Overview

EN ISO 10993-13:2010 (ISO 10993-13:2010) specifies requirements for identifying and quantifying chemical degradation products released from finished polymeric medical devices. It defines two laboratory test approaches - an accelerated degradation test (screening) and a real‑time degradation test in a simulated environment - and explains how the resulting data support the biological evaluation of non‑resorbable polymers. The standard focuses on chemical bond scission (hydrolytic/oxidative) products and excludes degradation caused by mechanical wear, electromagnetic radiation or biological factors (e.g., enzymes, cellular activity).

Key topics and technical requirements

Test methods
- Accelerated degradation test: used as a screening method to generate degradation products more rapidly.
- Real‑time degradation test in simulated environment: used to produce degradation products under conditions intended to mimic clinical exposure.
Material scope
- Applies to finished, non‑resorbable polymeric devices; for materials polymerized in situ, the cured/set polymer is tested.
Analytical considerations
- Identification and quantification of degradation products and differentiation from residuals and leachables (monomers, oligomers, solvents, catalysts, additives, fillers).
- Annexes include informative guidance on analytical methods and environmental stress cracking (ESC) of polymers.
Purpose and limitations
- Designed for screening and biological hazard assessment rather than full in vivo degradation reproduction.
- Data feed into the overall biological evaluation and risk assessment process.
Reporting
- The standard includes requirements for documenting test procedures and results to support regulatory and safety evaluations.

Practical applications and users

EN ISO 10993-13 is used by:

Medical device manufacturers developing polymer components or whole devices that contact the body
Regulatory affairs and quality teams preparing biological evaluation documentation and regulatory submissions
R&D and materials scientists screening new polymer formulations or design changes
Analytical labs contracted to perform degradation testing and chemical characterization

Typical applications:

Screening novel polymers for potentially toxic degradation products
Supporting biocompatibility assessments required by ISO 10993 family and EU medical device directives
Informing toxicokinetic or in vitro/in vivo follow-up studies when degradation products are identified

Related standards

This part is one element of the ISO 10993 biological evaluation series and is intended to be used alongside relevant parts such as:

ISO 10993-1 (evaluation and testing within a risk management process)
ISO 10993-9 (framework for identification/quantification of potential degradation products)
ISO 10993-12 (sample preparation and reference materials)
ISO 10993-16 / -17 / -18 (toxicokinetics, allowable limits, chemical characterization)

Keywords: ISO 10993-13, EN ISO 10993-13:2010, degradation products, polymeric medical devices, accelerated degradation, simulated environment, leachables, biological evaluation.

Overview

Key topics and technical requirements

Test methods
- Accelerated degradation test: used as a screening method to generate degradation products more rapidly.
- Real‑time degradation test in simulated environment: used to produce degradation products under conditions intended to mimic clinical exposure.
Material scope
- Applies to finished, non‑resorbable polymeric devices; for materials polymerized in situ, the cured/set polymer is tested.
Analytical considerations
- Identification and quantification of degradation products and differentiation from residuals and leachables (monomers, oligomers, solvents, catalysts, additives, fillers).
- Annexes include informative guidance on analytical methods and environmental stress cracking (ESC) of polymers.
Purpose and limitations
- Designed for screening and biological hazard assessment rather than full in vivo degradation reproduction.
- Data feed into the overall biological evaluation and risk assessment process.
Reporting
- The standard includes requirements for documenting test procedures and results to support regulatory and safety evaluations.

Practical applications and users

EN ISO 10993-13 is used by:

Medical device manufacturers developing polymer components or whole devices that contact the body
Regulatory affairs and quality teams preparing biological evaluation documentation and regulatory submissions
R&D and materials scientists screening new polymer formulations or design changes
Analytical labs contracted to perform degradation testing and chemical characterization

Typical applications:

Screening novel polymers for potentially toxic degradation products
Supporting biocompatibility assessments required by ISO 10993 family and EU medical device directives
Informing toxicokinetic or in vitro/in vivo follow-up studies when degradation products are identified

Related standards

This part is one element of the ISO 10993 biological evaluation series and is intended to be used alongside relevant parts such as:

ISO 10993-1 (evaluation and testing within a risk management process)
ISO 10993-9 (framework for identification/quantification of potential degradation products)
ISO 10993-12 (sample preparation and reference materials)
ISO 10993-16 / -17 / -18 (toxicokinetics, allowable limits, chemical characterization)

Keywords: ISO 10993-13, EN ISO 10993-13:2010, degradation products, polymeric medical devices, accelerated degradation, simulated environment, leachables, biological evaluation.

SIST EN ISO 10993-13:2010 PDF

Technical details

Abstract

Overview

Key topics and technical requirements

Practical applications and users

Related standards

Related standards

Abstract

Overview

Key topics and technical requirements

Practical applications and users

Related standards

Related standards

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