Skip to product information
1 of 12

PayPal, credit cards. Download editable-PDF & invoice in 1 second!

YY/T 0506.1-2005 English PDF (YYT0506.1-2005)

YY/T 0506.1-2005 English PDF (YYT0506.1-2005)

Regular price $205.00 USD
Regular price Sale price $205.00 USD
Sale Sold out
Shipping calculated at checkout.
Quotation: In 1-minute, 24-hr self-service. Click here YY/T 0506.1-2005 to get it for Purchase Approval, Bank TT...

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

This part of YY/T 0506 stipulates the information in addition to the general labeling 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.
YY/T 0506.1-2005
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
ICS 11.140
C 46
Surgical drapes, gowns and clean air suits for
patients, clinical staff and equipment - Part 1: General
requirements for manufacturers, processors and
products
(EN 13795-1:2002, MOD)
ISSUED ON: APRIL 05, 2005
IMPLEMENTED ON: JANUARY 01, 2006
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3
Introduction ... 4
1 Scope ... 5
2 Terms and definitions ... 5
3 Information to be provided by manufacturers and processors ... 9
4 Manufacturing and processing requirements ... 11
5 Inspection requirements ... 12
Appendix A (Informative) Comfort ... 13
Appendix B (Informative) Fixation and paste for wound isolation ... 14 Appendix C (Informative) Prevention of infection in operating room ... 15 References ... 16
Surgical drapes, gowns and clean air suits for
patients, clinical staff and equipment - Part 1: General
requirements for manufacturers, processors and
products
1 Scope
This part of YY/T 0506 stipulates the information in addition to the general labeling 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.
2 Terms and definitions
The following terms and definitions apply to this part of YY/T 0506.
2.1
Clean air suit
The clothing designed specially to minimize the contamination from the skin dirt of the wearer who carries the infective agent to the surgical wound through the air in the operating room, thereby reducing the risk of injury and infection.
1 At the time when this standard is published, the corresponding national standard is in the process of being approved.
2 It is planned to convert this international standard and include it as a part of this series of standards. methods.
2.6
Fixation
The attachability of surgical drapes on the patient in order to isolate the wound.
Note: See Appendix B
2.7
Infective agent
Microorganisms that have been shown to cause infection in surgical wounds or may cause infection in surgical staff or patients.
2.8
Linting
In use, the fabric will lose particles or fiber segments due to force.
Note: These fiber segments and particles come from the fabric itself.
2.9
Manufacturer
Before a device is placed on the market in its name, a natural or legal person responsible for its design, manufacturing, packaging, labeling, regardless of whether these operations are performed by the person himself or a third party.
2.10
Processor
A natural or legal person that processes repetitively used product items so that their performance meets the requirements of this standard.
Note: This standard regards those processors that put their products on the market as manufacturers.
2.11
Resistance to liquid penetration
The ability of a material to prevent liquid from passing from one side to the 2.17
Surgical procedure
The process of operation which penetrates the skin or mucosa as
implemented by the surgical staff.
2.17.1
Clean operation
Operation performed on uninfected, non-invasive tissue and does not enter the respiratory tract, digestive tract, or urethra.
2.17.2
Infection-prone operation
The operation which may cause infection due to even small contamination as determined by the nature of the operation or the patient?€?s condition. 2.17.3
Invasive surgical procedure
Surgery that reaches inside the body through the body surface.
2.18
Permeability to air
The ability of air to penetrate the fabric.
3 Information to be provided by manufacturers and
processors
3.1 The following information shall be provided:
a) If the manufacturer anticipates a device to be reused, there shall be disposal information for its reuse, including methods for cleaning,
disinfection, packaging, re-sterilization (if applicable), the number of reuses, any restrictions on reuse;
b) If the equipment is sterilized before supply, it needs providing the sterilization method;
c) If the manufacturer divides the critical area and non-critical area of the Table 3 -- Characteristics of clean air suits to be evaluated
Characteristics
Resistance to microbial penetration - Dry state
Cleanliness - Microbial
Cleanliness - Particulate matter
Linting
Bursting strength - Dry state
Tensile strength - Dry state
Note: Clean air suits are rarely used at present, but they are available on the market, so they are included in this standard.
4 Manufacturing and processing requirements
4.1 The manufacturer and the processor shall be able to provide proof that the product meets the requirements listed in this series of standards and is suitable for single-use and repeated use.
Note: It is recommended to use a quality system that complies with the requirements of YY/T 0287.
4.2 It shall use confirmed manufacturing and processing procedures.
