YY/T 0506.8-2019 Active Industry standards-Medicine

YY/T 0506.8-2019 Surgical drapes,gowns and clean air suits for patients, clinical staff and equipment—Part 8:Special requirements for products

YY/T 0506.8-2019 Surgical drapes,gowns and clean air suits for patients, clinical staff and equipment—Part 8:Special requirements for products

Publish Date: 2019-07-24 Implement Date: 2020-08-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0506.8-2019

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Surgical room equipment

ICS Name: Medical equipment

Publish Date: 2019-07-24

Implement Date: 2020-08-01

Pages: 19 pages

Scope

This part of YY/T 0506 specifies the special requirements for surgical drapes, surgical gowns, and clean garments used by patients, medical staff, and surgical instruments. This part applies to surgical drapes, surgical gowns, and clean garments used in surgeries requiring a high degree of purification and full body coverage of the patient. Note: The surgical drapes specified in this part do not include single-use and reusable surgical drapes used for minor surgeries with a small open wound area and low surgical purification level requirements. The clinical requirements for surgical drapes, surgical gowns, and clean garments used in operating rooms depend on the degree of openness of the surgical wound and the purification level of the clean operating room.

Development Information

Word Count: 32 Thousand words Pages: 19 pages

Referenced Standards

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 YY/T 0506.2-2016 Surgical drapes,gowns and clean air suits for patients,clinical staff and equipment—Part 2:Performance requirements and test methods YY 0852-2011 Sterile surgical films for single use GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.7-2001 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals GB/T 16886.7-2015 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals YY/T 0615.1-2007 Requirements for medical devices to be designated "STERILE"—Part 1:Requirements for terminally sterilized medical devices

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