NSF P182-2001 Pipeless Hydrotherapy Jets t《无管水疗喷嘴》.pdf

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1、 NSF Protocol P182 Pipeless Hydrotherapy Jets May 2001 May 2001 2001 NSF International Page i NSF International, an independent, not-for-profit organization, is dedicated to public health safety and protection of the environment by developing standards, by providing education and by providing superi

2、or third-party conformity assessment services while representing the interest of all stakeholders. This Protocol is subject to revision. Contact NSF to confirm this revision is current. Users of this Protocol may request clarifications and interpretations, or propose revisions by contacting: NSF Int

3、ernational 789 North Dixboro Road Ann Arbor, MI 48105 Phone: (734)769-8010 Telex: 753215 NSF INTL FAX: (734)769-0109 E-mail: infonsf.org Web: http:/www.nsf.org May 2001 2001 NSF International Page ii May 2001 NSF Protocol P182 Pipeless Hydrotherapy Jets Protocol Developer NSF International Engineeri

4、ng and model number and serial number. 4.4 Performance 4.4.1 The jet shall not leak through any of the seals at any point during testing according to section 5. All parts normally removed during cleaning shall remain tight fitting throughout testing according to section 5. 4.4.2 The jet shall show n

5、o signs of deformation, cracking, or corrosion following testing according to section 5. 4.4.3 The cleaning efficacy samples from the test vessels shall have an average bacterial count of less than 1 CFU/mL and a combined fungal/yeast count of less than 1/mL when evaluated according to section 5.4.

6、The control sample is evaluated as a method check. 4.4.4 Wetted materials used in the construction of the jet shall meet the acceptance criteria in annex A, section A.3.8 of ANSI/NSF Standard 50 2001. 4.4.5 The jet shall comply with all applicable requirements of IGC 155-2000. 4.5 Product literature

7、 Each system shall be accompanied by a comprehensive manual. This may consist of separate documents covering each of the following sections or may be combined into a single manual with subsections. May 2001 2001 NSF International Page 3 of 6 4.5.6 Owners manual: The manual or section intended for ow

8、ner reference shall be written so as to be easily understood by the intended reader and shall include, at a minimum: model designation; a statement confirming that the device meets the requirements of NSF Protocol P182 Pipeless Hydrotherapy Jets; a functional description of device operation, includi

9、ng diagrams illustrating basic design; a clear statement of the types of substances that can be placed in the device (This should be limited to substances that normally would be used in hydrotherapy devices.); a list of household substances that, if placed in the device, may adversely affect the dev

10、ice or the environment (This should be limited to substances that normally would be used in hydrotherapy devices.); operating instructions that clearly describe proper function of the device and the operating and maintenance responsibilities of the owner and authorized service personnel; instruction

11、s for cleaning the device; clear methods and criteria to be used to identify device malfunctions or problems; a statement instructing the owner to reference the data plate in the event that a problem arises or service is required; an overview of the function of each component and the expected functi

12、on of the entire device when all components are properly assembled and connected; and name and telephone number of an appropriate service representative to be contacted in the event that a problem with the device occurs. 4.5.7 Installation, operation, maintenance, and troubleshooting manual: The man

13、ual or sections intended for distribution to authorized representatives shall be written so as to be easily understood by the intended reader and shall include, at a minimum, the following: a numbered list of device components and an accompanying illustration, photograph, or print in which the compo

14、nents are respectively identified; off-loading and unpacking instructions, including safety considerations, identification of fragile components, and measures to be taken to avoid damage to the device; a clear definition of device installation requirements, including any applicable plumbing and elec

15、trical power requirements, water tightness, and slope; May 2001 2001 NSF International Page 4 of 6 a sequential installation procedure; repair or replacement instructions in the event that a device possesses flaws that would inhibit proper functioning and a list of sources where replacement componen

16、ts can be obtained; and a sequential method for isolating specific component failure. 5 Methods 5.3 Test vessels Three identical vessels, with covers, shall be used for the performance testing. The vessels shall be constructed of a smooth material and contain no internal seams. One of the vessels is

