GOST 31214-2016 PDF

Full title and description

GOST 31214-2016 — "Medical devices. Requirements for samples and documentation presented for toxicological tests, sanitary and chemical analyses, tests for sterility and pyrogenicity." The standard specifies the documentation and sample requirements that manufacturers and testing laboratories must submit to support biological-safety evaluation of medical devices and materials.

Abstract

GOST 31214-2016 establishes rules for selection, preparation and presentation of samples and accompanying documentation required when medical devices and related materials undergo toxicological, sanitary‑chemical, sterility and pyrogenicity testing. It is intended to harmonize sample sizes, traceability information and documentation content to ensure reproducible and reliable biological‑safety testing.

General information

• Status: In force / active (implemented and in effect).
• Publication date: Approved 21 October 2016; put into effect 1 October 2017.
• Publisher: Federal Agency for Technical Regulation and Metrology (Rosstandart).
• ICS / categories: Health care / Medical equipment — classification corresponding to medical devices (11.040.01 / related ICS grouping for medical equipment).
• Edition / version: 2016 edition (designation GOST 31214-2016). Supersedes GOST 31214-2003.
• Number of pages: 12 pages (typical published text length).

Scope

The standard applies to finished medical devices, device materials or appropriately prepared extracts presented for biological‑safety evaluation in Russia and other adopting states. It covers the required sample types and quantities, conditions for sample preparation and storage, and the accompanying documentation needed to perform toxicological, sanitary‑chemical, sterility and pyrogenicity testing. GOST 31214-2016 is used to ensure test laboratories receive representative, traceable material and consistent information to assess device safety.

Key topics and requirements

• Definitions of sample types (finished device, processed material, and extracts) and requirements for representative sampling.
• Minimum number of items/samples for different device categories (annexed tables set sample counts for implantable, ophthalmic, contraceptive and other device types).
• Documentation content requirements: device description, materials list, manufacturing and processing history, sterilization status, intended use, shelf life and traceability information.
• Conditions for preparation, labeling, packaging, transport and storage of samples to preserve test validity.
• Instructions for presentation of extracts/extractions when required (reference to appropriate extraction methods and related standards such as ISO/GOST biocompatibility methods).
• Cross‑references to related test methods and standards for biological evaluation (used as a procedural framework for laboratories).

Typical use and users

Primary users are medical‑device manufacturers and their regulatory/quality teams preparing submissions for biological‑safety testing, contract testing laboratories that conduct toxicology, sanitary‑chemical and sterility/pyrogenicity tests, conformity assessment bodies, and national regulators reviewing test dossiers. It is commonly used when planning biocompatibility studies, defining sample numbers and preparing technical files for market authorization or registration.

Related standards

GOST 31214-2016 is used alongside other national and international documents governing biocompatibility and sampling, notably GOST ISO 10993 series (biological evaluation of medical devices), GOST 31576 (classification and sampling of dental/medical materials), and other national GOST/GOST‑R standards for safety and test methods; subsequent standards on biological‑effect evaluation (for example GOST 34901 series) reference or build on these requirements.

Keywords

medical devices; samples; sample preparation; documentation; toxicological tests; sanitary‑chemical analyses; sterility tests; pyrogenicity; biocompatibility; sampling plan; traceability.

FAQ

Q: What is this standard?

A: GOST 31214-2016 is a Russian (interstate) standard that defines requirements for samples and supporting documentation submitted for toxicological, sanitary‑chemical, sterility and pyrogenicity testing of medical devices and materials.

Q: What does it cover?

A: It covers what kinds of samples to submit (finished devices, materials, extracts), minimum sample quantities for many device categories, how samples must be prepared, labeled, packaged and transported, and what documentation must accompany them so that test laboratories can perform valid biological‑safety evaluations.

Q: Who typically uses it?

A: Medical‑device manufacturers, regulatory and quality assurance teams, contract testing laboratories, conformity assessment bodies and regulators responsible for reviewing biological‑safety dossiers.

Q: Is it current or superseded?

A: The 2016 edition (GOST 31214-2016) is the current edition (implemented in 2017) and replaced the earlier 2003 edition (GOST 31214-2003). Always check national registries for the latest status or amendments.

Q: Is it part of a series?

A: It is part of the body of standards governing biological‑safety and testing of medical devices and is commonly used with the ISO/GOST biocompatibility standards (ISO 10993 / corresponding GOST ISO documents), GOST 31576 and related national test‑method standards.

Q: What are the key keywords?

A: Medical devices, samples, sampling plan, documentation, toxicology, sanitary‑chemical analysis, sterility, pyrogenicity, biocompatibility, test dossier.