Standard No.:	YY/T 0506.2-2016
Chinese Name:	病人、医护人员和器械用手术单、手术衣和洁净服 第2部分：性能要求和试验方法
English Name:	Surgical drapes,gowns and clean air suits for patients,clinical staff and equipment—Part 2:Performance requirements and test methods
Professional Classification:	C46 Surgery devices
ICS Classification:	11.040
Issued by:
Issued on:	2016-01-26
Implemented on:	2017-01-01
Status:	VALID
Replace:	YY/T0506.2-2009 Surgical drapes,gowns and clean air suits for patients,clinical staff and equipment—Part 2:Performance requirements and performance levels
Target Language:	English
File Format:	PDF
Word Count:	6000 words
Translation Price:	180 (USD)
Delivery:	via email in 1-3 business day

Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment—
Part 2: Performance requirements and test methods

1 Scope

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

2 Normative references

The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

GB/T 4744 Textile fabrics—Determination of resistance to water penetration—Hydro static 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)
YY/T 0506.1 Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment—Part 2: Performance requirements and test methods
YY/T 0506.4 Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment—Part 4: Test method for linting in the dry state
YY/T 0506.5 Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment—Part 5: Test method for resistance to dry microbial penetration
YY/T 0506.6 Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment—Part 6: Test method to determine the resistance to wet bacterial penetration
YY/T 0506.7 Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment—Part 7: Test methods for determination of cleanliness-microbial

3 Terms and definitions

For the purposes of this standard, the terms and definitions specified in YY/T 0506.1 as well as the followings apply.

3.1
cfu (colony forming unit)
unit by which the culturable number of microorganisms is expressed

Note: The culturable number is the number of microorganisms, single cells or aggregates, able to form colonies on solid nutrient medium.

3.2
less critical product area
product area with less likely to be involved in the transfer of infective agents to or from the wound, e.g. back of surgical gowns

Note 1: See YY/T 0506.1 for the definition of critical product area.

Note 2: If the manufacturer distinguishes between critical product area and less critical product area, the manufacturer is required by YY/T 0506.1 to identify these areas and provide explanatory information on the difference upon request. For additional information, see YY/T 0506.1.

3.3
performance level
discrete standard defined to classify products according to the performance requirements of this part

Note: Within the introduction of two performance levels, YY/T 0506 series standards acknowledge the fact that products are challenged to differing extents during surgical procedures, dependent upon the duration, mechanical stress and liquid challenge.