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YY/T 0591-2011: Implants for orthosynthesis. Metallic lockable intramedullary nail
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Basic data | Standard ID | YY/T 0591-2011 (YY/T0591-2011) | | Description (Translated English) | Implants for orthosynthesis. Metallic lockable intramedullary nail | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 32,319 | | Date of Issue | 2011-12-31 | | Date of Implementation | 2013-06-01 | | Older Standard (superseded by this standard) | YY 0591-2005 | | Quoted Standard | GB 4234; GB/T 10623; GB/T 12417.1; GB 23102; JJG 139; YY 0605.9; YY/T 0640-2008; YY/T 0727.1; YY/T 0727.2; YY/T 0727.3; ISO 5832-3; ASTM D790 | | Regulation (derived from) | State Food and Drug Administration Notice 2011 No. 106; industry standard filing Notice 2013 No. 6 (No. 162 overall) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the metal interlocking intramedullary nail (metallic lockable intramedullary nail, hereinafter referred to as interlocking intramedullary nail) design features and mechanical properties, provides basic geometric definitions, dimensions, classification, terminology, materials, surface treatment, sterilization, packaging and manufacturer's information requirements, providing a characterization of the mechanical properties of intramedullary nail test method to determine the continued improvement of test methods and performance criteria for necessity. | YY/T 0591-2011: Implants for orthosynthesis. Metallic lockable intramedullary nail---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Implants for orthosynthesis.Metallic lockable intramedullary nail
ICS 11.040.40
C35
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0591-2005
Bone-engagement implant metal with interlocking intramedullary nail
Published on.2011-12-31
2013-06-01 implementation
State Food and Drug Administration released
Content
Foreword III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 2
4 Category 3
5 material 4
6 Surface treatment 4
7 Performance and test methods 4
8 Insert and remove mode 5
9 manufacturing 5
10 sterilization 5
11 Packing 5
12 Information provided by the manufacturer 5
Appendix A (Normative Appendix) Static Four Point Bending Test Method 6
Appendix B (Normative) Static torsion test method with interlocking intramedullary nails 14
Appendix C (Normative) Test method for bending fatigue of interlocking intramedullary nails 18
Appendix D (Normative) Test method for bending fatigue strength of locking screws with interlocking intramedullary nails 23
Appendix E (informative) Basic Principles 28
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard shall replace and abolish YY 0591-2005 "Bone-joined implant metal-locked intramedullary nail" from the date of implementation.
This standard also refers to the contents of YY 0341, YY/T 0727.1~0727.3 to establish enterprise standards.
This standard uses the redrafting method to refer to ASTMF1264-07 "Intramedullary Fixator Standards and Test Methods", instead of YY 0591-
2005 "Bone-joined implant metal with interlocking intramedullary nail", this standard does not inherit the specific content and layout structure of YY 0591-2005,
There has been a big change in the content. In the selection of raw materials for products, this standard adds GB 23102 "Surgical implant metal material Ti-6Al-
7Nb alloy processing material, other technical content except the original standard, has been used in YY 0341 "non-active surgical metal implant for bone bonding"
General Technical Conditions and YY/T 0727 "Surgical Implant Metal Intramedullary Nail System" have been stipulated, this standard mainly adds products
Static four-point bending test, torsion test and dynamic bending fatigue test and bending fatigue strength test of locking screw.
The technical differences between this standard and ASTMF1264-2007 are as follows.
--- Regarding the scope of application of the standard, this standard only applies to metal interlocking intramedullary nails.
---About the normative reference documents, this standard has made technical adjustments to adapt to China's technical conditions, adjustments
The situation is reflected in Chapter 2, “Regulatory Citations”, and the specific adjustments are as follows.
● Replace ASTMF138 with GB 4234;
● Replace ASTME1823 with GB/T 10623;
● Replace ASTMF1611 with YY/T 0727.1, YY/T 0727.2 and YY/T 0727.3;
● Replaced ASTME4 with JJG139.
● Removed ASTM A214/A214M, ASTM A450/A450M, ASTME467, ASTME691, ASTM
F86, ASTMF339, ASTMF383, ASTMF565, ASTMF1611, AMS5050, SAEJ524.
● Added GB 23102, ISO 5832-3, YY 0605.9 according to national conditions.
--- Removed the discussion of the old version of ASTMF1264.
--- Removed Chapter 9 "Keywords".
--- Change Appendix A.1 to Appendix A, Appendix A.2 to Appendix B, Appendix A.3 to Appendix C, and Appendix A.4 to Appendix
Record D, replace Appendix X1 with Appendix E, and delete the contents of Appendix A for laboratory comparison. The other contents remain unchanged.
