Tiêu chuẩn quốc tế

Số hiệu

Standard Number

EN 13532:2002
Năm ban hành 2002

Publication date

Tình trạng A - Còn hiệu lực

Status

Tên tiếng Anh

Title in English

General requirements for in vitro diagnostic medical devices for self-testing
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Price

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Phạm vi áp dụng

Scope of standard

This European Standard specifies general requirements for in vitro diagnostic medical devices (IVD MDs) for self-testing in order to ensure that IVD MDs for self-testing are safe and suitable for the purposes as specified by the manufacturer. This standard does not address medical aspects of IVD MDs for self-testing.