ISO 18113-4:2009 PDF
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
- Статус документа:
- Отменён
- Формат:
- Электронный (PDF)
- Количество страниц:
- 10
- Дата публикации:
- 17 декабря 2009 г.
- Издание:
- ISO IS 18113 edition 1 version 1
- ICS:
- 11.100.10
ISO 18113-4:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents for self-testing. ISO 18113-4:2009 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing. ISO 18113-4:2009 can also be applied to accessories, where appropriate. ISO 18113-4:2009 applies to the labels for outer and immediate containers and to the instructions for use.
Технические детали
- Технический комитет
- ISO/TC 212 - Clinical laboratory testing and in vitro diagnostic test systems
- SKU
- ISO 18113-4:2009