Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
For the purpose of this standard, 4.1.1, 4.1.2, 5.2.7, 5.2.8, 5.3.3, 5.3.7, 5.3.8, 5.3.9b), 5.3.11c)2), 5.3.11e)2), 5.3.11f)2), 6.1.2c), 6.1.4a)1), 6.2.2g), 6.3.2, 6.4.5a)1), 7.1.2 and 7.6.4 are voluntary and the rest are compulsory.
This standard is developed in accordance with the rules given in GB/T 1.1-2009.
Regulation for cleaning and disinfection technique of flexible endoscope
1 Scope
This standard specifies the management requirements, layout and facilities, equipment requirements, cleaning and disinfection operation procedures, detection and recording, etc., related to cleaning and disinfection of flexible endoscopes.
This standard is applicable to medical institutions providing medical services using flexible endoscope.
Note: For the purpose of this standard, “endoscope" refers to flexible endoscope.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated reference, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB 5749 Standards for drinking water quality
GB 15982 Hygienic standard for disinfection in hospitals
GB 28234 Safety and sanitation standard for acidic electrolyzed-oxidizing water generator
GB 30689 Hygienic requirements for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
WS/T 311 Technique standard for isolation in hospitals
WS/T 313 Standard for hand hygiene for healthcare workers in healthcare settings
WS/T 367 Regulation of disinfection technique in healthcare settings
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
flexible endoscope
flexional endoscope for diagnosis and treatment of diseases
3.2
cleaning
process of removing contaminants attached to an endoscope using a cleaning solution
3.3
rinsing
process of rinsing the residue on the endoscope after cleaning with running water
3.4
final rinsing
process of rinsing sterilized endoscope with purified water or sterile water as the final step
3.5
cleaning solution
liquid with working concentration prepared by adding medical cleaning agent into proper amount of water according to the product instructions
4 Management requirements
4.1 Management requirements for medical institutions
4.1.1 If conditions permit, hospitals should establish centralized endoscopic diagnosis and treatment centers (rooms), which are responsible for endoscopic diagnosis and treatment as well as cleaning and disinfection of these endoscopes.
4.1.2 The cleaning and disinfection of endoscopes may also be carried out by the central sterile supply department (CSSD) in accordance with this standard.
4.1.3 Endoscopic cleaning and disinfection shall be included in the medical quality management, and various rules and regulations on nosocomial infection management and endoscopic cleaning and disinfection in the endoscopic diagnosis and treatment center (room) shall be formulated and implemented, with detection strengthened.
4.1.4 Nursing management, personnel management, nosocomial infection management, equipment and logistics management departments shall perform the following duties for managing the endoscopic diagnosis and treatment center (room) within their respective authorities:
a) Assign staff working in the endoscopic diagnosis and treatment center (room) reasonably based on their own workload.
b) Implement the on-the-job training system. Incorporate the specialized knowledge of endoscope cleaning and disinfection and knowledge related to nosocomial infection prevention and control into the continuing education plan for personnel working in the endoscope diagnosis and treatment center (room).
c) Guide and supervise the cleaning, disinfection, sterilization and quality detection of the endoscopic diagnosis and treatment center (room), and conduct regular inspection and evaluation.
d) Organize and coordinate the endoscopic diagnosis and treatment center (room) and relevant departments to investigate and analyze, and put forward improvement measures in case of suspicious endoscope-related infection.
e) Make hygienic review of design schemes for new construction, reconstruction and expansion of endoscopic diagnosis and treatment centers (rooms) and make suggestions on the configuration and quality indicators of cleaning, disinfection and sterilization equipment.
f) Review equipment purchase (certificate of conformity, technical parameters), establish a quality audit and acceptance system for equipment installation and maintenance by manufacturers and assign specific personnel for the maintenance and regular overhaul of equipment in the endoscopic diagnosis and treatment center (room), and establish equipment files.
g) Ensure the supply and quality of water, electricity and compressed air for the endoscopic diagnosis and treatment centers (rooms), and regularly maintain and overhaul facilities and pipelines.
4.2 Management requirements for the endoscopic diagnosis and treatment center (room)
4.2.1 The endoscopic diagnosis and treatment center (room) shall establish and improve management systems on job responsibilities, cleaning and disinfection operation procedures, quality management, detection, equipment management, device management and occupational safety protection, continuing education, training, etc., as well as contingency plans for emergencies.
4.2.2 Specially-assigned personnel (relatively regular) shall be engaged in endoscope cleaning and disinfection, and the number of such personnel shall match with the workload of the unit.
4.2.3 Special personnel shall be appointed to take charge of quality detection.
4.2.4 When performing endoscopic diagnosis and treatment or cleaning and disinfection the endoscope, the staff shall do well at personal protection and wear necessary protective equipment in accordance with the principles of standard precautions and the requirements of WS/T 311. See Annex A for protective dress requirements for personnel in different areas.
