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GOST R 53005-2008

ГОСТ Р 53005-2008

Surgical suture materials. General technical requirements. Test methods

Материалы хирургические шовные. О��щие технические требования. Методы испытаний

Status: Not effective - Canceled. Registration information 671-st dated November 1, 2012 (official website of Rosstandart)

The standard applies to surgical suture materials (hereinafter referred to as suture materials), including those with atraumatic needles according to GOST 26641 in terms of requirements for the suture material anchoring strength in the needle. The standard does not apply to special-purpose suture materials and metal from precious metals. The standard establishes general requirements for suture materials, their packaging, labeling, sterilization, consumer information and is intended for use in the development, production, registration and certification.

Стандарт распространяется на хирургические шовные материалы (далее - шовные материалы), в том числе с иглами атравматическими по ГОСТ 26641 в части требований к прочности крепления шовного материала в игле. Стандарт не распространяется на шовные материалы специального назначения и металлические из драгоценных металлов. Стандарт устанавливает общие требования к шовным материалам, их упаковке, маркировке, стерилизации, информации для потребителя и предназначен для применения при разработке, производстве, регистрации и сертификации.

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Format: Electronic (pdf/doc)

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

SKU: RUSS68765

Price: $328.68



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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 »

PromExpert » SECTION I. TECHNICAL REGULATION » V Testing and control » 4 Testing and control of products » 4.9 Testing and control of chemical and industrial products » 4.9.4 Pharmaceutical products »

ISO classifier » 11 HEALTH » 11.120 Pharmaceuticals » 11.120.20 Dressings and compresses »

National standards » 11 HEALTH » 11.120 Pharmaceuticals » 11.120.20 Dressings and compresses »

National Standards for KGS (State Standards Classification) » Latest edition » R Health. Sanitation and hygiene items » R1 Pharmaceutical and perfumery and cosmetic products » R12 Textile sanitation and hygiene »


The Document References:

GOST 10197-70: Stands and supports for measuring heads. Specifications

GOST 15139-69: Plastics. Methods for the determination of density (mass density)

GOST 16218.1-93: Small wares. Method for determination of linear dimensions

GOST 19814-74: Synthetic and regenerated acetic acid. Specifications

GOST 2.601-2006: Unified system for design documentation. Exploitative documents

GOST 20289-74: Reagents. Dimethyl formamide. Specifications

GOST 21241-89: Medical pincers

GOST 21553-76: Plastics. Methods for determination of melting temperature

GOST 23519-93: Technical synthetic phenol. Specifications

GOST 2405-88: Pressure gauges, vacuum gauges, pressure-vacuum gauges, pressure meters, draft gauges and draft-pressure gauges

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

GOST 2603-79: Reagents. Acetone. Specifications

GOST 26641-85: Non-traumatizing needles

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

GOST 3118-77: Reagents. Hydrochloric acid. Specifications

GOST 4159-79: Reagents. Iodine. Specifications

GOST 4204-77: Reagents. Sulphuric acid. Specifications

GOST 4232-74: Reagents. Potassium iodide. Specifications

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

GOST 4328-77: Reagents. Sodium hydroxide. Specifications

GOST 450-77: Calcium chloride technical. Technical conditions

GOST 4529-78: Reagents. Zinc chloride. Specifications

GOST 5848-73: Reagents. Formic acid. Specifications

GOST 6552-80: Reagents. Orthophosphoric acid. Specifications

GOST 6611.2-73: Textile threads. Methods for determination of breaking load and elongation at rupture

GOST 6709-72: Distilled water. Specifications

GOST 7502-98: Measuring metal tapes. Specifications

GOST 8.579-2002: State system for ensuring the uniformity of measurements. Requirements established for the quantity of prepackaged goods in packages of any kind during their manufacturing, packaging, selling or importing

GOST 8422-76: Reagents. Sodium iodide 2-aqueous. Specifications

GOST 9410-78: Petroleum xylol. Specifications

GOST 9696-82: Multi-revolution dial indicators graduated in 0,001 and 0,002 mm. Types. Basic parameters. Specifications

GOST 9805-84: Isopropyl alcohol. Specifications

GOST R 50460-92: Mark of conformity for obligatory certification form, dimensions dnd technical requirements

GOST R 51293-99: Identification of products. General principles

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

GOST R 51652-2000: Rectified ethyl alcohol of food raw material. Specifications

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

GOST R ISO 11134-2000: Sterilization of health care products. Requirements for validation and routine control. Industrial moist heat sterilization

GOST R ISO 11135-2000: Medical devices. Validation and routine control of ethylene oxide sterilization

GOST R ISO 11137-2000: Sterilization of health care products. Requirements for validation and routine control. Radiation sterilization

GOST R ISO 11607-2003: Packaging for terminally sterilized medical devices. General requirements

GOST R ISO 11737-2-2003: Sterilization of medical devices. Microbiological methods. Part 2. Tests of sterility performed in the validation of a sterilization process

GOST R ISO 13683-2000: Sterilization of health care products. Requirements for validation and routine control of moist heat sterilization in health care facilities

GOST R ISO 139-2007: Textiles. Standard atmospheres for conditioning and testing

GOST R ISO 14160-2003: Sterilization of single-use medical devices incorporating materials of animal origin. Validation and routine control of sterilization by liquid sterilants

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

GOST R ISO 14971-2006: Medical devices. Application of risk management to medical devices

GOST R ISO 15223-2002: Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied

GOST R ISO 2859-1-2007: Statistical methods. Sampling procedures for inspection by attributes. Part 1. Sampling schemes indexed by acceptance quality limit for lot-by-lot inspection

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