Korea Food and Drug Administration  
Public Announcement No. 2009 -269 
 
 
 
 
 
 
 
Public Notice for Proposed Partial Revision to  
‘Medical Devices Standard ’  
 
 
 
 
 
 
 
October, 2009  
 
 
 
 
 
 
 
 
 
 
Korea Food and Drug Administration  
 
  
Korea Food and Drug Administration   
Public Announcement No. 2009 -269 
 
We hereby announce, in accordance with provisions in the Article 46 of the ‘Administrative 
Procedures Act’, the intent, reason and the key elements of the partial revision to ‘ Standard for 
Medical Devices ’; to notify the  citizens in advance and to collect the public’s opinions.  
                                                                                                                                                                          
October 23, 2009  
                                                                                                                                                                                   
Commissioner,                                                                         
Korea Food and Drug Administration  
 
 
 
Public Notice for Proposed Partial Revision to  
‘Medical Devices Standard ’  
 
 
1. Reason for the revision  
 
The reason for this revision is to reflect  the changes made to some of item names in ‘Regulations 
for medical device items and the classification’, to revise the Medical Devices Standard to 
conform to the international standard, and to establish the standard for “ Acrylic resin  based bone 
cement”; in order  to stipulate the needed standard to ensure the safety and effectiveness of the 
devices.  
 
2. Key Elements  
 
A. Revise the item name and standard for “ Dental Noble Metal Alloy (Porcelain Fused to 
Alloy )” (Appendix).  
(1) Changed the item name to “ Metal Ceramic Alloy ” in accordance with the ‘Regulations 
for medical device items and the classification’.  
(2) Established a standard for the contents of hazardous elements (nickel, cadmium, and 
beryllium) in a product.  
(3) Established physical, chemical and performance test specifications for melting range, 
coefficient  of linear thermal expansion  etc. to conform to the international standard.  
 
B. Revise the item name and standard for “ Dental Noble Metal Alloy (Brazing materials )” 
(Appendix).  
(1) Changed the item name to “ Alloy for brazing” in accordance with the ‘Regulations for 
medical device items and the classification’.  
(2) Established a standard for the contents of hazardous elements (nickel, cadmium, 
beryllium, and lead) in a product.  (3) Established physical, chemical and perf ormance test specifications for melting range, 
coefficient of linear thermal expansion  etc. to conform to the international standard.  
 
C. Establish the standard for “ Acrylic resin  based bone cement”  (Appendix).  
(1) Established test methods and standards for compressive strength, flexural strength , and 
component checking or content testing in that they conform to the international standard.  
 
3. Presenting written opinions  
 
Any individual or group who has opinion(s) about the Proposed Partial Revision to ‘Medical  
Devices Standard ’ (Attachment)  is welcome to present opinions in writing to the Commissioner 
of the Korea Food and Drug Administration ( CC: Medical Device Standardization Division, 
Address: 194 Tongilro, Eunpyeong -gu Seoul ( Postal Code: 122 -704), Phone: 02-350-4951 Fax: 
02-350-4950)  with the following information by November 16th, 2009 : 
 
 A. Opinions about this announcement (Whether you are for or against it and the reasoning)  
B. Your name (for groups, name of the group and name of the representative), ad dress and phone 
number   
C. Other references  
 
Attachment:  Proposed Partial Revision to ‘Medical Devices Standard ’  
Korea Food and Drug Administration  
Public Notice No. 2009 - 
 
We hereby revise the ‘Medical Devices Standard’,  which is u nder the provision o f the Article 18 
of ‘Medical Devices Act’, (Korea Food and Drug Administration, Public Notice No. 2009 -134, 
Dated August 24, 2009), as follows.  
 
2009  
                                                                                                          
Commissioner,                                                                                                                                               
Korea Food and Drug Adminis tration  
 
 
Proposed Partial Revision to  
‘Medical Devices Standard ’  
 
 
‘Medical Devices Standard’  shall be revised as follows:  
 
Change “Dental Noble Metal Alloy (Porcelain Fused to Alloy )”, “Dental Noble Metal Alloy 
(Brazing materials )” to “ Metal Ceramic Alloy”, “Alloy for Brazing” respectively a s per the 
enclosure, and newly add “ Acrylic resin  based bone cement” as per the enclosure.  
 
 
ADDENDUM (2009. .)  
 
Article 1 (Date of Enforcement)  This regulation shall take effect from the date of the notice.  
 
Article  2 (Transitional Measures)  If any written requests for review of “ Metal ceramic Alloy” 
and “Alloy for Brazing ”, such as application for permission, permission for changes, or review 
of technical documents has already submitted at the time of the enforcemen t of this notice, they 
may follow the previous standard . 
 
 
 
 
  
[Enclosure]  
 
Metal Ceramic Alloy  
(Related Standards: ISO 22674 and ISO 9693)  
 
1. Scope  
1.1 Scope of application  
This standard applies to metal ceramic alloys that come under the classificati on C03000 of 
‘Regulations for medical device items and the classification’ ( Korea Food and Drug 
Administration Notice), and is limited to metallic materials that are suitable to use for dental 
restoration, which is combination of metal and ceramic.  
 
