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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

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Format: Electronic (pdf/doc)

Approved: Federal Agency for Technical Regulation and Metrology, 11/1/2012

SKU: RUSS69416

Price: $162.00



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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

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