--- According to the requirements of GB/T 12417.1-2008, Chapter 6 "Surface Treatment", Chapter 9 "Manufacturing", Chapter 10 "Destroy"
"Properties", Chapter 11, "Information Provided by Manufacturers", adjusted the contents and order of Chapters 5 through 12.
--- The contents of Chapter 8 are modified to refer to YY/T 0727.1, YY/T 0727.2 and YY/T 0727.3.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Food and Drug Administration.
This standard is supported by the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices and the Technical Committee of Orthopedic Implants (SAC/
TC110/SC1) is under the jurisdiction.
This standard was drafted. National Food and Drug Administration Tianjin Medical Device Quality Supervision and Inspection Center, Genesis Medical Devices (Jiangsu)
Limited.
The main drafters of this standard. Zhang Shu, Zhang Lu, Dong Shuangpeng, Jiao Yongzhe, Cai Yong, Yan Jianhong, Wang Hao.
Bone-engagement implant metal with interlocking intramedullary nail
1 Scope
This standard specifies the design of metal-locked intramedullary nails (hereinafter referred to as interlocking intramedullary nails).
Characteristics and mechanical properties, specifying basic geometric definitions, dimensions, classifications, terms, materials, surface treatments, sterilization, packaging, and manufacturer
The information requirements provide a test method for characterizing the mechanical properties of the interlocking intramedullary nail, and determine the need to continue to improve the test method and performance criteria.
Essential.
The ultimate goal of this standard is to define the performance criteria for the interlocking intramedullary nail and the performance-related mechanical properties and the test for fixation to the bone.
law. Because there is not enough knowledge, it is impossible to predict the use of special activities of the interlocking intramedullary nail in the daily life of individual patients. This standard
The purpose of quasi-implication is not to define the performance level of the interlocking intramedullary nail or the clinical performance of the specific case, and the standard does not describe or standardize the lock.
Special design of the intramedullary nail.
This standard describes interlocking intramedullary nails for surgical fixation of the skeletal system. Provides basic geometric definitions, dimensions, classifications, and
Terminology, label and material standards, performance definitions, and assays and characterization methods for important properties associated with the use of interlocking intramedullary nails in vivo.
This standard includes four standard test methods.
---Static four-point bending test method (Appendix A);
--- Static torsion test method with interlocking intramedullary nail (Appendix B);
---The method of bending fatigue of the interlocking intramedullary nail (Appendix C);
--- Bending fatigue test method for locking screws with interlocking intramedullary nails (Appendix D).
The basic principles are given in Appendix E.
This standard adopts the International System of Units (SI).
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB 4234 Surgical Implant Stainless Steel (ISO 5832-1)
GB/T 10623 Metallic material mechanical properties test terminology (ISO 23718)
GB/T 12417.1. Orthopaedic implants - Bone joints and joint replacement implants - Part 1
(ISO 14620)
GB 23102 Surgical implant metal material Ti-6Al-7Nb alloy processing material (ISO 5832-11)
JJG139 Tension, Pressure and Universal Testing Machine
Surgical implants, metallic materials - Part 9. Forged high-nitrogen stainless steel (ISO 5832-9)
YY/T 0640-2008 General requirements for passive surgical implants (ISO 14630.2005, IDT)
YY/T 0727.1 Surgical implant metal intramedullary nail system - Part 1. Intramedullary nails (ISO 15142-1)
SY/T 0727.2 Surgical implants - Intramedullary nail systems - Part 2. Locking parts (ISO 15142-2)
Surgical implants - Intramedullary nail systems - Part 3. Measurement of s
(ISO 15142-3)
ISO 5832-3 - Surgical implants - Metallic materials - Part 3. Forged titanium - 6 - - - - - - - - -
Metalicmaterials-Part 3. Wroughttitanium6-aluminium4-vanadiumaloy)
ASTMD790 Test Method for Flexural Properties of Reinforced or Unreinforced Plastics and Insulating Materials (Testmethodsforflexuralprop-
Ertiesofunreinforcedandreinforcedplasticsandelectricalinsulatingmaterials)
3 Terms and definitions
The following terms and definitions as defined in YY/T 0727.1, YY/T 0727.2 and YY/T 0727.3 apply to this document.
3.1 Geometric terms
3.1.1
Closed section closed section
A section perpendicular to the longitudinal axis of a solid or hollow interlocking intramedullary nail having a continuous outer wall.
Discussion. For the purpose of trial and insertion, the irregularity and asymmetry of the sagittal and coronal planes of the interlocking intramedullary nail should be expected.
