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| Название (рус.): | Стерилизация медицинской продукции. Требования к валидации и текущему контролю. Радиационная стерилизация |
| Название (англ.): | Sterilization of health care products. Requirements for validation and routine control. Radiation sterilization |
| Описание (англ.): | Specifies requirements for validation, process control and routine monitoring in the radiation sterilization of health care products. Applies to continuous and batch type gamma irradiators using the radionuclides 60 Co and 137 Cs, and to irradiators using a beam from an electron or x-ray generator. Does not cover facility design, licensing, operator training, factors related to radiation safety, the assessment of thesuitability of the product for its intended use. |
| Область применения: | Eingeschraenkter sachlicher Geltungsbereich siehe Abschnitt 1(Scope). |
| Изменён стандартами: | ISO 11137:1995/Cor.1:1997, ISO 11137:1995/Amd.1:2001 |
| Дата регистрации: | 01.04.95 |
| Дата введения: | 01.03.95 |
| Код КГС: | Р08 |
| Код ОКСТУ: | 9404 |
| Код ОКС(МКС): | 11.080.01 |
| Код ОКП: | 9404 |
| Нормативные ссылки: | ISO 9001-1994*ISO 9002-1994*ISO 11737-1 |
| Ключевые слова: | DEFINITIONS ELECTRON BEAMS MEDICAL EQUIPMENT MEDICAL PRODUCTS SPECIFICATION (APPROVAL) STERILIZATION (HYGIENE) STERILIZATION BY IRRADIATION SURVEILLANCE (APPROVAL) VALIDATION SPECIFICATIONS STERILIZATION SAMPLE SURVEYS |
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