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ISO 10524-3 Pressure regulators for use with medical gases - Part 3 Pressure regulators integrated with cylinder valves (Full)
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TC ISO 10524-3 BỘ ĐIỀU ÁP DÙNG CHO KHÍ Y TẾ - PHẦN 3: BỘ ĐIỀU ÁP CÓ VAN ĐIỀU CHỈNH
This document specifies design, type testing, and marking requirements for cylinder valves with integrated pressure regulators [as defined in 3.26 and referred to hereafter as valves with integrated pressure regulators (VIPRs)] intended for the administration of medical gases in the treatment, management, diagnostic evaluation and care of patients or for gases used for driving surgical tools.
Examples of gases include oxygen, medical air and oxygen/nitrous oxide mixtures.
This document applies to VIPRs mounted on refillable cylinders with a working pressure up to 30 000 kPa (300 bar) intended to be filled in cylinder filling facilities or on self-filling systems as used in homecare applications.
VIPRs covered by this document are pressure pre-set and provided with a pressure outlet and/or pre-set flow outlet(s).
CONTENTS:
14
Introduction ............................................................................................................................................8 15
1 Scope ..................................................................................................................................................9 16
2 Normative references ..................................................................................................................9 17
3 Terms and definitions ............................................................................................................... 10 18
4 Nomenclature .............................................................................................................................. 13 19
5 General requirements............................................................................................................... 13 20
5.1 Safety ............................................................................................................................................... 13 21
5.2 Usability ......................................................................................................................................... 14 22
5.3 Materials ........................................................................................................................................ 14 23
5.4 Potential contamination of the gas pathway .................................................................... 15 24
5.5 Cleaning and disinfection ........................................................................................................ 15 25
6 Design requirements ................................................................................................................. 15 26
6.1 Environmental conditions ....................................................................................................... 15 27
6.1.1 Road transport and storage ......................................................................................... 16 28
6.1.2 VIPR transient operating conditions ........................................................................ 16 29
6.1.3 VIPR clinical use ............................................................................................................... 16 30
6.2 Integrated electronic device ................................................................................................... 16 31
6.3 Filling port ..................................................................................................................................... 17 32
6.4 Connections .................................................................................................................................. 18 33
6.4.1 Valve inlet connection ..................................................................................................... 18 34
6.4.2 Flow outlet .......................................................................................................................... 18 35
6.4.3 Pressure outlet .................................................................................................................. 18 36
6.5 Content indicator ......................................................................................................................... 18 37
6.6 Filtration ........................................................................................................................................ 19 38
6.7 Primary valve operating mechanism ................................................................................... 19 39
6.7.1 General ................................................................................................................................ 19 40
6.7.2 Resistance to excessive torques ................................................................................. 19 41
6.8 Residual pressure ....................................................................................................................... 19 42
6.8.1 Residual pressure device.............................................................................................. 19 43
6.8.2 Means of venting the residual pressure .................................................................. 20 44
6.9 Pressure-relief device................................................................................................................. 20 45
6.9.1 General ................................................................................................................................ 20 46
6.9.2 Leakage ............................................................................................................................... 20 47
6.9.3 Opening pressure ............................................................................................................ 20 48
6.9.4 Closing pressure .............................................................................................................. 20 49
6.9.5 Minimum discharge capacity ...................................................................................... 21 50
6.10 Additional features .............................................................................................................. 21 51
6.11 Leakage .................................................................................................................................... 21 52
6.11.1 Leakage in transport and storage conditions ....................................................... 21 53
6.11.2 Internal leak tightness................................................................................................... 21 54
6.11.3 External leak tightness .................................................................................................. 21 55
6.11.4 Internal leakage through the pressure regulator valve ..................................... 22 56
6.12 Mechanical strength ............................................................................................................ 22 57
6.12.1 Resistance of the high-pressure side........................................................................ 22 58
6.12.2 Resistance of the low-pressure side to excessive pressure ............................. 22 59
6.12.3 Resistance of the low-pressure side to P1 ............................................................... 22 60
6.12.4 Impact test ......................................................................................................................... 22 61
