YY/T 0330-2015Medical absorbent cotton (English PDF)

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules.

This standard replaces YY 0330-2002 "Absorbent." Compared with YY 0330-2002 main technical differences are as follows.

--- Remove the white degree requirements (2002 Version 3.2) and test methods (2002 Version 4.3);

--- Easy to remove oxide requirements (2002 Version 3.5) and test methods (2002 Version 4.6);

--- Modify the absorption time sinking time (see 37, 2002. Version 3.6.);

--- Increased identification (see 3.2) and test methods (see 4.3);

--- Increased foreign fiber requirements (see 3.3);

--- Increased neps requirements (see 3.4);

--- Can increase the leaching colored substances requirements (see 3.14) and test methods (see 4.12);

--- Of cotton non-sterile medical supplies, increased labeling requirements for microbial limits (see 3.16) and test methods (see 4.14);

--- Modify the pH requirements (see 36, 2002 Version 3.4.) And test methods (see 45, 2002 Version 4.5.);

--- The residue on ignition is amended as sulfated ash (see 3.12, 3.11, 2002 edition), and modify the test methods (see section 4.10, 2002 Version 4.12);

--- Modify the surface active materials (see 313, 2002 edition 3.12.);

--- Canceled Inspection Rules (2002 Edition 5);

--- Cancel the request flag, the label (2002 Version 6).

This standard reference the 2010 edition of the British Pharmacopoeia "cotton." Please note that some content of this document may involve patents, the issuing authority of this document does not assume responsibility for the identification of these patents.

Introduction

Absorbent After rinsing and drying only in self purification conditions for production and processing, in order to make the pollution of the environment caused by products Minimized. However, no international evaluation Absorbent contaminated foreign substance approach.

Absorbent stars sterile non-sterile supplies supply two. Because cotton has a high adsorption, if ethylene oxide sterilization, suck Ethylene oxide disease patients and will bring a higher officer attached to the harm, so this standard does not recommend the use of ethylene oxide sterilization of cotton wool.

For Absorbent non-sterile supply manufacturer Microbiological parameters can be determined as the sterilization of medical sterilization agency basis.

1 Scope

This standard specifies requirements for medical cotton wool.

This standard applies to any free use of cotton grass cotton plants mature sunflower seeds furry by removing inclusions, degreasing, bleaching, processing of He added Absorbent colored substance. Absorbent main hospital for clinical use as a dressing.

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.

GB/T 14233.1 Infusion, transfusion, injection equipment - Part 1. Chemical analysis Microbiological sterilization method GB/T 19973.1 medical devices - Part 1. Total estimated microorganisms

YY/T 0615.1 labeling requirements "sterile" medical devices - Part 1.

3 Requirements