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
Choose Language:
Format: Electronic (pdf/doc)
Approved: Federal Agency for Technical Regulation and Metrology,
4/27/2015
SKU: RUSS139635
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
|
Customers Who Viewed This Item Also Viewed:
 |
Metals. Methods of tension test
Language: English
|
Manual are welding. Welding joints. Main types, design elements and dimensions
Language: English
|
Vessels and apparatus. Norms and methods of strength calculation
Language: English
|
Weldable deformed reinforcing rolled products of A500C and B500C classes for reinforcement of concrete constructions. Specifications
Language: English |
Welding steel wire. Specifications
Language: English
|
Safety guidelines. Standardized methods of control of basic materials (semi-finished products), welded joints and surfacing of NPP equipment and piping. Dye penetrant inspection
Language: English
|
Bearing and enclosing structures. Updated living edition of SNiP 3.03.01-87
Language: English
|
Corrosion protection of buildings structures. Updated living edition of SNiP 2.03.11-85
Language: English
|
Standardized methods of testing of basic materials (semifinished products, weld joints and surfacing of equipment and piping of npp. Ultrasonic inspection. Part I. Control of basic materials (semifinished products)
Language: English
|
Steel and alloys. Methods for detection and determination of grain size
Language: English
|
Armour clothes. Classification and general technical requirements
Language: English |
Steel. Metallographic methods for the determination of non-metallic inclusions
Language: English
|
Welded reinforcing products and inserts, welded, lap and mechanical joints for reinforced concrete structures. General specifications
Language: English
|
Welded joints of reinforcement and inserts for reinforced concrete structures. Types, constructions and dimensions
Language: English
|
Reinforcing rolled products for reinforced concrete constructions. Specifications
Language: English
|
Steel and corrosion resistant alloys. Test methods for resistance to intergranular corrosion
Language: English
|
Armored clothing. Classification and general specifications
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.