1.2 C lassification  
The classification of alloys used for metal ceramic alloy shall follow the classifications of dental 
noble metal alloy, dental base -metal alloy I (Cobalt based), dental base metal alloy II (Nickel 
based) in this notice, or ISO 22674 classific ation system.  
 
1.2.1 Class 0: A fixed dental restoration that stands against low load. For example, one surface 
inlay covered with small veneer and a veneer crown.  
* The metallic material for metal ceramic gold crown made by a way of e lectroforming or 
sintering also belongs to the Class 0.  
 
1.2.2 Class 1: A fixed dental restoration that stands against low load. For example, one surface 
inlays with veneer and a veneer crown.  
 
1.2.3 Class 2: A fixed dental restoration with ceramic veneer. For example, a vene er crown that 
has multiple surfaces.  
 
1.2.4 Class 3: Multiple -unit fixed dental restoration with ceramic veneer, such as a bridge.  
 
1.2.5 Class 4: An implant that supports the superstructure. It is applied to a thin layer, which 
receives a large force. For  example, removable partial denture, clasp, thin veneer crown, wide 
and long briefs or bridge with narrow surface, bar, and attachment.  
 
2. Test Standard  
 
2.1 Physical and chemical test  
 
2.1.1 Indication of elements  The elements in raw materials that take  more than 1.0 wt. % of the total elements of alloy must 
be represented in ±0.1 wt. % precision. And elements that take between 0.1 wt. % and 1.0 wt. % 
of the total elements must be represented by its name or symbol.  
 
2.1.2 Element content tolerance  
 
2.1.2 .1 The content of silver or each alloy component in the noble metal alloy shall be within 
±0.5 wt. % tolerance range of the value provided by the manufacturer.  
 
2.1.2.2 For base metal alloy, the content of elements that take more than 20 wt. % of the total  
elements shall be within ±2 wt. % of the value provided by the manufacturer, and the content of 
elements that take between 1 wt. % and 20 wt. % of the total elements shall be within ±1 wt. % 
of the value provided by the manufacturer.  
 
2.1.2.3 Contents of hazardous elements  
Nickel, cadmium, beryllium are regarded as hazardous elements. The contents of cadmium and 
beryllium shall not exceed 0.02 wt. %. If the nickel content exceeds 0.1 wt. %, its amount shall 
be displayed on the package in 0.1 wt. % precisio n. 
 
2.1.2.4 Titanium  
The standard specification data, in accordance with ASTM B 348 -03, shall be applied to 
unalloyed titanium. And data identifying its grade shall be submitted.  
 
2.1.3 Characteristics  
The mechanical attributes, density, corrosion resistan ce, dis colour ation resistance shall 
compatible with the classifications of dental noble metal alloy, dental base metal alloy I (Cobalt 
based), dental base metal alloy II (Nickel based) in this notice, or ISO 22674. However, in case 
of Class 0 alloys, the s pecimen for tensile strength shall be prepared according to the ISO 22674.  
 
2.1.4 Melting range  
If the solidus temperature of the alloy is below 1,200 °C, both the solidus and liquidus 
temperature shall be within ±20°C of the represented value, and within ±50°C if the solidus 
temperature of the alloy is above 1,200 °C.  
 
However, if the melting point of unalloyed metal is below 1,200 °C, the melting point shall be 
within ±20 ° C of the represented value and ±50 ° C if it is above 1,200 °C.  
 
2.1.4.1 Test meth od 
Using cooling curve test, measure alloys of which the solidus temperature is below 1,200 °C and 
unalloyed metals of which the melting point is below 1,200 °C in ±10°C precision. For alloys of 
which the solidus temperature is above 1,200 °C and unalloyed  metal of which the melting point 
is above 1,200 °C, measure in ±25°C precision.  
 
2.2 Performance test  
 
2.2.1 C oefficient of linear thermal expansion   
2.2.1.1 Standard  
Measured value for c oefficient of linear thermal expansion  shall be within ±0.5x10-6xK1 of the 
value provided by the manufacturer. But this value is not guaranteed to conform to all ceramics.  
 
2.2.1.2 Equipment  
Use a d ilatometer  that has been properly rectified for the test.  
 
2.2.1.3 Test specimen preparation  
Following the manufacturer’s dire ction, prepare 2 metal specimens. Each specimen shall be in 
bar or rod shape with a cross section of less than 30mm2. Polish both ends of each specimen, and 
make sure they are at right angles to the major axis of the specimen.   
 
2.2.1.4 Test method  
Apply heat treatment with the same method as the one used for mechanical attribute test 
specimen preparation. Measure the thermal expansion  up to 550 °C for each of 2 specimens with 
the heating speed of 5±1°C/min. Calculate the coefficient of linear thermal expa nsion  for each 
specimen from between 25°C  and 500°C of the thermal expansion  curve, which has been 
generated as the temperature increases. In the case of titanium and other unalloyed metals, 
relevant documents may be referred.  
 
