BS EN ISO 18113-5:2011
In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) - In vitro diagnostic instruments for self-testing
Название (английский):
BS EN ISO 18113-5:2011
In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) - In vitro diagnostic instruments for self-testing
- Статус документа:
- Отменён
- Формат:
- Электронный (PDF)
- Дата публикации:
- 30 ноября 2011 г.
- ICS:
- 11.100.10
- Технический комитет:
- CEN
- SKU:
- BS EN ISO 18113-5:2011
Тип поставки:
Язык документа:
Срок поставки:1 рабочий день
Цена:50 €
Abstract
1 Scope This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments for self-testing. This part of ISO 18113 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing. This part of ISO 18113 can also be applied to accessories. This part of ISO 18113 does not apply to
a) instructions for instrument servicing or repair,
b) IVD reagents, including calibrators and control materials for use in control of the reagent,
c) IVD instruments for professional use.
Похожие стандарты
Упомянутые в описании и другие стандарты BS