GOST R 52770-2016

ГОСТ Р 52770-2016

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

Price: $226.00




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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