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6.13 Resistance to ignition ......................................................................................................... 22 62
6.14 Requirements for VIPR fitted with an integral flow control device .................... 23 63
6.15 Guard ........................................................................................................................................ 23 64
6.16 Endurance ............................................................................................................................... 23 65
6.16.1 Integral flow control device .......................................................................................... 23 66
6.16.2 Filling port non-return valve ........................................................................................ 23 67
6.16.3 Isolating valve fitted to the filling port .................................................................... 24 68
6.16.4 Primary valve operating mechanism ........................................................................ 24 69
6.16.5 Pressure regulator ........................................................................................................... 24 70
7 Performance requirements .................................................................................................... 25 71
7.1 VIPRs fitted with a pressure outlet ........................................................................................ 25 72
7.1.1 Outlet pressure(P2) limits ............................................................................................ 25 73
7.1.2 Multiple pressure outlets .............................................................................................. 25 74
7.2 VIPRs fitted with an integral flow control device ............................................................. 25 75
7.2.1 Flow outlet pressure ........................................................................................................ 25 76
7.2.2 Stability and accuracy of flow ...................................................................................... 25 77
8 Construction requirements .................................................................................................... 25 78
8.1 Cleanliness .................................................................................................................................... 25 79
8.2 Lubricants ..................................................................................................................................... 26 80
8.3 Loosening torques ...................................................................................................................... 26 81
8.3.1 Filling port .......................................................................................................................... 26 82
8.3.2 Outlet connector .............................................................................................................. 26 83
8.3.3 Integral flow control device .......................................................................................... 26 84
8.3.4 Content indicator.............................................................................................................. 26 85
8.3.5 Inlet connection ............................................................................................................... 27 86
9 Marking, and packaging ........................................................................................................... 27 87
9.1 Marking .......................................................................................................................................... 27 88
9.1.1 General ................................................................................................................................ 27 89
9.1.2 Marked information ....................................................................................................... 27 90
9.2 Packaging ...................................................................................................................................... 27 91
10 Instructions for use and technical description ................................................................ 28 92
10.1 General ..................................................................................................................................... 28 93
10.2 Specific requirements for VIPRs ..................................................................................... 28 94
10.2.1 Technical description .................................................................................................... 28 95
10.2.2 Use of the VIPR .................................................................................................................. 28 96
10.2.3 Performance information ............................................................................................ 28 97
10.2.4 Guard .................................................................................................................................... 28 98
10.2.5 Valve fitting........................................................................................................................ 28 99
10.2.6 Filling operation .............................................................................................................. 29 100
10.2.7 Inspection and maintenance operation .................................................................. 29 101
11 Test methods for non-gas specific type tests .................................................................... 29 102
11.1 General conditions ............................................................................................................... 29 103
11.1.1 Ambient conditions ........................................................................................................ 29 104
11.1.2 Test gas................................................................................................................................ 29 105
11.1.3 Reference conditions ..................................................................................................... 30 106
11.2 Test schedule ......................................................................................................................... 30 107
11.3 Test methods for outlet pressure .................................................................................... 32 108
11.3.1 Purpose ............................................................................................................................... 34 109
11.3.2 Test equipment ................................................................................................................ 34 110
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© ISO/DIS 10524-3:2024(1) – All rights reserved
11.3.3 Test methods for determining outlet pressure limits for VIPRs fitted with a 111
pressure outlet .................................................................................................................. 35 112
11.3.4 Test method for determining outlet pressure limits for a VIPR only fitted 113
with a flow outlet .............................................................................................................. 36 114
11.4 Test method for pressure-relief device ......................................................................... 36 115
11.4.1 Purpose ............................................................................................................................... 36 116
11.4.2 Test procedure ................................................................................................................. 36 117
11.5 Test methods for internal leakage through the pressure regulator valve ....... 37 118