Use for description.
3.1.2
Curved curvature
Bending is machined based on size and position, mathematical description or other quantifiable description and tolerances.
Discussion. For the positioning during the trial and insertion, the curvature of the sagittal and coronal planes of the interlocking intramedullary nail should be given for the intended use.
description.
3.1.3
Diameter diameter
The diameter of the circumcircle that surrounds the section of the interlocking intramedullary nail when measured along the working length of the interlocking intramedullary nail. If the measured diameter is working along
If the length is not constant, the measurement position should be indicated.
3.1.4
Length length
The length of the straight line between the most distal and proximal ends of the interlocking intramedullary nail.
3.1.5
Open section opensection
A section of the longitudinal axis of the hollow interlocking intramedullary nail having a discontinuity perpendicular to the outer wall.
Discussion. For the positioning during the trial and insertion, the curvature of the sagittal and coronal planes of the interlocking intramedullary nail should be given for the intended use.
description.
3.1.6
Potential critical stress concentration
CSC
Factors expected to cause stress concentration, including changes in section modulus, material properties, discontinuities, or other characteristics, where the region
High stresses are generated under expected normal load conditions.
3.1.7
Working length workinglength
The length of the uniform section of the interlocking intramedullary nail that fits the medullary cavity in the backbone region.
3.1.8
Tolerance tolerance
Describe the acceptable deviation of the nominal size of the interlocking intramedullary nail.
3.2 Mechanical properties/structure
3.2.1
Flexibility compliance
According to the definition and measurement method of the static four-point bending test described in Appendix A, it is locked under a certain bending load in a prescribed plane.
The reciprocal of the intramedullary nail stiffness.
3.2.2
Fatigue strength after N cycles of fatiguestrengthatNcycles
According to the definition and measurement method of the test, the interlocking intramedullary nail is given at a given load ratio and not less than N cycles of loading.
Maximum cyclic mechanical parameters (eg, load, bending moment, torque, stress, etc.) that damage or meet other failure criteria.
3.2.3
Failure strength failurestrength
The mechanical parameters (eg, load, bending moment, torque, stress, etc.) of the failure criteria are met according to the definition and measurement method of the test. (See Note 1)
Note 1. There is currently no test standard for this type of interlocking intramedullary nail.
3.2.4
Yield strength yieldstrength
According to the definition and measurement method of the test, the mechanical parameters of residual deformation (for example, load, bending moment, torque, stress, etc.) begin to occur.
3.2.5
No-load motion noloadmotion
The relative motion between the interlocking intramedullary nail and the bone in the absence of elastic strain and no (or very small) load changes. (See Note 1)
3.2.6
Structural stiffness structuralstiffness
The maximum slope of the elastic portion of the load-displacement curve line according to the definition and measurement method of the test.
Discussion. For the bending of the specified plane, this is defined and determined in the static four-point bending test, as described in Appendix A.
3.2.7
Ultimate strength ultimatestrength
The maximum mechanical parameters (eg, load, bending moment, torque, stress, etc.) that the structure can withstand in accordance with the definition and method of testing.
3.2.8
Represents a variable that specifies the number of cycles.
4 classification
4.1 The following interlocking intramedullary nails are generally used in combination.
4.2 Type of interlocking intramedullary nail. solid section, hollow section (open, closed, mixed).
4.3 Use specially designed interlocking intramedullary nails depending on the application
4.3.1 Preferred positioning
4.3.1.1 Right-left.
4.3.1.2 Sagittal plane - coronal plane.
4.3.1.3 proximal-distal.
4.3.1.4 Universal selection or multiple selection.
4.3.2 Preferred anatomical location
4.3.2.1 Specific bone.
4.3.2.2 Far-near-middle.
4.3.2.3 Universal selection or multiple selection.
4.3.3 Limited use only for special procedures
4.3.3.1 Emergency treatment of fractures.
a) the specified type;
b) Specify the location.
4.3.3.2 Reconstruction steps.
4.3.3.3 General selection or multiple selection.
5 materials
The material of the metal interlocking intramedullary nail should be selected according to the requirements of GB 4234, GB 23102, YY 0605.9 or ISO 5832-3. Manufacturing
The material of the locking component should be consistent with the material of the intramedullary nail.
6 surface treatment
Surface treatment should not adversely affect the biocompatibility of the metal materials used. Surface measurements should be considered in the risk analysis of the device.
Rationale on biocompatibility (GB/T 12417.1).
The implant is usually surface treated to prevent bone growth on the surface of the contact site, which may make the implant difficult to remove or unable to
take out.
