GOST R ISO 13485-2004
ГОСТ Р ИСО 13485-2004
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Medical devices. Quality management systems. System requirements for regulatory purposes
Изделия медицинские. Системы менеджмента качества. Системные требования для целей регулирования
Status: Not effective - Canceled. Registration information 1361-st dated 12/13/2011 (official website of Rosstandart); (IUS 5-2013)
This standard defines the requirements for a quality management system in cases where an organization needs to demonstrate the ability to supply medical devices and provide related services that meet customer requirements and established requirements applicable to these medical devices and related services. The purpose of this standard is to promote the introduction of harmonized established requirements for medical devices into quality management systems. The requirements of this standard apply to organizations offering medical devices to the market, regardless of the type or number of these organizations.
Настоящий стандарт определяет требования к системе менеджмента качества в случаях, когда организации необходимо продемонстрировать способность поставлять медицинские изделия и предоставлять связанное с ними обслуживание, отвечающее требованиям потребителя и установленным требованиям, применимым к этим медицинским изделиям и сопутствующим услугам. Цель настоящего стандарта - содействие внедрению в системы менеджмента качества гармонизированных установленных требований к медицинским изделиям. Требования настоящего стандарта распространяются на организации, предлагающие на рынок медицинские изделия, независимо от вида или численности этих организаций
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Format: Electronic (pdf/doc)
Approved: Federal Agency for Technical Regulation and Metrology,
11/10/2004
SKU: RUSS72934
The Product is Contained in the Following Classifiers:
Construction (Max) »
Standards »
Other state standards used in construction »
03 Sociology. Services. Organization of firms and their management. Administration. Transport »
PromExpert »
SECTION I. TECHNICAL REGULATION »
III Quality »
2 Product quality assurance »
2.3 Quality Management »
2.3.1 Fundamentals of quality management »
ISO classifier »
03 SOCIOLOGY. SERVICES ORGANIZATION AND MANAGEMENT OF COMPANIES. ADMINISTRATION. TRANSPORT »
03.120 Quality »
03.120.01 Quality in general »
National standards »
03 SOCIOLOGY. SERVICES ORGANIZATION AND MANAGEMENT OF COMPANIES. ADMINISTRATION. TRANSPORT »
03.120 Quality »
03.120.01 Quality in general »
ISO classifier »
11 HEALTH »
11.020 Medical sciences and health care conditions in general »
National standards »
11 HEALTH »
11.020 Medical sciences and health care conditions in general »
National Standards for KGS (State Standards Classification) »
Latest edition »
R Health. Sanitation and hygiene items »
R0 General rules and regulations on health »
R09 Test methods. Packaging. Marking »
As a Replacement Of:
GOST R 51536-99: Quality systems. Medical devices. Particular requirements for the application of GOST R ISO 9001-96
GOST R 51537-99: Quality systems. Medical devices. Particular requirements for the application of GOST R ISO 9002-96
The Document References:
GOST R 1.0-92: State system for standardization of the Russian Federation. Basic principles
GOST R 1.2-92: State system for standardization of the Russian Federation. Procedure for developing state standards
GOST R 51536-99: Quality systems. Medical devices. Particular requirements for the application of GOST R ISO 9001-96
GOST R 51537-99: Quality systems. Medical devices. Particular requirements for the application of GOST R ISO 9002-96
GOST R 51538-99: Quality systems. Medical devices. Guidance on the application of GOST R 51536-99 and GOST R 51537-99
GOST R ISO 14001-98: Environmental management systems. Specification with guidance for use
GOST R ISO 14971.1-99: Medical devices. Risk management. Part 1. Application of risk analysis
GOST R ISO 19011-2003: Guidelines for quality and/or environmental management systems auditing
GOST R ISO 9000-2001: Quality management systems. Fundamentals and vocabulary
GOST R ISO 9001-2001: Quality management systems. Requirements
GOST R ISO 9001-96: Quality systems. Model for quality assurance in design, development, production, installation and servicing
GOST R ISO 9002-96: Quality systems. Model for quality assurance in production, installation and servicing
GOST R ISO 9004-2001: Quality management systems. Guidelines for performance improvements
The Document is Referenced By:
GOST R 50325-2011: Medical products. Radiation sterilization. Dosimetric techniques
GOST R 51352-2013: In vitro diagnostic medical devices. Test methods
GOST R 52999.2-2009: Cardiac valve prostheses. Part 2. Risk management
GOST R 53078-2008: Ophthalmic implants. Ophthalmic viscosurgical devices. General safety requirements
GOST R 54421-2011: Guidelines for regulatory auditing of quality management systems of medical device manufacturers. Part 1. General requirements
GOST R 54881-2011: Guidelines for auditing of quality management systems of medical device manufacturers to conform to regulating requirements. Part 3. Audit report
GOST R 54882-2011: Guidelines for regulatory auditing of quality management systems of medical device manufacturers. Part 2. Regulatory auditing strategy
GOST R 56278-2014: Medical electrical equipment. Videoendoskopic complexes with installations for ultrasonic and fluorescence endoscopy. Specifications for governmental purchase
GOST R 56279-2014: Medical electrical equipment. Endoscopic racks. Specifications for governmental purchase
GOST R 56280-2014: Medical electrical equipment. Neurosurgical operating racks with a set of endoscopes. Specifications for governmental purchase
GOST R 57386-2017: Implants for surgery. Fundamental principles
GOST R EN 13060-2011: Small steam sterilizers
GOST R EN 556-1-2009: Sterilization of medical devices. Requirements for medical devices to be designated 'sterile'. Part 1. Requirements for terminally sterilized medical devices
GOST R ISO 11140-1-2009: Sterilization of health care products. Chemical indicators. Part 1. General requirements
GOST R ISO 14937-2012: Sterilization of health care products. General criteria for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
GOST R ISO 14971-2006: Medical devices. Application of risk management to medical devices
GOST R ISO 15197-2009: In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
GOST R ISO 16054-2013: Implants for surgery. Minimum data sets for surgical implants
GOST R ISO 17593-2009: Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
GOST R ISO 25539-1-2012: Cardiovascular implants. Endovascular devices. Part 1. Endovascular prostheses
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