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| Название (рус.): | Изделия медицинские. Валидация и текущий контроль стерилизации оксидом этилена |
| Название (англ.): | Medical devices. Validation and routine control of ethylene oxide sterilization |
| Описание (англ.): | Establishes requirements and guidance. Particular attention is drawn to the need for specific testing for safety, quality and efficacy, possibly exceeding the general requirements, which may be necessary for a specific product. Attention is drawn to the existence in some countries of regulations laying down safety requirements forhandling ethylene oxide and for premises in which it is used as well as of regulations laying down limits for the level of ethylene oxide residues within medical devices and products. |
| Изменён стандартами: | ISO 11135:1994/Cor.1:1994 |
| Дата регистрации: | 01.04.94 |
| Дата введения: | 01.02.94 |
| Код ОКС(МКС): | 11.080.01 |
| Нормативные ссылки: | ISO 9001-1987*ISO 9002-1987*ISO 9004-1987 |
| Дополнительная информация: | Попр.01:1994 ТК 198 Код 1 с. Изд.1; |
| Ключевые слова: | CHECKS ETHYLENE OXIDE HYGIENE MEDICAL DEVICES MEDICAL EQUIPMENT MEDICAL SCIENCES MEDICAL TECHNOLOGY ROUTINE TESTS STERILIZATION (HYGIENE) VALIDATION MEDICINE STERILIZATION |
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