2.2.1.5 Analysing the resul t 
For metals, average the values taken from between 25°C  and 500°C of the thermal expansion  
curve to get the  linear thermal expansion  coefficient   (25°C  ~ 500°C), round this average value 
off to the degree of 0.1 x 10-6K-1 and record it as the average coefficient of thermal expansion . 
 
2.2.2 Metal -ceramic combination (Schwickerath crack initiation test)  
 
2.2.2.1 Standard  
The debonding/crack initi ation strength of the metallic materials and the ceramics shall be 
greater than 25 MPa for at least one ceramic.  
 
2.2.2.2 Equipment  
Flexural strength tester:  
It shall be 3 -point flexural  strength testing machine, which the distance between the supports is 
20mm. The crosshead speed shall be 1.5 ± 0.5 mm/min, and the ends of the supports and the 
bending bar shall have hemispherical  surfaces with radius of 1mm.  
 
2.2.2.3 Test specimen preparation  
Cast 6 of 25 ± 1 mm * 3 ± 0.1 mm * 0.5 ± 0.05 mm alloy/metal spec imens, to be used as the base 
structures for metal ceramic dental prostheses, according to the manufacturer’s processing 
procedure. Examine the specimens by closely watching the surface finishing (for example, 
washing, sandblasting and oxidation etc.) as d irected by the manufacturer.  
Before applying the ceramic as a specimen, fix the electric kiln for calcinations as recommended 
by the manufacturer. Perform test calcinations with raw ceramic to get the appropriate grade of calcinations and surface grossing on opaque ceramic and body ceramic. Adjust the temperature 
and time when necessary.  
As shown in Figure 1, symmetrically apply opaque ceramic to the 3mm sides with 8 ± 0.1 mm 
distance as directed by the manufacturer. Add each specimen on top of the casted c eramic in that 
the total thickness of the ceramic to be 1.1 ± 0.1 mm after the calcinations.  
 
 
 
 
 
 
 
 
 
 
<Figure 1> Arrangement of specimens  (unit: mm)  
 
 
The layers of ceramic shall be rectangular. Body ceramics can be added to calcinations to get 
needed th ickness and shape, if necessary. Carefully polish the rectangular shape using a disk. If 
needs be, remove ceramics overflowed from the metal plate. Perform the second calcinations as 
directed by the manufacturer.  
 
2.2.2.4 Test method  
Place the calcinated s pecimen on a ceramic flexural strength test fixture (distance between the 
supports: 20 mm, radius of the bending piston: 1 mm) that is located symmetrically on the 
opposite side of the load. Apply force at a constant speed of 1.5 ± 0.5 mm/min until the spe cimen 
fractures and record the force. The fracture force for each of 6 specimens Ffail (Newton) shall be 
measured from specimens failing, which ruptured due to debonding or cracking initiation at one 
end of the ceramic layer. If there is any fractured spec imen due to the cracking in the middle of 
the ceramic layer, replace it to keep the number of appropriate specimens to 6.  
 
2.2.2.5 Analysing the result  
Coefficient k shall be multiplied by the fracture force Ffail. Coefficient k can be read from Figure 
2. Coefficient k is the thickness factor of the 0.5 ± 0.05 mm metal plate dM and the value of the 
modulus of elasticity EM for the used metallic material. To see the k value for a certain thickness 
dM, select the corresponding curve for proper EM value, and then read the value of that thickness 
dM from the curve. Debonding/crack initiation strength Tb can be calculated using the following 
formula.  
 
Tb = k *  Ffail 
 
 
If more than 4 out of 6 specimens satisfy the requirements, the metal -ceramic combination is 
considered as compatible. If 3 of them were satisfied, perform the test over again. When less than 3 specimens satisfied the requirements after the retest, the metal -ceramic combination is 
considered as incompatible.  
 
 
<Figure 2> Diagram for measuring coef ficient k 
 
 
2.2.2.6 Alternative procedure  
Debonding/crack initiation strength Tb also can be calculated based on the flowchart in Figure 3.  
 
 <Figure 3> Flowchart for debonding/crack initiation strength calculation  
 
2.3 Biological safety test  
The biocompa tibility shall be evaluated. When the test standard on biological safety is needed, the 
standard shall conform to the ‘Common Standard for Biological Safety of Medical Devices’ 
(Korea Food and Drug Administration Notice), ISO 10993 and ISO 7405 etc.  
 
3. Items to record  
 
The test results shall be recorded in accordance with the items mentioned in the ‘Regulations for 
examining technical document etc. of medical devices’ (Korea Food and Drug Administration 
Notice) including following items.  In addition, the material, manufacturer or supplier of ingot 
shall be clearly represented. Metals that are supplied in too small or irregular particles to express 
are excluded.   
 
3.1 Chemical composition (wt. %)  
(In the case of titanium, indicate the class specified in AS TM Designation B 265 -03 or B 348 -
03) 
 
3.2 Classification of dental noble metal alloy, dental base metal alloy I (Cobalt based), dental 
base metal alloy II (Nickel based), or ISO 22674 classification.  
 
