SIST EN 12006-2:2000/kprA1:2009

Overview

SIST EN 12006-2:2000/kprA1:2009 is a European Standard developed by CEN/TC 285 that specifies particular requirements for non-active surgical implants, focusing on cardiac and vascular implants. This standard, a part of the broader EN 12006 series, addresses vascular prostheses including cardiac valve conduits. It targets manufacturers, regulatory bodies, and healthcare professionals involved in the design, production, and regulation of these critical medical devices.

This standard aids in ensuring safety, quality, and regulatory compliance of non-active vascular prosthetic implants used in cardiac and vascular surgery. It supports conformity with the European Medical Devices Directive 93/42/EEC, providing harmonized technical specifications that contribute to the development of reliable and effective implants.

Key Topics

• Scope and Application
  EN 12006-2 delineates requirements specifically for vascular prostheses and cardiac valve conduits that are surgically implanted but non-active. The focus is on implants used in cardiovascular repair or replacement, excluding active devices such as pacemakers.

• Materials and Performance Requirements
  The standard outlines criteria related to biocompatibility, mechanical strength, durability, and physiological compatibility of materials used for vascular prostheses. It ensures materials meet rigorous safety standards for long-term implantation.

• Design Specifications
  Details on design aspects emphasize functionality, reliability, and patient safety. This includes dimensional parameters and compatibility with the human cardiovascular anatomy.

• Regulatory Compliance and Essential Requirements
  EN 12006-2/prA1 aligns with the EU Directive 93/42/EEC on medical devices, particularly the essential requirements relevant to vascular implants. Annex ZA provides a clear relationship between the standard clauses and the Directive’s requirements, facilitating regulatory approval and CE marking processes.

• Documentation and Instructions for Use
  The standard recommends comprehensive and clear labelling, user manuals, and risk information for healthcare providers to ensure proper usage, handling, and implantation.

Applications

• Medical Device Manufacturing
  Manufacturers of cardiac and vascular prostheses leverage EN 12006-2 to design and produce implants that meet high safety and performance standards, easing market access across Europe.

• Regulatory Compliance
  Compliance with EN 12006-2 enables medical device companies to demonstrate conformity with EU regulations, facilitating the CE marking process for vascular prosthetic devices.

• Healthcare Providers
  Clinicians and hospital procurement teams rely on certified implants adhering to this standard to ensure patient safety and effective treatment outcomes in cardiovascular surgeries.

• Quality Assurance
  Quality management systems integrate the standard's requirements to maintain the consistency and reliability of vascular prostheses throughout the product lifecycle.

Related Standards

• EN 12006-1 - General requirements for non-active surgical implants, providing overarching principles applicable across different implant categories.
• EN ISO 10993 Series - Standards on the biological evaluation of medical devices, critical for assessing the biocompatibility of vascular prostheses.
• EU Medical Device Regulation (MDR) 2017/745 - Regulation superseding directive 93/42/EEC, applicable for ongoing compliance and market access.
• EN 368-1 to EN 368-4 - Standards covering cardiac valve prostheses testing and performance methods.

By adhering to SIST EN 12006-2:2000/kprA1:2009, stakeholders in the medical device sector ensure the production and use of safe, effective, and compliant vascular prostheses and cardiac valve conduits, supporting improved patient outcomes and regulatory confidence in the European market.