4.2.1 The manufacturing and processing specifications of the product shall be designed and confirmed, including appearance and sanitary cleanliness.
4.2.2 Confirmation shall include all steps of manufacturing and processing. 4.2.3 The frequency of re-confirmation in the confirmation process shall be determined. Any changes in manufacturing or processing shall be re-evaluated on whether it will have a substantial impact on the product.
4.2.4 It shall identify, monitor, record key production or processing parameters; the form and frequency of routine monitoring shall be documented.
4.2.5 The results of confirmation and routine monitoring shall be recorded and retained.
Note: The confirmation and monitoring process is preferably a biological test, chemical test and/or physical test.
4.3 During manufacturing and processing, it shall maintain the control of decontamination and disinfection procedures and traceability of sterilization. 4.4 It shall be demonstrated that the properties of the material have been maintained during manufacturing and processing.
Appendix A
(Informative)
Comfort
A.1 General
The concept of comfort is based on several different aspects, such as
physiological comfort, ease of exercise, or other factors that affect personal satisfaction with the product
Fabric and design, especially hand washing clothes and operating room clothes, shall minimize the physical stress generated during the work.
The climatic comfort of clothing depends on thermal insulation, permeability to air, water vapor permeability and drapeability.
The tactile comfort of clothes mainly depends on the stretchability, drapeability and surface structure of the fabric; it also depends on the quality, specifications, sewing and manufacturing of the clothes.
Other performances such as sounding, softness, skin irritation, etc., which are difficult to measure, it should be evaluated based on trial use or practical experience of the product.
A.2 Surgical gowns and clean air suits
The overall comfort of surgical gowns and clean air suits is affected by many factors, including design, sewing, permeability to air, quality, surface thickness, electrostatic properties, color, light reflection, odor, skin sensitization. Other important parameters that can affect comfort are underwear, health and physiological conditions, workload, mental stress, operating room temperature, relative humidity, ventilation and other environmental conditions.
Comfort also varies from person to person or is affected by one or a
combination of the above factors.
A.3 Surgical drapes
The surgical drapes shall be soft, so that it can cover the patient closely; it is conducive to the placement and operation of the instrument, and to the
coverage of other related instruments.
The surgical drapes shall have reasonable physiological comfort and support the patient's physical condition.
Appendix C
(Informative)
Prevention of infection in operating room
Most postoperative infections in the surgical area are caused during the operation, because the microorganisms have the opportunity to reach the open wound at this time. Microbial sources either come from outside (i.e. from medical personnel, inanimate objects or other patients), or from inside (i.e. from patients). In aseptic surgery (that is, surgery in sterile tissue without entering cavity organs), the skin of clinical staff and patients in the operating room is the most important source of microorganisms. In susceptible surgery (such as orthopedic and intravascular implant surgery), the microbial flora common in the skin is the main source of infection at the surgical area.
The route of infection is contact or airborne. In the latter case, diffused human dander is often a carrier of infective agents. The various barriers involved in this part are used to reduce infection at the surgical area.
When a healthy person walks, it will diffuse 5000 bacteria-containing dander into the air every minute. The size of these particles is 5 ??m ~ 60 ??m. Each dander is estimated to carry an average of about 5 aerobic and anaerobic bacteria. These airborne particles may be directly deposited on the wound surface, or first deposited on the equipment or other equipment that is in contact with the wound surface, then indirectly contaminate the wound surface through them. Fabrics with a gap greater than 80 ??m, such as traditional cotton fabrics, cannot basically prevent the spread of dander.
Clean air suits can be used to reduce the spread of bacteria-carrying dander from the operator to the air in the operating room. Clean air suits should be used together with surgical gowns, but not a substitute for surgical gowns. Surgical gowns are used to prevent direct contact transmission and reverse transmission of infective agents from the surgical staff to the surgical wound. Surgical gowns can only be able to prevent the spread of dander into the operating room air if it is made of suitable materials and used with ultra-clean air systems.
The surgical drape is used to provide microbially clean area around the wound surface. It can be used to prevent the spread of the patient's skin flora to the wound if it is closely held to the wound and is fixed to the skin. The surgical drape and/or collection equipment are also used to control the spread of contaminated body fluids in the wound area.

View full details