YY 0321.1-2009_English: PDF (YY0321.1-2009)
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Single-use puncture set local anaesthesia
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YY 0321.1-2009
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YY 0321.1-2009
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| Standard ID | YY 0321.1-2009 (YY0321.1-2009) | | Description (Translated English) | Single-use puncture set local anaesthesia | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.040.20 | | Word Count Estimation | 15,135 | | Date of Issue | 2009-06-16 | | Date of Implementation | 2010-12-01 | | Older Standard (superseded by this standard) | YY 0321.1-2000 | | Quoted Standard | GB/T 191; GB/T 1962.1; GB/T 1962.2; GB/T 6682; GB/T 14233.1; GB/T 14233.2; GB/T 16886.1; YY/T 0313; YY 0321.2; YY 0321.3; YY 0466 | | Drafting Organization | AIC Ai Yi Xie Plastics Co., Ltd. | | Administrative Organization | National Standardization Technical Committee of medical syringes (needles) | | Regulation (derived from) | Industry standard filing Notice 2009 No. 9 | | Proposing organization | State Food and Drug Administration | | Issuing agency(ies) | China Food and Drug Administration | | Summary | This standard provides for human epidural nerve block (referred to epidural anesthesia), spinal anesthesia (spinal anesthesia abbreviation), epidural and spinal anesthesia, a local anesthetic nerve block sexual use of narcotic puncture kits (hereinafter referred to as anesthesia kits) requirements. | YY 0321.1-2009
Single-use puncture set local anaesthesia
ICS 11.040.20
C31
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0321.1-2000
One-time use of anesthesia puncture pack
2009-06-16 release
2010-12-01 implementation
State Food and Drug Administration issued
Preface
YY 0321 is divided into the following sections.
A one-time use of anesthesia puncture packs;
One-time use of anesthesia needle;
- One-time use of anesthesia filter.
This part is part 1 of YY 0321.
YY 0321 this part of the replacement YY 0321.1-2000 "one-time use of anesthesia puncture package."
This section is the main change compared with YY 0321.1-2000 as follows.
--- increase the catheter specifications, an increase of the total spacing tolerance (YY 0321-2000 3.4 Table 2, this part of the 5.3.2 Table 2);
- increase the ductile line index (5.3.3 for this section);
- increased catheter flow (4.2.3.4 for YY 0321-2000, 5.3.6 in this section);
- improved duct breakage index (4.2.3.2 of YY 0321-2000, 5.3.7 of this section);
- improved connection between the catheter and the joint seal test water pressure (YY 0321-2000 4.2.3.6, 5.3.11 of this part);
--- sterile, pyrogen test was modified (YY 0321-2000 4.3.1,4.3.2, this part of the 7.1,7.2);
--- The ethylene oxide residue index was modified (4.4.4 of YY 0321-2000, 6.4 of this section).
Appendix B, Appendix C, Appendix D, Appendix E, Appendix F are normative appendices, Appendix A is an informative appendix.
This part is made by the State Food and Drug Administration.
This part of the National Medical Syringe (needle) Standardization Technical Committee.
This part of the main drafting unit. Shanghai Esso Medical Plastic Products Co., Ltd.
This part involved in the drafting unit. Zhejiang Volt Medical Devices Co., Ltd., Beijing Volt Technology Co., Ltd., Xinxiang City Camel Health
Equipment Co., Ltd.
This part of the main drafters. Cao Xianming, Zhang Jiansheng.
This part participates in the drafters. Ma Jianqiang, Su Weidong, Yan Shaojun, Wang Guosheng.
This part was first released in September.2000 and revised for the first time in.2009.
One-time use of anesthesia puncture pack
1 range
YY 0321 this part of the provisions for the human epidural nerve block (referred to as epidural anesthesia), subarachnoid block (Jane
Called lumbar anesthesia), epidural and lumbar anesthesia, nerve block local anesthesia with a one-time use of anesthesia puncture package (hereinafter referred to as anesthesia package)
The request.
2 normative reference documents
The terms of the following documents are entered into the terms of this section by reference to this part of YY 0321, whichever is dated
After all the amendments (not including the contents of the errata) or the revised version are not applicable to this part, however, to encourage the parties to reach an agreement under this part
To study whether a new version of these standards can be used. For undated references, the latest edition of this section applies.
GB/T 191 packaging and storage icon
GB/T 1962.1 Syringes, injection needles and other medical devices 6% (Ruhr) Conical joints Part 1. General requirements
GB/T 1962.2 Syringes, injection needles and other medical devices 6% (Ruhr) Conical joints Part 2. Locking joints
GB/T 6682 Analytical laboratory water specifications and test methods
GB/T 14233.1 Methods of test for medical infusion, blood transfusion, and injectable utensils - Part 1. Chemical analysis methods
GB/T 14233.2 Methods of test for medical infusion, blood transfusion, and injectable utensils - Part 2. Biological test methods
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing
YY/T 0313 Medical polymer packaging, marking, transportation and storage
YY 0321.2 disposable needle for anesthesia
YY 0321.3 One-time use of anesthesia filter
YY 0466 Medical devices are used for medical device labeling, marking and providing information symbols
Classification and marking
3.1 Classification
Divided into the following categories.
a) epidural anesthesia package;
b) lumbar anesthesia package;
c
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