Tiêu chuẩn quốc tế
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Số hiệu
Standard Number
EN ISO 18113-5:2011
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 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
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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 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.
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