3.3 Yield strength (MPa) and fracture elongation (%), density (g/cm2) 
 
3.4 Casting temperature range and melting temperature range (°C)  
 
3.5 C oefficient of linear thermal expansion  (10-6K-1) 
 
3.6 The name and content of hazardous element, if exists.  
 
3.7 The message of warning and caution for hazardous elemen t, if exists.  
 
3.8 The colour  of the metallic material (“white” or “yellow”)  
 
3.9 Recommended combination technique or method.  
 
4. Other References  
The distributor of metallic material shall provide a detailed guide to the metallic material 
including the d irections on brazing or welding, and the surface finishing needed to get a 
satisfactory combination for at least one particular (name of) ceramic raw material. In relation to 
titanium, the distributor of related processing system(s) shall provide the above  mentioned guide. 
The manufacturer’s recommendations for at least one (name of) metallic material to provide 
satisfactory combination with the ceramic material, and guide to applying the ceramic material 
and detailed direction of calcinations schedule shal l be provided by the distributor of the ceramic. 
Detailed direction with regard to matters that require attention shall be written on the package or 
attached document.   
Alloy for Brazing  
(Related Standards: ISO 9333)  
 
 
 
1. Scope  
This standard applies to a lloy for brazing used to connect dental alloys and come under the 
classification C04000 of ‘ Regulations for medical device items and the classification ’ (Korea 
Food and Drug Administration Notice).  
 
2. Test Standard  
 
2.1 Physical and chemical Test  
 
2.1.1 Indication of elements  
 
2.1.1.1 Standard  
The elements in raw material that take more than 1.0 wt. % of the total elements must be 
represented in ±0.1 wt. % precision. And elements that take between 0.1 wt.%  and 1.0 wt.% of 
the total elements must be repre sented by its name or symbol.  
 
2.1.2 Element content tolerance  
 
2.1.2.1 Standard  
The content of silver or each alloy component in a noble metal alloy shall be within ±0.5 wt. % 
tolerance range of the value provided by the manufacturer.  
For base metal alloy , the content of elements that take more than 20 wt.% of the total elements 
shall be within ±2 wt.% of the value provided by the manufacturer, and the content of elements 
that take between 1 wt.% and 20 wt.% of the total elements shall be within ±1 wt.% of  the value 
provided by the manufacturer.  
Nickel, cadmium, beryllium, and lead are regarded as hazardous elements. The contents of 
cadmium, beryllium and lead shall not exceed 0.02 wt.%. If the content of nickel exceeds 0.1 
wt. %, its amount shall be displa yed in 0.1 wt. % precision on the package.  
 
2.1.2.2 Test method  
Test with one of commonly used quantitative analysis methods by which greater than 0.1 wt. % 
precision is guaranteed.  
 
2.1.3 Melting range  
 
2.1.3.1 Standard  
Both the solidus and liquidus tempe ratures of alloy shall be within ±20°C of the value 
represented by the manufacturer.  
 2.1.3.2 Test method  
Using cooling curve test, measure the solidus and liquidus temperatures in ±10°C precision.  
 
2.1.4 Corrosion resistance (static immersion test)  
 
2.1.4 .1 Standard  
When the tested and untested specimens were compared with naked eyes, any differences due to 
chemical reaction shall not be observed.  
 
2.1.4.2 Test specimen preparation  
Prepare 4 of approximately 10 mm * 10 mm * 1 mm specimens and wash the surf aces. Cut the 
specimens in halves so that the size becomes 5 mm * 10 mm * 1 mm, and then braze two of 
these halves. If two different kinds of metallic materials are being brazed, make sure one of each 
half is being used. Keep the gap between the halved spe cimens to be 0.2 ±  0.1 mm.  Use 
recommended fluxing agent and follow brazing process provided by the manufacturer. Perform 
surface polishing according to the standardized metal surface polishing procedure so that 
minimum 0.1 mm of all the surfaces is groun d and all foreign substances  can be completely 
removed. At the final phase of the surface polishing, finish with wet silicon carbide papers that 
conform to ASTM 600 or FEPA P 1200 standard. The same kind of carbide paper should be used 
for all specimens, s o that ev ery specimen will have the same components . 
 
2.1.4.3 Reagents  
Lactic acid (90%)  (C 3H6O3)   For analysis  
Sodium chloride (NaCl)   For analysis  
Distilled water     Grade 2 (see ISO 696 for reference)  
Ethanol (C 2H5OH) or methanol (CH 3OH) 
 
2.1.4.4 Etch ing solution preparation  
Use new etching solution for each test. Dissolve 10.0 ± 0.1 g of lactic acid and 5.85 ± 0.05 g of 
sodium chloride in approximately 300 ml of distilled water to prepare the etching solution. The 
pH of the etching solution shall be 2 .3 ± 1.0.  
 
2.1.4.5 Test method  
Measure the surface of prepared specimen in 0.1cm2 precision.  
Steep the specimen in ethanol or methanol for ultrasonic cleaning for 2 minutes. Next, wash with 
distilled water and then dry it completely.  
Put each specimen int o an individual borosilicate glass container (approximately 16 mm in 
diameter, 160 mm in depth); measure the Potential Hydrogen (pH) of the test solution; fill the 
glass container with this test solution to completely submerge the specimen(about 10 ml). Re cord 
the amount of the test solution used for corrosion test  in 0.1 ml precision. Make the glass 
container airtight to prevent the etching solution from evaporation; keep it for 7 ± 0.1 days at 37 
±1 °C. Remove the specimen from the glass container; measur e and record the pH of the 
remaining etching solution.  
 
