ISO 10993-13:2010 PDF

Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices

First page of standard ISO 10993-13:2010

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Title (English):

ISO 10993-13:2010

Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices

Document status:: Active
Format:: Electronic (PDF)
Number of pages:: 14
Publication date:: June 4, 2010
Edition:: ISO IS 10993 edition 2 version 1
ICS:: 11.100.20

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Description (English):

ISO 10993‑13:2010 provides general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use. ISO 10993‑13:2010 describes two test methods to generate degradation products, an accelerated degradation test as a screening method and a real-time degradation test in a simulated environment. For materials that are intended to polymerize in situ, the set or cured polymer is used for testing. The data generated are used in the biological evaluation of the polymer. ISO 10993‑13:2010 considers only non-resorbable polymers. Similar, but appropriately modified procedures may be applicable for resorbable polymers. ISO 10993‑13:2010 considers only those degradation products generated by a chemical alteration of the finished polymeric device. It is not applicable to degradation of the device induced during its intended use by mechanical stress, wear or electromagnetic radiation or biological factors such as enzymes, other proteins and cellular activity.

Technical details

Technical committee: ISO/TC 194 - Biological and clinical evaluation of medical devices
SKU: ISO 10993-13:2010

Abstract

Overview

ISO 10993-13:2010 - Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices - defines requirements for generating, identifying and quantifying chemical degradation products from finished polymeric medical devices in a simulated environment. The standard describes two complementary test approaches: an accelerated degradation test for screening and a real‑time degradation test in a simulated environment when accelerated data are insufficient. ISO 10993-13:2010 applies primarily to non‑resorbable polymers and addresses chemical bond scission (hydrolytic and oxidative degradation), not mechanical wear, radiation or biologically mediated degradation (e.g., enzymes or cellular activity).

Key topics and technical requirements

Test methods: Two methods are specified - accelerated screening tests and real‑time simulated‑environment tests. Accelerated testing can obviate the need for real‑time tests if no degradation is observed.
Test solutions: Guidance for hydrolytic solutions (analytical‑grade water, buffers) and oxidative solutions (e.g., hydrogen peroxide, Fenton’s reagent) is provided; solution stability must be justified and reported.
Sample preparation and reporting: Sample prep should follow ISO 10993-12 where applicable; test solutions, containers, apparatus and controls must be described and justified in the report.
Analytical characterization: Initial material characterization is required; Annex A lists analytical methods (no single technique is mandated). The user must justify chosen methods.
Mass measurement precision: Balance precision expectations are given (e.g., for materials intended to resorb, initial mass precision ~1% and final mass precision ~0.1%; for stable polymers, more stringent precision such as 0.1% initial and 0.01% final of total mass).
Scope limits: Only chemical degradation products of the finished polymeric device are considered. Mechanical, electromagnetic or biologically driven degradation is excluded.
Purpose: Data feed into biological evaluation (ISO 10993-1), allowable limits (ISO 10993-17) and toxicokinetic studies (ISO 10993-16).

Applications and practical value

Supports safety/risk assessment and biocompatibility evaluation for polymeric medical devices by identifying potential leachables and degradation products.
Useful for device manufacturers, materials scientists, analytical laboratories, regulatory affairs and quality assurance teams preparing preclinical dossiers or supporting regulatory submissions.
Enables screening of new or modified polymers to prioritize follow‑up testing and inform toxicological risk assessments.

Who should use this standard

Medical device manufacturers (polymer components)
Test laboratories performing degradation and chemical characterization
Biocompatibility assessors and toxicologists
Regulatory and quality professionals preparing ISO 10993 conformity evidence

Related standards

ISO 10993-1 (biological evaluation framework)
ISO 10993-9 (framework for identification/quantification of potential degradation products)
ISO 10993-12 (sample preparation)
ISO 10993-16 and ISO 10993-17 (toxicokinetics and allowable limits)

Related standards

Standards mentioned in the description

Abstract

Overview

Key topics and technical requirements

Test methods: Two methods are specified - accelerated screening tests and real‑time simulated‑environment tests. Accelerated testing can obviate the need for real‑time tests if no degradation is observed.
Test solutions: Guidance for hydrolytic solutions (analytical‑grade water, buffers) and oxidative solutions (e.g., hydrogen peroxide, Fenton’s reagent) is provided; solution stability must be justified and reported.
Sample preparation and reporting: Sample prep should follow ISO 10993-12 where applicable; test solutions, containers, apparatus and controls must be described and justified in the report.
Analytical characterization: Initial material characterization is required; Annex A lists analytical methods (no single technique is mandated). The user must justify chosen methods.
Mass measurement precision: Balance precision expectations are given (e.g., for materials intended to resorb, initial mass precision ~1% and final mass precision ~0.1%; for stable polymers, more stringent precision such as 0.1% initial and 0.01% final of total mass).
Scope limits: Only chemical degradation products of the finished polymeric device are considered. Mechanical, electromagnetic or biologically driven degradation is excluded.
Purpose: Data feed into biological evaluation (ISO 10993-1), allowable limits (ISO 10993-17) and toxicokinetic studies (ISO 10993-16).

Applications and practical value

Supports safety/risk assessment and biocompatibility evaluation for polymeric medical devices by identifying potential leachables and degradation products.
Useful for device manufacturers, materials scientists, analytical laboratories, regulatory affairs and quality assurance teams preparing preclinical dossiers or supporting regulatory submissions.
Enables screening of new or modified polymers to prioritize follow‑up testing and inform toxicological risk assessments.

Who should use this standard

Medical device manufacturers (polymer components)
Test laboratories performing degradation and chemical characterization
Biocompatibility assessors and toxicologists
Regulatory and quality professionals preparing ISO 10993 conformity evidence

Related standards

ISO 10993-1 (biological evaluation framework)
ISO 10993-9 (framework for identification/quantification of potential degradation products)
ISO 10993-12 (sample preparation)
ISO 10993-16 and ISO 10993-17 (toxicokinetics and allowable limits)

ISO 10993-13:2010 PDF

Technical details

Abstract

Overview

Key topics and technical requirements

Applications and practical value

Who should use this standard

Related standards

Related standards

Abstract

Overview

Key topics and technical requirements

Applications and practical value

Who should use this standard

Related standards

Related standards

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