GOST ISO 10993-12-2015

ГОСТ ISO 10993-12-2015

Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and reference materials

Изделия медицинские. Оценка биологического действия медицинских изделий. Часть 12. Приготовление проб и контрольные образцы

Status: Effective - Supersedes. IUS 12-2015

This standard establishes methods for sample preparation and selection of control samples used to assess the biological effect of materials and medical devices in biological systems in accordance with the standards of the ISO 10993 series, and includes: - the choice of material for the study; - selection of a representative part of the product; - preparation of the test; - experimental control; - selection of control samples and requirements for them. This standard does not apply to materials or products containing living cells, but may refer to the material or components of a product of combination products containing living cells.

Настоящий стандарт устанавливает методы приготовления проб и выбора контрольных образцов, используемых для оценки биологического действия материалов и медицинских изделий в биологических системах в соответствии со стандартами серии ISO 10993, и включает в себя: - выбор материала для исследования; - выбор репрезентативной части изделия; - приготовление исследуемой пробы; - экспериментальный контроль; - выбор контрольных образцов и требования к ним. Настоящий стандарт не распространяется на материалы или изделия, содержащие живые клетки, но может относиться к материалу или компонентам изделия комбинированных продуктов, содержащих живые клетки

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Format: Electronic (pdf/doc)

Approved: Federal Agency for Technical Regulation and Metrology, 4/27/2015

SKU: RUSS139635

Price: $414.00




The Product is Contained in the Following Classifiers:

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 » 11.100 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 »

National Standards for KGS (State Standards Classification) » Latest edition » R Health. Sanitation and hygiene items » R2 Equipment and tools of medical institutions » R20 Classification, nomenclature and general norms »


As a Replacement Of:

GOST ISO 10993-12-2011: Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and control materials

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 10993-11-2011: Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity

GOST ISO 10993-1-2011: Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing

GOST ISO 10993-12-2011: Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and control materials

GOST ISO 10993-13-2011: 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 10993-16-2011: Medical devices. Biological evaluation of medical devices. Part 16. Toxic kinetic study design for degradation products and leachable

GOST ISO 10993-17-2011: Medical devices. Biological evaluation of medical devices. Part 17. Establishment of allowable limits for leachable substances

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

GOST ISO 10993-3-2011: Medical devices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity

GOST ISO 10993-4-2011: Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood

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

GOST ISO 10993-6-2011: Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation

GOST ISO 10993-7-2011: Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals

GOST ISO 10993-9-2011: Medical devices. Biological evaluation of medical devices. Part 9. Framework for identification and quantification of potential degradation products

GOST ISO 14971-2011: Medical devices. Application of risk management to medical devices

GOST ISO/TS 10993-19-2011: Medical devices. Biological evaluation of medical devices. Part 19. Tests physico-chemical, morphological and topographical characterization of materials

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

The Document is Referenced By:

GOST 34901-2022: Medical devices. System for evaluation of biological effect. General requirements for research (tests)

GOST ISO 10282-2017: Sterile rubber surgical gloves, disposable. Technical requirements

GOST ISO 10993-16-2016: Medical devices. Biological evaluation of medical devices. Part 16. The concept of toxic kinetic studies of decomposition products and leachable

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

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

GOST R 57762-2017: Absorbent underwear for disabled people. General specifications

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

Resolution 2425: On approval of the single list of products subject to mandatory certification and the single list of products subject to declaration of conformity, amending the decree of the Government of the Russian Federation of December 31, 2020 N 2467 and repealing certain acts of the Government of the Russian Federation

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