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EVS-EN ISO 18113-4:2024

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2022)

General information

Valid from 15.07.2024
Base Documents
ISO 18113-4:2022; EN ISO 18113-4:2024
ICS Groups
11.100.10 In vitro diagnostic test systems
Directives or regulations
None

Standard history

Status
Date
Type
Name
15.07.2024
Main
EVS-EN ISO 18113-4:2024
02.11.2011
Main
EVS-EN ISO 18113-4:2011

ISO 18113-4 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators, and controls intended for self-testing. It can also be applied to accessories. It is applied to the labels for outer and immediate containers and to the instructions for use.

ISO 18113-4 is concerned solely with information supplied with IVD reagents, calibrators, and control materials intended for self-testing. It is intended to be used in conjunction with ISO 18113-1, which contains the general requirements for information supplied by the manufacturer and definitions of general labelling concepts.

ISO 18113-4:2022 text has been approved in Europe as EN ISO 18113-4:2024 without any changes.

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English (PDF 553 KB)

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English