GOST R ISO 10993.13-99
ГОСТ Р ИСО 10993.13-99
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Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
Изделия медицинские. Оценка биологического действия медицинских изделий. Часть 13. Идентификация и количественное определение продуктов деструкции полимерных медицинских изделий
Status: Not effective - Superseded. IUS 12-2009
This standard applies to degradation products, which are formed as a result of changes in the chemical properties of a ready-to-use polymer product. The standard does not apply to products whose destruction is caused by stress, wear and electromagnetic radiation during clinical use, as well as fragments and soluble degradation products
Настоящий стандарт распространяется на продукты деструкции, которые образуются в результате изменения химических свойств готового к употреблению полимерного изделия. Стандарт не распространяется на изделия, деструкция которых вызвана нагрузкой, износом и электромагнитным излучением во время клинического применения, а также на осколки и растворимые продукты деструкции
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Format: Electronic (pdf/doc)
Approved: Gosstandart of Russia,
12/29/1999
SKU: RUSS68851
The Product is Contained in the Following Classifiers:
ISO classifier »
11 HEALTH »
11.120 Pharmaceuticals »
11.120.20 Dressings and compresses »
National standards »
11 HEALTH »
11.120 Pharmaceuticals »
11.120.20 Dressings and compresses »
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 »
National Standards for OKSTU »
MEDICINES, CHEMICAL AND PHARMACEUTICAL PRODUCTS AND PRODUCTS FOR MEDICAL PURPOSES »
Materials, medical supplies and other medical products »
National Standards for OKSTU »
MEDICAL EQUIPMENT »
Calculation and design standards. Technical documentation »
The Document is Replaced With:
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
The Document References:
GOST R ISO 10993.12-99: Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and reference materials
GOST R ISO 10993.16-99: Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachable
GOST R ISO 10993.1-99: Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing
GOST R ISO 10993.9-99: Medical devices. Biological evaluation of medical devices. Part 9. Framework for identification and quantification of potential degradation products
The Document is Referenced By:
GOST R 51892-2002: Ophthalmic implants. Intraocular lenses. Part 1. Terms and definitions
GOST R 51932-2002: Ophthalmic optics. Spectacle frames for corrective eyeglasses. General technical requirements and test methods
GOST R 52770-2007: Medical products. Safety requirements. Methods of sanitation-chemical and toxicological tests
GOST R ISO 10993.9-99: Medical devices. Biological evaluation of medical devices. Part 9. Framework for identification and quantification of potential degradation products
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