GB 8368-2018Infusion sets for single use -- Gravity feed (English PDF)

Foreword

The full technical content of this Standard is mandatory.

This Standard is drafted in accordance with the rules given in GB/T 1.1-2009.

This Standard replaces GB 8368-2005 "Infusion sets for single use, gravity

feed". Compared with GB 8368-2005, in addition to editorial changes, the main

technical changes of this Standard are as follows:

- CHANGE the note in Tubing to the text (see 6.6; 6.6 of the 2005 edition);

- Delete the limit on the colour of the flow regulator (6.9 of the 2005 edition);

- Modify the position requirement of injection site to mandatory requirement

and add a note (see 6.11; 6.11 of the 2005 edition);

- Modify the requirement of male conical fitting to mandatory requirement

(see 6.12; 6.12 of the 2005 edition);

- Modify the requirements for reducing matter and the method of presentation

of test method (see 7.1 and B.2; 7.1 and B.2 of the 2005 edition);

- In Labelling, add a requirement that the presence of substances of interest

can be indicated by using symbol 2725 of ISO 7000 (see notes to 9.1 and

9.2);

- ADD packaging requirement (see 10.3);

- ADD disposal requirement (see Clause 11);

- Modify particulate contamination index and its test method (see A.1; A.1 of

the 2005 edition);

- Modify tests for leakage (see A.2; A.2 of the 2005 edition).

This Standard uses the redraft law to modify and adopt ISO 8536-4:2010

"Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity

feed".

There are technical differences between this Standard and ISO 8536-4:2010.

The clauses involved in these differences have been marked by a vertical single

line (|) at the blank of the outer margin. Annex E gives a list of the corresponding

technical differences and their causes.

This Standard incorporates the amendment contents of ISO 8356-

4:2010/Amd.1:2013. The clause-subclause involved in these amendment

contents has been marked by vertical double line (||) at the blank of the outer

margin.

This Standard also makes the following editorial changes:

- ADD the informative Annex D, to provide guidelines for the design and

implementation of infusion sets in China;

- ADD the informative Annex E, giving a list of corresponding technical

differences and their causes compared to ISO 8536-4:2010.

Attention is drawn to the possibility that some of the elements of this document

may be the subject of patent rights. The issuing authority of this document shall

not be held responsible for identifying any or all such patent rights.

This Standard was proposed by and shall be under the jurisdiction of China

Food and Drug Administration.

Main drafting organizations of this Standard: Shandong Quality Inspection

Center for Medical Devices, Shandong Weigao Group Medical Polymer Co.,

Ltd., Shinva Ande Healthcare Apparatus Co., Ltd., Shanghai Kindly Enterprise

Development Group Co., Ltd., Jiangxi Hongda Medical Equipment Group Ltd.,

Tianjin Hanaco Medical Co., Ltd., Jiangxi Sanxin Medtec Co., Ltd., Chengdu

Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd., Shandong

Zhongbaokang Medical Implements Co., Ltd.

Main drafters of this Standard: Wan Min, Wang Yi, Li Songhua, Pan Huaxian,

Gao Yicen, Wang Haiyin, Hou Li, Zhu Li, Liu Xiaohong, Tian Xinglong, Zhang

Min.

The previous editions of the standard replaced by this Standard were released

as follows:

- GB 8368-1987, GB 8368-1993, GB 8368-1998, GB 8368-2005.

Infusion sets for single use - Gravity feed

1 Scope

This Standard specifies the designation, materials, physical, chemical, and

biological requirements for single-use gravity feed infusion sets.

This Standard applies to single-use gravity feed infusion sets for use with

infusion containers and intravenous equipment.

2 Normative references

The following documents are indispensable for the application of this document.

For the dated references, only the editions with the dates indicated are

applicable to this document. For the undated references, the latest edition

(including all the amendments) are applicable to this document.

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,

ISO 594-2:1998, IDT)

GB/T 6682 Water for analytical laboratory use - Specification and test

methods (GB/T 6682-2008, ISO 3696:1987, MOD)

GB/T 14233.1-2008 Test methods for 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 Sterile hypodermic needles for single use (GB 15811-2016, ISO

7864:1993, NEQ)

GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation

and testing within a risk management process (GB/T 16886.1-2011, ISO

10993-1:2009, IDT)

GB/T 25915.1 Cleanrooms and associated controlled environments - Part 1:

Classification of air cleanliness (GB/T 25915.1-2010, ISO 14644-1:1999, IDT)

YY/T 0466.1 Medical devices - Symbols to be used with medical device

labels, labelling and information to be supplied - Part 1: General

requirements (YY/T 0466.1-2016, ISO 15223-1:2012, IDT)

3 General requirements