2.1.4.6 Analysing the result  
Observe the brazed gap of specimen with a microscope of 10 magnifications.   
2.2 Performance test  
 
2.2.1 Tensile strength  
 
2.2.1.1 Standard  
The tensile strength at the braz ed joint shall be higher than 250 MPa. If the 0.2% offset yield 
strength of one or both of metals to be soldered by brazing material is lower than 250 MPa, the 
tensile strength of the brazing material shall be higher than the 0.2% offset yield strength of the 
one that has lower yield strength of the two metals.  
 
2.2.1.2 Specimen preparation  
The specimen consists of metallic materials to be combined with the brazing material, which is 
provided by the manufacturer. Produce the specimen using an investment cas ting that is also 
known as “lost wax process”, the commonly used metal casting method. For metallic material to 
be tested with brazing material, another method provided by the manufacturer can be used and 
can be prepared as follows.  
Prepare 6 test specimen s as shown in Figure 1 or Figure 2. If any visible fault is detected in a 
specimen, replace it with another. Cut each specimen, using a sharp saw, at the centre  of gauge 
length perpendicular to the major axis; remove the rough edge. Polish the cutting plan e to be flat 
and perpendicular to the major axis of specimen. Align two of halved specimens using any 
device or a jig. When brazing with different metallic materials, use each half of the two 
specimens. Make the gap distance to be 0.2 ± 0.1 mm. Braze accor ding to the direction provided 
by the manufacturer with the recommended fluxing agent. The diameter of each tensile test 
specimen after the brazing shall be within the tolerance range as shown in Figure 1 and Figure 2, 
and any partial disposition shall not  be observed when rotated.  If the yield strength of the base 
alloy is lower than 250 MPa, prepare additional 6 specimens of the base alloy to get 0.2% offset 
yield strength.  
 
 
<Figure 1> Rodlike Tensile Strength I  (unit: mm)  
  
<Figure 2> Rodlike Tensile  Strength II  (unit: mm)  
2.2.1.3 Test method  
Perform tensile test on brazed specimen with 1.5 ± 0.5 mm per minute cross -head speed until the 
specimen ruptured. If the rupture occurred outside of the gauge length, ignore the specimen and 
the result value; re place the specimen with another and repeat the test. Calculate the tensile 
strength for initial cross section of each specimen from the load -displacement record.  
 
Record the measured value from the test and the average value in 1 MPa and 5 MPa respectively . 
 
2.2.1.4 Analysing the result  
If 4 out of 6 specimens satisfied the standard value, it will be deemed as compatible. If satisfied 
specimens are less than 2, it will be deemed as incompatible. When satisfied specimens were 3, 
retest with 6 specimens on an other lot. It will be deemed as compatible only if more than 5 
specimens satisfied the standard value from the retest.  
 
2.3 Biological safety test  
The biocompatibility shall be evaluated. When the test standard on biological safety is needed, the 
standard shall conform to the ‘Common Standard for Biological Safety of Medical Devices’ 
(Korea Food and Drug Administration Notice), ISO 10993 and ISO 7405 etc.  
 
3. Items to record  
The test results shall be recorded in accordance with the mentioned items in the ‘R egulations for 
examining technical document etc. of medical devices’ (Korea Food and Drug Administration 
Notice) including following items.     
 
3.1 Chemical composition (wt.%), density (g/cm2) 
 
3.2 Tensile strength  
 
3.3 Recommended fluxing agent and meta llic material etc.  
 
3.4 Detailed direction on brazing for the recommended metallic material  
 
3.5 The name and content of hazardous element, if it exists.  
 
3.6 The message of warning and caution for hazardous element, if it exists.  
  
Acrylic Resin based Bo ne Cement  
(Related Standard: ISO 5833)  
 
 
 
1. Scope  
1.1 Scope of application  
This standard applies to bone cement that come under the classification B03190.01 of 
‘Regulations for medical device items and the classification’ ( Korea Food and Drug 
Administra tion Notice); is limited to acrylic resin based bone cement intended to use for the 
fixation of polymer or metallic implant , such as artificial hipbone joint  and artificial kneecap 
joint, to living bone.  
 
1.2 Types  
Acrylic resin based bone cement has two types; intended for use with a syringe or in dough state. 
These are supplied as units containing premeasured amounts of sterile powder and of sterile 
liquid in forms suitable for mixing at the time of implantation. Powder contains polymer 
particles and ini tiator, and radio -opacifier when necessary. In some cases, the radio -opacifier is 
supplied separately.  
 
2. Test Standard  
 
2.1 Physical and chemical Test  
 
2.1.1Appearance  
There shall not be any other particles or pollutants, and the powder shall not have an y lumps in it.  
 
