HOME   Cart(0)   Quotation   About-Us Policy PDFs Standard-List
www.ChineseStandard.net Database: 189760 (18 Oct 2025)

YY/T 1438-2016 English PDF

US$499.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1438-2016: Anaesthetic and respiratory equipment. Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans
Status: Valid
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 1438-2016English499 Add to Cart 4 days [Need to translate] Anaesthetic and respiratory equipment. Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans Valid YY/T 1438-2016

PDF similar to YY/T 1438-2016


Standard similar to YY/T 1438-2016

YY/T 1543   YY/T 0799   YY 0671.1   YY/T 1440   YY/T 1439.2   

Basic data

Standard ID YY/T 1438-2016 (YY/T1438-2016)
Description (Translated English) Anaesthetic and respiratory equipment. Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C46
Classification of International Standard 11.040.10
Word Count Estimation 25,241
Date of Issue 2016-01-26
Date of Implementation 2017-01-01
Quoted Standard GB 9706.1-2007; GB/T 16886.1; GB/T 19974; YY/T 0466.1-2009
Adopted Standard ISO 23747-2007, MOD
Regulation (derived from) China Food and Drug Administration Bulletin 2016 No.25
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the requirements of the expiratory peak flowmeter (PEFM), which is expected to be used to evaluate the lung function of spontaneous respiration. This standard applies to all equipment used to measure the peak expiratory flow rate of autonomous respites, whether it is part of an integrated lung function device or a separate device.

YY/T 1438-2016: Anaesthetic and respiratory equipment. Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans


---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.
Anaesthetic and respiratory equipment.Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans ICS 11.040.10 C46 People's Republic of China Pharmaceutical Industry Standard Anesthesia and respiratory equipment were evaluated for spontaneous respiration Pulmonary function of the expiratory peak flowmeter (ISO 23747..2007, MOD) 2016-01-26 release 2017-01-01 Implementation State Food and Drug Administration issued Directory Preface III Introduction IV 1 Scope 1 2 normative reference document 1 3 Terms and definitions 1 4 General requirements 2 4.1 Safety of electronic PEFM 2 4.2 Mechanical safety of all PEFMs 5 identification, marking and document 2 5.1 mark or display mark 2 5.2 PEFM or mark on packaging 2 5.3 User's Manual 3 5.4 Technical Manual 3 6 PEFM measuring range 3 Performance requirements 4 7.1 Measurement error 4 7.2 Linearity 4 7.3 Air resistance 4 7.4 Frequency response 4 8 disassembly and reassembly 4 Impact of Mechanical Aging 4 10 Handle PEFM Falling Impact 4 11 Cleaning, disinfection and sterilization 5 11.1 Reuse of PEFM and Parts 5 11.2 PEFM and parts for aseptic packaging 5 12 Compatibility with materials 5 Biocompatibility 5 Appendix A (informative) Test principle and test equipment Example 6 Appendix B (normative) Tests for errors, reproducibility and resistance of PEFM outputs 9 Appendix C (normative appendix) Determination of frequency response 12 Appendix D (normative appendix) Test methods for determining the effects of disassembly, aging and fall 14 Appendix E (informative) Environmental Impact 16 Appendix F (informative) Reference to basic principles 18 Reference 20

