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GOST 34901-2022

ГОСТ 34901-2022

Medical devices. System for evaluation of biological effect. General requirements for research (tests)

Изделия медицинские. Система оценки биологического действия. Общие требования к проведению исследований (испытаний)

Status: Status information is available in the commercial version of NormaCS 07/01/2023


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Format: Electronic (pdf/doc)

Approved: Rosstandart, 10/26/2022

SKU: RUSS435426

Price: $478.00

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The Product is Contained in the Following Classifiers:

ISO classifier » 11 HEALTH » 11.100 Laboratory preparations » 11.100.20 Biological evaluation of medical devices »

National standards » 11 HEALTH » 11.100 Laboratory preparations » 11.100.20 Biological evaluation of medical devices »


The Document References:

FR 1.31.2018.31084: Quantitative chemical analysis of water. Method for measuring mass concentrations of aldehydes in samples of drinking and natural waters by high performance liquid chromatography (2018 edition)

GOST 1.0-2015: Interstate system for standardization. Basic principles

GOST 1.2-2015: Interstate System for Standardization. Interstate standards. Rules for development, taking over, renovation and cancellation

GOST 12.1.004-91: Fire safety. General requirements

GOST 12.1.007-76: Noxious substances. Classification and general safety requirements

GOST 12.1.008-76: Occupational safety standards system. Biological safety. General requirements

GOST 12.1.018-93: Fire and explosion safety of static electricity. General requirements.

GOST 25737-91: Plastics. Homopolymeric and copolymer resins of vinyl chloride. Determination of residual vinyl chloride monomer. Gas chromatographic method

GOST 30351-2001: Polyamides, polyamide fibres, fabrics, films. Determination of mass fraction of residual caprolactam and low-molecular compounds and their concentration of migration in water. Methods of liquid and gas-liquid chromatography

GOST 31209-2003: Containers for blood and its components. Requirements for chemical and biological safety and methods of testing

GOST 31214-2016: Medical devices. Requirements for samples and documentation submitted for toxicological, sanitary and chemical studies, tests for sterility and pyrogenicity

GOST 31576-2012: Evaluation of biological hazard of medical dental materials and articles. Classification and sampling

GOST 31579-2012: Ophthalmic implants. Ophthalmic viscosurgical devices. General safety requirements

GOST 31580.5-2012: Ophthalmic implants. Intraocular lenses. Part 5. Biocompatibility

GOST 31866-2012: Drinking water. Determination of elements content by stripping voltammetric method

GOST 31870-2012: Drinking water. Determination of elements content by atomic spectrometry methods

GOST 31950-2012: Water. Method for determination of total mercury by flameless atomic absorption spectrometry

GOST 32378-2013: Testing of chemicals of human hazard. One-generation reproduction toxicity study

GOST 32379-2020: Test methods for the effect of chemical products on the human body. Tests for the assessment of reproductive / developmental toxicity (screening method)

GOST 32380-2020: Test methods for the effect of chemical products on the human body. Tests to assess toxic effects on prenatal development

GOST 32647-2014: OECD guidelines for the testing of chemicals. Combined chronic toxicity\carcinogenicity studies

GOST 34100.3-2017: Uncertainty of measurement. Part 3. Guide to the expression of uncertainty in measurement

GOST 34169-2017: Packaging. Determination of epsilon-caprolactam content in model media by high performance liquid chromatography

GOST 34171-2017: Packaging. Determination of phenol and epichlorohydrin content by gas chromatography in model media

GOST EN 556-1-2011: Sterilization of medical devices. Requirements for medical devices to be designated «sterile». Part 1. Requirements for terminally sterilized medical devices

GOST ISO 10993-10-2011: Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and delayed-type hypersensitivity

GOST ISO 10993-11-2021: Medical devices. Evaluation of the biological effect of medical devices. Part 11. General toxicity studies

GOST ISO 10993-1-2021: Medical devices. Evaluation of the biological effect of medical devices. Part 1. Evaluation and research in risk management

GOST ISO 10993-12-2015: Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and reference materials

GOST ISO 10993-13-2016: Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices

GOST ISO 10993-14-2011: Medical devices. Biological evaluation of medical devices. Part 14. Identification and quantification of degradation products from ceramics

GOST ISO 10993-15-2011: Medical devices. Biological evaluation of medical devices. Part 15. Identification and quantification of degradation products from metals and alloys

GOST ISO 10993-16-2021: Medical devices. Evaluation of the biological effect of medical devices. Part 16. Concept of toxicokinetic studies of degradation products and leachables

GOST ISO 10993-18-2011: Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials

GOST ISO 10993-18-2022: Medical products. Evaluation of the biological effect of medical devices. Part 18. Investigation of the chemical properties of materials as part of the risk management process

GOST ISO 10993-3-2018: Medical levices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicit

GOST ISO 10993-4-2020: Medical products. Assessment of the biological effect of medical devices. Part 4. Research on products that interact with blood

