This standard specifies the requirements for the information supplied by the manufacturer of in vitro diagnostic reagents including reagent products, calibrators, control materials and kits for professional use, which hereafter are called reagents. This standard can also be applied to accessories.
Số hiệu tiêu chuẩn
DS/EN 375
Tên tiêu chuẩn
Information supplied by the manufacturer with in vitro diagnostic reagents for professional use
Ngày phát hành
2001-06-11
Tiêu chuẩn tương đương
IDTEN 375:2001, IDT
Thay thế bằng
DS/EN ISO 18113-2:2010
Lịch sử ban hành
DS/EN ISO 18113-2:2010*DS/EN 375
Từ khóa
DEFINITION * DIAGNOSIS * IN-VITRO DIAGNOSTIC * LABELLING * REAGENTS * PRODUCT INFORMATIONS * Labelling * Diagnosis * Diagnosis (medical) * Reagents * In-vitro diagnostic