BS EN ISO 14708-2:2022 - Implants for Surgery. Active Implantable Medical Devices Cardiac Pacemakers

Standard Number: BS EN ISO 14708-2:2022

Pages: 80

Released: 2022-08-04

ISBN: 978 0 580 94684 4

Name: Implants for Surgery. Active Implantable Medical Devices Cardiac Pacemakers

Status: Standard

Overview

The BS EN ISO 14708-2:2022 standard is an essential document for professionals in the medical field, particularly those involved in the design, manufacture, and application of cardiac pacemakers. This comprehensive standard provides detailed guidelines and requirements for active implantable medical devices, ensuring they meet the highest levels of safety and performance.

Key Features

• Comprehensive Coverage: Spanning 80 pages, this standard offers an in-depth look at the specifications and requirements for cardiac pacemakers, ensuring that all aspects of design, testing, and application are thoroughly covered.
• Up-to-Date Information: Released on August 4, 2022, this standard reflects the latest advancements and best practices in the field of active implantable medical devices.
• International Recognition: As a part of the ISO (International Organization for Standardization) series, this standard is recognized and respected globally, making it a valuable resource for international compliance and quality assurance.
• ISBN: 978 0 580 94684 4, ensuring easy reference and cataloging for libraries and institutions.

Why Choose BS EN ISO 14708-2:2022?

Choosing the BS EN ISO 14708-2:2022 standard means opting for a document that is meticulously crafted to ensure the highest standards of safety and efficacy in cardiac pacemakers. Here are some reasons why this standard is indispensable:

• Enhanced Patient Safety: By adhering to the guidelines set forth in this standard, manufacturers can ensure that their devices are safe for patient use, minimizing the risk of complications and failures.
• Regulatory Compliance: This standard helps manufacturers meet regulatory requirements, facilitating smoother approval processes and market entry.
• Quality Assurance: The detailed requirements and testing protocols outlined in this standard help ensure that devices are of the highest quality, providing reliable performance over their intended lifespan.
• Global Acceptance: As an internationally recognized standard, BS EN ISO 14708-2:2022 is accepted by regulatory bodies and healthcare institutions worldwide, making it easier to market and distribute products globally.

Detailed Content

The BS EN ISO 14708-2:2022 standard covers a wide range of topics essential for the development and application of cardiac pacemakers. Some of the key areas include:

• Design Requirements: Detailed specifications for the design and construction of cardiac pacemakers, ensuring they meet stringent safety and performance criteria.
• Testing Protocols: Comprehensive testing procedures to validate the safety, efficacy, and reliability of the devices under various conditions.
• Biocompatibility: Guidelines for ensuring that materials used in the construction of pacemakers are biocompatible and do not cause adverse reactions in patients.
• Electrical Safety: Requirements for electrical safety to prevent malfunctions and ensure consistent performance.
• Software Validation: Protocols for validating the software used in pacemakers, ensuring it operates correctly and safely.
• Clinical Evaluation: Guidelines for conducting clinical evaluations to assess the performance and safety of the devices in real-world settings.

Who Should Use This Standard?

The BS EN ISO 14708-2:2022 standard is an invaluable resource for a wide range of professionals in the medical device industry, including:

• Medical Device Manufacturers: Companies involved in the design and production of cardiac pacemakers will find this standard essential for ensuring their products meet the highest standards of safety and performance.
• Regulatory Affairs Specialists: Professionals responsible for ensuring compliance with regulatory requirements will benefit from the detailed guidelines and requirements outlined in this standard.
• Quality Assurance Teams: QA professionals can use this standard to develop and implement robust quality management systems, ensuring that devices are consistently manufactured to the highest standards.
• Clinical Researchers: Researchers conducting clinical trials and evaluations of cardiac pacemakers will find the guidelines for clinical evaluation particularly useful.
• Healthcare Providers: Medical professionals involved in the selection and use of cardiac pacemakers can use this standard to make informed decisions about the devices they choose for their patients.

Conclusion

The BS EN ISO 14708-2:2022 standard is a comprehensive and authoritative resource for anyone involved in the design, manufacture, and application of cardiac pacemakers. With its detailed guidelines and requirements, this standard ensures that devices meet the highest levels of safety and performance, providing peace of mind for manufacturers, healthcare providers, and patients alike.

Invest in the BS EN ISO 14708-2:2022 standard to ensure your cardiac pacemakers are designed and manufactured to the highest standards, meeting regulatory requirements and providing reliable, safe performance for patients worldwide.

BS EN ISO 14708-2:2022

This standard BS EN ISO 14708-2:2022 Implants for surgery. Active implantable medical devices is classified in these ICS categories:

• 11.040.40 Implants for surgery, prosthetics and orthotics

This document specifies requirements that are applicable to those active implantable medical devices intended to treat bradyarrhythmias and devices that provide therapies for cardiac resynchronization. The tests that are specified in this document are type tests, and are to be carried out on samples of a device to show compliance. This document was designed for bradyarrhythmia pulse generators used with endocardial leads or epicardial leads. At the time of this edition, the authors recognized the emergence of leadless technologies for which adaptations of this part will be required. Such adaptations are left to the discretion of manufacturers incorporating these technologies. This document is also applicable to some non-implantable parts and accessories of the devices (see Note 1). The electrical characteristics of the implantable pulse generator or lead are determined either by the appropriate method detailed in this particular standard or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In case of dispute, the method detailed in this particular standard applies. Any features of an active implantable medical device intended to treat tachyarrhythmias are covered by ISO 14708-6. NOTE 1 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 some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device. NOTE 2 In this document, terms printed in italics are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in italics unless the concept thus qualified is also defined.