YY/T 0720-2023Single-use maternity kits - General requirements (English PDF)

1 Scope

This document specifies the general requirements, configuration and technical requirements, manufacturing information and packaging provided by the manufacturer.

This document applies to surgical packs for caesarean section and natural childbirth.

2 Normative references

The contents of the following documents constitute the essential provisions of this document through normative references in the text. Among them, dated references

For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to this document.

GB/T 7543 Disposable sterile rubber surgical gloves

GB/T 14233.1-2008 Test methods for medical infusion, blood transfusion and injection equipment Part 1.Chemical analysis methods

GB/T 16886.1 Biological evaluation of medical devices Part 1.Evaluation and testing in the risk management process

YY/T 0313 Medical Polymer Product Packaging and Requirements for Manufacturers to Provide Information

YY/T 0466.1 Symbols for Medical Device Labeling, Marking and Information Provision for Medical Devices Part 1.General Requirements

YY 0469 Medical Surgical Mask

YY/T 0506.1 Surgical drapes, surgical gowns and clean clothes for patients, medical staff and instruments - Part 1.General requirements

YY 0594 General requirements for surgical gauze dressings

YY 0852-2011 Disposable sterile surgical film

YY/T 0854.2-2011 Performance requirements for cotton nonwoven surgical dressings Part 2.Finished dressings

YY/T 1470-2016 Disposable umbilical cord cutter (cutter)

3 Terms and Definitions

The following terms and definitions defined in YY/T 0506.1 apply to this document.