ISO 15814-1999 PDF

Full title and description

ISO 15814:1999 — Implants for surgery — Copolymers and blends based on polylactide — In vitro degradation testing. This International Standard specifies laboratory methods for determining chemical and mechanical changes in polylactide-based copolymers and blends under controlled in vitro degradation conditions, intended to compare and evaluate materials and processing conditions for surgical implants.

Abstract

Provides standardized procedures for in vitro degradation testing of copolymers and blends based on polylactide (bulk or processed forms) used in surgical implants. It describes required apparatus and reagents, control of buffer solutions, degradation test protocols, mechanical and physicochemical test methods (mass loss, limiting viscosity), test termination criteria and reporting. The methods are intended to determine relative degradation rates and property changes in vitro and are not predictive of definitive in vivo behaviour without validation.

General information

• Status: Withdrawn (replaced by ISO 13781:2017).
• Publication date: November 1999 (Edition 1, 1999).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.40 — Implants for surgery, prosthetics and orthotics.
• Edition / version: Edition 1 (1999).
• Number of pages: 9 pages.

Scope

Applicable to copolymers and/or blends based on polylactide (including combinations with comonomers such as glycolide, trimethylene carbonate, ε‑caprolactone) in bulk or processed forms used for manufacture of surgical implants. Describes in vitro test methods to measure degradation rate and related changes in mechanical and physicochemical properties; intended for material comparison and evaluation rather than definitive prediction of in vivo performance.

Key topics and requirements

• Definitions and terms specific to polylactide copolymers and blends.
• Descriptions of degradation methods: apparatus, reagents and control of buffer solution (pH, ionic strength, temperature).
• Detailed in vitro degradation test procedures, sample preparation and environmental controls.
• Mechanical testing post‑degradation (tensile/other relevant mechanical properties) and required procedures.
• Physicochemical measurements: mass loss, limiting viscosity (intrinsic/viscosity number) and related analyses.
• Test termination criteria, accelerated degradation annex (informative) and required test reporting elements.

Typical use and users

Used by materials scientists, medical device and implant manufacturers, regulatory and conformity assessment bodies, and independent testing laboratories to characterize and compare polylactide‑based materials and to support product development, quality control and regulatory submissions. Laboratories implementing these tests require access to controlled incubation and analytical equipment for viscosity, mass and mechanical property measurement.

Related standards

Replaced by ISO 13781:2017 (Homopolymers, copolymers and blends on poly(lactide) — In vitro degradation testing), which expands and updates the scope and methods. Normative and informative references in the original document include related ISO test methods and biological evaluation guidance (for example ISO/TR 10993‑9 and other polymer testing standards referenced in the original text).

Keywords

polylactide, poly(lactide), PLA, copolymers, blends, in vitro degradation, surgical implants, biodegradation testing, limiting viscosity, mass loss, mechanical testing.

FAQ

Q: What is this standard?

A: ISO 15814:1999 is an ISO International Standard titled "Implants for surgery — Copolymers and blends based on polylactide — In vitro degradation testing", providing laboratory methods for characterizing in vitro degradation behavior of PLA‑based implant materials.

Q: What does it cover?

A: It covers procedures for in vitro degradation testing including apparatus, buffer control, degradation protocols, mechanical and physicochemical tests (e.g., mass loss, limiting viscosity), termination criteria and reporting—intended to compare materials or processing conditions rather than to predict in vivo results without validation.

Q: Who typically uses it?

A: Medical device manufacturers, polymer/materials researchers, testing laboratories and regulatory reviewers use the standard to evaluate and compare polylactide‑based materials for surgical implants.

Q: Is it current or superseded?

A: ISO 15814:1999 has been withdrawn and superseded by ISO 13781:2017; users should refer to ISO 13781:2017 for the current, updated methods and scope.

Q: Is it part of a series?

A: It sits in the body of ISO standards for medical implants and polymer testing (ISO/TC 150/SC 1). The subject matter is related to earlier and later ISO documents addressing poly(lactide) materials, and ISO 13781 provides the consolidated, newer version.

Q: What are the key keywords?

A: polylactide, poly(lactide), PLA, copolymer, blend, in vitro degradation, biodegradation testing, surgical implants, limiting viscosity, mass loss.