ISO 10993-5:2009

Name: ISO 10993-5:2009 — Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
SKU: ISO 10993-5:2009
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Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity

Название (английский):

ISO 10993-5:2009

Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 34
Дата публикации:: 20 мая 2009 г.
Издание:: ISO IS 10993 edition 3 version 1
ICS:: 11.100.20

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Описание (английский):

ISO 10993-5:2009 describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells in contact with a device and/or extracts of a device either directly or through diffusion. These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.

Abstract

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Упомянутые в описании и другие стандарты ISO

Overview

ISO 10993-5:2009, "Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity," specifies methods to assess the in vitro cytotoxicity of medical devices and materials. The standard defines extract, direct-contact and indirect-contact test approaches in which cultured mammalian cells are incubated with devices or device extracts to determine cellular responses using appropriate biological endpoints. ISO 10993-5 is part of the ISO 10993 series for biological evaluation of medical devices.

Key topics and technical requirements

Test categories:

Extract tests (expose cells to liquid extracts of the device)
Direct-contact tests (device placed directly onto cell monolayer)
Indirect-contact tests (diffusion-based exposure)

Sample and control preparation:

Sample preparation per ISO 10993-12; include negative, positive and blank controls in each assay. Examples in the standard include organotin‑stabilized polyurethane or phenol as positive controls and high‑density polyethylene as a negative control.

Extraction vehicles and conditions:

Preferred vehicle: culture medium with serum; other vehicles (saline, purified water, DMSO) may be used with justification.
Typical extraction conditions (historical precedent): 24 ±2 h at 37 ±1 °C; 72 ±2 h at 50 ±2 °C; 24 ±2 h at 70 ±2 °C; or 1 ±0.2 h at 121 ±2 °C - choice depends on device characteristics and intended use.

Cell systems and media: selection of appropriate cell lines and culture media; maintain subconfluent cultures for exposure.

Endpoints and evaluation methods: morphological assessment, measures of cell damage, cell growth/clonogenic assays, and metabolic assays. Informative annexes provide example protocols (e.g., Neutral Red Uptake, colony formation, MTT, XTT).

Reporting and result interpretation: requirements for test reports and guidance on assessing cytotoxic effects.

Applications and who uses it

Medical device manufacturers for preclinical biocompatibility screening and material selection

Contract testing laboratories performing cytotoxicity assays

Regulatory and quality assurance teams preparing submissions and risk assessments

R&D and toxicology scientists evaluating new materials, coatings or sterilization effects

Practical uses include screening raw materials, evaluating finished device extracts, verifying sterilization/processing effects, and providing evidence for regulatory dossiers.

Related standards

ISO 10993-1: Evaluation and testing within a risk management process (normative reference)

ISO 10993-12: Sample preparation and reference materials (normative reference)

Other parts of ISO 10993 (e.g., Parts 6, 7, 10, 11) provide complementary guidance on implantation, sterilization residuals, irritation, and systemic toxicity.

Keywords: ISO 10993-5:2009, in vitro cytotoxicity, cytotoxicity testing, medical devices, biological evaluation, extract test, direct contact, indirect contact, MTT, NRU, XTT.

ISO 10993-5:2009

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and who uses it

Related standards

Технические детали

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