YY/T 0506.1-2005Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products (English PDF)

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.

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 […]

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.

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.