YY/T 0506.1-2023_English: PDF (YY/T0506.1-2023)
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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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| Standard ID | YY/T 0506.1-2023 (YY/T0506.1-2023) | | Description (Translated English) | (Medical surgical drapes, surgical gowns and clean clothes - Part 1: General requirements) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of International Standard | 11.040 | | Word Count Estimation | 24,218 | | Date of Issue | 2023-01-13 | | Date of Implementation | 2024-01-15 | | Drafting Organization | Shandong Provincial Institute of Medical Devices and Drug Packaging Inspection, Zhende Medical Supplies Co., Ltd., Weihai Weigao Medical Materials Co., Ltd., Beijing Quexiang Tengfei Medical Technology Co., Ltd., Henan Yadu Industrial Co., Ltd., Jiangsu Weihu Medical Technology Co., Ltd., Hefei Gobes Medical and Sanitary Products Co., Ltd., Pujie Nonwovens (China) Co., Ltd. | | Administrative Organization | Shandong Institute of Medical Devices and Drug Packaging Inspection | | Proposing organization | State Drug Administration | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the general requirements for medical surgical drapes, surgical gowns and clean clothes. Including performance requirements, manufacturing requirements, post-use disposal requirements for reusable products, and information requirements provided by the manufacturer. Does not include anti-laser penetration properties, antimicrobial treatment requirements for gowns or drapes. This standard applies to medical surgical drapes, surgical gowns and clean clothes. This standard does not apply to surgical membranes. | | 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 & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C46 | | Classification of International Standard | 11.140 | | Word Count Estimation | 13,159 | | Date of Issue | 2005-04-05 | | Date of Implementation | 2006-01-01 | | Adopted Standard | EN 13795-1-2002, MOD | | Drafting Organization | Shandong Province Quality Inspection Center of Medical Devices | | Administrative Organization | Jinan, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center | | 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. |
YY/T 0506.1-2023
ICS 11.040
CCSC46
Pharmaceutical Industry Standard of the People's Republic of China
Replacing YY/T 0506.1-2005, YY/T 0506.2-2016, YY/T 0506.7-2014
Medical surgical drapes, surgical gowns and clean clothes
Part 1.General requirements
Part 1.General requirements
2024-01-15 Implementation
Released by the State Drug Administration
table of contents
Preface III
Introduction IV
1 Range 1
2 Normative references 1
3 Terms and Definitions 1
4 Performance requirements 3
4.1 Surgical gowns 3
4.2 Drapes 4
4.3 Clean clothes 5
5 Manufacture and handling requirements and documentation requirements 5
6 Information supplied with the product6
6.1 Information provided to users6
6.2 Information provided to processors6
Appendix A (Normative) Test Method 7
Appendix B (Normative) Bioburden Test Method 10
Appendix C (Informative) Other characteristic information 13
Appendix D (Informative) User's Guide to Selecting Products 14
Reference 16
foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules for Standardization Documents"
drafting.
This document is Part 1 of YY/T 0506 "Medical Surgical Drapes, Surgical Gowns and Clean Clothes". YY/T 0506 has issued the following
part.
--- Part 1.General requirements for manufacturing plants, processing plants and products;
--- Part 2.Performance requirements and test methods;
--- Part 4.Dry flocculation test method;
--- Part 5.Test method for resistance to dry microbial penetration;
--- Part 6.Test method for moisture resistance to microbial penetration;
--- Part 7.Cleanliness - microbiological test methods;
--- Part 8.Product-specific requirements.
This document replaces YY/T 0506.1-2005 "Surgical drapes, surgical gowns and clean clothes for patients, medical staff and instruments - Part 1.Manufacturing
General requirements for manufacturing plants, processing plants and products", YY/T 0506.2-2016 "Surgical drapes, surgical gowns and cleanliness for patients, medical staff and equipment
Clothing Part 2.Performance requirements and test methods", YY/T 0506.7-2014 "Surgical drapes, surgical gowns and gowns for patients, medical staff and equipment
Clean clothing - Part 7.Cleanliness - Microbiological test methods". This document is based on YY/T 0506.2-2016, integrating
The content of YY/T 0506.1-2005 and YY/T 0506.7-2014, compared with YY/T 0506.2-2016, except for structural adjustment and editing
In addition to sexual changes, the main technical changes are as follows.
a) Delete the requirement of "cleanliness - particulate matter" (see Table 1, Table 2 and Table 3, Table 1, Table 2 and Table 3 of the.2016 edition);
b) Changed the general rules of "Appendix A" (see A.1 in Appendix A, A.1 in Appendix A of the.2016 edition), and deleted "Cleanliness-particulate matter
"Quality evaluation test method" (see A.3 of the.2016 edition), added "result processing" (see A.3);
c) Added "bioburden test method" (see Appendix B);
d) Deleted "Optional Test Method" (see Appendix B of the.2016 edition).
Please note that some contents of this document may refer to patents. The issuing agency of this document assumes no responsibility for identifying patents.
This document is proposed by the State Drug Administration.
This document is under the jurisdiction of Shandong Academy of Medical Devices and Drug Packaging Inspection.
This document was drafted by. Shandong Institute of Medical Devices and Drug Packaging Inspection, Zhende Medical Supplies Co., Ltd., Weihai Weigao
Medical Materials Co., Ltd., Beijing Quexiang Tengfei Medical Technology Co., Ltd., Henan Yadu Industrial Co., Ltd., Jiangsu Weihu Medical Technology Co., Ltd.
Company, Hefei Gaobeisi Medical and Sanitary Products Co., Ltd., Pujie Nonwovens (China) Co., Ltd.
