GOST R ISO 10993-10-2009
ГОСТ Р ИСО 10993-10-2009
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Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and delayed-type hypersensitivity
Изделия медицинские. Оценка биологического действия медицинских изделий. Часть 10. Исследования раздражающего и сенсибилизирующего действия
Status: Not effective - Canceled. Registration information 1347-st dated 12/13/2011 (official website of Rosstandart); IUS 3-2013
This standard describes methods for evaluating the possible irritant and sensitizing effects of medical devices and materials that make up their composition. This standard includes: a) requirements for the description of the test samples; b) a detailed description of research methods; c) key factors affecting the interpretation of the results. See Appendix A for sample preparation instructions for the above studies. This standard applies to product categories in accordance with ISO 10993-1. Preparation of samples for research is carried out in accordance with Appendix A. Appendix B provides additional specific research methods for products used intradermally, orally, vaginally, in contact with the penis, in ophthalmology
Настоящий стандарт описывает методы оценки возможного раздражающего и сенсибилизирующего действия медицинских изделий и материалов, входящих в их состав. Настоящий стандарт включает в себя: а) требования к описанию исследуемых образцов; b) детальное описание методов исследования; c) ключевые факторы, влияющие на интерпретацию полученных результатов. В приложении А приведены инструкции по подготовке образцов для проведения вышеуказанных исследований. Настоящий стандарт распространяется на категории изделий в соответствии с ИСО 10993-1. Подготовку образцов к исследованиям проводят в соответствии с приложением А. В приложении B приведены дополнительные специфические методы исследования для изделий, используемых интрадермально, орально, вагинально, контактирующих с пенисом, в офтальмологии
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Format: Electronic (pdf/doc)
Approved: Federal Agency for Technical Regulation and Metrology,
12/2/2009
SKU: RUSS72149
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 »
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 R ISO 10993.10-99: Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and sensitization
The Document References:
GOST R ISO 10993-1-2009: Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing
GOST R ISO 10993-12-2009: Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and control materials
GOST R ISO 10993-13-2009: Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
GOST R ISO 10993-14-2009: Medical devices. Biological evaluation of medical devices. Part 14. Identification and quantification of degradation products from ceramics
GOST R ISO 10993-2-2009: Standardization in the Russian Federation. Medical devices. Biological evaluation of medical devices. Part 2. Animal welfare requirements
GOST R ISO 10993-9-2009: Medical devices. Biological evaluation of medical devices. Part 9. Framework for identification and quantification of potential degradation products
GOST R ISO 14155-1-2008: Clinical investigation of medical devices for human subjects. Part 1. General requirements
GOST R ISO 14155-2-2008: Clinical investigation of medical devices for human subjects. Part 2. Clinical investigation plans
The Document is Referenced By:
GOST R 52114-2009: Units mechanics of upper-limb prostheses. Technical requirements and test methods
GOST R 52238-2004: Single-use sterile rubber surgical gloves. Specification
GOST R 52239-2004: Single-use medical examination gloves. Part 1. Specification for gloves made from rubber latex or rubber solution
GOST R 53468-2009: Implants ophthalmic. Irrigating solutions for ophthalmic surgery. General safety requirements
GOST R 53498-2009: Plaster type dressing. General technical requirements. Test methods
GOST R 53869-2010: Prostheses of lower-limb. Technical requirements
GOST R 54739-2011: Orthopaedic footwear products. General specifications
GOST R 55038-2012: Ophthalmic optics. Ophthalmic implants. Ocular endotamponades. General safety requirements
GOST R 57892-2017: Spinal assistants and headholders. Тechnical requirements and test methods
GOST R ISO 10993-7-2009: Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals
GOST R ISO 25539-2-2012: Cardiovascular implants. Endovascular devices. Part 2. Vascular stents
GOST R ISO 7405-2011: Dentistry. Evaluation of biocompatibility of medical devices used in dentistry
GOST R ISO/TS 10993-20-2009: Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing of medical devices
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