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GOST R 53000-2008

ГОСТ Р 53000-2008

Implantable mammary prostheses. General technical requirements. Test methods

Эндопротезы молочных желез. Общие технические требования. Методы испытаний

Status: Not effective - Canceled. Registration information 679-st from 11/01/2012

This standard applies to single-chamber silicone, silicone gel implanted breast prostheses and establishes general technical requirements, test methods, packaging and labeling requirements. This standard does not apply to silicone breast prostheses with other fillers.

Настоящий стандарт распространяется на силиконовые однокамерные, наполненные силиконовым гелем эндопротезы молочных желез и устанавливает общие технические требования, методы испытаний, требования к упаковке и маркировке. Настоящий стандарт не распространяется на силиконовые эндопротезы молочных желез с другими наполнителями

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Format: Electronic (pdf/doc)

Approved: Federal Agency for Technical Regulation and Metrology, 11/10/2008

SKU: RUSS55491

Price: $142.56



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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 » 11.040 Medical equipment » 11.040.40 Implants for surgery, prosthetics and orthoptics »

National standards » 11 HEALTH » 11.040 Medical equipment » 11.040.40 Implants for surgery, prosthetics and orthoptics »

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 11358-89: Dial-type thickness gauges and dial-type wall thickness gauges graduated in 0,01 and 0,1 mm. Specifications

GOST 12026-76: Filter paper for laboratory application

GOST 13835-73: Low-molecular thermal shock resistant synthetic rubber СКТН. Specifications

GOST 166-89: Vernier callipers. Specifications

GOST 17035-86: Plastics. Method for measuring thickness of plastic films and sheets

GOST 17527-2003: Package. Terms and definitions

GOST 24104-2001: Laboratory scales. General technical requirements

GOST 25336-82: Laboratory glassware and equipment. Basic parameters and dimensions

GOST 25706-83: Magnifiers

GOST 270-75: Rubber. Method of the determination elastic and tensile stress-strain properties

GOST 28498-90: Liquid-in-glass thermometers

GOST 28840-90: Machines for tension, compression and bending tests of materials

GOST 427-75: Measuring metal rules. Basic parameters and dimensions. Specifications

GOST 7328-2001: Weights. General specifications

GOST 745-2003: Aluminium foil for packing. Specifications

GOST 8.423-81: State system for ensuring the uniformity of measurements. Mechanical stop-watches. Methods and means for verification

GOST 9.030-74: Unified system of corrosion and ageing protection. Vulcanized rubbers. Method of testing resistance to attack by corrosive media in limp state

GOST R 51609-2000: Medical products. Classification in accordance with potential risk of using. General requirements

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

GOST R ISO 10993.1-99: Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing

GOST R ISO 14630-99: Non-active surgical implants. General technical requirements

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