ISO 10993-13-2010 PDF

Full title and description

ISO 10993-13:2010 — Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices. This part of the ISO 10993 series defines laboratory approaches for producing, identifying and measuring chemical degradation products released from finished polymeric medical devices to support biological evaluation and risk assessment.

Abstract

ISO 10993-13:2010 provides general requirements for planning and performing tests in simulated environments to identify and quantify degradation products from finished, non‑resorbable polymeric medical devices. It describes two main laboratory methods — an accelerated degradation screening test and a real‑time degradation test in a simulated environment — and explains how resulting chemical data feed into the overall biological evaluation of the device. The standard applies to chemical degradation (bond scission e.g., hydrolytic or oxidative processes) and excludes degradation caused by mechanical wear, electromagnetic radiation or biological agents such as enzymes or cellular activity.

General information

• Status: Published (Edition 2); confirmed current following ISO review.
• Publication date: June 2010 (ISO publication date: 2010-06; commonly cited as 04 June 2010).
• Publisher: International Organization for Standardization (ISO), prepared by ISO/TC 194 (Biological evaluation of medical devices).
• ICS / categories: 11.100.20 — Biological evaluation of medical devices.
• Edition / version: Edition 2 (2010).
• Number of pages: 14 pages (ISO bibliographic entry).

Scope

Specifies methods and reporting principles for generating, identifying and quantifying chemical degradation products from finished polymeric medical devices under simulated conditions. The document covers accelerated and real‑time degradation tests intended to produce representative chemical degradation products for subsequent chemical analysis and toxicological consideration. It applies primarily to non‑resorbable polymers and to set/cured forms of materials intended to polymerize in situ. The standard is limited to chemical degradation processes (e.g., hydrolysis, oxidation) and is not intended for degradation driven by mechanical damage, wear, electromagnetic radiation or biological processes such as enzymatic or cellular activity.

Key topics and requirements

• Definition of two test approaches: an accelerated degradation test used as a screening method and a real‑time degradation test in a simulated environment to better mimic clinical conditions.
• Guidance on specimen selection and on using the finished device or cured/set polymer for materials polymerized in situ.
• Analytical objectives: identification, differentiation (from residuals, extractables and leachables) and quantification of degradation products to support toxicological assessment.
• Limitations and exclusions: focuses on chemical bond‑scission products and excludes mechanical, wear, electromagnetic or biologically mediated degradation mechanisms.
• Reporting and documentation requirements to ensure data support biological evaluation and regulatory submissions.

Typical use and users

Used by medical device manufacturers, materials scientists, analytical laboratories, regulatory and quality personnel, and toxicologists for: supporting biocompatibility and chemical characterization activities; screening new polymer formulations or design changes for hazardous degradation products; producing data for regulatory submissions and risk assessments. Laboratories performing extractables/leachables and degradation studies commonly apply the methods described.

Related standards

ISO 10993-13 is part of the ISO 10993 family on biological evaluation. Close, related parts include ISO 10993-1 (selection of tests and evaluation), ISO 10993-9 (framework for degradation identification/quantification), ISO 10993-12 (sample preparation), ISO 10993-14 and -15 (degradation products from ceramics and metals/alloys), ISO 10993-16 (toxicokinetic study design), ISO 10993-17 (toxicological risk assessment), and ISO 10993-18 (chemical characterization of device materials). These documents are typically used together as part of a chemical/biological evaluation and risk management process.

Keywords

degradation products, polymeric medical devices, accelerated degradation test, real‑time degradation, chemical characterization, extractables, leachables, biocompatibility, ISO 10993, non‑resorbable polymers.

FAQ

Q: What is this standard?

A: ISO 10993-13:2010 is an international standard that provides guidance for identifying and quantifying chemical degradation products released from finished polymeric medical devices to support biological evaluation.

Q: What does it cover?

A: It covers laboratory methods for producing degradation products (accelerated screening and real‑time simulated tests), analytical objectives for identification and quantification, specimen selection (including cured forms of in‑situ polymerizing materials) and reporting requirements; it applies to chemical degradation of non‑resorbable polymers and excludes mechanically or biologically induced degradation.

Q: Who typically uses it?

A: Medical device manufacturers, analytical test laboratories, materials scientists, regulatory affairs and quality teams, and toxicologists use this standard when preparing biocompatibility documentation, performing degradation/chemical characterization studies, and assessing chemical risks.

Q: Is it current or superseded?

A: The 2010 edition is the published and confirmed version; ISO records indicate it was reviewed and confirmed in subsequent reviews and remains the current published edition while a revision project for a new edition is listed as under development. Users should check the latest ISO catalogue or national standards body for any published revisions.

Q: Is it part of a series?

A: Yes — it is Part 13 of the ISO 10993 series on the biological evaluation of medical devices and is intended to be used alongside other relevant parts (for example ISO 10993-1, -9, -12, -16, -17 and -18) as part of a comprehensive risk‑based biological evaluation.

Q: What are the key keywords?

A: Degradation products, polymeric devices, identification, quantification, accelerated degradation, real‑time degradation, extractables/leachables, biocompatibility, chemical characterization.