2.1.2 Capacity  
When the volume of liquid and the weight of powder in 5 bone cements were measured with 
±0.1 ml and ±0.1g precision respectively, the tolerance range shall be within 5% of the claimed 
value.  
 
2.1.3 Heavy metal test  
Mix and ha rden the bone cement and elute it at 37 ± 1 °C for 72 ± 2 hours; put in the test 
solution and test according to Method 1, Heavy Metal Test Methods, General Test Methods of 
the Korean Pharmacopoeia; the colour  of the test solution shall not be darker than t he 
comparative solution (comparative solution : standard lead solution 2.0 ml).  
 
2.1.4 Component checking or Content testing  
Perform the component checking for powder and liquid components as listed in the Table 1 
using the following methods; GC (Gas Chrom atography), FTIR (Fourier Transform Infra -Red), 
HPLC (High -Performance Liquid Chromatography), MS (Mass Spectroscopy), X -ray, Titration 
and other test methods that are equivalent to these. Examine if all the components of each product are presented as they  were claimed to be. This component checking  can be replaced 
with contents testing.  
 
[Table 1. Example of Components ] 
 
Type  Example of Components  
Powder  PMMA ( Poly Methyl Methacrylate, Barium Sulphate (BaSO4), DiBenzoyl Peroxide 
(BPO), Antibiotics (only if they are contained in the product) etc.  
Liquid  MMA ( Methyl Methacrylate), DMPT (N, N -Dimethyl Para Toluidine), Hydroquinone 
etc. 
* The components may vary with products.  
 
2.1.5 Stability of liquid component  
 
2.1.5.1  
When tested with the method below, the viscosity of the liquid (streaming time) shall not 
increase more than 10%. Test with two liquid components.  
 
2.1.5.2 Equipment and the test solution preparation  
Keep the viscometer and the liquid component of bone cement at 23 ± 1°C for at least 1 hour  
before the test. Process the test at this temperature.  
 
2.1.5.3 Test method  
a. Fill the viscometer with the liquid  
b. Measure the time taken for the liquid to be in equilibrium with the meniscus, and record the 
time as the streaming time ta (ta). 
c. Put t he liquid in an airtight container in a dark place; heat it at 60 ± 2 °C for 48 ± 2 hours; cool 
it down to 23 ± 1°C and leave it for an hour at this temperature.  
d. Repeat the steps a and b, record the streaming time as tb (tb). 
 
2.1.5.4 Analysing the resu lt 
Calculate the change in streaming times ( t) of the liquid in percentage using the formula below.  
 
 
t = tb - ta / ta * 100%  
 
2.1.6 Kneading time  
 
2.1.6.1 Standard  
When tested with the method below, the kneading  time of dough state bone cement shall be 
under 5 minutes on average, and the accepta ble kneading time tolerance between bone cements 
shall not exceed 1minute 30 seconds.  
 
2.1.6.2 Equipment and test environment  Regulate the temperature of bone cements for kneading and related equipment to be 23± 1 °C ; 
keep at least for 2 hours in relative  humidity of above 40% ; test under these temperature and 
humidity conditions.  
 
2.1.6.3 Test method  
a. Mix the bone cement as guided in the maker’s manual.  
b. Start to measure the time from the point when the liquid component is added to the powder 
compone nt. 
c. Wait about a minute, wear powder -free and non -washed surgical latex gloves; carefully feel 
the surface of the mixture; observe whether there any fibres have formed between the bone 
cement and the glove when fingers are taken away.  
d. Continue knead ing while the lower part of the bone cement is exposed to the air; observe 
frequently, at the maximum 15 seconds interval, as described in step c. New globes shall be used 
every time.  
e. Record the first time the gloved fingers were clearly separated from the bone cement; this will 
be the kneading time.  
f. Repeat step a through e for the second bone cement.  
g. If the difference of the two kneading times is more than 30 seconds, test again with two 
additional bone cements.  
h. Test 2 or 4 times and calculate  the average kneading time. Round the values off to the closest 
15 seconds to get the average.  
 
2.1.7 The highest temperature and hardening time  
 
2.1.7.1 Standard  
When tested using the mould  depicted in Figure 1, the highest temperature and hardening time  
shall be the same as specified in the table below.  
 
Highest Temperature (°C)  Hardening Time (minute)   
Average  Tolerance  Average  
For Syringe  90 ±5 6.5 ~ 15  
For Dough  90 ±5 3 ~15  
 
2.1.7.2 Equipment and test environment  
Regulate the temperature of bone cements for kneading and related equipment to be 23± 1 °C ; 
keep at least for 2 hours in relative humidity of above 40% ; test under these temperature and 
humidity conditions.  
 
2.1.7.3 Test method  
a. Measure the ambient temperature from 0.5mm radius wire thermoelectric couple in the mould . 
b. Mix the bone cement as guided in the maker’s manual.  
c. Start to measure the time from the point when the liquid component is added to the powder 
component in ±0.1 second precision.  d. Knead the bone cement well, and t hen fill the mould  with 25g of bone cement; install a 
plunger and remove the cement that brimmed over the mould . In the case of bone cement for 
syringe, fill the mould  from the syringe.  
e. Measure temperatures until the point the temperature began to drop.  
f. Repeat the step a through e for the second bone cement.  
g. If the difference of the highest temperature and the hardening time is more than 10 °C and 1 
minute respectively, test again with two additional bone cements.  
h. Draw a temperature/time curve f or each bone cement as depicted in Figure 2. Record the 
highest temperature in terms of 1°C.  
 
