Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
YY 0286 consists of the following parts, under the general title Special Infusion Sets:
— YY 0286.1 Infusion Sets for Single Use with Micropore Filters;
— YY 0286.2 Burette-type Infusion Sets for Single Use, Gravity Feed;
— YY 0286.3 Light-resistant Infusion Sets for Single Use;
— YY 0286.4 Infusion Sets for Single Use with Pressure Infusion Apparatus;
— YY 0286.5 Bottle-type and Bag-type Infusion Sets for Single Use;
— YY 0286.6 Infusion Sets for Single Use with Graduated Flow Regulator;
This part is Part 4 of YY/T 0286.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This part replaces YY/T 0286.4-2006, and the following technical deviations have been made with respect to YY/T 0286.4-2006:
— the standard is changed from mandatory to recommendatory;
— the standard adoption degree is changed from "IDT" (identical) to "MOD" (modified);
— the Clause of Normative References is updated (see Clause 2; Clause 2 of Edition 2006);
— Clause 3 "Terms and Definitions" is added (see Clause 3);
— the former Clause 4 on designation is deleted (see Clause 4 of Edition 2006);
— the requirements of tube length are modified, which is identical with those for piping length in accordance with ISO 8536-8 (see 6.11; 6.11 of Edition 2006);
— the requirements of storage volume are modified, and the test methods for storage volume are added in Annex B (see 6.14; 6.14 of Edition 2006);
— Clause 10 on labelling is modified (see Clause 10; Clause 10 of Edition 2006);
— Clause 11 on disposal is added; (see Clause 11);
— the former A.4 “Test methods” is deleted (see A.4 of Edition 2006);
— A.3 “Tests for leakage” is modified (see A.3; A.3 of Edition 2006);
— the Bibliography is updated.
This part has been redrafted and modified adoption of International Standard ISO 8536-8:2015 Infusion Equipment for Medical Use — Part 8: Infusion Sets for Single Use with Pressure Infusion Apparatus.
There are technical deviations between this part and the International Standard ISO 8536-8:2015; Annex C is added after Annexes A and B, and a complete list of technical deviations, together with their justifications, is given in Annex C
For the purposes of this part, the following editorial changes have also been made:
— Annex C (informative) is added, which gives the technical deviations, together with their justifications, between this part and ISO 8536-8:2015.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This part was proposed by the National Medical Products Administration of People’s Republic of China.
The previous editions of this part are as follows:
— YY 0286.4-2006.
Introduction
With the continuous development of infusion technology and the increasing of clinical requirements, some special infusion sets that can adapt to the special clinical requirements have appeared one after another, and Special Infusion Sets series of standards are specially used to regulate these special infusion sets. Due to the endless development of infusion sets, it is impossible to expect to include all infusion sets with special requirements in one standard. Therefore, each part of the Special Infusion Sets series of standards is only for one specific clinical requirement to regulate these infusion sets. If a certain infusion set belongs to more than one special infusion sets, the appropriate part of YY 0286 should be implemented simultaneously.
For the purpose of this part, Annex D of GB 8368 applies.
Special Infusion Sets — Part 4: Infusion Sets for Single Use with Pressure Infusion Apparatus
1 Scope
This part of Special Infusion Sets series of standards specifies the requirements on sterilized infusion sets for single use with pressure infusion apparatus up to a maximum of 200 kPa.
This part is applicable to the sterilized infusion sets for single use with pressure infusion apparatus up to a maximum of 200 kPa.
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/T 1962.2-2001, ISO 594-2:1998, IDT)
GB 8368 Infusion Sets for Single Use — Gravity Feed (GB 8368-2005, ISO 8536-4:2004, MOD)
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 Terms and Definitions
For the purposes of this document, the following terms and definitions apply.
3.1
filling volume
VF
volume of tube filling by gravity, the tube remains unstressed
Note: The filling volume is to be equated with the calculated volume of the tube.
3.2
bolus volume
VB
increased tube volume during pressurization (storage volume VS) in comparison to the unstressed tube (filling volume VF)
Note: For illustration of the bolus volume see Figure 1.
3.3
storage volume
VS
tube volume during pressurization equal to filling volume (VF) plus bolus volume (VB):
VS = VF + VB
4 General Requirements
4.1 The nomenclature to be used for components of infusion sets and of a separate air-inlet device is given in Figures 2, 3, and 4. 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 3 should only be used for collapsible plastics containers. Infusion sets as illustrated in Figure 3 used with separate air-inlet devices as illustrated in Figure 4, or infusion sets as illustrated in Figure 2 shall be used for rigid containers.