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Management requirements
5 Layout and facility and equipment requirements
6 Cleaning and disinfection operation procedures
7 Detection and record
Annex A (Normative) Protective dress requirements for personnel in different areas of an endoscopic diagnosis and treatment center (room)
Annex B (Normative) Use method of some disinfectants (sterilants)
Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
For the purpose of this standard, 4.1.1, 4.1.2, 5.2.7, 5.2.8, 5.3.3, 5.3.7, 5.3.8, 5.3.9b), 5.3.11c)2), 5.3.11e)2), 5.3.11f)2), 6.1.2c), 6.1.4a)1), 6.2.2g), 6.3.2, 6.4.5a)1), 7.1.2 and 7.6.4 are voluntary and the rest are compulsory.
This standard is developed in accordance with the rules given in GB/T 1.1-2009.
Regulation for cleaning and disinfection technique of flexible endoscope
1 Scope
This standard specifies the management requirements, layout and facilities, equipment requirements, cleaning and disinfection operation procedures, detection and recording, etc., related to cleaning and disinfection of flexible endoscopes.
This standard is applicable to medical institutions providing medical services using flexible endoscope.
Note: For the purpose of this standard, “endoscope" refers to flexible endoscope.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated reference, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB 5749 Standards for drinking water quality
GB 15982 Hygienic standard for disinfection in hospitals
GB 28234 Safety and sanitation standard for acidic electrolyzed-oxidizing water generator
GB 30689 Hygienic requirements for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
WS/T 311 Technique standard for isolation in hospitals
WS/T 313 Standard for hand hygiene for healthcare workers in healthcare settings
WS/T 367 Regulation of disinfection technique in healthcare settings
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
flexible endoscope
flexional endoscope for diagnosis and treatment of diseases
3.2
cleaning
process of removing contaminants attached to an endoscope using a cleaning solution
3.3
rinsing
process of rinsing the residue on the endoscope after cleaning with running water
3.4
final rinsing
process of rinsing sterilized endoscope with purified water or sterile water as the final step
3.5
cleaning solution
liquid with working concentration prepared by adding medical cleaning agent into proper amount of water according to the product instructions
4 Management requirements
4.1 Management requirements for medical institutions
4.1.1 If conditions permit, hospitals should establish centralized endoscopic diagnosis and treatment centers (rooms), which are responsible for endoscopic diagnosis and treatment as well as cleaning and disinfection of these endoscopes.
4.1.2 The cleaning and disinfection of endoscopes may also be carried out by the central sterile supply department (CSSD) in accordance with this standard.
4.1.3 Endoscopic cleaning and disinfection shall be included in the medical quality management, and various rules and regulations on nosocomial infection management and endoscopic cleaning and disinfection in the endoscopic diagnosis and treatment center (room) shall be formulated and implemented, with detection strengthened.
4.1.4 Nursing management, personnel management, nosocomial infection management, equipment and logistics management departments shall perform the following duties for managing the endoscopic diagnosis and treatment center (room) within their respective authorities:
a) Assign staff working in the endoscopic diagnosis and treatment center (room) reasonably based on their own workload.
b) Implement the on-the-job training system. Incorporate the specialized knowledge of endoscope cleaning and disinfection and knowledge related to nosocomial infection prevention and control into the continuing education plan for personnel working in the endoscope diagnosis and treatment center (room).
c) Guide and supervise the cleaning, disinfection, sterilization and quality detection of the endoscopic diagnosis and treatment center (room), and conduct regular inspection and evaluation.
d) Organize and coordinate the endoscopic diagnosis and treatment center (room) and relevant departments to investigate and analyze, and put forward improvement measures in case of suspicious endoscope-related infection.
e) Make hygienic review of design schemes for new construction, reconstruction and expansion of endoscopic diagnosis and treatment centers (rooms) and make suggestions on the configuration and quality indicators of cleaning, disinfection and sterilization equipment.
f) Review equipment purchase (certificate of conformity, technical parameters), establish a quality audit and acceptance system for equipment installation and maintenance by manufacturers and assign specific personnel for the maintenance and regular overhaul of equipment in the endoscopic diagnosis and treatment center (room), and establish equipment files.
g) Ensure the supply and quality of water, electricity and compressed air for the endoscopic diagnosis and treatment centers (rooms), and regularly maintain and overhaul facilities and pipelines.
4.2 Management requirements for the endoscopic diagnosis and treatment center (room)
4.2.1 The endoscopic diagnosis and treatment center (room) shall establish and improve management systems on job responsibilities, cleaning and disinfection operation procedures, quality management, detection, equipment management, device management and occupational safety protection, continuing education, training, etc., as well as contingency plans for emergencies.
4.2.2 Specially-assigned personnel (relatively regular) shall be engaged in endoscope cleaning and disinfection, and the number of such personnel shall match with the workload of the unit.
4.2.3 Special personnel shall be appointed to take charge of quality detection.
4.2.4 When performing endoscopic diagnosis and treatment or cleaning and disinfection the endoscope, the staff shall do well at personal protection and wear necessary protective equipment in accordance with the principles of standard precautions and the requirements of WS/T 311. See Annex A for protective dress requirements for personnel in different areas.
Contents of WS 507-2016
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Management requirements
5 Layout and facility and equipment requirements
6 Cleaning and disinfection operation procedures
7 Detection and record
Annex A (Normative) Protective dress requirements for personnel in different areas of an endoscopic diagnosis and treatment center (room)
Annex B (Normative) Use method of some disinfectants (sterilants)
