This International Standard specifies the physical, mechanical, packaging and labelling requirements for curing polymerizing radio-opaque and non-radio-opaque resin cements based on poly(methacrylic acid esters). It applies to two types of cement, intended respectively for use with a syringe or in the dough state, for the fixation of internal orthopaedic prostheses and supplied as units containing premeasured amounts of sterile powder and of sterile liquid in forms suitable for mixing at the time of implantation.<\/p>\n
This International Standard does not cover the hazards associated with the use of the cement in respect of either the patient or the user of the cement. All<\/p>\n
requirements apply to, and all tests are intended to be performed on, the sterile product.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 3<\/td>\n | TitlePage – Implants for surgery\ufffd\u2014 Acrylic resin cements <\/td>\n<\/tr>\n | ||||||
| 5<\/td>\n | TableofContent – Contents Page <\/td>\n<\/tr>\n | ||||||
| 6<\/td>\n | Foreword – Foreword <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | Scope – 1\ufffd\ufffd\ufffd Scope Clause1 – 3\ufffd\ufffd\ufffd Liquid component Subclause2 – 3.1\ufffd\ufffd\ufffd Appearance Subclause2 – 3.2\ufffd\ufffd\ufffd Stability Subclause2 – 3.3\ufffd\ufffd\ufffd Accuracy of contents <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | Clause1 – 4\ufffd\ufffd\ufffd Powder component Subclause2 – 4.1\ufffd\ufffd\ufffd General Subclause2 – 4.2\ufffd\ufffd\ufffd Appearance Subclause2 – 4.3\ufffd\ufffd\ufffd Accuracy of contents Clause1 – 5\ufffd\ufffd\ufffd Liquid-powder mixture intended for syringe usage <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | Clause1 – 6\ufffd\ufffd\ufffd Liquid-powder mixture intended for use in dough state Subclause2 – 6.1\ufffd\ufffd\ufffd Setting properties, test methods and requirements Subclause2 – 6.2\ufffd\ufffd\ufffd Intrusion Clause1 – 7\ufffd\ufffd\ufffd Set and polymerized cement Clause1 – 8\ufffd\ufffd\ufffd Packaging UntitledSubclause2 – 8.1\ufffd\ufffd\ufffd Each component of the cement shall be packaged and sterilized separat… UntitledSubclause2 – 8.2\ufffd\ufffd\ufffd In the case of cement being sold with two cement units per container,… UntitledSubclause2 – 8.3\ufffd\ufffd\ufffd The materials of the package should not contaminate or permit contami… Clause1 – 9\ufffd\ufffd\ufffd Labelling Subclause2 – 9.1\ufffd\ufffd\ufffd Unit package <\/td>\n<\/tr>\n | ||||||
| 10<\/td>\n | Subclause2 – 9.2\ufffd\ufffd\ufffd Accompanying documentation <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | AnnexNormative – Determination of stability of liquid component Clause1 – A.1\ufffd\ufffd\ufffd Principle Clause1 – A.2\ufffd\ufffd\ufffd Apparatus UntitledSubclause2 – A.2.1\ufffd\ufffd\ufffd Clean glass U-tube viscometer UntitledSubclause2 – A.2.2\ufffd\ufffd\ufffd Timing device UntitledSubclause2 – A.2.3\ufffd\ufffd\ufffd Means of heating test specimens Clause1 – A.3\ufffd\ufffd\ufffd Test conditions Clause1 – A.4\ufffd\ufffd\ufffd Procedure UntitledSubclause2 – A.4.1\ufffd\ufffd\ufffd Fill the viscometer in the usual way with the liquid component. UntitledSubclause2 – A.4.2\ufffd\ufffd\ufffd Record the flow time taken for the meniscus to fall to the equilibr… UntitledSubclause2 – A.4.3\ufffd\ufffd\ufffd Heat an aliquot of the liquid component at UntitledSubclause2 – A.4.4\ufffd\ufffd\ufffd Repeat UntitledSubclause2 – A.4.5\ufffd\ufffd\ufffd Repeat Clause1 – A.5\ufffd\ufffd\ufffd Calculation and expression of results <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | Clause1 – A.6\ufffd\ufffd\ufffd Test report <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | AnnexNormative – Determination of doughing time of liquid-powder mixture of cement intended for d… Clause1 – B.1\ufffd\ufffd\ufffd Principle Clause1 – B.2\ufffd\ufffd\ufffd Apparatus