17、 a control and is not modified. One jet shall be installed according to manufacturers instructions in each of the other two vessels. The vessels shall have a capacity of 35 liters when filled to at least 6 centimeters above the top of the jet. The testing in sections 5.2 through 5.4 is completed seq

18、uentially. 5.4 Wear testing The jet shall be disassembled according to the manufacturers instructions for cleaning then reassembled 200 times. All seals shall be evaluated for leaks throughout testing according to sections 5.3 and 5.4. 5.5 Chlorine resistance test The test vessel shall be filled wit

19、h 35 liters of a 0.5 percent sodium hypochlorite solution (2,400 ppm available chlorine) with the jet installed. To prepare this solution, add 3330 mL of standard household bleach (5.25% sodium hypochlorite) to the test vessel and dilute to 35 liters. The water pH shall be adjusted to 7.0 using 1 N

20、hydrochloric acid or 1 N sodium hydroxide as needed. The jet is operated for 5 minutes immediately after filling, and then the vessel is covered for 24 hours. The vessel is drained and thoroughly rinsed after 24 hours of exposure to the sodium hypochlorite solution. The jet is disassembled and all w

21、etted parts are inspected for signs of corrosion, cracking, or deformation. 5.6 Bacterial retention and cleaning efficacy testing The test and control vessels are filled with 35 liters of water meeting the characteristics in Table I. The vessels are inoculated with three bacteria, Pseudomonas aerugi

22、nosa (ATCC #15442), Staphylococcus aureus (ATCC #6538), and E. coli (ATCC11229), one yeast, Candida albicans (ATCC #10231), and one fungus, Aspergillus fumigatus (ATCC #10894) at a minimum concentration of 1,000/mL for each organism. Following addition of the microorganisms, 175 mL of sterile perito

23、neal dialysis effluent is added to each vessel as a nutrient source for the organisms, simulating bather residue. Avon Skin-So-Soft bath oil or equivalent (2.5 mL) and Softsoap liquid soap or equivalent (2.7 mL) are also added to the vessels. The jets are activated and the control vessel is mixed us

24、ing a mechanical mixer. After 60 minutes, the vessels are drained and allowed to air dry over night. Water drained from the vessels must be May 2001 2001 NSF International Page 5 of 6 sterilized before disposal. Collect the water in a separate vessel and add one part bleach to 10 parts bath water. A

25、llow 60 minutes contact time before disposal. Autoclaving is an alternative disinfection method. This process is repeated for six additional consecutive working days to simulate a one-week cleaning interval. On the seventh test day, the vessels are allowed to dry for 2 hours and are then cleaned usi

26、ng a non-abrasive antibacterial cleaner. The jet is cleaned according to the manufacturers instructions. Following cleaning, the vessels are rinsed twice with sterile buffer dilution water (SBDW), and then filled with SBDW. The jet is activated and the control vessel is mixed using a mechanical mixe

27、r for 5 minutes, then samples are collected using aseptic technique. Two sets of plates are prepared to analyze the samples. The first plates use SPCA agar with cyclohexamide (an antifungal agent) to measure the total bacterial count. The second plates use Potato Dextrose agar (PDA) to measure the t

28、otal yeast and fungus count. The pH of the PDA is reduced below 4 to prevent growth of bacteria. Table I. Test water characteristics pH 7.5 0.5 temperature 39 3C total dissolved solids (TDS) 200 600 mg/L total organic carbon (TOC) $ 2.0 mg/L total residual chlorine # 0.2 mg/L May 2001 2001 NSF Inter

29、national Page 6 of 6 Annex A Program Specific Policies for Pipeless Hydrotherapy Jets A.1 Marking the product In addition to that required in the NSF Certification Policies for NSF Protocols and Non-NSF Standards, certified individual products or packaging materials should bear the following informa

30、tion: A.2 Annual audits Audits of all facilities and production locations shall be conducted by NSF at least annually. Audits will cover the following basic items: no changes in labeling or product literature; no change in design, construction or materials without prior approval by NSF; and record keeping A.3 Re-testing Re-testing of certified systems shall occur every five years. NSF Protocol P182 Pipeless Hydrotherapy Jets