ISO 11658:2012 PDF

Cardiovascular implants and extracorporeal systems — Blood/tissue contact surface modifications for extracorporeal perfusion systems

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Title (English):

ISO 11658:2012

Cardiovascular implants and extracorporeal systems — Blood/tissue contact surface modifications for extracorporeal perfusion systems

Document status:: Active
Format:: Electronic (PDF)
Number of pages:: 6
Publication date:: May 11, 2012
Edition:: ISO IS 11658 edition 1 version 1
ICS:: 11.040.40

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Description (English):

This International Standard specifies requirements for the physical, biological and performance testing of biocompatible modifications on extracorporeal devices. This International Standard is applicable to components of heart-lung bypass equipment and of extracorporeal life support equipment that carry blood and have modifications on the blood and tissue-contacting surfaces of the device. The assumption is that these devices will be used at conventional ranges of hypothermia and normothermia. If hyperthermia (>37 °C) applications are indicated, then testing is performed over the indicated range.

Technical details

Technical committee: ISO/TC 150/SC 2 - Cardiovascular implants and extracorporeal systems
SKU: ISO 11658:2012

Abstract

Overview

ISO 11658:2012 applies to extracorporeal perfusion system components (for example, heart–lung bypass and ECMO equipment) that carry blood and incorporate biocompatible surface modifications on blood- or tissue-contacting surfaces. The standard specifies requirements for physical, biological and performance testing, and for manufacturer disclosure and labeling. Tests are expected to represent intended clinical temperature ranges (hypothermia, normothermia, and where indicated, hyperthermia).

Key Topics

Biological characteristics
- Sterility and non-pyrogenicity: verification by manufacturer documentation in accordance with applicable sterilization and pyrogen standards.
- Biocompatibility: finished-device assessment per ISO 10993 series where relevant.
- Biological activity: if claimed, quantification using validated methods and manufacturer protocols (example: heparin activity verified by antithrombin uptake/thrombin inhibition tests).
Physical characteristics
- Blood pathway integrity: devices with no specific standard are tested filled with water at 1,5 times the manufacturer’s rated pressure, or 152 kPa (22 psi) gauge, maintained for 6 hours or intended use time, and inspected for leakage.
- Surface modification coverage: validated verification of the extent of coverage (example: toluidine blue staining for heparin-containing coatings).
- Surface integrity: extraction and challenge testing under maximum rated conditions (temperature, flow, pressure, duration and mechanical stress) to detect leaching or loss of coating.
Performance characteristics
- Blood cell damage: assessment of plasma-free hemoglobin, platelets and white blood cells against manufacturer-specified ranges; use established methods where available.
- General device performance: verification that the modification does not impair intended function.
- Shelf life: accelerated or real-time aging of finished, packaged devices to confirm rated shelf life.

Applications

Manufacturers of oxygenators, reservoirs, tubing packs, arterial filters and other extracorporeal components will use ISO 11658:2012 to design verification programs for coatings and additives that contact blood.
Regulators and quality teams can reference the standard when reviewing test reports, labeling and Instructions for Use for modified blood-contacting devices.
Clinicians and purchasing professionals gain clarity from standardized disclosure of coverage, leaching potential and any claimed bioactivity.

Related Standards

ISO 11658:2012 references and aligns with several device and test standards, including:

ISO 7199 (oxygenators)
ISO 10993-1, ISO 10993-7, ISO 10993-11 (biological evaluation)
ISO 11135-1, ISO 11137-1, ISO 17665-1, ISO 14937 (sterilization)
ISO 15674, ISO 15675, ISO 15676 (cardiovascular device families)

Practical value: ISO 11658:2012 provides a clear framework for verifying the safety, integrity and functional impact of blood-contacting surface modifications and for consistent manufacturer disclosure to support device selection and regulatory compliance.

Related standards

Standards mentioned in the description

Abstract

Overview

Key Topics

Biological characteristics
- Sterility and non-pyrogenicity: verification by manufacturer documentation in accordance with applicable sterilization and pyrogen standards.
- Biocompatibility: finished-device assessment per ISO 10993 series where relevant.
- Biological activity: if claimed, quantification using validated methods and manufacturer protocols (example: heparin activity verified by antithrombin uptake/thrombin inhibition tests).
Physical characteristics
- Blood pathway integrity: devices with no specific standard are tested filled with water at 1,5 times the manufacturer’s rated pressure, or 152 kPa (22 psi) gauge, maintained for 6 hours or intended use time, and inspected for leakage.
- Surface modification coverage: validated verification of the extent of coverage (example: toluidine blue staining for heparin-containing coatings).
- Surface integrity: extraction and challenge testing under maximum rated conditions (temperature, flow, pressure, duration and mechanical stress) to detect leaching or loss of coating.
Performance characteristics
- Blood cell damage: assessment of plasma-free hemoglobin, platelets and white blood cells against manufacturer-specified ranges; use established methods where available.
- General device performance: verification that the modification does not impair intended function.
- Shelf life: accelerated or real-time aging of finished, packaged devices to confirm rated shelf life.

Applications

Manufacturers of oxygenators, reservoirs, tubing packs, arterial filters and other extracorporeal components will use ISO 11658:2012 to design verification programs for coatings and additives that contact blood.
Regulators and quality teams can reference the standard when reviewing test reports, labeling and Instructions for Use for modified blood-contacting devices.
Clinicians and purchasing professionals gain clarity from standardized disclosure of coverage, leaching potential and any claimed bioactivity.

Related Standards

ISO 11658:2012 references and aligns with several device and test standards, including:

ISO 7199 (oxygenators)
ISO 10993-1, ISO 10993-7, ISO 10993-11 (biological evaluation)
ISO 11135-1, ISO 11137-1, ISO 17665-1, ISO 14937 (sterilization)
ISO 15674, ISO 15675, ISO 15676 (cardiovascular device families)

ISO 11658:2012 PDF

Technical details

Abstract

Overview

Key Topics

Applications

Related Standards

Related standards

Abstract

Overview

Key Topics

Applications

Related Standards

Related standards

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