7 Performance and test methods
7.1 Cross-sectional dimensional tolerances will affect the matching of the medullary cavity treatment tool (ie the medullary cavity expander) with the diameter of the interlocking intramedullary nail and will also affect the interlocking intramedullary nail.
The nail is fixed in the bone.
Terms related to the dimensional measurement of the interlocking intramedullary nail and its tools are given in YY/T 0727.1, YY/T 0727.2 and YY/T 0727.3.
7.2 Longitudinal shape tolerances (along with flexural compliance) can affect the fit and fixation of the interlocking intramedullary nail to the bone.
7.3 Fatigue strength in cases where delayed healing is expected (ie infection non-union, allograft, bone defect, composite injury, etc.)
Will affect the choice of implant.
7.3.1 For the interlocking intramedullary nail subjected to cyclic bending force, the fatigue strength and/or fatigue life shall be as specified in Appendix C.
The cyclic bending fatigue test method was used for the measurement.
7.3.2 For the interlocking intramedullary nail subjected to cyclic bending force, the fatigue strength and/or fatigue life of the locking screw shall be in Appendix D.
The locking screw cycle bending fatigue test method specified in the test is performed.
7.4 In the case of reduced implant load distribution and/or severe load (ie distal or proximal locking, subtrochanteric fracture, comminuted)
Fracture, bone defects, poor patient adaptability, etc.), bending strength will affect the choice of implant.
The static four-point bending test method specified in Appendix A shall be used to determine the yield of a locked intramedullary nail that is bent in a single plane.
Failure and ultimate strength.
7.5 Bending and torsional stiffness may affect the type of healing and healing rate (first or second healing), depending on the type of fracture (horizontal,
Oblique, etc.).
7.5.1 The static four-point bending test method specified in Appendix A shall be used to determine the bending of the interlocking intramedullary nail that is subjected to bending in a single plane.
Structural rigidity.
7.5.2 The torsional stiffness of the interlocking intramedullary nail subjected to pure torque should be determined using the static torsion test method specified in Appendix B.
7.6 For the use of a second additional fixed interlocking intramedullary nail, the allowable axial axial movement and torsional motion of the nail will affect the operation of the fracture site.
Degree of movement. (See Note 1)
7.7 Remove the system. Ensure that the interlocking intramedullary nail is removed with a suitable tool. If there is mechanical failure, the removal tool should be prior to the interlocking intramedullary nail.
effect. (See Note 1)
8 Insert and remove methods
Where applicable, the method of insertion and removal shall be in accordance with YY/T 0727.1, YY/T 0727.2, YY/T 0727.3. Enterprises can also participate
Other methods of insertion and removal are specified in accordance with this standard.
9 manufacturing
It shall comply with the provisions of Chapter 8 of YY/T 0640-2008.
10 sterilization
It shall comply with the provisions of Chapter 9 of YY/T 0640-2008.
11 packaging
It shall comply with the provisions of Chapter 10 of YY/T 0640-2008.
12 Information provided by the manufacturer
12.1 mark
It shall comply with the provisions of Chapter 11 of YY/T 0640-2008 and the marking of the implant shall not affect its intended performance.
12.2 Tags
It shall comply with the provisions of Chapter 11 of YY/T 0640-2008 and meet the following requirements.
a) diameter of the interlocking intramedullary nail (3.1.3);
b) Length of the interlocking intramedullary nail (3.1.4).
12.3 User's Manual
It shall comply with the provisions of Chapter 11 of YY/T 0640-2008.
Appendix A
(normative appendix)
Static four-point bending test method
A.1 Scope
A.1.1 This test method specifies a static four-point bend for determining the inherent structural properties of interlocking intramedullary nails for surgical fixation of the skeletal system.
Curve test. This test method includes bending tests in various planes defined relative to the main anatomical plane. Its purpose is to measure and lock the marrow
The inner nail design is related to the bending strength and bending stiffness of the material.
A.1.2 This test method specifically defines a uniform open or closed section working length along the length of the body (WL ≥ 10 × diameter)
(WL) a locking intramedullary nail that is applied to the full length of the femur, tibia, tibia, tibia or ulna. This test method does not apply to only
It is used as an intramedullary anchor for fixing a part of the long bone or short bone (such as metacarpal, humerus, toe bone, etc.).
A.1.3 This test method is not suitable for determining the intrinsic properties of the interaction between a locked intramedullary nail and bone or other biological material.
A.1.4 This test method cannot be used because there is not enough knowledge to predict the use of interlocking intramedullary nails in individual patients.
The clinical performance level of the interlocking intramedullary nail in special cases.
