Name:
ISO 18113-5:2022 PDF
Published Date:
09/30/2022
Status:
Active
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for self-testing.
This document is also applicable to apparatus and equipment intended to be used with IVD instruments for self-testing.
This document can also be applicable to accessories.
This document 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.
| File Size : | 1 file , 2.2 MB |
| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Published : | 09/30/2022 |