YY/T 0506.2-2016Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment - Part 2: Performance requirements and test methods (English PDF)

Foreword

YY/T 0506 "Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment" is divided into 7 parts.

- Part 1: General requirements for manufacturers processors and products;

- Part 2: Performance requirements and performance levels;

- Part 4: Test method for linting in the dry state;

- Part 5: Test method for resistance to dry microbial penetration;

- Part 6: Test method to determine the resistance to wet bacterial penetration;

- Part 7: Test methods for determination of cleanliness-microbial. This part is part 2 of YY/T 0506.

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

This part replaces YY/T 0506.2-2009 "Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment - Part 2: Performance requirements and test methods" and YY/T 0506.3-2005 "Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment - Part 3: Test methods".

Compared with YY/T 0506.2-2009 and YY/T 0506.3-2005, except for editorial changes, the main technical changes in this part are as follows.

- COMBINE the performance requirements, performance levels, test methods into one standard;

- UPDATE the normative references;

- MODIFY the unit of the performance requirements for prevention of microbial penetration-dry state and cleanliness-microbial;

- CHANGE the cleanliness-microbial test method to quoting YY/T 0506.7;

- MODIFY the calculation formula of cleanliness-particulate matter;

- ADD Appendix B optional test methods.

This part was modified with reference to the test methods, performance requirements and performance levels in EN 13795:2011 "Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels".

1 Scope

This part of YY/T 0506 specifies the performance requirements and test methods of surgical drapes, surgical gowns and clean air suits.

2 Normative references

The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) are applicable to this standard.

GB/T 4744 Textile fabrics - Determination of resistance to water penetration - Hydrostatic pressure test

GB/T 6529 Textiles - Standard atmospheres for conditioning and testing

GB/T 7742.1 Textiles. Bursting properties of fabrics - Part 1: Hydraulic method for determination of bursting strength and bursting distension

GB/T 24218.3 Textiles - Test methods for nonwovens - Part 3: Determination of tensile strength and elongation (strip method) A unit for expressing the number of microorganisms that can be cultivated.

3 Terms and definitions

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

4 Performance requirements

The product must comply with the YY/T 0506 series of standards. When tested according to this standard, it shall meet the requirements specified in Table 1,

Appendix A (Normative) Test method