GOST 31508-2012
ГОСТ 31508-2012
|
|
Medical products. Classification in accordance with potential risk of using. General requirements
Изделия медицинские. Классификация в зависимости от потенциального риска применения. Общие требования
Status: Effective - Introduced for the first time. IUS 7-2013
This standard: - applies to medical products (hereinafter - MI) of domestic and foreign production, intended for use for medical purposes on the territory of the states mentioned in the preface, as voted for the adoption of this interstate standard; - establishes the rules and order of classification of MI, depending on the potential risk of their use; - used when conducting registration and certification of MI to determine the scope of work, rules and procedures for monitoring compliance with MI and the quality systems of their production requirements of regulatory documents. - non-medicinal and disinfectants do not apply
Настоящий стандарт: - распространяется на медицинские изделия (далее - МИ) отечественного и зарубежного производства, предназначенные для применения в медицинских целях на территории государств, упомянутых в предисловии, как проголосовавших за принятие настоящего межгосударственного стандарта; - устанавливает правила и порядок классификации МИ в зависимости от потенциального риска их применения; - применяют при проведении регистрации и сертификации МИ для определения объемов работ, правил и процедур контроля над соответствием МИ и систем качества их производства требованиям нормативных документов. - не распространяются не лекарственные и дезинфицирующие средства
Choose Language:
Format: Electronic (pdf/doc)
Approved: Federal Agency for Technical Regulation and Metrology,
11/1/2012
SKU: RUSS69416
The Product is Contained in the Following Classifiers:
ISO classifier »
11 HEALTH »
11.040 Medical equipment »
National standards »
11 HEALTH »
11.040 Medical equipment »
ISO classifier »
11 HEALTH »
11.040 Medical equipment »
11.040.01 Medical equipment in general »
National standards »
11 HEALTH »
11.040 Medical equipment »
11.040.01 Medical equipment in general »
National Standards for KGS (State Standards Classification) »
Latest edition »
R Health. Sanitation and hygiene items »
R2 Equipment and tools of medical institutions »
R20 Classification, nomenclature and general norms »
The Document References:
GOST 15.013-86: System of product development and launching it into manufacture
GOST R 15.013-94: System of product development and launching into manufacture. Medical products
The Document is Referenced By:
GOST 25377-2015: Needles for injections for repeated use. Specifications
GOST 31579-2012: Ophthalmic implants. Ophthalmic viscosurgical devices. General safety requirements
GOST 31585-2012: Ophthalmic Implants. Irrigating solutions for ophthalmic surgery. General safety requirements
GOST 31590.1-2012: Ophtnalmic instruments. Part 1. General requirements applicable to all ophthalmic instruments and test methods
GOST 31619-2012: Implantable mammary prostheses. General technical requirements. Test methods
GOST 31620-2012: Surgical sutures. General technical requirements. Test method
GOST 31626-2012: Plaster of Paris for medical use. General technical requirements. Test methods
GOST 33665-2015: Road ambulances. Technical requirements and test methods
GOST R 56328-2014: Medical equipment. Mobile complexes for medical purpose. General specifications and test methods
GOST R 57266-2016: Safes for storing drugs, psychotropic substances and their precursors. Requirements, classification and test methods
GOST R 58236-2018: Medical elastic manufactured articles for the compression. General technical requirements. Test methods
GOST R 58236-2020: Medical elastic compression products. General technical requirements. Test methods
GOST R 58280.3-2018: Medical Products. Equipment for thermal disinfection / disposal of medical waste. Dry hot air method and saturated water vapor method. Part 3. Requirements for samples, consumables, documentation
GOST R 58454-2019: The system of development and putting products into production. Medical Products. Terms and Definitions
GOST R 58852-2020: Medical elastic fixing products. General technical requirements. Test methods
GOST R 58936-2020: Optics and Photonics. Endoscopes and medical endotherapeutic devices. General technical requirements and test methods
Customers Who Viewed This Item Also Viewed:
 |
Building materials. Methods for combustibility test
Language: English |
Cylindrical evolvent gears of external engagment. Strength calculation
Language: English |
Building materials spread flame test method
Language: English |
Food products, food raw materials. Method for determination of the non-steroidal anti-inflammatory drug residue content by high performance liquid chromatography – mass spectrometry
Language: English |
Steel welded vessels and apparatus. General technical conditions
Language: English |
Plywood for general use with outer layers of deciduous veneer. Specifications
Language: English |
System of Standards for Occupational Safety and Health (SSBT). Personal protective equipment for respiratory organs. Self-rescuers insulating on chemically bound or with compressed oxygen. Technical requirements. Test methods. Marking. Sampling rules
Language: English |
 |
|
YOUR ORDERING MADE EASY!
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.