GOST ISO 10993-5-2011: Medical devices. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity

GOST ISO 10993-6-2021: Medical devices. Evaluation of the biological effect of medical devices. Part 6. Local action studies after implantation

GOST ISO 10993-7-2016: Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals

GOST ISO 11737-1-2012: Sterilization of medical devices. Microbiological methods. Part 1. Estimation of population of microorganisms on products

GOST ISO 11737-2-2011: Sterilization of medical devices. Microbiological methods. Part 2. Tests of sterility performed in the validation of a sterilization process

GOST ISO 9000-2011: Quality management systems. Fundamentals and vocabulary

GOST ISO/IEC 17025-2019: General competency requirements for testing and calibration laboratories

GOST ISO/TR 10993-22-2020: Medical products. Assessment of the biological effect of medical devices. Part 22. Guide to nanomaterials

GOST ISO/TR 10993-33-2018: Medical levices. Biological evaluation of medical devices. Part 33. Guidance on tests to evaluate genotoxicity. Supplement to ISO 10993-3

GOST ISO/TS 10993-20-2011: Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing of medical devices

GOST R 52770-2016: Medical devices. Safety requirements. Methods of sanitation-chemical and toxicological tests

GOST R 55038-2012: Ophthalmic optics. Ophthalmic implants. Ocular endotamponades. General safety requirements

GOST R 55227-2012: Water. Methods for determination of formaldehyde content

GOST R 57162-2016: Water. Determination of elements content by graphite furnace atomic absorption spectrometry

GOST R 57165-2016: Water. Determination of elements by inductively coupled plasma atomic emission spectrometry

GOST R 58396-2019: Masks are medical. Requirements and Test Methods

GOST R 58972-2020: Conformity assessment. General rules for sampling for testing products for confirmation of conformity

GOST R ISO 13022-2016: Medical products containing viable human cells. Application of risk management and requirements for processing practices

GOST R ISO 22442-1-2011: Medical devices utilizing animal tissues and their derivatives. Part 1. Application of risk management

GOST R ISO 22442-2-2011: Medical devices utilizing animal tissues and their derivatives. Part 2. Controls on sourcing, collection and handling

GOST R ISO 22442-3-2011: Medical devices utilizing animal tissues and their derivatives. Part 3. Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy agents

MR 01.025-07: Gas chromatographic determination of dimethyl phthalate, dimethyl terephthalate, diethyl phthalate, dibutyl phthalate, butyl benzyl phthalate, bis (2-ethylhexyl) phthalate and dioctyl phthalate in aqueous extracts from materials of different composition

MUK 4.1.1209-03: Gas chromatographic determination of E-caprolactam in water

MUK 4.1.3086-13: Gas chromatographic determination of hexamethylenediamine in aqueous extracts of polymeric materials used in the food industry

MUK 4.1.3166-14: Gas chromatographic determination of hexane, heptane, acetaldehyde, acetone, methyl acetate, ethyl acetate, methanol, isopropanol, acrylonitrile, n-propanol, n-propyl acetate, butyl acetate, isobutanol, n-butanol, benzene, toluene, ethyl benzene, m-o, and

MUK 4.1.3169-14: Gas chromatographic determination of dimethyl phthalate, dimethyl terephthalate, diethyl phthalate, dibutyl phthalate, butyl benzyl phthalate, bis (2-ethylhexyl) phthalate and dioctyl phthalate in water and aqueous extracts from materials of different com

MUK 4.1.3171-14: Gas chromatographic determination of acetaldehyde, acetone, methyl acetate, methanol, ethanol, methyl acrylate, methyl methacrylate, ethyl acrylate, isobutylacrylate, butyl acrylate, butyl methacrylate, toluene, styrene, alpha-methylstyrene in water and a

MUK 4.1.3645-20: Measurement of the concentration of zinc dimethyldithiocarbamate (cymate) and zinc diethyldithiocarbamate (ethylcimate) in aqueous extracts

MUK 4.1.752-99: Gas chromatographic determination of phenol in water

PND F 14.1:2:4.139-98: Quantitative chemical analysis of water. Method of measurement of mass concentrations of iron, cobalt, manganese, copper, nickel, silver, chromium and zinc in samples of potable, natural and waste waters by atomic absorption spectrometry

PND F 14.1:2:4.140-98: Quantitative chemical analysis of water. Methods for measuring mass concentrations of beryllium, vanadium, bismuth, cadmium, cobalt, copper, molybdenum, arsenic, nickel, tin, lead, selenium, silver, antimony, chromium in drinking, natural and waste waters using atomic absorption spectrometry with electrothermal atomization

PND F 14.1:2:4.214-06: Quantitative chemical analysis of water. Methods for measuring the mass concentration of iron, cadmium, cobalt, manganese, nickel, copper, zinc, chromium and lead in samples of natural and waste waters using plasma atomic absorption spectrophotometry

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