GOST R 56137-2014
ГОСТ Р 56137-2014
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Prosthetics and orthotics. Quality control prostheses and orthoses lower limb with individual parameters manufacturing
Протезирование и ортезирование. Контроль качества протезов и ортезов нижних конечностей с индивидуальными параметрами изготовления
Status: Effective - Introduced for the first time. IUS 8-2015
This standard establishes the types, methods and procedure for quality control of external prostheses and orthoses (orthopedic devices and splints) of lower limbs with individual manufacturing parameters. This standard is intended for use by federal state unitary prosthetic and orthopedic enterprises and organizations of other forms of ownership that manufacture products for the orders of disabled users. This standard does not apply to quality control systems "man-prosthesis (orthosis)"
Настоящий стандарт устанавливает виды, методы и порядок контроля качества наружных протезов и ортезов (ортопедических аппаратов и туторов) нижних конечностей с индивидуальными параметрами изготовления. Настоящий стандарт предназначен для применения федеральными государственными унитарными протезно-ортопедическими предприятиями и организациями других форм собственности, изготавливающими изделия по заказам инвалидов-пользователей. Настоящий стандарт не распространяется на контроль качества систем «человек-протез (ортез)»
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Format: Electronic (pdf/doc)
Approved: Federal Agency for Technical Regulation and Metrology,
9/19/2014
SKU: RUSS287650
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 56137-2021: Prosthetics and orthotics. Quality control of prostheses and orthoses of the upper and lower extremities with individual manufacturing parameters
The Document References:
GOST 16504-81: The state system of testing products. Product test and quality inspection. General terms and definitions
GOST ISO 10993-10-2011: Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and delayed-type hypersensitivity
GOST ISO 10993-1-2011: Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing
GOST ISO 10993-5-2011: Medical devices. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity
GOST ISO 9000-2011: Quality management systems. Fundamentals and vocabulary
GOST R 15.111-97: System product development and launching into manufacture. Technical aids for disabled persons
GOST R 51632-2000: Technical aids for disabled persons. General technical requirements and test methods
GOST R 51819-2001: Prosthetics and orthotics of upper-limb and lower-limb components. Terms and definitions
GOST R 52878-2007: Tutors on upper and lower-limbs. Technical requirements and test methods
GOST R 53869-2010: Prostheses of lower-limb. Technical requirements
GOST R 53871-2010: Methods of evaluation of rehabilitation efficiency of lower-limb prosthetics
GOST R ISO 22523-2007: External limb prostheses and external orthoses. Requirements and test methods
GOST R ISO 8549-1-2011: Prosthetics and orthotics. Vocabulary. Part 1. General terms for external limb prostheses and external orthoses
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