ISO 7198-2016 PDF

Full title and description

Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches. ISO 7198:2016 specifies requirements and recommended practices for the evaluation, design attributes, nomenclature and information supplied by the manufacturer for tubular vascular grafts and vascular patches used as vascular prostheses. It includes guidance for development of in vitro test methods (informative annex) and is intended as a supplement to general requirements for non‑active surgical implants.

Abstract

ISO 7198:2016 (Edition 2) defines essential requirements for tubular vascular grafts and vascular patches, covering nomenclature, expected performance, design properties, materials, biocompatibility and manufacturer information. The standard gives requirements for evaluation and reporting, and provides an informative annex with guidance for in vitro test method development. It supports consistent specification, testing and regulatory assessment of vascular prostheses.

General information

• Status: Published — current (this edition reviewed and confirmed in 2023)
• Publication date: August 2016 (Edition 2)
• Publisher: ISO — International Organization for Standardization
• ICS / categories: 11.040.40 (Implants for surgery, prosthetics and orthotics / Cardiovascular implants)
• Edition / version: Edition 2 (2016)
• Number of pages: 54

Scope

This standard applies to tubular vascular grafts and vascular patches intended to be implanted as vascular prostheses or used in extracorporeal vascular systems. It specifies requirements for nomenclature, design attributes, expected performance, materials and the information that manufacturers should supply. It is applicable to a range of designs (including conventional and newer technologies) but recognizes that for some novel implants (for example certain bioabsorbable or tissue‑engineered constructs) standardized in vitro tests or clinical data may be limited; additional or modified testing may therefore be necessary.

Key topics and requirements

• Definitions and nomenclature for tubular grafts and vascular patches
• Design attributes and expected performance characteristics (patency, handling, mechanical compatibility)
• Materials and material characterization (including requirements relevant to biocompatibility)
• Information the manufacturer must supply (indications, contraindications, instructions for use, labeling and sizing)
• Requirements and guidance for in vitro test method development (informative annex)
• Durability and physical testing considerations (mechanical strength, burst pressure, fatigue where applicable)
• Sterility and reprocessing considerations where relevant (normative references to sterilization standards)
• Requirements for reporting test results and conformity assessment support

Typical use and users

Manufacturers and designers of vascular grafts and patches, test laboratories performing bench and in vitro evaluation, regulatory assessors and notified bodies, clinical engineers, and hospital procurement and quality teams. The standard is also used by standards committees and device developers as a baseline for product specifications, preclinical testing programs and regulatory submissions.

Related standards

ISO 7198:2016 is used alongside and references other medical device and implant standards, commonly including ISO 14630 (non‑active surgical implants — general requirements), the ISO 10993 series (biological evaluation of medical devices), relevant sterilization standards (ISO 11135, ISO 11137), packaging standards (ISO 11607), and ISO 14971 (risk management for medical devices). The 1998 edition of ISO 7198 was withdrawn and superseded by the 2016 edition.

Keywords

vascular graft, vascular patch, vascular prosthesis, cardiovascular implants, extracorporeal systems, tubular graft, in vitro test methods, biocompatibility, sterility, device labeling, performance requirements

FAQ

Q: What is this standard?

A: ISO 7198:2016 is an international standard that sets requirements and guidance for tubular vascular grafts and vascular patches used as vascular prostheses, covering nomenclature, design attributes, performance expectations, materials and manufacturer information.

Q: What does it cover?

A: It covers specification and evaluation aspects for tubular grafts and patches — including expected performance, material and biocompatibility considerations, required manufacturer information, and guidance for developing in vitro test methods (informative annex). It is intended to supplement general implant requirements.

Q: Who typically uses it?

A: Device manufacturers, test laboratories, regulatory authorities and conformity assessment bodies, clinical engineers, and standards developers use ISO 7198:2016 for product development, testing programs and regulatory submissions related to vascular grafts and patches.

Q: Is it current or superseded?

A: The 2016 edition (Edition 2) is the current published edition; the previous 1998 edition was withdrawn and superseded by ISO 7198:2016. The 2016 edition was reviewed and confirmed in 2023.

Q: Is it part of a series?

A: ISO 7198 is a stand‑alone standard addressing vascular grafts and patches but is commonly used in conjunction with related medical device standards (for example ISO 14630, the ISO 10993 biocompatibility series, sterilization and packaging standards, and ISO 14971 for risk management).

Q: What are the key keywords?

A: Vascular graft, vascular patch, vascular prosthesis, cardiovascular implant, tubular graft, biocompatibility, sterility, in vitro testing, device labeling, performance requirements.