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GOST R ISO 22523-2007

ГОСТ Р ИСО 22523-2007

External limb prostheses and external orthoses. Requirements and test methods

Протезы конечностей и ортезы наружные. Требования и методы испытаний

Status: Effective - Introduced for the first time. With early application right

This standard establishes the requirements and test methods for external prostheses of limbs and orthoses belonging to the following groups according to ISO 9999: 06 03-06 15 orthoses; 06 18-06 27 prosthetic limbs. Requirements for strength, materials, restrictions on the application of risk-based and requirements for the provision of information are established for normal conditions of use for assemblies of elements, as well as individual elements. This standard does not apply to special seals which, according to ISO 9999, do not belong to orthoses and, as a rule, do not fit on the body.

Настоящий стандарт устанавливает требования и методы испытаний наружных протезов конечностей и ортезов, относящихся к следующим группам по ИСО 9999: 06 03-06 15 ортезы; 06 18-06 27 протезы конечностей. Требования к прочности, материалам, ограничения по применению с учетом риска и требования по предоставлению информации установлены для нормальных условий применения как для сборок элементов, так и отдельных элементов. Настоящий стандарт не распространяется на специальные уплотнения, которые по ИСО 9999 не относятся к ортезам и, как правило, не надеваются на тело

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Format: Electronic (pdf/doc)

Approved: Federal Agency for Technical Regulation and Metrology, 12/27/2007

SKU: RUSS73406

Price: $1,111.00



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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 » 11.180.01 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 »

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 References:

GOST R 50267.0.2-2005: Medical electrical equipment. Part 1-2. General requirements for safety. Electromagnetic compatibility. Requirements and test methods

GOST R 51079-2006: Technical aids for persons with disabilities. Classification.

GOST R 51317.4.3-2006: Electromagnetic compatibility of technical equipment. Radio-frequency electromagnetic field immunity. Requirements and test methods.

GOST R 51317.6.2-2007: Electromagnetic compatibility of technical equipment. Immunity of technical equipment intended for use in industrial environments. Requirements and test methods

GOST R 52583-2006: Electromagnetic compatibility of tech. Part 21. Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs

GOST R ISO 10328-2007: Prosthetics. Structural testing of lower-limb prostheses. Requirements and test methods

GOST R ISO 13405-1-2001: Prosthetics and orthotics. Classification and description of prosthetic components. Part 1. Classification of prosthetic components

GOST R ISO 13405-2-2001: Prosthetics and orthotics. Classification and description of prosthetic components. Part 2. Description of lower-limb prosthetic components

GOST R ISO 13405-3-2001: Prosthetics and orthotics. Classification and description of prosthetic components. Part 3. Description of upper-limb prosthetic components

GOST R ISO 15032-2001: Prostheses. Structural testing of hip units

The Document is Referenced By:

GOST 59882-2021: Orthopedic hip joint appliances. General technical requirements. Classification

GOST R 51191-2007: Units of lower-limb prostheses. Technical requirements and test methods

GOST R 51191-2019: Nodes of prostheses of the lower extremities. Technical requirements and test methods

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

GOST R 52114-2021: Units of mechanical prostheses of the upper extremities. Technical requirements and test methods

GOST R 52878-2007: Tutors on upper and lower-limbs. Technical requirements and test methods

GOST R 52878-2021: Splints for the upper and lower extremities. Technical requirements and test methods

GOST R 53346-2009: Units of lower-limb orthoses. Technical requirements and test methods

GOST R 53869-2010: Prostheses of lower-limb. Technical requirements

GOST R 53869-2021: Lower limb prostheses. Technical requirements

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

GOST R 56138-2014: Upper limb prostheses. Technical requirements

GOST R 56138-2021: Upper limb prostheses. Technical requirements

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

GOST R 57765-2021: Prosthetic and orthopedic products. General technical requirements

GOST R 57768-2021: Orthopedic braces for the joints of the upper and lower extremities for people with disabilities. Types and basic parameters

GOST R 57771-2017: Electronic units of the prostheses of the upper and lower limb. Technical requirements

GOST R 57892-2017: Spinal assistants and headholders. Тechnical requirements and test methods

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

GOST R 58269-2018: Prostheses external lower limbs. Terms and Definitions. Classification

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

GOST R 58523-2019: Hip abduction apparatus for children. Technical requirements and test methods

GOST R 59151-2020: Orthopedic devices for hydrorehabilitation. Technical requirements and test methods

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

GOST R 59228-2020: Orthopedic abduction devices for upper limbs. Technical requirements. Classification. Test methods

GOST R 59229-2020: Orthopedic devices for the ankle joint. Technical requirements

GOST R 59231-2020: Lower limb orthoses with external energy source. General technical requirements

GOST R 59438-2021: Orthopedic corsets of soft fixation. Classification, technical requirements and control methods

GOST R 59443-2021: Posture correctors. Technical requirements and test methods

GOST R 59444-2021: Reclinators. Classification, technical requirements and control methods

GOST R 59445-2021: Orthopedic braces for the cervical spine, soft fixation head holders. Classification, technical requirements and control methods

GOST R 59526-2021: Orthopedic support braces. Classification. Technical requirements and control methods

GOST R 59527-2021: Orthopedic thoracic bandages. Classification. Technical requirements and control methods

GOST R 59863-2021: Orthopedic reciprocating devices. General technical requirements. Classification

GOST R 59881-2021: Orthopaedic knee joint devices. General technical requirements. Classification

GOST R 59882-2021: Orthopedic devices for hip joints. General technical requirements. Classification

GOST R 59903-2021: Orthopedic devices for lower limbs with a corset. General technical requirements. Classification

GOST R 70053-2022: Full-foot orthopedic devices. General technical requirements. Classification

GOST R 70054-2022: Orthoses for shoulder injuries. General technical requirements. Classification

GOST R 70057-2022: Orthopedic devices for the wrist joint. Classification. General technical requirements

GOST R 70136-2022: Lower limb prosthesis assemblies with individual manufacturing parameters by additive manufacturing technology. Technical requirements and control methods

GOST R 70489-2022: Children's orthopedic spacers. General technical requirements

GOST R 70490-2022: Orthopedic devices for hydro-rehabilitation. Terms and definitions

GOST R 70491-2022: Hydrotherapy devices for hydrotherapy. Classification. General technical requirements

GOST R 70494-2022: Functionally corrective corsets of modular type. General technical requirements. Classification

GOST R 70503-2022: Microprocessor-controlled upper limb orthopedic devices. General technical requirements. Classification

GOST R 70685-2023: Full arm orthopedic devices. General technical requirements. Classification

GOST R 70698-2023: Nodes of electronic devices of upper and lower extremities. General technical requirements

GOST R 70700-2023: Verticalizers orthopedic children. Classification. General technical requirements

GOST R 70710-2023: Prosthetics. Quantitative assessment of physical parameters of ankle and foot nodes of lower limb prostheses

GOST R ISO 10328-2007: Prosthetics. Structural testing of lower-limb prostheses. Requirements and test methods

GOST R ISO 22675-2009: Prosthetics. Testing of ankle-foot devices and foot units. Requirements and test methods

GOST R ISO 22675-2019: Prosthetics. Test ankle nodes and nodes of prosthetic feet of the lower extremities. Requirements and Test Methods

PNST 897-2023: Orthopedic abduction multifunctional upper limb orthopedic device. General technical requirements

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