GOST R 58447-2019
ГОСТ Р 58447-2019
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Lower limb prostheses with an external energy source. General technical requirements
Протезы нижних конечностей с внешним источником энергии. Общие технические требования
Status: The document is enacted from 04/01/2020. Registration information 378-st dated 07/11/2019 (Rosstandart official website) 04/01/2020
The standard applies to prostheses of the lower extremities with an external energy source - prostheses of the lower leg, thigh and hip isolation (hereinafter referred to as dentures), including mechanical and electronic components and intended for users weighing from 60 to 150 kg after amputation at the level of the lower leg, thigh, and hip isolation.
Стандарт распространяется на протезы нижних конечностей с внешним источником энергии — протезы голени, бедра и вычленения бедра (далее — протезы), включающие механические и электронные узлы и предназначенные для пользователей массой от 60 до 150 кг после ампутации на уровне голени, бедра, вычленения бедра.
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Format: Electronic (pdf/doc)
Approved: Federal Agency for Technical Regulation and Metrology,
7/11/2019
SKU: RUSS375401
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 »
The Document References:
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 51191-2007: Units of lower-limb prostheses. Technical requirements and test methods
GOST R 51819-2017: Prosthetics and orthotics of upper-and lower-limb. Terms and definitions
GOST R 52770-2016: Medical devices. Safety requirements. Methods of sanitation-chemical and toxicological tests
GOST R 53869-2010: Prostheses of lower-limb. Technical requirements
GOST R 57771-2017: Electronic units of the prostheses of the upper and lower limb. Technical requirements
GOST R IEC 60601-1-2010: Medical electrical equipment. Part 1. General requirements for basic safety and essential performance (IEC 60601-1:1988, IEC 60601-2-17(2004))
GOST R IEC 60601-1-2-2014: Medical electrical equipment. Part 1-2. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests
GOST R ISO 13405-2-2018: Prosthetics and orthopedics. Classification and description of prosthetic nodes. Part 2. Description of the nodes of prostheses of the lower extremities
GOST R ISO 22523-2007: External limb prostheses and external orthoses. Requirements and test methods
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