11.5.1 Purpose ............................................................................................................................... 37 119
11.5.2 Test procedure ................................................................................................................. 37 120
11.6 Test method for mechanical strength ........................................................................... 37 121
11.6.1 Purpose ............................................................................................................................... 37 122
11.6.2 Test procedure ................................................................................................................. 37 123
11.7 Test method for resistance to ignition through the valve inlet connection ..... 38 124
11.7.1 Purpose ............................................................................................................................... 38 125
11.7.2 General ................................................................................................................................ 38 126
11.7.3 Test procedure ................................................................................................................. 38 127
11.8 Test methods for the stability and accuracy of flow of VIPRs fitted with an 128
integral flow control device ............................................................................................... 39 129
11.8.1 Purpose ............................................................................................................................... 39 130
11.8.2 Test procedure ................................................................................................................. 39 131
11.9 Test method for flow setting torque .............................................................................. 39 132
11.9.1 Purpose ............................................................................................................................... 39 133
11.9.2 Test procedure ................................................................................................................. 39 134
11.10 Test method for loosening torques................................................................................ 39 135
11.10.1 Purpose ............................................................................................................................... 39 136
11.10.2 Test procedure ................................................................................................................. 39 137
11.11 Test for integrity of the filling port non-return valve under high flow 138
condition ................................................................................................................................. 39 139
11.11.1 Purpose ............................................................................................................................... 39 140
11.11.2 Test procedure ................................................................................................................. 40 141
11.12 Integral flow control device endurance test ................................................................ 41 142
11.12.1 Purpose ............................................................................................................................... 41 143
11.12.2 Test procedure ................................................................................................................. 42 144
11.13 Pressure regulator endurance test for VIPRs type A ................................................ 42 145
11.13.1 Purpose ............................................................................................................................... 42 146
11.13.2 Test procedure ................................................................................................................. 42 147
12 Gas-specific type tests ................................................................................................................ 43 148
12.1 Purpose .................................................................................................................................... 43 149
12.2 Apparatus ................................................................................................................................ 44 150
12.3 General test conditions ...................................................................................................... 45 151
12.3.1 Test conditions ................................................................................................................. 45 152
12.4 Test procedure ...................................................................................................................... 45 153
12.4.1 Test method for determining outlet pressure limits for a VIPR fitted with a 154
pressure outlet .................................................................................................................. 45 155
12.4.2 Test method for stability and accuracy of flow of a VIPR fitted with an 156
integral flow control device .......................................................................................... 46 157
12.4.3 Test method for residual pressure device ............................................................... 46 158
(informative) Example of VIPRs .................................................................................. 47 159
(Normative) Specific requirements for VIPRs intended to supply air or 160
nitrogen for driving surgical tools ................................................................................. 49 161
ISO/DIS 10524-3:2025(en)
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© ISO/DIS 10524-3:2024(1) – All rights reserved
B6.4.2 Flow outlet .............................................................................................................................. 49 162
B.6.9 Pressure-relief device.............................................................................................................. 49 163
(informative) Rationale ................................................................................................. 50 164
(informative) How to qualify a VIPR for use in an air (according to EN 165
13718-1
[4]) / road (according to EN 1789
[5]) ambulance ....................................... 54 166
(informative) ASTM G175-24[2]
(Pill Test - Phase 2) Promoted ignition test 167
..................................................................................................................................................... 55 168
Bibliography .
LINK 3 - TÌM KIẾM SÁCH/TÀI LIỆU ONLINE (GIÁ ƯU ĐÃI NHẤT)
LINK 4 - TÌM KIẾM SÁCH/TÀI LIỆU ONLINE (GIÁ ƯU ĐÃI NHẤT)
ISO 10524-3 2005 Pressure regulators for use with medical gases - Part 3 Pressure regulators integrated with cylinder valves (2005).
LINK DOWNLOAD (TÀI LIỆU VIP MEMBER)
ISO 10524-3 2019 Pressure regulators for use with medical gases - Part 3 Pressure regulators integrated with cylinder valves (2019).
ISO 10524-3 2025 Pressure regulators for use with medical gases - Part 3 Pressure regulators integrated with cylinder valves (2025).
LINK ĐẶT MUA TÀI LIỆU ONLINE 1
LINK DOWNLOAD (UPDATING...)
TC ISO 10524-3 BỘ ĐIỀU ÁP DÙNG CHO KHÍ Y TẾ - PHẦN 3: BỘ ĐIỀU ÁP CÓ VAN ĐIỀU CHỈNH
This document specifies design, type testing, and marking requirements for cylinder valves with integrated pressure regulators [as defined in 3.26 and referred to hereafter as valves with integrated pressure regulators (VIPRs)] intended for the administration of medical gases in the treatment, management, diagnostic evaluation and care of patients or for gases used for driving surgical tools.
