GOST 31209-2003 PDF

Full title and description

GOST 31209-2003 — Containers for blood and its components. Requirements for chemical and biological safety and methods of testing. The standard specifies safety requirements and test methods for single‑use sterile polymer containers intended for collection, separation, storage, transport and transfusion of blood and its components.

Abstract

This interstate (GOST) standard defines chemical and biological safety criteria and prescribes laboratory and biological test methods (including preparation of extracts, toxicological and pyrogenicity tests) to verify that single‑use polymer blood containers are safe for intended medical use. It includes mandatory appendices describing control means, auxiliary devices, reagents, and a test stand for toxicity and pyrogenicity trials.

General information

• Status: Active / in force (listed as a действующий межгосударственный стандарт and adopted as a national standard of the Russian Federation).
• Publication date: Designation year 2003 (GOST 31209-2003); introduced into effect as a national standard of the Russian Federation on 1 January 2015 (Rosstandart order No. 1323‑ст).
• Publisher: Interstate (межгосударственный) standard — prepared under the Commonwealth/Euro‑Asian standards framework and used/adopted by national bodies (implemented in Russia by Rosstandart).
• ICS / categories: 11.040.20 (Medical equipment — transfusion, infusion and injection equipment).
• Edition / version: Original GOST 31209-2003 (first introduced 2003); current national application noted from 01.01.2015.
• Number of pages: 32 pages (typical commercial/official copies indicate 32 pp.).

Scope

The standard applies to single‑use sterile polymer containers intended for blood collection, component separation (e.g., red cells, plasma, platelets), storage, transport and transfusion. It sets limits and test procedures to detect harmful chemical extractables/leachables, cytotoxic and systemic toxic effects, and pyrogenic reactions, as well as requirements for preparation of test extracts and sampling for conformity tests.

Key topics and requirements

• Definitions and classification of blood containers and their intended uses.
• Chemical safety requirements: preparation of extracts, limits for extractables and methods for sanitary‑chemical testing.
• Biological safety and toxicology: cytotoxicity, systemic toxicity and pyrogenicity test methods and acceptance criteria.
• Sampling, batch/lot acceptance rules and numbers of items to be tested.
• Required test equipment, reagents and laboratory conditions (mandatory appendices describing control means and test stand for toxicity/pyrogenicity).

Typical use and users

Manufacturers of single‑use polymer blood containers, medical device quality and regulatory teams, hospital transfusion services, test laboratories performing biocompatibility/toxicology and sanitary‑chemical testing, and regulatory authorities assessing conformity of blood transfusion consumables. Users rely on the standard to demonstrate product safety for clinical use.

Related standards

References and related documents commonly cited with this standard include preceding national standards on blood containers (e.g., GOST R 50855‑96 which it replaces), and other biocompatibility/toxicity standards for medical devices and materials (national and international standards on biological evaluation, extractables/leachables and pyrogen testing).

Keywords

blood containers; blood bags; single‑use; polymer containers; chemical safety; biological safety; toxicology; pyrogenicity; extractables; leachables; transfusion equipment; GOST 31209‑2003.

FAQ

Q: What is this standard?

A: An interstate (GOST) standard — GOST 31209‑2003 — that specifies chemical and biological safety requirements and test methods for single‑use sterile polymer containers intended for blood and blood components.

Q: What does it cover?

A: Safety criteria and laboratory/biological test methods (preparation of extracts, toxicological tests, pyrogenicity testing), sampling rules and required test equipment/reagents for assessing containers used in blood collection, processing, storage, transport and transfusion.

Q: Who typically uses it?

A: Medical device manufacturers (blood bag/container producers), testing laboratories (biocompatibility/sanitary‑chemical), hospital transfusion services, and regulatory bodies responsible for device approval and market surveillance.

Q: Is it current or superseded?

A: The document is listed as active (действует) in public standards databases and was adopted as a national standard of the Russian Federation effective 1 January 2015; users should always check the national standards registry for any later amendments or replacements before relying on it.

Q: Is it part of a series?

A: It is a standalone GOST dealing specifically with blood containers but is used in conjunction with other standards on medical device biocompatibility, toxicology and product documentation (earlier national standards like GOST R 50855‑96 were replaced by or referenced in its preparation).

Q: What are the key keywords?

A: Blood containers; blood bags; polymer containers; biocompatibility; toxicology; pyrogenicity; extractables; sanitary‑chemical tests; transfusion equipment; GOST 31209‑2003.