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

Choose Language: 
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 » 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

Customers Who Viewed This Item Also Viewed:

Special railway rolling stok. Dynamic and strength testing procedures
Language: English
Price: $198.00
Blanks for marine shafts and rudder stocks. Specifications
Language: English
Price: $216.00


RussianGost.com is an industry-leading company with stringent quality control standards and our dedication to precision, reliability and accuracy are some of the reasons why some of the world’s largest companies trust us to provide their national regulatory framework and for translations of critical, challenging, and sensitive information.

Our niche specialty is the localization of national regulatory databases involving: technical norms, standards, and regulations; government laws, codes, and resolutions; as well as RF agency codes, requirements, and Instructions.

We maintain a database of over 220,000 normative documents in English and other languages for the following 12 countries: Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Mongolia, Russia, Tajikistan, Turkmenistan, Ukraine, and Uzbekistan.

Placing Your Order

Please select your chosen document, proceed to the ‘checkout page’ and select the form of payment of your choice. We accept all major credit cards and bank wire transfers. We also accept PayPal and Google Checkout for your convenience. Please contact us for any additional arrangements (Contract agreements, PO, etc.).

Once an order is placed it will be verified and processed within a few hours up to a rare maximum of 24 hours.

For items in stock, the document/web link is e-mailed to you so that you can download and save it for your records.

For items out of stock (third party supply) you will be notified as to which items will require additional time to fulfil. We normally supply such items in less than three days.

Once an order is placed you will receive a receipt/invoice that can be filed for reporting and accounting purposes. This receipt can be easily saved and printed for your records.

Your Order Best Quality and Authenticity Guarantee

Your order is provided in electronic format (usually an Adobe Acrobat or MS Word).

We always guarantee the best quality for all of our products. If for any reason whatsoever you are not satisfied, we can conduct a completely FREE revision and edit of products you have purchased. Additionally we provide FREE regulatory updates if, for instance, the document has a newer version at the date of purchase.

We guarantee authenticity. Each document in English is verified against the original and official version. We only use official regulatory sources to make sure you have the most recent version of the document, all from reliable official sources.

All Codes and Regulations

All Categories

Send us a message Expand Collapse

Leave your message in the form below, and we will write back by e-mail!