2.1.7.4 Analysing the result  
a. Calculate the average of 2 or 4 highest temperatures and record it in terms of 1°C (Round off 
the values of 0.5 °C). The resulting  value will be the highest temperature.  
b. Referring the table in Figure 2, get the hardening time ( tset) with the formula below.  
 
Tset = Tmax + T amb / 2 
(T amb : temperature recorded in xxx, Tmax : highest temperature)  
 
c. Record Tset values in 5 seconds . Calculate the average of 2 or 4 bone cements. Round the 
values off to the closest 15 seconds to get the average. The resulting value will be the hardening 
time.  
 
 
  
<Figure 1> Mould  to test the highest temperature and the hardening time  
 
1)Mould   2)Plun ger 
 
1. Outer ring 2. Floor 3. Passage for thermoelectric couple 4. Polymer screw of the proper size to 
easily remove the specimen  5. 4 holes that grow to a point. Used to discharge exceeding bone 
cement. a the diameter of thermoelectric couple (unit: mm,  tolerance: ±0.2 mm (only if this is not 
specified))  
* material for the mould : Select one from Polytetrafluoroethylene, Poly(ehtyleneterephthalate), 
Polyoxymethylene, and DDPE.  
 
 
 
 
<Figure 2> A typical curve to determine the highest temperature and harden ing time  
Temperature (°C)  Time (minute)  
 
2.2 Performance test  
 
2.2.1 Compressive strength   
 
2.2.1.1 Standard  
When tested as below, the compressive strength shall be higher than 70 MPa.  
 
2.2.1.2 Equipment and test environment  
a. Use a stainless steel moul d like the one in Figure 3, or an appropriate form of mould  to 
produce polished bone cement of 12 ± 0.1 mm in length and 6 ± 0.1 mm in diameter.  
b. Regulate the temperature of bone cements for kneading and related equipment to be 23± 1 °C ; 
keep at least f or 2 hours in relative humidity of above 40% ; test under these temperature and 
humidity conditions  
 
2.2.1.3 Test method  
a. Mix the bone cement as guided in the maker’s manual.  b. For dough state bone cement, fill the mould  with bone cement up to a little over the brim 
within 1 minute from the kneading time that had taken in 2.1.6, and then engage the opposite 
side plate. In case of the bone cement for use with a syringe, fill the mould  with bone cement 
using a syringe. The rest are the same as for dough st ate bone cement.  
c. Lock up the mould  with holes and the other side plate each other, and leave it in a clamp for 1 
hour to let the bone cement become hard.  
d. Get the cylinder shape bone cement out from the mould  with a removing bar.  
e. Leave the cylinder  for 24 hours at 23 ± 1°C, and then measure the average diameter of each 
specimen. The diameter shall be measured from two directions that are perpendicular to at least 
two cutting planes.   
f. Put the specimen on the tester; measure with 19.8 mm/min ~ 25. 6 mm/min crosshead speed to 
produce load -strain curve like Figure 4. If the specimen breaks, stop running the tester.  
g. Repeat steps a through f for each specimen.  
 
2.2.1.4 Analysing the result  
Record the force value or 2% offset load or maximum load that  caused cracking; divide the load 
value by the cross section of the specimen, and have the resulting value as the compressive 
strength of the product.  
 
 
 
<Figure 3> Mould  to test compressive strength  
 
1)Mould  with holes 2) other side plate 3) the mould  is tightened in a clamp 4) removing bar  
(unit: mm, tolerance: ±0.2 mm (only if this is not specified))  
 
  
  
<Figure 4> Ideal load -strain curve  
Load, N  
Strain, mm  
(inside the graph, from the top: maximum load, yield load, 2% offset)  
 
2.2.2 Flexural strength  and coefficient of flexion 
 
2.2.2.1 Standard  
When tested as below, the flexural strength  and the coefficient of flexion shall be higher than 50 
MPa and 1,800 MPa respectively.  
 
2.2.2.2 Equipment and test environment  
a. Prepare the flexural strength  testin g device like Figure 5 and 5 moulds , approximately 75 mm 
* 10 mm * 3.3 mm (width * length * height), that are made of polytetrafluorethylene, 
poly(ethylene tetrephthalate), polyoxymethylene, high density polyethylene,  and aluminum 
alloys.  
b. Prepare flat and smooth plates of which the material is proper to cover the top and bottom of 
the mould , polyester film, and a C -clamp per each mould . 
c. Regulate the temperature of bone cements for kneading and related equipment to be 23± 1 °C ; 
keep at least for 2 ho urs in relative humidity of above 40% ; test under these temperature and 
humidity conditions.  
 
