GOST ISO 10993-10-2011 PDF

Full title and description

GOST ISO 10993-10-2011 — "Изделия медицинские. Оценка биологического действия медицинских изделий. Часть 10. Исследование раздражающего и сенсибилизирующего действия" (English: Medical devices — Biological evaluation of medical devices — Part 10: Tests for irritation and delayed‑type hypersensitivity). This GOST is the Russian adoption (interstate version) of the ISO technical content for Part 10 of the ISO 10993 series, addressing irritation and sensitization testing for medical devices and their materials.

Abstract

This standard specifies procedures and considerations for assessing the potential of medical devices and constituent materials to cause skin irritation and delayed‑type hypersensitivity (sensitization). It covers pretest considerations, preparation of test materials, in vivo test methods and special procedures for non‑skin applications, plus interpretation and reporting of results.

General information

• Status: Withdrawn / replaced (superseded by a later GOST edition published in 2023/2024).
• Publication date: Approved by Rosstandart 13 December 2011; date of introduction into force listed as 1 January 2013. (Designation: GOST ISO 10993-10-2011).
• Publisher: Adopted and published as a GOST by the Federal Agency for Technical Regulation and Metrology (Rosstandart) / interstate standards system.
• ICS / categories: 11.100.20 — Biological evaluation of medical devices.
• Edition / version: GOST ISO 10993-10-2011 (national adoption of the ISO Part 10 text cited in the GOST).
• Number of pages: Published editions of this GOST are listed at approximately 46–47 pages in vendor catalogues; page counts vary slightly between providers.

Scope

Applies to medical devices and materials used in their manufacture to establish requirements and procedures for testing irritation and delayed‑type (contact) hypersensitivity. The standard provides guidance on selecting appropriate tests (including in vivo methods), preparing and extracting test samples, pretest considerations, special tests for devices applied to non‑skin sites, and interpreting results for biological evaluation.

Key topics and requirements

• Definitions and general principles for biological evaluation related to irritation and sensitization.
• Pretest considerations and decision logic for choosing in vitro, in silico or in vivo approaches where applicable.
• Preparation of test materials and extracts, including concentration limits and vehicle selection.
• Standard in vivo test procedures for irritation (skin/eye) and skin sensitization (historical guinea pig methods and contemporary approaches such as LLNA where applicable).
• Criteria and factors for interpretation of results, reporting requirements and documentation for biological evaluation files.
• Notes on special tests for device applications on mucous membranes or other non‑cutaneous sites and on animal welfare / ethical considerations.

Typical use and users

Used by medical device manufacturers (biocompatibility and regulatory teams), testing laboratories performing irritation and sensitization assays, notified bodies and regulators reviewing biological safety data, and quality/clinical evaluation personnel preparing technical files and submissions. It supports preclinical safety evaluation and regulatory compliance activities.

Related standards

Part of the ISO 10993 family of standards on biological evaluation of medical devices (notably ISO 10993‑1 general principles, ISO 10993‑12 sample preparation, ISO 10993‑11 systemic toxicity, and other related Parts). GOST ISO 10993‑10‑2011 has been superseded by later editions (see ISO 10993‑10:2021 and the GOST ISO 10993‑10‑2023 national edition).

Keywords

GOST ISO 10993-10, irritation, sensitization, skin sensitization, delayed-type hypersensitivity, biological evaluation, medical devices, biocompatibility, sample preparation, LLNA, guinea pig maximization.

FAQ

Q: What is this standard?

A: It is the GOST (Russian/interstate) adoption of Part 10 of the ISO 10993 series that specifies test methods and evaluation criteria for irritation and delayed‑type (contact) hypersensitivity of medical devices and materials.

Q: What does it cover?

A: It covers pretest decision‑making, preparation of materials/extracts, in vivo test procedures for irritation and sensitization, special test variants for non‑cutaneous applications, and interpretation and reporting of results used in biological evaluation.

Q: Who typically uses it?

A: Medical device manufacturers, contract testing laboratories, regulatory reviewers, notified bodies and internal QA/regulatory teams preparing safety documentation and submissions.

Q: Is it current or superseded?

A: GOST ISO 10993‑10‑2011 has been superseded by a more recent national edition (GOST ISO 10993‑10‑2023 / corresponding adoption of the updated ISO text). For international use, ISO 10993‑10:2021 is the more recent ISO edition covering skin sensitization tests. Users should apply the latest applicable edition required by their regulator or market.

Q: Is it part of a series?

A: Yes — it is Part 10 of the ISO 10993 series (Biological evaluation of medical devices), which includes Parts on general principles, sample preparation, cytotoxicity, systemic toxicity, extractables/leachables and other biocompatibility topics.

Q: What are the key keywords?

A: Irritation, sensitization, skin testing, delayed‑type hypersensitivity, biocompatibility, medical devices, biological evaluation, sample preparation, LLNA, guinea pig maximization.