GOST R 52770-2016
ГОСТ Р 52770-2016
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Medical devices. Safety requirements. Methods of sanitation-chemical and toxicological tests
Изделия медицинские. Требования безопасности. Методы санитарно-химических и токсикологических испытаний
Status: Effective - Supersedes. IUS 4-2017
The standard applies to MI and establishes a general procedure for conducting sanitary-chemical and toxicological tests (studies) in order to ensure their safe use when used in accordance with the purpose. The standard serves as a guide for the planning of testing (research) MI on sanitary-chemical indicators, indicators of biological action and microbiological indicators.
Стандарт распространяется на МИ и устанавливает общий порядок проведения санитарно-химических и токсикологических испытаний (исследований) с целью обеспечения их безопасного применения при использовании в соответствии с назначением. Стандарт служит в качестве руководства для планирования испытаний (исследований) МИ по санитарно-химическим показателям, показателям биологического действия и микробиологическим показателям.
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Format: Electronic (pdf/doc)
Approved: Federal Agency for Technical Regulation and Metrology,
10/31/2016
SKU: RUSS287565
The Product is Contained in the Following Classifiers:
PromExpert »
SECTION III. LABOR PROTECTION AND SAFETY »
III Occupational safety requirements for production equipment and processes »
2 Safety requirements for certain types of work »
2.10 Operation of electrical installations, electrical equipment and power tools »
PromExpert »
SECTION I. TECHNICAL REGULATION »
V Testing and control »
4 Testing and control of products »
4.13 Testing and control of products of engineering industry »
4.13.2 Machines and equipment for special purposes »
4.13.2.11 Equipment and instruments for medical industry »
ISO classifier »
07 MATHEMATICS. NATURAL SCIENCES »
07.100 Microbiology »
07.100.10 Medical Microbiology »
National standards »
07 MATHEMATICS. NATURAL SCIENCES »
07.100 Microbiology »
07.100.10 Medical Microbiology »
National Standards for KGS (State Standards Classification) »
Latest edition »
R Health. Sanitation and hygiene items »
R2 Equipment and tools of medical institutions »
R22 Devices, apparatus, accessories and equipment used in surgery, in dental and autopsy practice. Anesthetic and artificial respiration devices »
The Document is Replaced With:
GOST R 52770-2020: Medical products. Biological action assessment system. Part 1. General requirements for biological safety
As a Replacement Of:
GOST R 52770-2007: Medical products. Safety requirements. Methods of sanitation-chemical and toxicological tests
The Document References:
Decision 299: Uniform sanitary and epidemiological and hygienic requirements for products (goods) subject to sanitary and epidemiological supervision (control)
GN 2.3.3.972-00: Nutrition hygiene. Package, crockery, equipment and other types of productions, contacting with food. Maximum admissible amounts (MAA) of chemical substances, emitting from materials contacting with food
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 31580.5-2012: Ophthalmic implants. Intraocular lenses. Part 5. Biocompatibility
GOST 31814-2012: Conformity assessment. General sampling rules for products testing during attestation assessment
GOST 6709-72: Distilled water. Specifications
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 10993-12-2015: 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 10993-16-2016: Medical devices. Biological evaluation of medical devices. Part 16. The concept of toxic kinetic studies of decomposition products and leachable
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/IEC 17025-2009: General requirements for the competence of testing and calibration laboratories
GOST R 52501-2005: Water for analytical laboratory use. Specifications
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
The Document is Referenced By:
GOST 34901-2022: Medical devices. System for evaluation of biological effect. General requirements for research (tests)
GOST R 53498-2019: Medical products of a plaster type. General technical requirements. Test methods
GOST R 57492-2017: Medical devices. Implantable cardiac pacemakers. Technical requirements for governmental purchases
GOST R 57495-2017: Medical devices. Implantable neurostimulators. Technical requirements for governmental purchases
GOST R 57500-2017: Medical devices. Implantable infusion pumps. Technical requirements for governmental purchases
GOST R 57505-2017: Medical devices. Cochlear implant system. Technical requirements for governmental purchases
GOST R 57506-2017: Medical devices. Implantable defibrillators and other active implantable medical devices intended to treat tachyarrhythmia. Technical requirements for governmental purchases
GOST R 57629-2017: Medical devices. General safety and compatibility requirements for single use infusion sets
GOST R 57762-2017: Absorbent underwear for disabled people. General specifications
GOST R 57764-2017: Support canes and crutches axillary. Technical requirements and methods of control
GOST R 57766-2017: Chairs with medical equipment. Types, technical requirements and methods of control
GOST R 58236-2018: Medical elastic manufactured articles for the compression. General technical requirements. Test methods
GOST R 58281-2018: Crutches cane support. Technical conditions
GOST R 58447-2019: Lower limb prostheses with an external energy source. General technical requirements
GOST R 58523-2019: Hip abduction apparatus for children. Technical requirements and test methods
GOST R 58936-2020: Optics and Photonics. Endoscopes and medical endotherapeutic devices. General technical requirements and test methods
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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