Examples of gases include oxygen, medical air and oxygen/nitrous oxide mixtures.
This document applies to VIPRs mounted on refillable cylinders with a working pressure up to 30 000 kPa (300 bar) intended to be filled in cylinder filling facilities or on self-filling systems as used in homecare applications.
VIPRs covered by this document are pressure pre-set and provided with a pressure outlet and/or pre-set flow outlet(s).
CONTENTS:
14
Introduction ............................................................................................................................................8 15
1 Scope ..................................................................................................................................................9 16
2 Normative references ..................................................................................................................9 17
3 Terms and definitions ............................................................................................................... 10 18
4 Nomenclature .............................................................................................................................. 13 19
5 General requirements............................................................................................................... 13 20
5.1 Safety ............................................................................................................................................... 13 21
5.2 Usability ......................................................................................................................................... 14 22
5.3 Materials ........................................................................................................................................ 14 23
5.4 Potential contamination of the gas pathway .................................................................... 15 24
5.5 Cleaning and disinfection ........................................................................................................ 15 25
6 Design requirements ................................................................................................................. 15 26
6.1 Environmental conditions ....................................................................................................... 15 27
6.1.1 Road transport and storage ......................................................................................... 16 28
6.1.2 VIPR transient operating conditions ........................................................................ 16 29
6.1.3 VIPR clinical use ............................................................................................................... 16 30
6.2 Integrated electronic device ................................................................................................... 16 31
6.3 Filling port ..................................................................................................................................... 17 32
6.4 Connections .................................................................................................................................. 18 33
6.4.1 Valve inlet connection ..................................................................................................... 18 34
6.4.2 Flow outlet .......................................................................................................................... 18 35
6.4.3 Pressure outlet .................................................................................................................. 18 36
6.5 Content indicator ......................................................................................................................... 18 37
6.6 Filtration ........................................................................................................................................ 19 38
6.7 Primary valve operating mechanism ................................................................................... 19 39
6.7.1 General ................................................................................................................................ 19 40
6.7.2 Resistance to excessive torques ................................................................................. 19 41
6.8 Residual pressure ....................................................................................................................... 19 42
6.8.1 Residual pressure device.............................................................................................. 19 43
6.8.2 Means of venting the residual pressure .................................................................. 20 44
6.9 Pressure-relief device................................................................................................................. 20 45
6.9.1 General ................................................................................................................................ 20 46
6.9.2 Leakage ............................................................................................................................... 20 47
6.9.3 Opening pressure ............................................................................................................ 20 48
6.9.4 Closing pressure .............................................................................................................. 20 49
6.9.5 Minimum discharge capacity ...................................................................................... 21 50
6.10 Additional features .............................................................................................................. 21 51
6.11 Leakage .................................................................................................................................... 21 52
6.11.1 Leakage in transport and storage conditions ....................................................... 21 53
6.11.2 Internal leak tightness................................................................................................... 21 54
6.11.3 External leak tightness .................................................................................................. 21 55
6.11.4 Internal leakage through the pressure regulator valve ..................................... 22 56
6.12 Mechanical strength ............................................................................................................ 22 57
6.12.1 Resistance of the high-pressure side........................................................................ 22 58
6.12.2 Resistance of the low-pressure side to excessive pressure ............................. 22 59
6.12.3 Resistance of the low-pressure side to P1 ............................................................... 22 60
6.12.4 Impact test ......................................................................................................................... 22 61
ISO/DIS 10524-3:2025(en)
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oSIST prEN ISO 10524-3:2025
iT eh Standards
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oSISTprEN ISO 10524-3:2025
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© ISO/DIS 10524-3:2024(1) – All rights reserved
6.13 Resistance to ignition ......................................................................................................... 22 62
6.14 Requirements for VIPR fitted with an integral flow control device .................... 23 63
6.15 Guard ........................................................................................................................................ 23 64