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. This standard uses the re-drafting method to modify the international standard ISO 23747..2007 "Anesthesia and Respiratory Equipment Evaluation of Autonomous Respiratory Lung Functional Exhalation Peak Flowmeter "(English version). The main technical differences between this standard and ISO 23747..2007 are as follows. --- on the normative reference documents, the standard made a technical differences in the adjustment to meet China's technical conditions, adjust the situation The situation is reflected in Chapter 2, "Normative references", as follows. • Replace the international standard IEC 60601-1..2005 (see 4.1, D.3.3) with the national standard GB 9706.1-2007; • Replace the international standard ISO 14937 with the national standard GB/T.19974 (see 11.2); • Replace the international standard ISO 10993-1 with the national standard GB/T 16886.1 (see Chapter 13); --- "should not exceed 0.35kPa/L/min (0.006kPa/L/s) in 7.3" should be changed to "should not exceed 0.35kPa/(L/s) [0.006kPa / (L/min)]; - change the "IEC 60601-1..2005 15.3.4.1" in D.3 to "21.5" in GB 9706.1-2007; --- D.4 Chinese (D.1) by "dn = qpost-qpre qT Change to qpost, n- qpre, n qref, n "Changed to" dn% = qpost, n-qpre, n qpre, n × 100 ". This standard is compared with ISO 23747..2007, with the following editorial changes. - the "1 Scope" in the "plan and design applies to this standard products, should consider the entire life cycle of the product on the environment shadow ring. Environmental factors are given in Appendix E. "And" Note. more environmental impact factors are mentioned in YY/T 0316. "Move to the lead Words - to add a description of Appendix F to the introduction; - the international standard in the reference, there are corresponding to be used as industry standards, the standard to the corresponding industry standards as a reference use. Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This standard is proposed by the State Food and Drug Administration. This standard is nationalized by the National Standardization Technical Committee on Anesthesia and Respiratory Equipment (SAC/TC116). The drafting of the standard units. Shanghai Medical Devices Testing Institute, Anhui Institute of Electronic Science, Tianjin Medical Device Technology Review Center, call State Key Laboratory of Respiratory Diseases. The main drafters of this standard. Huang Jiahua, Xu Hui, Shi Wei, Zheng Jinping, Xu Chang.

Introduction

In order to strengthen the ability of medical staff to diagnose and monitor lung function, to ensure that peak expiratory flow (PEF) measurement equipment to meet the safety and performance The minimum requirements for the development of peak flow measurement for the standard is very important. With the consensus of the standard, it means that the most can use A new acceptable method to detect the expiratory peak flowmeter (PEFM) to achieve a uniform requirement. Health care workers and patients can be sure PEFM can meet the intended purpose. The American Society of Thoracic Society first proposed the standard for testing PEFM [15]. They made 26 Measure the PEF waveform, that the 26 waveforms can be used to check PEFM can correctly measure PEF. Miler et al. [17] first pointed out the problem of inaccurate PEFM, which recently defined the group of PEF waveforms [19] and demonstrated the limitations of the pumping system used to test PEFM [18]. The European Breathing Association published an article on PEF Summary [19]. This standard is based on the latest available methods and waveforms for testing PEFM. In this standard, the basic principles of the provision in Appendix A are identified by an asterisk (*) in the text. When planning and designing products that apply to this standard, the impact of the product on the environment throughout the life cycle should be considered. Environmental factors attached Recorded in E. This standard is in accordance with ISO /T R16142, ISO /T R16142 certain basic principles of compliance and the standard of the control table see attached Record F. Note. More environmental impact factors are mentioned in YY/T 0316. Anesthesia and respiratory equipment were evaluated for spontaneous respiration Pulmonary function of the expiratory peak flowmeter

1 Scope

This standard specifies the requirements of the expiratory peak flowmeter (PEFM), which is expected to be used to evaluate the lungs of spontaneous respiration Features. This standard applies to all equipment used to measure the peak expiratory flow rate of autonomous respites, whether it is part of an integrated lung function device Or a separate device.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1. 1988 A1..1992 A2. 1995, IDT) GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management (GB/T 16886.1- 2011, ISO 10993-1..2009, IDT) GB/T.19974 Characteristics of sterilization and sterilization factors for health care products and setting, confirmation and routine control of sterilization of medical devices (GB/T.19974-2005, ISO 14937..2000, IDT) Medical devices - Symbols for labeling, marking and providing information on medical devices - Part 1. Generic requirements for medical devices YY/T 0466.1-2009 (ISO 15223-1..2007, IDT)

3 terms and definitions

The following terms and definitions apply to this document. 3.1 BTPS Body temperature (37 ° C), saturated water vapor, ambient pressure state. 3.2 Dwell time dweltime; Exhalation flow is maintained at more than 90% of PEF. 3.3 Exhalation peak flow rate peakexpiratoryflowrate; PEF Expansive to the maximum immediately after the maximum strength to start breathing, at the mouth measured the maximum flow during the breath. 3.4 Exhalation peak flowmeter peakexpiratorymeter; PEFM Equipment for measuring peak expiratory flow (3.3).

Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1438-2016_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1438-2016_English as soon as possible, and keep you informed of the progress. The lead time is typically 2 ~ 4 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY/T 1438-2016_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1438-2016_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to [email protected]. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.