The main drafters of this document. Zhang Qing, Wang Wenqing, Chang Gailing, Yu Xujie, Jiang Liheng, Liu Bin, Duan Shuxia, Kou Wei, Nie Jiaqi, Gao Ming, Jin Yongji,
Li Cui, Li Xiuting, Zhu Yixin.
The release status of previous versions of this document and the documents it replaces are as follows.
---First published as YY/T 0506.1-2005 in.2005;
---This is the first revision, incorporating YY/T 0506.2-2016 "Surgical Drapes, Surgical Gowns and Cleaning Equipment for Patients, Medical Staff and Instruments"
Clean clothes Part 2.Performance requirements and test methods" and YY/T 0506.7-2014 "Patients, medical staff and equipment for surgery
Sheets, Surgical gowns and clean clothes - Part 7.Cleanliness - microbiological test method" (YY/T 0506.2-2016 history
The minor version releases are. YY/T 0506.2-2009, YY/T 0506.2-2016).
introduction
During invasive surgical procedures, infectious agents can be transmitted through various routes.
Surgical drapes and gowns are expected to serve as the establishment of a sterile field to minimize the possibility of transmission of infectious agents to or from wounds,
Thus helping to prevent postoperative infection.
Depending on the type of surgery, the timing and degree of moisture in the surgical field, the degree of mechanical stress on the material and the susceptibility of the patient to infection, the
The performance required for coverings for people, healthcare workers and equipment also varies.
The use of surgical gowns that prevent the penetration of liquids can also reduce the risk of transmission of infectious agents carried in blood or body fluids to medical staff.
Hygienic gowns are used to reduce the spread of infectious agents to surgical sites and instruments by preventing the spread of bacteria-laden skin debris from healthcare workers,
This helps prevent postoperative surgical site infection. In invasive surgical procedures with infectious agents, a combination of ventilation and proper handling
In this way, clean clothes can reduce the risk of infection.
Antimicrobial treatment of surgical drapes and surgical gowns may lead to environmental risks such as drug resistance and environmental contamination. This document does not apply to surgical gowns and hand
The antibacterial treatment of surgical drapes shall be regulated, but the surgical drapes and surgical gowns that have undergone antibacterial treatment belong to this standard when they are used as surgical drapes and surgical gowns.
Scope of application of the document.
YY/T 0506 aims to promote communication between manufacturers and third parties on the characteristics and performance of materials and products.
The purpose of YY/T 0506 is to ensure that disposable and reusable surgical gowns, surgical drapes and clean clothes are
It has the same security level inside and is proposed to be composed of five parts.
--- Part 1.General requirements. It specifies the performance requirements, manufacturing requirements, reusable
Disposal requirements for products after use and information requirements provided by manufacturers, etc.
--- Part 4.Test method for dry flocculation. It specifies the measurement of lint falling in surgical drapes, surgical gowns and clean clothes and materials under dry conditions
test method.
--- Part 5.Test method for blocking dry microbial penetration. Specified for the evaluation of surgical drapes, surgical gowns and clean clothing barrier materials
Test method for penetration resistance of bacteria-carrying particles.
--- Part 6.Test method for moisture resistance microbial penetration. It stipulates that surgical drapes, surgical gowns and clean clothing materials are subjected to mechanical friction
Test method for penetration of bacteria in time-resistant liquids.
--- Part 8.Product-specific requirements. It stipulates surgical drapes that require a high degree of purification and require the patient's whole body to be covered,
Specific requirements for surgical gowns and clean clothing products.
Medical surgical drapes, surgical gowns and clean clothes
Part 1.General requirements
1 Scope
This document specifies the general requirements for medical surgical drapes, surgical gowns and clean clothes. Include performance requirements, manufacturing requirements, reusable product
Requirements for post-use disposal of products and information requirements provided by manufacturers. Does not include anti-laser penetration properties, antimicrobial treatment of gowns or drapes
Require.
This document applies to medical surgical drapes, surgical gowns and clean clothes.
This document does not apply to surgical membranes.
Note 1.See YY/T 0506.8 for special requirements on surgical drapes, surgical gowns and clean clothes.
Note 2.See YY/T 0855 for the test method and classification of anti-laser penetration performance.
2 Normative references
The contents of the following documents constitute the essential provisions of this document through normative references in the text. Among them, dated references
For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to
this document.
GB/T 4744 Testing and Evaluation of Waterproof Performance of Textiles Hydrostatic Pressure Method
GB/T 6529 Standard atmosphere for textile humidity conditioning and testing
GB/T 7742.1 Burst properties of textile fabrics - Part 1.Determination of burst strength and burst expansion by hydraulic method
GB/T 16886.1 Biological evaluation of medical devices Part 1.Evaluation and testing in the risk management process
GB/T 24218.3 Test methods for textiles and nonwovens - Part 3.Determination of breaking strength and elongation at break (strip method)
YY/T 0287 Medical device quality management system for regulatory requirements
YY/T 0506.4 Surgical drapes, surgical gowns and clean clothes for patients, medical staff and instruments - Part 4.Test method for dry lint
YY/T 0506.5 Surgical drapes, surgical gowns and clean clothes for patients, medical staff and instruments - Part 5.Blocking the penetration of dry microorganisms
experiment method
YY/T 0506.6 Surgical drapes, surgical gowns and clean clothes for patients, medical staff and instruments Part 6.Resistance to penetration of microorganisms in wet state
experiment method
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Colony forming unit colonyforming unit; CFU
A unit of expression for the number of culturable microorganisms.
Note. The number of culturable microorganisms is the number of single-celled or aggregated microorganisms that can form colonies on solid nutrient media.
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YY/T 0506.1-2005
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S 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 µm ~ 60 µm. 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 µm, 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.
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