UntitledSubclause2 – B.2.1\ufffd\ufffd\ufffd Timing device UntitledSubclause2 – B.2.2\ufffd\ufffd\ufffd Unpowdered latex surgical gloves UntitledSubclause2 – B.2.3\ufffd\ufffd\ufffd Equipment Clause1 – B.3\ufffd\ufffd\ufffd Test conditions Clause1 – B.4\ufffd\ufffd\ufffd Procedure UntitledSubclause2 – B.4.1\ufffd\ufffd\ufffd Mix all the components of a single unit of cement following the man… UntitledSubclause2 – B.4.2\ufffd\ufffd\ufffd After approximately UntitledSubclause2 – B.4.3\ufffd\ufffd\ufffd Repeat the probing process at maximum intervals of UntitledSubclause2 – B.4.4\ufffd\ufffd\ufffd Repeat the process described in UntitledSubclause2 – B.4.5\ufffd\ufffd\ufffd If the two doughing times differ by more than Clause1 – B.5\ufffd\ufffd\ufffd Calculation and expression of results <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | Clause1 – B.6\ufffd\ufffd\ufffd Test report <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | AnnexNormative – Determination of maximum temperature and setting time of liquid-powder mixture Clause1 – C.1\ufffd\ufffd\ufffd Principle Clause1 – C.2\ufffd\ufffd\ufffd Apparatus UntitledSubclause2 – C.2.1\ufffd\ufffd\ufffd Mould and plunger UntitledSubclause2 – C.2.2\ufffd\ufffd\ufffd Device UntitledSubclause2 – C.2.3\ufffd\ufffd\ufffd C-clamp UntitledSubclause2 – C.2.4\ufffd\ufffd\ufffd Timing device UntitledSubclause2 – C.2.5\ufffd\ufffd\ufffd Equipment Clause1 – C.3\ufffd\ufffd\ufffd Test conditions Clause1 – C.4\ufffd\ufffd\ufffd Procedure UntitledSubclause2 – C.4.1\ufffd\ufffd\ufffd Record the ambient temperature from the thermocouple in the mould. UntitledSubclause2 – C.4.2\ufffd\ufffd\ufffd Mix all the components of a single unit of cement following the man… UntitledSubclause2 – C.4.3\ufffd\ufffd\ufffd Start the timing device as soon as the powder and liquid come into … UntitledSubclause2 – C.4.4\ufffd\ufffd\ufffd Fill the mould with approximately UntitledSubclause2 – C.4.5\ufffd\ufffd\ufffd Continue the temperature measurement until shortly after the temper… UntitledSubclause2 – C.4.6\ufffd\ufffd\ufffd Repeat UntitledSubclause2 – C.4.7\ufffd\ufffd\ufffd If the two maximum temperatures (see\ufffd <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | Clause1 – C.5\ufffd\ufffd\ufffd Calculation and expression of results Subclause2 – C.5.1\ufffd\ufffd\ufffd Maximum temperature UntitledSubclause3 – C.5.1.1\ufffd\ufffd\ufffd For each unit of cement, plot the recorded temperatures against t… UntitledSubclause3 – C.5.1.2\ufffd\ufffd\ufffd Calculate the average value for the two or four determinations. R… Subclause2 – C.5.2\ufffd\ufffd\ufffd Setting time UntitledSubclause3 – C.5.2.1\ufffd\ufffd\ufffd For each unit of cement, determine from the plot made in UntitledSubclause3 – C.5.2.2\ufffd\ufffd\ufffd Record the value of Clause1 – C.6\ufffd\ufffd\ufffd Test report <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | AnnexNormative – Determination of intrusion of liquid-powder mixture of cement intended for dough… Clause1 – D.1\ufffd\ufffd\ufffd Principle Clause1 – D.2\ufffd\ufffd\ufffd Apparatus UntitledSubclause2 – D.2.1\ufffd\ufffd\ufffd Mould and plunger UntitledSubclause2 – D.2.2\ufffd\ufffd\ufffd Means of applying a compressive force UntitledSubclause2 – D.2.3\ufffd\ufffd\ufffd Means of measuring UntitledSubclause2 – D.2.4\ufffd\ufffd\ufffd Equipment Clause1 – D.3\ufffd\ufffd\ufffd Test conditions Clause1 – D.4\ufffd\ufffd\ufffd Procedure UntitledSubclause2 – D.4.1\ufffd\ufffd\ufffd Mix all the components of a single unit of cement, following the ma… UntitledSubclause2 – D.4.2\ufffd\ufffd\ufffd By means of the procedure given in UntitledSubclause2 – UntitledSubclause2 – D.4.4\ufffd\ufffd\ufffd Remove the set cement from the mould and measure the extent of intr… UntitledSubclause2 – D.4.5\ufffd\ufffd\ufffd If the average intrusion is less than <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | Clause1 – D.5\ufffd\ufffd\ufffd Test report <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | AnnexNormative – Determination of compressive strength of polymerized cement Clause1 – E.1\ufffd\ufffd\ufffd Principle Clause1 – E.2\ufffd\ufffd\ufffd Apparatus UntitledSubclause2 – E.2.1\ufffd\ufffd\ufffd Mould UntitledSubclause2 – E.2.2\ufffd\ufffd\ufffd C-clamp UntitledSubclause2 – E.2.3\ufffd\ufffd\ufffd 24-mesh silicon carbide grinding abrasive UntitledSubclause2 – E.2.4\ufffd\ufffd\ufffd Mould release agent UntitledSubclause2 – E.2.5\ufffd\ufffd\ufffd Equipment UntitledSubclause2 – E.2.6\ufffd\ufffd\ufffd Test machine Clause1 – E.3\ufffd\ufffd\ufffd Test conditions Clause1 – E.4\ufffd\ufffd\ufffd Procedure UntitledSubclause2 – E.4.1\ufffd\ufffd\ufffd If required, lightly coat the interior faces of the mould and the i… UntitledSubclause2 – E.4.2\ufffd\ufffd\ufffd Place the mould on one end plate. UntitledSubclause2 – E.4.3\ufffd\ufffd\ufffd Mix all the components of a single unit of cement, following the ma… UntitledSubclause2 – E.4.4\ufffd\ufffd\ufffd For cements intended for dough usage, determine when the doughing t… UntitledSubclause2 – E.4.5\ufffd\ufffd\ufffd Clamp the end plates and the mould together and allow the cement to… UntitledSubclause2 – E.4.6\ufffd\ufffd\ufffd If using the mould shown in <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | UntitledSubclause2 – E.4.7\ufffd\ufffd\ufffd If using another type of mould, grind the cement cylinders so as to… UntitledSubclause2 – E.4.8\ufffd\ufffd\ufffd Condition the cylinders at UntitledSubclause2 – E.4.9\ufffd\ufffd\ufffd At UntitledSubclause2 – E.4.10\ufffd\ufffd\ufffd Repeat Clause1 – E.5\ufffd\ufffd\ufffd Calculation and expression of results Clause1 – E.6\ufffd\ufffd\ufffd Test report <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | AnnexNormative – Determination of bending modulus and bending strength of polymerized cement Clause1 – F.1\ufffd\ufffd\ufffd Principle Clause1 – F.2\ufffd\ufffd\ufffd Apparatus UntitledSubclause2 – F.2.1\ufffd\ufffd\ufffd Bend test machine UntitledSubclause2 – F.2.2\ufffd\ufffd\ufffd Four-point bend test rig UntitledSubclause2 – F.2.3\ufffd\ufffd\ufffd Moulds UntitledSubclause2 – F.2.4\ufffd\ufffd\ufffd Flat UntitledSubclause2 – F.2.5\ufffd\ufffd\ufffd Polyester film UntitledSubclause2 – F.2.6\ufffd\ufffd\ufffd C-clamp(s) UntitledSubclause2 – F.2.7\ufffd\ufffd\ufffd Equipment Clause1 – F.3\ufffd\ufffd\ufffd Test conditions Clause1 – F.4\ufffd\ufffd\ufffd Procedure UntitledSubclause2 – F.4.1\ufffd\ufffd\ufffd Cover the bottom plate(s) of the mould(s) with polyester film. Plac… UntitledSubclause2 – F.4.2\ufffd\ufffd\ufffd Mix all the components of a single unit of cement, following the ma… UntitledSubclause2 – F.4.3\ufffd\ufffd\ufffd For cements intended for dough usage, determine when the doughing t… <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | UntitledSubclause2 – F.4.4\ufffd\ufffd\ufffd After approximately UntitledSubclause2 – F.4.5\ufffd\ufffd\ufffd Take care to avoid overheating the test specimens. Wet-grind the ed… UntitledSubclause2 – F.4.6\ufffd\ufffd\ufffd Measure the specimen thickness and width to an accuracy of UntitledSubclause2 – F.4.7\ufffd\ufffd\ufffd By means of the bend test machine, increase the force on the centra… UntitledSubclause2 – F.4.8\ufffd\ufffd\ufffd Record the deflection occurring at applied forces of UntitledSubclause2 – F.4.9\ufffd\ufffd\ufffd Repeat Clause1 – F.5\ufffd\ufffd\ufffd Calculation and expression of results Subclause2 – F.5.1\ufffd\ufffd\ufffd Bending modulus <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | Subclause2 – F.5.2\ufffd\ufffd\ufffd Bending strength Clause1 – F.6\ufffd\ufffd\ufffd Test report <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Implants for surgery. Acrylic resin cements<\/b><\/p>\n |