investigation of medical devices for human subjects. Good clinical practice.

ISO 5840-2:2021/Amd 1:2025

Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes — A…