YY/T 0753.1-2009 English PDFUS$274.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0753.1-2009: Breathing system filters for anaesthetic and respiratory use. Part 1: Salt test method to assess filtration performance Status: Valid
Basic dataStandard ID: YY/T 0753.1-2009 (YY/T0753.1-2009)Description (Translated English): Breathing system filters for anaesthetic and respiratory use. Part 1: Salt test method to assess filtration performance Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C46 Classification of International Standard: 11.040.10 Word Count Estimation: 14,110 Date of Issue: 2009-11-25 Date of Implementation: 2010-12-01 Adopted Standard: ISO 23328-1-2003, IDT Regulation (derived from): Industry standard filing Notice 2010 No. 2 (No. 122 overall) Issuing agency(ies): State Food and Drug Administration Summary: This standard specifies the short-term challenges of the air particles of sodium chloride test method to evaluate the breathing gas for filtering respiratory filter filter performance. This standard applies to clinical respiratory system Breathing system filters. This section does not apply to other types of filters, such as the vacuum source or for protective gas sampling pipeline used to filter compressed gas or for the protection of biological respiration measurement test equipment filters. YY/T 0753.1-2009: Breathing system filters for anaesthetic and respiratory use. Part 1: Salt test method to assess filtration performance---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order. Breathing system filters for anaesthetic and respiratory use.Part 1. Salt test method to assess filtration performance ICS 11.040.10 C46 People's Republic of China pharmaceutical industry standards YY/T 0753.1-2009/ISO 23328-1.2003 Anesthesia and respiratory breathing system filters Part 1. Evaluation of filter performance test methods for salt (ISO 23328-1.2003, IDT) Posted 2009-11-15 2010-12-01 implementation State Food and Drug Administration issued ForewordYY/T 0753 "anesthesia and respiratory breathing system filters," including the following sections. Evaluation of filter performance test methods for salt;. --- Part 1 --- Part 2. Non-filtration aspects. This section is YY/T Section 10753 of. YY/T 0753 is identical with this part of ISO 23328-1.2003 "anesthesia and respiratory breathing system filters - Part 1. Review Test methods for filtering salt price performance. " Appendix A of this section is normative annex, appendix B, Appendices C and D are informative appendices. This standard by the National Standardization Technical Committee on Narcotic breathing apparatus and (SAC/TC116) and focal points. This standard drafting units. Shandong Medical Devices Product Quality Inspection Center. The main drafters of this standard. Ping Wu, Song Jinzai, Wan Min, Zhang Bo. YY/T 0753.1-2009/ISO 23328-1.2003IntroductionYY/T 0753 This section gives a test method for evaluating breathing system filters (BSF) filtration performance. Breathing system filters for reducing inhaled or exhaled by the number of particulate matter (including microbial). In clinical use of breathing system filters exposed to various humidity levels. Since the filtration performance of breathing system filters may be affected Effect of moist air, the test will be breathing system filters exposed to moist air simulated clinical use (see Appendix A). Trials, the most penetrating particle size range (ie, 0.1μm ~ 0.3μm) sodium chloride particles on the respiratory system as a particle filter Challenge tests (see Appendix C). As we all know, microbes and may pass through the "channel" (channeling) and "bypass" (grow-through) pathway across the filter broadcast. There is no acceptable quantitative methods for these occasional shortcomings. This test method is to provide comparable, but could not confirm the clinical Correlation. Therefore, this section only provides test methods should not be drawn from the risk factor. YY/T 0753.1-2009/ISO 23328-1.2003 Anesthesia and respiratory breathing system filters Part 1. Evaluation of filter performance test methods for salt1 ScopeYY/T 0753 This section gives a short-term challenge in the air particles of sodium chloride test method to evaluate the respiratory gas for filtering Breathing system filters the filtering performance. This section applies to clinical respiratory system Breathing system filters. This section does not apply to other types of filters, such as for protection Vacuum source or gas sampling lines are used to filter compressed gas or bio-filters for protecting respiratory measurement test equipment. NOTE. respiratory filters unfiltered aspect see YY/T 0753.2.2 Terms and definitionsThe following terms and definitions apply YY/T 0753 of this section. 2.1 Is expected to reduce the respiratory system, including means include microbial particles spread. 2.2 Sodium chloride flow breathing system filters the air flow concentration of particles. NOTE. Challenges concentration expressed in milligrams per cubic meter. 2.3 The concentration of the respiratory system filters the air discharged from the sodium chloride particles. Note. The breakthrough concentration expressed in mg per cubic meter. 2.4 Concentration flows through the respiratory system filters particles of sodium chloride concentration percentage of challenge. 2.5 100 minus penetration value. Method 3 3.1 Principle 3.1.1 allows sodium chloride solution by atomizing the stream of air atomized spray of sodium chloride and then these particles flowing through the respiratory system filters , Thereby measuring the breathing system filters ability to remove particles. Appendix B and Appendix C gives a further explanation. 3.1.2 generated aerosol containing particles from the atomizer with electrostatic charge, along with the air stream containing aerosol particles in the ionized air flow mix Together, the number of aerosol charge be reduced, the particles are neutralized to the Boltzmann equilibrium. 3.1.3 Test selected airflow represents the typical respiratory airflow filter intended use encountered. 3.1.4 By measuring the concentration of the respiratory system through the left filter a stream of particles of sodium chloride, and the air flow into the respiratory system filters YY/T 0753.1-2009/ISO 23328-1.2003 ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0753.1-2009_English be delivered?Answer: Upon your order, we will start to translate YY/T 0753.1-2009_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. 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