6.16 Endurance ............................................................................................................................... 23 65
6.16.1 Integral flow control device .......................................................................................... 23 66
6.16.2 Filling port non-return valve ........................................................................................ 23 67
6.16.3 Isolating valve fitted to the filling port .................................................................... 24 68
6.16.4 Primary valve operating mechanism ........................................................................ 24 69
6.16.5 Pressure regulator ........................................................................................................... 24 70
7 Performance requirements .................................................................................................... 25 71
7.1 VIPRs fitted with a pressure outlet ........................................................................................ 25 72
7.1.1 Outlet pressure(P2) limits ............................................................................................ 25 73
7.1.2 Multiple pressure outlets .............................................................................................. 25 74
7.2 VIPRs fitted with an integral flow control device ............................................................. 25 75
7.2.1 Flow outlet pressure ........................................................................................................ 25 76
7.2.2 Stability and accuracy of flow ...................................................................................... 25 77
8 Construction requirements .................................................................................................... 25 78
8.1 Cleanliness .................................................................................................................................... 25 79
8.2 Lubricants ..................................................................................................................................... 26 80
8.3 Loosening torques ...................................................................................................................... 26 81
8.3.1 Filling port .......................................................................................................................... 26 82
8.3.2 Outlet connector .............................................................................................................. 26 83
8.3.3 Integral flow control device .......................................................................................... 26 84
8.3.4 Content indicator.............................................................................................................. 26 85
8.3.5 Inlet connection ............................................................................................................... 27 86
9 Marking, and packaging ........................................................................................................... 27 87
9.1 Marking .......................................................................................................................................... 27 88
9.1.1 General ................................................................................................................................ 27 89
9.1.2 Marked information ....................................................................................................... 27 90
9.2 Packaging ...................................................................................................................................... 27 91
10 Instructions for use and technical description ................................................................ 28 92
10.1 General ..................................................................................................................................... 28 93
10.2 Specific requirements for VIPRs ..................................................................................... 28 94
10.2.1 Technical description .................................................................................................... 28 95
10.2.2 Use of the VIPR .................................................................................................................. 28 96
10.2.3 Performance information ............................................................................................ 28 97
10.2.4 Guard .................................................................................................................................... 28 98
10.2.5 Valve fitting........................................................................................................................ 28 99
10.2.6 Filling operation .............................................................................................................. 29 100
10.2.7 Inspection and maintenance operation .................................................................. 29 101
11 Test methods for non-gas specific type tests .................................................................... 29 102
11.1 General conditions ............................................................................................................... 29 103
11.1.1 Ambient conditions ........................................................................................................ 29 104
11.1.2 Test gas................................................................................................................................ 29 105
11.1.3 Reference conditions ..................................................................................................... 30 106
11.2 Test schedule ......................................................................................................................... 30 107
11.3 Test methods for outlet pressure .................................................................................... 32 108
11.3.1 Purpose ............................................................................................................................... 34 109
11.3.2 Test equipment ................................................................................................................ 34 110
ISO/DIS 10524-3:2025(en)
iv
© ISO 2025 – All rights reserved
oSIST prEN ISO 10524-3:2025
iT eh Standards
(https://standards.iteh.ai)
Document Preview
oSISTprEN ISO 10524-3:2025
https://standards.iteh.ai/catalog/standards/sist/0458de8b-e548-447a-9fc2-4d21aebb8087/osist-pren-iso-10524-3-2025
© ISO/DIS 10524-3:2024(1) – All rights reserved
11.3.3 Test methods for determining outlet pressure limits for VIPRs fitted with a 111
pressure outlet .................................................................................................................. 35 112
11.3.4 Test method for determining outlet pressure limits for a VIPR only fitted 113
with a flow outlet .............................................................................................................. 36 114
11.4 Test method for pressure-relief device ......................................................................... 36 115
11.4.1 Purpose ............................................................................................................................... 36 116
11.4.2 Test procedure ................................................................................................................. 36 117