2.2.2.3 Test specimen preparation  
a. Cover the bottom of the mould  with a polyester film, and then put the mould  on a plate.  
b. Mix the bone cement as guided in the maker’s manual.  
c. For dough state bone cement, fill the mould  with bone cement within 1 minute from the 
kneading time that had taken in 2.1.6; place a polyester film on it and then a plate; put it into a 
clamp. In case of the bone cement for use with a syringe, fill the mould  with bone cement using a 
syringe. Prepare the rest as the same way as for dough state bone cement.  d. Wait about an hour; remove the specimen from the clamp; separate the polyester film from the 
specimen; remove the specimen from the mould . 
e. Wet polish the rim and the top of the specimen with grade 400 sandpaper to make required 
size (75 mm * 10 mm* 3.3 mm; tolerance: ±0.1 mm). Be careful to not break the specimen when 
polishing. Mark the bottom side that was not polished; this s ide will be used as a force receiving 
side during the flexural strength  test.  
  
2.2.2.4 Test method  
a. Leave the above specimen for 24 ±2 hours at 23±1 °C before testing.  
b. Measure the size of at least 3 sections of the specimen (tolerance: 0.1 mm); place it 
symmetrically to 4 -point flexural strength  testing device.  
c. Apply force to central loading plunger starting from crosshead speed of 5 ±1 mm/min and then 
slowly increase the speed. Record the level of flexion caused by the force. Increase the force 
until the specimen breaks.  
d. Apply 15N and 50N of force; r ecord the level of each flexion to the nearest 0.05mm; record 
the force value to the nearest 0.5N at the point when the specimen has broken.  
e. Repeat steps a through e for each of the rest 4 specimens . 
 
2.2.2.5 Calculating the result  
Calculate the f lexural strength  and the coefficient of flexion with the formula below; calculate 
the average and the standard deviation  of the f lexural strength  and the coefficient of flexion in 
MPa for 5 specimens.  
 
Flexu ral strength  (B) = 3 Fa / bh2 
 
F: The force when the specimen was broken (N)  
b: Average vertical length of specimens (mm)  
h: Average height of specimens (mm)  
a: Distance between inner and outer loading points (20mm)  
 
Coefficient of flexion (E) = Fa / 4fbh3 * (3l2 – 4a2) 
 
f: Difference in flexions when 15N and 50N of forces were applied (mm)  
b: Average vertical length of specimens (mm)  
h: Average height of specimens (mm)  
l: Distance between outer loading points (60mm)  
F: Load range (50N – 15N = 35 N)  
a: Dis tance between inner and outer loading points (20 mm)  
 
  
 
1. Central loading plunger  
2. Inner loading points  
3. Test specimen  
4. Device for measuring deflection (dial gauge or other)  
5. Outer loading points  
<Figure 5> 4 -point f lexural strength  testing devi ce 
 
2.2.3 Overflow  
 
2.2.3.1 Standard  
This only applies to dough state bone cement. When tested with the method below, average 
overflow of at least one specimen shall be over 2 mm.  
 
2.2.3.2 Test environment  
Regulate the temperature of bone cements for knead ing and related equipment to be 23± 1 °C ; 
keep at least for 2 hours in relative humidity of above 40% ; test under these temperature and 
humidity conditions.  
 
2.2.3.3 Test method  
a. Mix the bone cement as guided in the maker’s manual.  
b. For dough state b one cement, determine the kneading time that had taken in 2.1.6; put the 
dough into the mould  as in Figure 6 and insert a plunger.  
c. After 1 minute ± 10 seconds after reached the kneading time, apply force of 49 ± 1 N to the 
plunger for 1 minute ± 2 secon ds. Remove the force and leave the bone cement to harden.  
d. Separate the hardened bone cement from the mould ; measure the bone cement overflowed 
through 4 holes.  e. Subtract the depth of the hole that was not filled with bone cement from the initial depth  of the 
hole to get the amount of overflowed bone cement; measure the average of 4 holes to the nearest 
0.5 mm.  
f. If the average overflow is less than 2 mm, repeat steps a through e to retest.  
 
 
unit: mm  
tolerance: ±0.2 mm (only if this is not specified)  
 
 
<Figure 6> Mould  to test overflow  
(1. outer ring  2. Floor  3. Polymer screw in appropriate size to remove the specimen (optional))  
 
2.3 Biological safety test  
Test according to the ‘Common Standard for  Biological Safety of Medical Devices’ (Korea Food 
and Drug Administration Notice).  
 
2.4 Sterility Test  
When tested according to Sterility Test Methods in General Test Methods of the Korean 
Pharmacopoeia, the result shall conform to its standard.  
 
2.5 EO g as residue test  
If sterilizing with EO gas, the amount of residue for both ethylene oxide  (EO) and ethylene 
chlorohydrins (ECH) shall be less than 25 ppm when tested according to the ‘test method for 
amount of ethylene oxide  (EO) residue  after sterilizatio n’ in the  ‘Common Standard for 
Biological Safety of Medical Devices’ notified by the Commissioner of Korea Food and Drug 
Administration . 
 
3. Items to record  The recording shall follow the ‘Regulations for examining technical document etc. of medical 
device s’ (Korea Food and Drug Administration Notice).