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Position: Chinese Standard in English/GB 8368-2005
GB 8368-2005   Infusion sets for single use, gravity feed (English Version)
Standard No.: GB 8368-2005 Status:abolished remind me the status change

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Language:English File Format:PDF
Word Count: 8000 words Price(USD):130.0 remind me the price change

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Implemented on:1988-6-1 Delivery: via email in 1 business day
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Standard No.: GB 8368-2005
English Name: Infusion sets for single use, gravity feed
Chinese Name: 一次性使用输液器,重力输液式
Chinese Classification: C31    General and microsurgical devices
Professional Classification: GB    National Standard
ICS Classification: 11.040.20 11.040.20    Transfusion, infusion and injection equipment 11.040.20
Issued by: AQSIQ
Issued on: 1987-7-10
Implemented on: 1988-6-1
Status: abolished
Superseded by:GB 8368-2018 Infusion sets for single use—Gravity feed
Superseded on:2021-4-1
Abolished on:2021-04-01
Superseding:GB 8368-1998 Medical infusion sets for single use
Language: English
File Format: PDF
Word Count: 8000 words
Price(USD): 130.0
Delivery: via email in 1 business day
Infusion Sets for Single Use, Gravity Feed 1 Scope This standard specifies requirements for single use, gravity feed infusion sets in order to ensure their compatibility with containers for infusion solutions and intravenous equipment. Secondary aims of this standard are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components. 2 Normative References The following normative documents contain provisions which, through reference in this text, constitute provisions of this standard. For dated references, subsequent amendments (excluding corrections), or revisions, of any of these publications do not apply to this standard. However parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. GB/T 1962.1 Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 1: General Requirements (GB/T 1962.1-2001, idt ISO 594-1:1986) GB/T 1962.2 Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 2: Lock Fittings (GB/T 1962.2-2001, idt ISO 594-2:1998) GB/T 6682-1992 Water for Analytical Laboratory Use - Specification and Test Methods (neq ISO 3696:1987) GB/T 14233.1-1998 Infusion, Transfusion, Injection Equipment for Medical Use - Part 1: Chemical Analysis Methods GB/T 14233.2 Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use - Part 2: Biological Test Methods GB 15811-2001 Sterile Hypodermic Needles for Single Use (eqv ISO 7864:1993) YY 0466 Medical Devices - Symbols to be Used with Medical Device Labels, Labelling, and Information to be Supplied (YY 0466-2003, ISO 15223:2000, IDT) ISO 14644-1:1999 Cleanrooms and Associated Controlled Environments - Part 1: Classification of Air Cleanliness 3 General Requirements 3.1 The nomenclature to be used for components of infusion sets and of a separate air-inlet device is given in Figures 1, 2 and 3. These figures illustrate examples of the configuration of infusion sets and air-inlet devices; other configurations may be used provided they lead to the same results. Infusion sets as illustrated in Figure 2 should only be used for collapsible plastics containers. Infusion sets as illustrated in Figure 2 used with separate air-inlet devices as illustrated in Figure 3, or infusion sets as illustrated in Figure 1, shall be used for rigid containers. 3.2 The infusion set shall be provided with protective caps to maintain sterility of the internal parts of the set until the set is used. The air-inlet device shall be provided with a protective cap over the closure-piercing device or needle.
Foreword i 1 Scope 2 Normative References 3 General Requirements 4 Designation 5 Materials 6 Physical Requirements 7 Chemical Requirements 8 Biological Requirements 9 Labelling 10 Packaging Annex A (Normative) Physical Tests Annex B (Normative) Chemical Tests Annex C (Normative) Biological Tests
Referred in GB 8368-2005:
*GB/T 1962.1-2015 Conical fittings with a 6%(Luer) taper for syringes,needles and certain other medical equipment—Part 1: General requirement
*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/T 6682-1992 Water for laboratory use; Specifications
*GB/T 14233.1-1998 Infusion,transfusion,injection equipment for medical use--Part 1:Chemical analysis methods
*GB/T 14233.2-2005 Test methods for infusion, transfusion, injection equipment for medical use-Part 2: Biological test methods
*GB 15811-2001/XG1 Sterile hypodermic needles for single use (including Amendment 1)
*YY 0466-2003 Medical devices -- Symbols to be used with medical device labels labelling and information to be supplied
GB 8368-2005 is referred in:
* YY/T 0821-2010 Dispensing syringe for single use
* YY 0321.3-2009 Single-use filter for anaesthesia
* YY/T 0908-2013 Single-use filter for syringe
* YY 0321.3-2009 Single-use filter for anaesthesia
* YY 0321.3-2009 Single-use filter for anaesthesia
*GB 18458.3-2005 Special infusion sets - Part 3 : Light-resistant infusion sets for single use
*GB 18671-2009 Intravenous needles for single use
Code of China
Standard
GB 8368-2005  Infusion sets for single use, gravity feed (English Version)
Standard No.GB 8368-2005
Statusabolished
LanguageEnglish
File FormatPDF
Word Count8000 words
Price(USD)130.0
Implemented on1988-6-1
Deliveryvia email in 1 business day
Detail of GB 8368-2005
Standard No.
