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Position: Chinese Standard in English/YY 0581.2-2011
YY 0581.2-2011   Infusion access adapter—Part 2:Needleless access adapters (English Version)
Standard No.: YY 0581.2-2011 Status:superseded remind me the status change

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Language:English File Format:PDF
Word Count: 7000 words Price(USD):210.0 remind me the price change

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Implemented on:2013-6-1 Delivery: via email in 1 business day
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Standard No.: YY 0581.2-2011
English Name: Infusion access adapter—Part 2:Needleless access adapters
Chinese Name: 输液连接件 第2部分:无针连接件
Chinese Classification: C31    General and microsurgical devices
Professional Classification: YY    Professional Standard - Pharmaceutics
ICS Classification: 11.040.20 11.040.20    Transfusion, infusion and injection equipment 11.040.20
Issued by: China Food and Drug Administration
Issued on: 2011-12-31
Implemented on: 2013-6-1
Status: superseded
Superseded by:YY 0581.2-2011/XG1-2018 Infusion access adapter—Part 2:Needleless access adapters, includes Amendment 1
Superseded on:2018-4-11
Language: English
File Format: PDF
Word Count: 7000 words
Price(USD): 210.0
Delivery: via email in 1 business day
Infusion access adapter - Part 2: Needleless access adapters English 1 Scope This part of YY 0581 specifies the requirements and test methods of needless automatic closed access adapters (hereinafter referred to as access adapters) for single use. This part may be referred to by the access adapter products, which are integrated with intravascular indwelling devices (such as intravenous indwelling needles). The backflow preventers specified in YY 0286.6 are excluded from the scope of this part. The switches specified in YY 0585.2 are excluded from the scope of this part. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB/T 1962.2 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings GB 8368 Infusion sets for single use - Gravity feed GB 15810 Sterile syringes for single use GB 15811 Sterile hypodermic needles for single use YY/T 0466.1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 positive displacement flowing of the liquid in the system towards the body on the moment the infusion equipment is pulled out from the access port to avoid blood backflow due to pulling out the infusion equipment 3.2 access port liquid inlet port composed of sealing components on the access adapter, which are applicable to be accessed to conical lock fitting with a 6% (Luer) taper of infusion equipment, with the expected sealing property during access and after separation Note: Different from the backflow preventer, the adapted access port may make the liquid flow backward and forward.
Foreword i Introduction ii 1 Scope 2 Normative references 3 Terms and definitions 4 Materials 5 Physical requirements 6 Chemical requirements 7 Biological requirements 8 Evaluation of microorganism invasion 9 Packaging 10 Marking Annex A (Normative) Physical test Annex B (Normative) Chemical test Annex C (Informative) Clinical implication and method guide of microorganism invasion test of needleless access adapters Bibliography
Referred in YY 0581.2-2011:
*GB/T 1962.2-2001 Conical fittings with a 6%(Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
*GB 8368-2018 Infusion sets for single use—Gravity feed
*GB 15810-2019 Sterile syringes for single use
*GB 15811-2016 Sterile hypodermic needles for single use
*YY/T 0466.1-2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
YY 0581.2-2011 is referred in:
*YY 1282-2016 Intravenous catheter for single use
Code of China
Standard
YY 0581.2-2011  Infusion access adapter—Part 2:Needleless access adapters (English Version)
Standard No.YY 0581.2-2011
Statussuperseded
LanguageEnglish
File FormatPDF
Word Count7000 words
Price(USD)210.0
Implemented on2013-6-1
Deliveryvia email in 1 business day
Detail of YY 0581.2-2011
Standard No.
YY 0581.2-2011
English Name
Infusion access adapter—Part 2:Needleless access adapters
Chinese Name
输液连接件 第2部分:无针连接件
Chinese Classification
C31
Professional Classification
YY
ICS Classification
Issued by
China Food and Drug Administration
Issued on
2011-12-31
Implemented on
2013-6-1
Status
superseded
Superseded by
YY 0581.2-2011/XG1-2018 Infusion access adapter—Part 2:Needleless access adapters, includes Amendment 1
Superseded on
2018-4-11
Abolished on
Superseding
Language
English
File Format
PDF
Word Count
7000 words
Price(USD)
210.0
Keywords
YY 0581.2-2011, YY/T 0581.2-2011, YYT 0581.2-2011, YY0581.2-2011, YY 0581.2, YY0581.2, YY/T0581.2-2011, YY/T 0581.2, YY/T0581.2, YYT0581.2-2011, YYT 0581.2, YYT0581.2
Introduction of YY 0581.2-2011
Infusion access adapter - Part 2: Needleless access adapters English 1 Scope This part of YY 0581 specifies the requirements and test methods of needless automatic closed access adapters (hereinafter referred to as access adapters) for single use. This part may be referred to by the access adapter products, which are integrated with intravascular indwelling devices (such as intravenous indwelling needles). The backflow preventers specified in YY 0286.6 are excluded from the scope of this part. The switches specified in YY 0585.2 are excluded from the scope of this part. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB/T 1962.2 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings GB 8368 Infusion sets for single use - Gravity feed GB 15810 Sterile syringes for single use GB 15811 Sterile hypodermic needles for single use YY/T 0466.1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 positive displacement flowing of the liquid in the system towards the body on the moment the infusion equipment is pulled out from the access port to avoid blood backflow due to pulling out the infusion equipment 3.2 access port liquid inlet port composed of sealing components on the access adapter, which are applicable to be accessed to conical lock fitting with a 6% (Luer) taper of infusion equipment, with the expected sealing property during access and after separation Note: Different from the backflow preventer, the adapted access port may make the liquid flow backward and forward.
Contents of YY 0581.2-2011
Foreword i Introduction ii 1 Scope 2 Normative references 3 Terms and definitions 4 Materials 5 Physical requirements 6 Chemical requirements 7 Biological requirements 8 Evaluation of microorganism invasion 9 Packaging 10 Marking Annex A (Normative) Physical test Annex B (Normative) Chemical test Annex C (Informative) Clinical implication and method guide of microorganism invasion test of needleless access adapters Bibliography
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