GB/T 29791.1-2013In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 1: Terms, definitions and general requirements (English PDF)

1 Scope

This section GB/T 29791 for information on the definition of the concept of in vitro diagnostic medical devices supplied by the manufacturer to establish the general principles and provisions basic requirements.

Language belongs to the scope of national laws and regulations, we will not be discussed in this section.

This section does not apply to.

a) Performance evaluation of in vitro diagnostic medical devices (such as for research use only);

b) instrument mark;

c) safety data sheet.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein

Member. For undated references, the latest edition (including any amendments) applies to this document.

ISO 1000 SI units and their multiples and of certain other units of applications recommended (SIunitsandrecommendationsfor theuseoftheirmultiplesandofcertainotherunits)

ISO 13485 medical device quality management system for regulatory requirements (Medicaldevices-Qualitymanagement systems-Requirementsforregulatorypurposes)

ISO 14971 Medical Device Risk Management for Medical Device Applications (Medicaldevices-Applicationofriskmanage- menttomedicaldevices)

ISO 15223-1 medical equipment with medical device labels, labeling and information provided by graphical symbols - Part 1. General requirements (Medicaldevices-Symbolstobeusedwithmedicaldevicelabels, labelingandinformationtobesup- plied-Part 1. Generalrequirements)

IEC 62366 Medical Devices to use engineering applications (Medicaldevices-Applicationofusability on medical devices engineeringtomedicaldevices)

EN980 medical devices used in the labeling symbol (Symbolsforuseinthelabelingofmedicaldevices)

3 Terms and Definitions

For this portion, and GB/T 29791.2 ~ 29791.5, the following terms and definitions apply. However, given the national and regional regulations

The definition should be used in preference. Information and when the use of international standards in terms and definitions, in vitro diagnostic medical devices supplied by the manufacturer

Terms and definitions used should comply with the requirements of 4.6.2.

When synonyms are given, each term can be used, but it is best to use the first term.

Some definitions in accordance with the relevant in vitro diagnostic label or term in order to meet ISO rules must be modified, in this case, explanatory notes

Definition has been adapted and gives references

In some cases, existing Notes requires additional notes or modified to illustrate the applicability of the in vitro diagnostic medical devices, as well as provincial

Omitted some notes do not apply to in vitro diagnostic medical devices, these cases are not considered to be modified and are not defined as "adaptation."

GB/T 29791.3 | GB/T 26124 | GB/T 19634 | GB/T 21415 | GB/T 29791.5 | GB/T 29791.4 | […]