4.2 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 II
Introduction IV
1 Scope
2 Normative References
3 Terms and Definitions
4 General Requirements
5 Materials
6 Physical Requirements
7 Chemical Requirements
8 Biological Requirements
9 Packaging
10 Labelling
11 Disposal
Annex A (Normative) Physical Tests
Annex B (Normative) Storage Volume
Annex C (Informative) Technical Deviations between This Part and ISO 8536-8:2015 and Their Justifications
Bibliography
Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
YY 0286 consists of the following parts, under the general title Special Infusion Sets:
— YY 0286.1 Infusion Sets for Single Use with Micropore Filters;
— YY 0286.2 Burette-type Infusion Sets for Single Use, Gravity Feed;
— YY 0286.3 Light-resistant Infusion Sets for Single Use;
— YY 0286.4 Infusion Sets for Single Use with Pressure Infusion Apparatus;
— YY 0286.5 Bottle-type and Bag-type Infusion Sets for Single Use;
— YY 0286.6 Infusion Sets for Single Use with Graduated Flow Regulator;
This part is Part 4 of YY/T 0286.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This part replaces YY/T 0286.4-2006, and the following technical deviations have been made with respect to YY/T 0286.4-2006:
— the standard is changed from mandatory to recommendatory;
— the standard adoption degree is changed from "IDT" (identical) to "MOD" (modified);
— the Clause of Normative References is updated (see Clause 2; Clause 2 of Edition 2006);
— Clause 3 "Terms and Definitions" is added (see Clause 3);
— the former Clause 4 on designation is deleted (see Clause 4 of Edition 2006);
— the requirements of tube length are modified, which is identical with those for piping length in accordance with ISO 8536-8 (see 6.11; 6.11 of Edition 2006);
— the requirements of storage volume are modified, and the test methods for storage volume are added in Annex B (see 6.14; 6.14 of Edition 2006);
— Clause 10 on labelling is modified (see Clause 10; Clause 10 of Edition 2006);
— Clause 11 on disposal is added; (see Clause 11);
— the former A.4 “Test methods” is deleted (see A.4 of Edition 2006);
— A.3 “Tests for leakage” is modified (see A.3; A.3 of Edition 2006);
— the Bibliography is updated.
This part has been redrafted and modified adoption of International Standard ISO 8536-8:2015 Infusion Equipment for Medical Use — Part 8: Infusion Sets for Single Use with Pressure Infusion Apparatus.
There are technical deviations between this part and the International Standard ISO 8536-8:2015; Annex C is added after Annexes A and B, and a complete list of technical deviations, together with their justifications, is given in Annex C
For the purposes of this part, the following editorial changes have also been made:
— Annex C (informative) is added, which gives the technical deviations, together with their justifications, between this part and ISO 8536-8:2015.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This part was proposed by the National Medical Products Administration of People’s Republic of China.
The previous editions of this part are as follows:
— YY 0286.4-2006.
Introduction
With the continuous development of infusion technology and the increasing of clinical requirements, some special infusion sets that can adapt to the special clinical requirements have appeared one after another, and Special Infusion Sets series of standards are specially used to regulate these special infusion sets. Due to the endless development of infusion sets, it is impossible to expect to include all infusion sets with special requirements in one standard. Therefore, each part of the Special Infusion Sets series of standards is only for one specific clinical requirement to regulate these infusion sets. If a certain infusion set belongs to more than one special infusion sets, the appropriate part of YY 0286 should be implemented simultaneously.
For the purpose of this part, Annex D of GB 8368 applies.
Special Infusion Sets — Part 4: Infusion Sets for Single Use with Pressure Infusion Apparatus
1 Scope
This part of Special Infusion Sets series of standards specifies the requirements on sterilized infusion sets for single use with pressure infusion apparatus up to a maximum of 200 kPa.
This part is applicable to the sterilized infusion sets for single use with pressure infusion apparatus up to a maximum of 200 kPa.
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/T 1962.2-2001, ISO 594-2:1998, IDT)
GB 8368 Infusion Sets for Single Use — Gravity Feed (GB 8368-2005, ISO 8536-4:2004, MOD)
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 Terms and Definitions
For the purposes of this document, the following terms and definitions apply.
3.1
filling volume
VF
volume of tube filling by gravity, the tube remains unstressed
Note: The filling volume is to be equated with the calculated volume of the tube.
3.2
bolus volume
VB
increased tube volume during pressurization (storage volume VS) in comparison to the unstressed tube (filling volume VF)
Note: For illustration of the bolus volume see Figure 1.
3.3
storage volume
VS
tube volume during pressurization equal to filling volume (VF) plus bolus volume (VB):
VS = VF + VB
4 General Requirements
4.1 The nomenclature to be used for components of infusion sets and of a separate air-inlet device is given in Figures 2, 3, and 4. 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 3 should only be used for collapsible plastics containers. Infusion sets as illustrated in Figure 3 used with separate air-inlet devices as illustrated in Figure 4, or infusion sets as illustrated in Figure 2 shall be used for rigid containers.
4.2 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 YY/T 0286.4-2020
Foreword II
Introduction IV
1 Scope
2 Normative References
3 Terms and Definitions
4 General Requirements
5 Materials
6 Physical Requirements
7 Chemical Requirements
8 Biological Requirements
9 Packaging
10 Labelling
11 Disposal
Annex A (Normative) Physical Tests
Annex B (Normative) Storage Volume
Annex C (Informative) Technical Deviations between This Part and ISO 8536-8:2015 and Their Justifications
Bibliography