GB 8368-2005
English Name
Infusion sets for single use, gravity feed
Chinese Name
一次性使用输液器,重力输液式
Chinese Classification
C31
Professional Classification
GB
ICS Classification
Issued by
AQSIQ
Issued on
1987-7-10
Implemented on
1988-6-1
Status
abolished
Superseded by
GB 8368-2018 Infusion sets for single use—Gravity feed
Superseded on
2021-4-1
Abolished on
2021-04-01
Superseding
GB 8368-1998 Medical infusion sets for single use
Language
English
File Format
PDF
Word Count
8000 words
Price(USD)
130.0
Keywords
GB 8368-2005, GB/T 8368-2005, GBT 8368-2005, GB8368-2005, GB 8368, GB8368, GB/T8368-2005, GB/T 8368, GB/T8368, GBT8368-2005, GBT 8368, GBT8368
Introduction of GB 8368-2005
Infusion Sets for Single Use, Gravity Feed 1 Scope This standard specifies requirements for single use, gravity feed infusion sets in order to ensure their compatibility with containers for infusion solutions and intravenous equipment. Secondary aims of this standard are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components. 2 Normative References The following normative documents contain provisions which, through reference in this text, constitute provisions of this standard. For dated references, subsequent amendments (excluding corrections), or revisions, of any of these publications do not apply to this standard. However parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. GB/T 1962.1 Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 1: General Requirements (GB/T 1962.1-2001, idt ISO 594-1:1986) GB/T 1962.2 Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 2: Lock Fittings (GB/T 1962.2-2001, idt ISO 594-2:1998) GB/T 6682-1992 Water for Analytical Laboratory Use - Specification and Test Methods (neq ISO 3696:1987) GB/T 14233.1-1998 Infusion, Transfusion, Injection Equipment for Medical Use - Part 1: Chemical Analysis Methods GB/T 14233.2 Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use - Part 2: Biological Test Methods GB 15811-2001 Sterile Hypodermic Needles for Single Use (eqv ISO 7864:1993) YY 0466 Medical Devices - Symbols to be Used with Medical Device Labels, Labelling, and Information to be Supplied (YY 0466-2003, ISO 15223:2000, IDT) ISO 14644-1:1999 Cleanrooms and Associated Controlled Environments - Part 1: Classification of Air Cleanliness 3 General Requirements 3.1 The nomenclature to be used for components of infusion sets and of a separate air-inlet device is given in Figures 1, 2 and 3. These figures illustrate examples of the configuration of infusion sets and air-inlet devices; other configurations may be used provided they lead to the same results. Infusion sets as illustrated in Figure 2 should only be used for collapsible plastics containers. Infusion sets as illustrated in Figure 2 used with separate air-inlet devices as illustrated in Figure 3, or infusion sets as illustrated in Figure 1, shall be used for rigid containers. 3.2 The infusion set shall be provided with protective caps to maintain sterility of the internal parts of the set until the set is used. The air-inlet device shall be provided with a protective cap over the closure-piercing device or needle.
Contents of GB 8368-2005
Foreword i 1 Scope 2 Normative References 3 General Requirements 4 Designation 5 Materials 6 Physical Requirements 7 Chemical Requirements 8 Biological Requirements 9 Labelling 10 Packaging Annex A (Normative) Physical Tests Annex B (Normative) Chemical Tests Annex C (Normative) Biological Tests
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Keywords:
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