YY/T 0804-2010 Transfer sets for pharmaceutical preparations - Requirements and test methods
1 Scope
This standard is applicable to sterilized single use transfer sets that are used for pharmaceutical preparations.
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 1962.1 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirement (GB/T 1962.1-2001, ISO 594-1:1986, IDT)
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)
GB 15811-2001 Sterile hypodermic needles for single use (eqv ISO 7864:1993)
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 0466.1-2009, ISO 15223-1:2007, IDT)
ISO 8362 Injection container and its accessories
ISO 8536-2 Infusion equipment for medical use - Part 2: Closures for infusion bottles
ISO 15747:2003 Plastics containers for intravenous injection
ISO 15759:2005 Medical infusion equipment - Plastics caps with inserted elastomeric liner for containers manufactured by the blow-fill-seal (BFS) process
3 Design and designation
3.1 Design of transfer set without housing
The designs of the individual components are given in the drawings (Figures 1 to 4). The drawings serve as an illustration of possible designs of transfer sets. Other designs are acceptable.
a) Transfer set with one channel b) Transfer set with one channel, combined with a Luer taper
Figure 1 Transfer set with one channel
a) Transfer set with an air inlet/air outlet b) Alternative transfer set with an air inlet/air outlet
c) Transfer set with an air inlet, combined with a Luer taper
Figure 2 Transfer set with an air inlet
a) Transfer set with two channels b) Alternative transfer set with two channels
Figure 3 Transfer set with two channels
Key for Figures 1 to 3
1——piercing device;
2——channel;
3——channel with air filter for ventilation, optionally lockable;
4——protective cap;
5——connection of piercing devices by hub, grip plate or tube;
6——internal Luer taper.
3.2 Design of a transfer set with housing
The design of a transfer set with housing is given in Figure 4. The drawings serve as an illustration of possible types of transfer sets. Other designs are acceptable.
Foreword i Introduction ii 1 Scope 2 Normative references 3 Design and designation 4 Material 5 Physical requirements 6 Chemical requirements 7 Biological requirements 8 Test method 9 Testing of chemical requirements 10 Testing of biological requirements 11 Packaging 12 Storage 13 Labelling Annex A (Normative) Testing of fragmentation of transfer sets with plastic piercing devices Annex B (Normative) Testing of fragmentation of transfer sets with metal piercing devices Annex NA (Normative) Technical differences between this standard and ISO 22413:2007 and their justifications Bibliography
YY/T 0804-2010 Transfer sets for pharmaceutical preparations - Requirements and test methods
1 Scope
This standard is applicable to sterilized single use transfer sets that are used for pharmaceutical preparations.
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 1962.1 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirement (GB/T 1962.1-2001, ISO 594-1:1986, IDT)
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)
GB 15811-2001 Sterile hypodermic needles for single use (eqv ISO 7864:1993)
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 0466.1-2009, ISO 15223-1:2007, IDT)
ISO 8362 Injection container and its accessories
ISO 8536-2 Infusion equipment for medical use - Part 2: Closures for infusion bottles
ISO 15747:2003 Plastics containers for intravenous injection
ISO 15759:2005 Medical infusion equipment - Plastics caps with inserted elastomeric liner for containers manufactured by the blow-fill-seal (BFS) process
3 Design and designation
3.1 Design of transfer set without housing
The designs of the individual components are given in the drawings (Figures 1 to 4). The drawings serve as an illustration of possible designs of transfer sets. Other designs are acceptable.
a) Transfer set with one channel b) Transfer set with one channel, combined with a Luer taper
Figure 1 Transfer set with one channel
a) Transfer set with an air inlet/air outlet b) Alternative transfer set with an air inlet/air outlet
c) Transfer set with an air inlet, combined with a Luer taper
Figure 2 Transfer set with an air inlet
a) Transfer set with two channels b) Alternative transfer set with two channels
Figure 3 Transfer set with two channels
Key for Figures 1 to 3
1——piercing device;
2——channel;
3——channel with air filter for ventilation, optionally lockable;
4——protective cap;
5——connection of piercing devices by hub, grip plate or tube;
6——internal Luer taper.
3.2 Design of a transfer set with housing
The design of a transfer set with housing is given in Figure 4. The drawings serve as an illustration of possible types of transfer sets. Other designs are acceptable.
Contents of YY/T 0804-2010
Foreword i
Introduction ii
1 Scope
2 Normative references
3 Design and designation
4 Material
5 Physical requirements
6 Chemical requirements
7 Biological requirements
8 Test method
9 Testing of chemical requirements
10 Testing of biological requirements
11 Packaging
12 Storage
13 Labelling
Annex A (Normative) Testing of fragmentation of transfer sets with plastic piercing devices
Annex B (Normative) Testing of fragmentation of transfer sets with metal piercing devices
Annex NA (Normative) Technical differences between this standard and ISO 22413:2007 and their justifications
Bibliography
