Tiêu chuẩn quốc tế
Số hiệu
Standard Number
EN ISO 18113-4:2011
Năm ban hành 2011
Publication date
Tình trạng
A - Còn hiệu lực
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Tên tiếng Anh
Title in English In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
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Giá:
Price Liên hệ / Contact us
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Phạm vi áp dụng
Scope of standard This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for self-testing. This part of ISO 18113 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for self-testing. This part of ISO 18113 can also be applied to accessories. This part of ISO 18113 applies to the labels for outer and immediate containers and to the instructions for use. This part of ISO 18113 does not apply to: a) IVD instruments or equipment, b) IVD reagents for professional use.
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