GOST R 15.111-97
ГОСТ Р 15.111-97
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System product development and launching into manufacture. Technical aids for disabled persons
Система разработки и постановки продукции на производство. Технические средства реабилитации инвалидов
Status: Not effective - Superseded. Registration information 2166-st dated 10.28.2015 (the official website of FSUE "Standartinform"); IUS 6-2016
The standard applies to technical means of rehabilitation of persons with disabilities (hereinafter - TCP) and establishes: - the stages of the typical TCP life cycle; - requirements for research and development justification for TCP, including the development of initial technical specifications for the creation of TCP, the implementation of research projects; - TCP development requirements, including development work; - requirements for setting up TCP production and their production; - the order of control and testing of TCP in their development, setting on the production, production, operation and overhaul; - requirements for the operation (application) of TCP, including service maintenance and repair. The provisions of the standard are to be applied by enterprises and associations located on the territory of the Russian Federation, including unions, associations, technical committees for standardization, concerns, business partnerships, public, production cooperatives, inter-sectoral, regional and other associations regardless of their form of ownership and subordination, as well as federal executive authorities of the Russian Federation and executive authorities of the constituent entities of the Russian Federation directly and / or directly related to the creation, production, operation and maintenance of TCP. The standard is a fundamental state standard (normative document), which establishes the procedure for creating, producing, operating and repairing TCP in the System for developing and putting products into production. The standard does not apply to products developed in accordance with GOST R 15.013.
Стандарт распространяется на технические средства реабилитации инвалидов (далее - TCP) и устанавливает: - стадии типового жизненного цикла TCP; - требования по исследованиям и обоснованию разработки TCP, включая разработку исходных технических заданий на создание TCP, выполнение научно-исследовательских работ; - требования по разработке TCP, включая выполнение опытно-конструкторских работ; - требования по постановке на производство TCP и их производству; - порядок контроля и испытаний TCP при их разработке, постановке на производство, производстве, эксплуатации и капитальном ремонте; - требования по эксплуатации (применению) TCP, в том чис��е по сервисному техническому обслуживанию и ремонту. Положения стандарта подлежат применению расположенными на территории Российской Федерации предприятиями и объединениями, в том числе союзами, ассоциациями, техническими комитетами по стандартизации, концернами, хозяйственными товариществами, общественными, производственными кооперативами, межотраслевыми, региональными и другими объединениями независимо от форм собственности и подчинения, а также федеральными органами исполнительной власти Российской Федерации и органами исполнительной власти субъектов Российской Федерации, имеющими прямое и (или) непосредственное отношение к созданию, производству, эксплуатации и ремонту TCP. Стандарт является основополагающим государственным стандартом (нормативным документом), устанавливающим порядок создания, производства, эксплуатации и ремонта TCP в Системе разработки и постановки продукции на производство. Стандарт не распространяется на изделия, разрабатываемые по ГОСТ Р 15.013.
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Format: Electronic (pdf/doc)
Approved: Gosstandart of Russia,
9/16/1997
SKU: RUSS69084
The Product is Contained in the Following Classifiers:
PromExpert »
SECTION I. TECHNICAL REGULATION »
III Quality »
2 Product quality assurance »
2.1 Ensuring product quality at stage of technical preparation of production »
2.1.2 Technological preparation of production »
ISO classifier »
01 GENERAL PROVISIONS. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION »
01.110 Technical product documentation »
National standards »
01 GENERAL PROVISIONS. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION »
01.110 Technical product documentation »
ISO classifier »
11 HEALTH »
11.180 Aids for persons with physical disabilities and injuries »
National standards »
11 HEALTH »
11.180 Aids for persons with physical disabilities and injuries »
ISO classifier »
11 HEALTH »
11.180 Aids for persons with physical disabilities and injuries »
11.180.01 Aids for persons with physical disabilities and injuries in general »
National standards »
11 HEALTH »
11.180 Aids for persons with physical disabilities and injuries »
11.180.01 Aids for persons with physical disabilities and injuries in general »
National Standards for KGS (State Standards Classification) »
Latest edition »
T General technical and organizational and methodological standards »
T5 Documentation System »
T52 Design Documentation System »
National Standards for OKSTU »
SYSTEMS OF GENERAL TECHNICAL AND ORGANIZATIONAL-METHODOLOGICAL STANDARDS »
Development and launch of products for production »
The Document is Replaced With:
GOST R 15.111-2015: System of product development and launching into manufacture. Technical aids for disabled persons
The Document References:
GOST 15.311-90: System of product development and launching into manufacture. Launching of products under foreign companies technical documents
GOST 16504-81: The state system of testing products. Product test and quality inspection. General terms and definitions
GOST 18322-78: Equipment maintenance and repair system. Terms and definitions
GOST 2.124-85: Sequence of application of purchased products
GOST 2.601-95: Operational documents
GOST 2.602-95: Unified system for design documentation. Repair documents
GOST 24297-87: Input inspection of products. General provisions.
GOST 25866-83: Exploitation of technique. Terms and definitions
GOST 3.1102-81: Unified system for technological documentation. Stages of designing and types of documents
GOST R 15.000-94: System of product development and launching into manufacture. Basic provisions
GOST R 15.011-96: System of products development and launching into manufacture. Patent investigations. Procedure and scope
GOST R 15.013-94: System of product development and launching into manufacture. Medical products
GOST R 40.002-2000: GOST R certification system. Quality systems register. Basic regulations
GOST R 40.002-96: GOST R. Certification System Quality Systems Register. Basic regulations
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 9003-96: Quality system. Model for quality assurance in final inspection and test
R 50-605-80-93: System of products development and launching it into manufacture. Terms and definitions
The Document is Referenced By:
GOST R 51083-2015: Wheelchairs for disabled persons. General specifications
GOST R 51260-99: Rehabilitation simulators for disabled persons. General specifications
GOST R 51261-99: Support stationary devices for disabled persons. Types and technical requirements
GOST R 51264-99: Electronics aids disabled persons. General specifications
GOST R 51265-2015: Appliances, apparatus and equipment for rehabilitation of individuals with disabilities. General technical requirements
GOST R 51265-99: Household appliances, apparatus and equipment for rehabilitation of individuals with disabilities. General technical requirements
GOST R 51632-2000: Technical aids for disabled persons. General technical requirements and test methods
GOST R 51632-2014: Technical aids for disabled persons. General technical requirements and test methods
GOST R 51633-2000: Devices and adapters, which are used to rehabilitation of individuals with disabilities at home. General technical requirements
GOST R 51646-2000: Rehabilitation telephonies means of communication for disable persons with violations of hearing or eyesight. Classification. Basic parameters
GOST R 51647-2000: Electronic aids for communication and information. Operational documents. Types and rules of implements
GOST R 51764-2001: Rehabilitation transportation boarding devices for disabled persons. General technical requirements
GOST R 52286-2004: Push-chairs for carrying disabled persons. Main parameters. Technical requirements
GOST R 53871-2010: Methods of evaluation of rehabilitation efficiency of lower-limb prosthetics
GOST R 54739-2011: Orthopaedic footwear products. General specifications
GOST R 56137-2014: Prosthetics and orthotics. Quality control prostheses and orthoses lower limb with individual parameters manufacturing
PB 10-403-01: Rules of design and safe operation of lifting platforms for disabled persons
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