GOST 31212-2003

ГОСТ 31212-2003

Implantable cardiac pacemakers. General specifications and basic test methods

Электрокардиостимуляторы имплантируемые. Общие технические требования и методы испытаний

Status: Effective - Introduced for the first time. IUS 8-2013

This standard applies to implantable electric cardiac pacemakers (hereinafter referred to as ECS) intended for the correction of various rhythm disturbances and cardiac conduction system. This standard does not apply to non-tachyarrhythmic EX and EX with a defibrillator function. The standard establishes the requirements for the EX-manufactured for the health of the Russian Federation and exports to countries with temperate and tropical climates and supplied in sterile and non-sterile packaging. Types of climatic versions - U and T according to GOST 15150, category 6 according to GOST 20790

Настоящий стандарт распространяется на имплантируемые электрокардостимуляторы (далее - ЭКС), предназначенные для коррекции разнообразных нарушений ритма и проводящей системы сердца. Настоящий стандарт не распространяется не тахиаритмические ЭКС и ЭКС с функцией дефибриллятора. Стандарт устанавливает требования к ЭКС, изготовляемым для здравоохранения Российской Федерации и экспорта в страны с умеренным и тропическим климатом и поставляемым в стерильной и нестерильной упаковке. Виды климатических исполнении - У и Т по ГОСТ 15150, категории 6 по ГОСТ 20790

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Format: Electronic (pdf/doc)
Page Count: 20

Approved: Federal Agency for Technical Regulation and Metrology, 11/29/2012

SKU: RUSS65365

Price: $252.00




The Product is Contained in the Following Classifiers:

PromExpert » SECTION I. TECHNICAL REGULATION » V Testing and control » 4 Testing and control of products » 4.13 Testing and control of products of engineering industry » 4.13.2 Machines and equipment for special purposes » 4.13.2.11 Equipment and instruments for medical industry »

ISO classifier » 11 HEALTH » 11.040 Medical equipment » 11.040.40 Implants for surgery, prosthetics and orthoptics »

National standards » 11 HEALTH » 11.040 Medical equipment » 11.040.40 Implants for surgery, prosthetics and orthoptics »


The Document References:

GOST 14192-96: Cargo marking

GOST 15.013-86: System of product development and launching it into manufacture

GOST 15150-69: Machines, instruments and other industrial products. Modifications for different climatic regions. Categories, operating, storage and transportation conditions as to environment climatic aspects influence

GOST 20790-93: Medical instruments, apparatus and equipment. General specifications

GOST 30324.0-95: Medical electrical equipment. Part 1. General safety requirements

GOST 9.014-78: Unified system of corrosion and ageing protection. Temporary corrosion protection of products. General requirements

The Document is Referenced By:

GOST 30324.31-2002: Medical electrical equipment. Part 2. Particular requirements for the safety of external cardiac pacemakers with internal power source

GOST 31582-2012: Implantable electrodes for cardiac pacemakers. Technical requirements and test methods

GOST R 57492-2017: Medical devices. Implantable cardiac pacemakers. Technical requirements for governmental purchases

GOST R 57506-2017: Medical devices. Implantable defibrillators and other active implantable medical devices intended to treat tachyarrhythmia. Technical requirements for governmental purchases

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