GOST R 56138-2014

ГОСТ Р 56138-2014

Upper limb prostheses. Technical requirements

Протезы верхних конечностей. Технические требования

Status: Effective - Introduced for the first time. IUS 12-2015

The standard applies to external prostheses of the upper limbs of individual production (hereinafter referred to as prostheses) intended for users with amputation and

Стандарт распространяется на наружные протезы верхних конечностей индивидуального изготовления (далее - протезы), предназначенные для пользователей, имеющих ампутационные и/или врожденные дефекты верхних конечностей. Стандарт не распространяется на рабочие протезы и приспособления для самообслуживания.

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Format: Electronic (pdf/doc)

Approved: Federal Agency for Technical Regulation and Metrology, 9/22/2014

SKU: RUSS287651

Price: $151.00


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 » 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 56138-2021: Upper limb prostheses. Technical requirements

The Document References:

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 2.601-2013: Unified system for design documentation. Exploitative documents

GOST 9.301-86: Unified system of corrosion and ageing protection. Metal and non-metal inorganic coatings. General requirements

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 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 52114-2009: Units mechanics of upper-limb prostheses. Technical requirements and test methods

GOST R 52770-2007: Medical products. Safety requirements. Methods of sanitation-chemical and toxicological tests

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

The Document is Referenced By:

GOST R 57765-2017: Products prosthetic-orthopedic. General technical requirements

GOST R 58267-2018: Prostheses outer upper limbs. Terms and Definitions. Classification

GOST R 58288-2018: Assistive tools and technologies for people with disabilities. Terms and Definitions

GOST R 59226-2020: Upper limb prostheses with external energy source. General technical requirements

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