GOST ISO 10993-10-2011

ГОСТ ISO 10993-10-2011

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: Effective - Introduced for the first time. 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 applies to product categories in accordance with ISO 10993-1.

Настоящий стандарт описывает методы оценки возможного раздражающего и сенсибилизирующего действия медицинских изделий и материалов, входящих в их состав. Настоящий стандарт распространяется на категории изделий в соответствии с ISO 10993-1

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Format: Electronic (pdf/doc)
Page Count: 80

Approved: Federal Agency for Technical Regulation and Metrology, 12/13/2011

SKU: RUSS72362

Price: $607.22




The Product is Contained in the Following Classifiers:

Evidence base (TR CU, Technical Regulation of the Customs Union) » 019/2011 TR CU. On safety of personal protective equipment » Regulations and standards (to ТР ТС 019/2011) »

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 »


The Document References:

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 10993-18-2011: Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials

GOST ISO 10993-9-2011: Medical devices. Biological evaluation of medical devices. Part 9. Framework for identification and quantification of potential degradation products

The Document is Referenced By:

GOST 31579-2012: Ophthalmic implants. Ophthalmic viscosurgical devices. General safety requirements

GOST 31580.5-2012: Ophthalmic implants. Intraocular lenses. Part 5. Biocompatibility

GOST 31585-2012: Ophthalmic Implants. Irrigating solutions for ophthalmic surgery. General safety requirements

GOST 31589-2012: Ophthalmic optics. Spectacle frames for corrective eyeglasses. General technical requirements and test methods

GOST ISO 10282-2017: Sterile rubber surgical gloves, disposable. Technical requirements

GOST ISO 10993-12-2015: Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and reference materials

GOST ISO 10993-7-2011: Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals

GOST ISO 10993-7-2016: Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals

GOST ISO/TS 10993-20-2011: Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing of medical devices

GOST R 52770-2016: Medical devices. Safety requirements. Methods of sanitation-chemical and toxicological tests

GOST R 56137-2014: Prosthetics and orthotics. Quality control prostheses and orthoses lower limb with individual parameters manufacturing

GOST R 56138-2014: Upper limb prostheses. Technical requirements

GOST R 56328-2014: Medical equipment. Mobile complexes for medical purpose. General specifications and test methods

GOST R 56330-2014: Medical equipment. Technical means of placement and transfer of patients in the prehospital. General specifications and 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 57497-2017: Medical devices. Implantable active devices intended to circulatory support. 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 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 57765-2017: Products prosthetic-orthopedic. General technical requirements

GOST R 57766-2017: Chairs with medical equipment. Types, technical requirements and methods of control

GOST R 57768-2017: Orthopedic bandages for joints of the upper and lower extremities. Types and basic parameters

GOST R 57769-2017: Antidecubital mattresses and pillows. Types and basic parameters

GOST R 57770-2017: Orthopedic mattresses. Types and basic parameters

GOST R 58281-2018: Crutches cane support. Technical conditions

GOST R ISO 16840-2-2015: Wheelchair seating. Part 2. Determination of physical and mechanical characteristics of devices intended to manage tissue integrity. Seat cushions

MR 3.5.1.0113-16: Use of gloves to prevent healthcare-associated infections in health organizations

Decision 180: On the list of international and regional (interstate) standards, and in their absence - national (state) standards, as a result of which, on a voluntary basis, compliance with the requirements of the technical regulations of the Customs Union "On the safety of light industry products" (TR CU 017/2011) , and a list of international and regional (interstate) standards, and in their absence - national (state) standards containing rules and methods of research (testing) and measurements, including sampling rules necessary for the application and implementation of the requirements of the technical regulations of the Customs Union "On the safety of light industry products" (TR CU 017/2011) and the implementation of conformity assessment of objects of technical regulation

GOST ISO 8009-2019: Mechanical contraceptives. Reusable rubber and silicone diaphragms. Technical requirements and test methods

GOST R 51191-2019: Nodes of prostheses of the lower extremities. Technical requirements and test methods

GOST R 58396-2019: Masks are medical. Requirements and Test Methods

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

PNST 425-2020: Hygienic gauze mask. Specifications

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