11.5 Test methods for internal leakage through the pressure regulator valve ....... 37 118
11.5.1 Purpose ............................................................................................................................... 37 119
11.5.2 Test procedure ................................................................................................................. 37 120
11.6 Test method for mechanical strength ........................................................................... 37 121
11.6.1 Purpose ............................................................................................................................... 37 122
11.6.2 Test procedure ................................................................................................................. 37 123
11.7 Test method for resistance to ignition through the valve inlet connection ..... 38 124
11.7.1 Purpose ............................................................................................................................... 38 125
11.7.2 General ................................................................................................................................ 38 126
11.7.3 Test procedure ................................................................................................................. 38 127
11.8 Test methods for the stability and accuracy of flow of VIPRs fitted with an 128
integral flow control device ............................................................................................... 39 129
11.8.1 Purpose ............................................................................................................................... 39 130
11.8.2 Test procedure ................................................................................................................. 39 131
11.9 Test method for flow setting torque .............................................................................. 39 132
11.9.1 Purpose ............................................................................................................................... 39 133
11.9.2 Test procedure ................................................................................................................. 39 134
11.10 Test method for loosening torques................................................................................ 39 135
11.10.1 Purpose ............................................................................................................................... 39 136
11.10.2 Test procedure ................................................................................................................. 39 137
11.11 Test for integrity of the filling port non-return valve under high flow 138
condition ................................................................................................................................. 39 139
11.11.1 Purpose ............................................................................................................................... 39 140
11.11.2 Test procedure ................................................................................................................. 40 141
11.12 Integral flow control device endurance test ................................................................ 41 142
11.12.1 Purpose ............................................................................................................................... 41 143
11.12.2 Test procedure ................................................................................................................. 42 144
11.13 Pressure regulator endurance test for VIPRs type A ................................................ 42 145
11.13.1 Purpose ............................................................................................................................... 42 146
11.13.2 Test procedure ................................................................................................................. 42 147
12 Gas-specific type tests ................................................................................................................ 43 148
12.1 Purpose .................................................................................................................................... 43 149
12.2 Apparatus ................................................................................................................................ 44 150
12.3 General test conditions ...................................................................................................... 45 151
12.3.1 Test conditions ................................................................................................................. 45 152
12.4 Test procedure ...................................................................................................................... 45 153
12.4.1 Test method for determining outlet pressure limits for a VIPR fitted with a 154
pressure outlet .................................................................................................................. 45 155
12.4.2 Test method for stability and accuracy of flow of a VIPR fitted with an 156
integral flow control device .......................................................................................... 46 157
12.4.3 Test method for residual pressure device ............................................................... 46 158
(informative) Example of VIPRs .................................................................................. 47 159
(Normative) Specific requirements for VIPRs intended to supply air or 160
nitrogen for driving surgical tools ................................................................................. 49 161
ISO/DIS 10524-3:2025(en)
v
© ISO 2025 – All rights reserved
oSIST prEN ISO 10524-3:2025
iT eh Standards
(https://standards.iteh.ai)
Document Preview
oSISTprEN ISO 10524-3:2025
https://standards.iteh.ai/catalog/standards/sist/0458de8b-e548-447a-9fc2-4d21aebb8087/osist-pren-iso-10524-3-2025
© ISO/DIS 10524-3:2024(1) – All rights reserved
B6.4.2 Flow outlet .............................................................................................................................. 49 162
B.6.9 Pressure-relief device.............................................................................................................. 49 163
(informative) Rationale ................................................................................................. 50 164
(informative) How to qualify a VIPR for use in an air (according to EN 165
13718-1
[4]) / road (according to EN 1789
[5]) ambulance ....................................... 54 166
(informative) ASTM G175-24[2]
(Pill Test - Phase 2) Promoted ignition test 167
..................................................................................................................................................... 55 168
Bibliography .
LINK 3 - TÌM KIẾM SÁCH/TÀI LIỆU ONLINE (GIÁ ƯU ĐÃI NHẤT)
LINK 4 - TÌM KIẾM SÁCH/TÀI LIỆU ONLINE (GIÁ ƯU ĐÃI NHẤT)
ISO 10524-3 2005 Pressure regulators for use with medical gases - Part 3 Pressure regulators integrated with cylinder valves (2005).
LINK DOWNLOAD (TÀI LIỆU VIP MEMBER)
ISO 10524-3 2019 Pressure regulators for use with medical gases - Part 3 Pressure regulators integrated with cylinder valves (2019).
ISO 10524-3 2025 Pressure regulators for use with medical gases - Part 3 Pressure regulators integrated with cylinder valves (2025).
LINK ĐẶT MUA TÀI LIỆU ONLINE 1
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