GOST R ISO 10993-10-2009
ГОСТ Р ИСО 10993-10-2009
|
|
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
Choose Language:
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
|
Customers Who Viewed This Item Also Viewed:
 |
Controllers acting without
Language: English |
Building materials. Methods for combustibility test
Language: English |
Building materials spread flame test method
Language: English |
Polyvinyl chloride insulated cables of rated voltages up to and including 450/750 V. Non-sheathed cables for fixed wiring
Language: English |
Clear sheet glass. Specifications
Language: English |
Natural gas. Methods of calculation of physical properties. Calculation of physical properties on base information on density of standards conditions and nitrogen and carbon dioxide contents
Language: English |
Steel welded vessels and apparatus. General technical conditions
Language: English |
System of Standards for Occupational Safety and Health (SSBT). Personal protective equipment for respiratory organs. Self-rescuers insulating on chemically bound or with compressed oxygen. Technical requirements. Test methods. Marking. Sampling rules
Language: English |
 |
|
YOUR ORDERING MADE EASY!
RussianGost.com is an industry-leading company with stringent quality control standards and our dedication to precision, reliability and accuracy are some of the reasons why some of the world’s largest companies trust us to provide their national regulatory framework and for translations of critical, challenging, and sensitive information.
Our niche specialty is the localization of national regulatory databases involving: technical norms, standards, and regulations; government laws, codes, and resolutions; as well as RF agency codes, requirements, and Instructions.
We maintain a database of over 220,000 normative documents in English and other languages for the following 12 countries: Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Mongolia, Russia, Tajikistan, Turkmenistan, Ukraine, and Uzbekistan.
Placing Your Order
Please select your chosen document, proceed to the ‘checkout page’ and select the form of payment of your choice. We accept all major credit cards and bank wire transfers. We also accept PayPal and Google Checkout for your convenience. Please contact us for any additional arrangements (Contract agreements, PO, etc.).
Once an order is placed it will be verified and processed within a few hours up to a rare maximum of 24 hours.
For items in stock, the document/web link is e-mailed to you so that you can download and save it for your records.
For items out of stock (third party supply) you will be notified as to which items will require additional time to fulfil. We normally supply such items in less than three days.
Once an order is placed you will receive a receipt/invoice that can be filed for reporting and accounting purposes. This receipt can be easily saved and printed for your records.
Your Order Best Quality and Authenticity Guarantee
Your order is provided in electronic format (usually an Adobe Acrobat or MS Word).
We always guarantee the best quality for all of our products. If for any reason whatsoever you are not satisfied, we can conduct a completely FREE revision and edit of products you have purchased. Additionally we provide FREE regulatory updates if, for instance, the document has a newer version at the date of purchase.
We guarantee authenticity. Each document in English is verified against the original and official version. We only use official regulatory sources to make sure you have the most recent version of the document, all from reliable official sources.
