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YY/T 1522-2017 (YYT 1522-2017)

YY/T 1522-2017_English: PDF (YYT1522-2017)
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YY/T 1522-2017English419 Add to Cart 5 days Flow-metering devices for connection to terminal units of medical gas pipeline systems YY/T 1522-2017 Valid YY/T 1522-2017

BASIC DATA
Standard ID YY/T 1522-2017 (YY/T1522-2017)
Description (Translated English) Flow-metering devices for connection to terminal units of medical gas pipeline systems
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C46
Classification of International Standard 11.040.10
Word Count Estimation 21,215
Date of Issue 2017-03-28
Date of Implementation 2018-04-01
Drafting Organization Shanghai Medical Device Testing Institute, Shanghai Draeger Medical Devices Co., Ltd., Jie Rui Enterprise (Shanghai) Co., Ltd.
Administrative Organization National Anesthetic and Respiratory Equipment Standardization Technical Committee (SAC/TC 116)
Regulation (derived from) China Food & Drug Administration Announcement 2017 No. 38
Proposing organization China Food and Drug Administration
Issuing agency(ies) State Food and Drug Administration

YY/T 1522-2017
Flow-metering devices for connection to terminal units of medical gas pipeline systems
ICS 11.040.10
C46
People's Republic of China Pharmaceutical Industry Standard
Connected to medical gas pipeline
System terminal flow measuring device
(ISO 15002.2008, MOD)
Released on.2017-03-28
2018-04-01 implementation
State Food and Drug Administration issued
Content
Foreword III
Introduction IV
1 range 1
2 Normative references 1
3 Terms and Definitions 2
4 Flow measurement system and device configuration 3
5 General requirements 3
6 Test method 8
7 Logo, color identification and packaging 9
8 Information provided by the manufacturer 11
Appendix A (informative) Basic Principles 12
Appendix B (informative) Configuration of flow measurement systems and devices 13
Appendix C (informative) Environmental issues 16
Reference 17
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard uses the redrafting method to modify the flow measurement device connected to the terminal of the medical gas pipeline system using ISO 15002.2008.
Set" (English version).
The technical differences between this standard and ISO 15002.2008 and their reasons are as follows.
--- Regarding the normative reference documents, this standard has made technical adjustments to adapt to China's technical conditions, adjustments
The situation is reflected in Chapter 2, “Regulatory References”, and the specific adjustments are as follows.
● Replace ISO 32 with GB 50751-2012 (see Table 2);
● Replace ISO 5359 with YY/T 0799 (see 5.4.1.1, Table 2);
● Replace ISO 15001 with YY/T 0882 (see 5.3.1, 5.5.1);
● Replace ISO 14971 with YY/T 0316 (see 5.1, 5.2);
● Replace ISO 9170-1 with YY 0801.1 (see 5.4.1.1);
● Added normative reference document GB/T 1226-2010 (see 5.4.7.5.1).
Compared with ISO 15002.2008, this standard makes the following editorial changes.
--- "This International Standard" is replaced by the word "this standard";
---Involving numbers with the decimal symbol "." instead of the symbol ",";
--- Removed the preface of ISO 15002.2008;
--- Removed from 1.2" Note. Certain regional or national regulations may allow oxygen connectors to be used in oxygen-enriched air."
--- Removed 5.2, 5.3.2, 5.3.6, 5.4.1.2, 5.4.6.2, 5.4.6.3, 5.4.7.2, 5.4.7.3, 5.4.7.5.1, 5.4.8.2, 5.4.8.3.1 ,
5.5.1, 5.5.2, 5.5.3 “Note. Certain regional or national regulations may require an authoritative authority or assessment agency with decision
Provision of evidence (such as the reporting body of the EEA). ”
--- Removed the word ''oil ban'' in 7.1.1 from the relevant national language."
--- The international standards involved in the references are correspondingly adopted as national standards and industry standards. This standard is based on the corresponding national standard.
Standard and industry standards are used as references.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Food and Drug Administration.
This standard is under the jurisdiction of the National Technical Committee for Standardization of Anesthesia and Respiratory Equipment (SAC/TC116).
This standard was drafted. Shanghai Medical Device Testing Institute, Shanghai Dräger Medical Devices Co., Ltd., Jierui Enterprise (Shanghai) Co., Ltd.
the company.
The main drafters of this standard. Li Min, Ding Deping, Hu Yuegang.
introduction
Flow measuring devices are widely used to deliver medical gases provided by medical gas supply systems to patients. These devices need to be at different temperatures
Provides accurate gas flow under conditions of inlet and inlet pressure. Therefore, it is important to specify the operating characteristics and test methods of the flow measuring device.
Special attention to this standard.
---Safety (safe handling of mechanical strength, overpressure, fire protection);
--- Gas specificity;
---clean;
---Material suitability;
---Accuracy;
---test