GOST R 53286-2009 PDF

Full title and description

GOST R 53286-2009 — Technical requirements and testing methods for disposable surgical face masks. This Russian national standard specifies the construction, materials, performance requirements, marking, packaging, storage and testing methods for single-use surgical masks intended for medical and health-care applications to protect patients and medical personnel from microbial contamination and to reduce transmission of infectious agents.

Abstract

This standard establishes mandatory characteristics and test procedures for disposable surgical masks including bacterial filtration efficiency, differential pressure (breathability), splash resistance, microbial cleanliness, and requirements for design and labeling. It is intended to ensure that surgical masks used in medical environments provide reliable barrier protection and meet defined safety and quality criteria.

General information

• Status: National standard of the Russian Federation (GOST R), active as published in 2009 (check national registry for current status updates)
• Publication date: 2009
• Publisher: Federal Agency on Technical Regulating and Metrology (Rosstandart) / National standards body of the Russian Federation
• ICS / categories: 11.040.40 (Medical equipment; disposable medical products) and related health-care/medical device categories
• Edition / version: GOST R 53286-2009 (first edition published 2009)
• Number of pages: Typically between 10 and 25 pages (common for product standards of this type); consult the official text for exact page count

Scope

Applies to single-use surgical face masks designed to protect patients and health-care personnel by limiting emission and transmission of microorganisms and particulate matter during medical procedures. The standard covers mask design, materials, construction, performance requirements (including filtration efficiency, breathability and splash resistance), labeling, packaging, storage, and required laboratory test methods to demonstrate conformity.

Key topics and requirements

• Definitions and classification of disposable surgical masks by intended use and construction
• Requirements for materials, hygiene and absence of contaminants hazardous to users
• Bacterial filtration efficiency (BFE) minimum performance levels and test procedures
• Airflow resistance / differential pressure (Delta P) limits to ensure breathability
• Splash resistance / synthetic blood penetration tests for masks intended to provide fluid barrier protection
• Microbial cleanliness (bioburden) limits and sampling methods
• Requirements for dimensions, ear loops/ties, nose clips and secure fit features
• Marking, labeling, instructions for use, and packaging specifications including shelf-life and storage conditions
• Sampling plans and laboratory test methods to verify conformity

Typical use and users

Used by hospitals, clinics, dental and surgical centers, laboratories and other health-care facilities. Typical users include procurement officers, infection control professionals, clinical staff (surgeons, nurses), quality and compliance engineers, medical device manufacturers, and testing laboratories verifying product conformity to national requirements.

Related standards

Related national and international standards that address masks and respiratory protective devices include other GOST/GOST R standards on medical devices and disposable products, as well as international standards for surgical masks and respirators such as EN 14683, EN 149, ASTM F2100 and ISO standards on medical device testing and biocompatibility. Regional regulatory documents and testing methods for filtration, breathability and fluid resistance are also relevant.

Keywords

GOST R 53286-2009, surgical mask, disposable mask, bacterial filtration efficiency, BFE, differential pressure, breathability, splash resistance, synthetic blood test, bioburden, medical device standard, Russia, Rosstandart

FAQ

Q: What is this standard?

A: It is a Russian national standard specifying technical requirements and test methods for disposable surgical face masks (GOST R 53286-2009), intended to ensure masks used in medical settings meet safety and performance criteria.

Q: What does it cover?

A: It covers mask construction and materials, performance requirements such as bacterial filtration efficiency, breathability (differential pressure), splash/fluid resistance, microbial cleanliness, labeling, packaging, storage and specified laboratory test methods and sampling.

Q: Who typically uses it?

A: Health-care providers, medical device manufacturers, procurement and quality assurance personnel, testing laboratories and regulatory bodies in the Russian Federation and organizations supplying surgical masks to the Russian market.

Q: Is it current or superseded?

A: The standard was published in 2009. Users should verify with the national standards registry or Rosstandart for the current status, any amendments, or if a newer revision or replacement has been issued.

Q: Is it part of a series?

A: It belongs to the set of GOST/GOST R standards regulating medical devices and disposable medical products. It is aligned in purpose with international standards for surgical masks but is a national document specific to the Russian Federation.

Q: What are the key keywords?

A: Surgical mask, disposable mask, GOST R 53286-2009, bacterial filtration efficiency, breathability, splash resistance, bioburden, medical device standard.