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YY/T 0506.1-2005 English PDF (YY/T0506.1-2005)
YY/T 0506.1-2005 English PDF (YY/T0506.1-2005)
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YY/T 0506.1-2005: Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment. Part 1: General requirements for manufacturers, processors and products
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Scope
This part of YY/T 0506 stipulates the information in addition to the generallabeling of medical devices (see YY 0466 and EN 1041) provided to users and
third-party certification; involves manufacturing and processing requirements.
This part provides general guidelines for the performance of single-use and
reusable surgical drapes, surgical gowns, clean air suits for patients, clinical
staff, equipment, to prevent the spread of infective agents between patients and
clinical staff in the surgical procedure and other invasive examination process.
This part does not include surgical masks, surgical gloves, packaging materials,
shoes, caps, surgical incision films. GB 7543 gives the requirements for medical
gloves, while ISO 11607 1) gives requirements for packaging materials.
This part does not include flammability requirements for products used in laser
surgery. ISO 11810 2) gives the test methods for flammability and penetration
resistance during laser irradiation, as well as the corresponding classification
system. Other basic requirements for surgical gowns and surgical drapes will
be included in YY/T 0506.2.
Basic Data
Standard ID | YY/T 0506.1-2005 (YY/T0506.1-2005) |
Description (Translated English) | Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment. Part 1: General requirements for manufacturers, processors and products |
Sector / Industry | Medical Device and Pharmaceutical Industry Standard (Recommended) |
Classification of Chinese Standard | C46 |
Classification of International Standard | 11.140 |
Word Count Estimation | 13,190 |
Date of Issue | 2005-04-05 |
Date of Implementation | 2006-01-01 |
Adopted Standard | EN 13795-1-2002, MOD |
Regulation (derived from) | Industry standard filing Notice 2005 No. 5 (No. 65 overall) |
Issuing agency(ies) | State Food and Drug Administration |
Summary | This standard specifies the use of party and third-party certification to provide medical equipment in addition to the general label (see YY 0466 and EN 1041) other than the information relates to the manufacturing and processing requirements. This part of the patient, staff and equipment and the repetitive use of single-use surgical single, gowns and clean clothes performance gives general guidelines to prevent invasive surgical procedures and other examinations between patients and health care workers the spread of infectious agents. This section does not include surgical masks, surgical gloves, packaging materials, shoes, hats and surgical incision film. GB 7543 gives the requirements for medical gloves, and ISO 11607 ^ (1)) is given a packaging material requirements. This section does not include products used in laser surgery flammability requirements. ISO 11810 ^ (2)) gives the laser irradiation and the flammability test method for penetration resistance, and the corresponding classification system. Other suitable surgical gowns, surgical drapes basic requirements will be included in YY/T 0506. 2 in. |
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