A.1.5 This test method cannot be used as a quality assurance document. Therefore, the statistical sampling technique for the production of interlocking intramedullary nails is not described.
A.1.6 This standard may not apply to all types of interlocking intramedullary nails. Recommended from the specific interlocking intramedullary nail and its potential use
Carefully consider the applicability of this standard.
A.1.7 This standard adopts the International System of Units (SI).
A.1.8 This standard does not attempt to address all of the safety issues involved, even those related to their use.
It is the responsibility of the users of this standard to establish appropriate safety and health practices and to clarify the applicability of regulatory restrictions prior to application.
A.2 Terms and definitions
The following terms and definitions apply to this document.
A.2.1
Flexibility compliance
Reciprocal of the stiffness of the interlocking intramedullary nail under a certain bending load in a defined plane (1/EIe. interlocking intramedullary nail, y/F. test system).
A.2.2
Bending moment
The bending moment of the failure criterion is achieved in accordance with the definition and measurement method of A.5.
Discussion. Failure can be defined as residual deformation, fracture or distortion.
A.2.3
Yielding moment bendingmomenttoyield
The bending moment of plastic deformation defined by the 0.2% strain migration method is used on the load-displacement curve.
A.2.4
Bending structure stiffness bendingstructuralstiffness
Test according to A.5, calculate according to the description in A.4.1.8 (equivalent bending stiffness EIe of the tested area) and the resistance of the interlocking intramedullary nail
Bending ability. The stiffness of the curved structure is the normative property of the section within the working length of the interlocking intramedullary nail, regardless of the length of the interlocking intramedullary nail.
A.2.5
Fixture/locked intramedullary nail flexibility fixture/devicecompliance
The combination of the clamp and the interlocking intramedullary nail measured when the loading point is collinear with the support point (eg A.6.2). This value depends on the interlocking intramedullary nail
Positioning, load, load direction and support span.
A.2.6
Ultimate bending moment ultimatebendingmoment
The bending moment at the maximum or ultimate load measured on the load-displacement curve in accordance with A.5.
A.2.7 Test mode
It consists of a compression load cycle, a constant displacement rate, and a specified failure.
The test mode is a single cycle loading, and the distance from the nearest critical stress concentration (CSC) is at least the interlocking intramedullary nail.
Three times the diameter, unless otherwise specified or the CSC is a feature of a conventional cross section over the working length.
A.3 Classification
The types of tests included in this standard are as follows.
a) Measurement of the intrinsic structural mechanical properties of the interlocking intramedullary nail - intrinsic performance.
b) Measurement of elastic stiffness and elastic strength in a four-point bending of a single cycle.
c) Measurement of the elastic compliance of a single-cycle clamp/locked intramedullary nail.
A.4 steps
A.4.1 Bending test of the inherent performance of working length (WL)
A.4.1.1 Determine the span according to the provisions of A.4.1.2 and A.4.1.3, and set the span, s, c and L not to exceed 1% of the specified value.
A.4.1.2 As shown in Figure A.1, a four-point bending test is performed under laboratory conditions, and the support span L between the two rollers used is
10cm~50cm, the span c between the loading points should not be greater than L/3. The loading point is also loaded using the roller and loads and supports the roller shaft
The diameter should be between 1.0cm and 2.6cm. Select the span according to the method given in A.7.1.
Figure A.1 Four-point bending test
A.4.1.3 The recommended loading and support spans below can reduce laboratory-to-labor differences. If the general requirements of A.7.1 can be met,
Use the recommended long or short span whenever possible.
Short span s=c=38mm L=114mm
Long span s=c=76mm L=228mm
A.4.1.4 Apply the same load at each loading point using a constant displacement rate of no more than 1 mm/s (Figure A.1 and Figure A.2).
As shown, a separate loading method located in the middle of the load point is usually used. The relative deflection y between the support point and the loading point (inside and outside) is measured. Correct
For interlocking intramedullary nails made with strain rate sensitive materials, the displacement rate at a given strain rate can be calculated using the following approximate calculation method.
Estimate.
yR=St1% and c=L-2s (A.1)
Y1% =sL 2( )c/300( )D (A.2)
=s3L-4( )s/300( )D
=s3c 2( )s/300( )D
In the formula.
St --- expected strain rate;
Y1%---the deflection of the maximum strain 1% estimated value at the loading point of the interlocking intramedullary nail;
s --- the span of the loading point and the nearest support point;
c --- intermediate span;
L --- total span (c 2s);
D --- with the diameter of the interlocking intramedullary nail.
Note. The deformation rate corresponding to the expected strain rate is only a ro...
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