GOST R 53869-2010
ГОСТ Р 53869-2010
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Prostheses of lower-limb. Technical requirements
Протезы нижних конечностей. Технические требования
Status: Effective - Introduced for the first time. IUS 3-2012
This standard applies to prosthetic lower limbs for individual use, intended for users weighing from 45 to 125 kg, at any level of amputation and congenital underdevelopment of the lower extremities by type of stump or longitudinal form of underdevelopment with marked shortening of the segments. The standard does not apply to prostheses for children and special prostheses (sports, work, training)
Настоящий стандарт распространяется на протезы нижних конечностей индивидуального назначения, предназначенные для пользователей массой от 45 до 125 кг, при любом уровне ампутации и врожденном недоразвитии нижних конечностей по типу культи или продольной форме недоразвития с выраженным укорочением сегментов. Стандарт не распространяется на протезы для детей и специальные протезы (спортивные, рабочие, учебно-тренировочные)
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Format: Electronic (pdf/doc)
Approved: Federal Agency for Technical Regulation and Metrology,
9/17/2010
SKU: RUSS57624
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 »
4.13.2.11 Equipment and instruments for medical industry »
ISO classifier »
11 HEALTH »
11.180 Aids for persons with physical disabilities and injuries »
11.180.10 Aids and mobility aids »
National standards »
11 HEALTH »
11.180 Aids for persons with physical disabilities and injuries »
11.180.10 Aids and mobility aids »
National Standards for KGS (State Standards Classification) »
Latest edition »
R Health. Sanitation and hygiene items »
R2 Equipment and tools of medical institutions »
R23 Instruments, apparatus, accessories and equipment used in traumatology and orthopedics. Prostheses »
The Document is Replaced With:
GOST R 53869-2021: Lower limb prostheses. Technical requirements
The Document References:
GOST 10354-82: Polyethylene film Specifications
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 17308-88: Twines. Specifications
GOST 18251-87: Gummed tape on paper substrate. Specifications
GOST 1904-81: Leather for saddlery. Specifications
GOST 2.601-2006: Unified system for design documentation. Exploitative documents
GOST 20477-86: Polyethylene tape with adhesive layer. Specifications
GOST 25346-89: Basic norms of interchangeability. Unified system of tolerances and fits. General, series of tolerances and fundamental deviations
GOST 29298-2005: Cotton and mixed domestic fabrics. General specifications
GOST 30019.1-93: Textile fastener. General specifications
GOST 7933-89: Cardboard for the retail containers
GOST 8273-75: Packing paper
GOST R 51191-2007: Units of lower-limb prostheses. Technical requirements and test methods
GOST R 51632-2000: Technical aids for disabled persons. General technical requirements and test methods
GOST R ISO 10993-10-2009: Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and delayed-type hypersensitivity
GOST R ISO 10993-1-2009: Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing
GOST R ISO 10993-5-2009: Medical devices. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity
GOST R ISO 22523-2007: External limb prostheses and external orthoses. Requirements and test methods
The Document is Referenced By:
GOST R 56137-2014: Prosthetics and orthotics. Quality control prostheses and orthoses lower limb with individual parameters manufacturing
GOST R 57765-2017: Products prosthetic-orthopedic. General technical requirements
GOST R 58288-2018: Assistive tools and technologies for people with disabilities. Terms and Definitions
GOST R 58447-2019: Lower limb prostheses with an external energy source. General technical requirements
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