REQUIREMENTS TO MATERIALS FOR MANUFACTURING OF MEDICAL PRODUCTS

1. REQUIREMENTS TO MATERIALS FOR MANUFACTURING OF MEDICAL PRODUCTS

2. For manufacturing of medical tools, devices, equipment and so forth use set of materials: • - Threw also their alloys; • - Plastic weights; • - Rubber; • - Glass; • - Ceramics; • - A skin and its substitutes; • - Wood, etc.

3. Materials for manufacturing of medical products should satisfy such requirements: • > To be harmless, biologically inert and non toxic concerning fabrics of an organism and not to allocate substances harmful to a human body; • > To have firmness to sterilisation and disinfection; • > To be mechanically strong, to store the constant form and volume; • > To have beautiful technological properties; • > To be proof to corrosion.

4. THE GENERAL DATA ON PROPERTIES OF MATERIALS Distinguish such properties of materials: • - The mechanical; • - The technological; • - The physical; • - The chemical; • - The biological.

5. MECHANICAL PROPERTIES • Strength, hardness, toughness, elasticity, plasticity, brittleness, and ductility and malleability are mechanical properties used as measurements of how metals behave under a load. These properties are described in terms of the types of force or stress that the metal must withstand and how these are resisted. • Common types of stress are compression, tension, shear, torsion, impact, 1-2 or a combination of these stresses, such as fatigue.

6. Technological properties To the technological refer to properties which allow to define, to what technological machining there can be submitted a material, and also possibility of its most effective use at manufacturing of products. It first of all: • - Forgeability; • - A shrinkage; • - Abrasion.

7. Physical properties Physical properties of materials are defined by such basic parametres: • - In density; • - In fusion temperature; • - In boiling temperature; • - Warmly - and an electrical conduction;

8. Biological and chemical properties • To chemical properties of materials refer abilities by which their interacting with medium in which they constantly or temporarily are, for example, during sterilisation, disinfection and so forth is defined. Chemical properties are defined by a chemical compound of materials. • Biological properties of materials fathom their agency on living tissues and an organism as a whole. All materials which use for manufacturing of products medical appointments pass special check on biological inertia in laboratories on animal that to biological medium.

9. METAL MATERIALS FERROUS METALS AND THEIR ALLOYS •  The term 'ferrous' comes from a Latin word ferrum, meaning 'containing iron'. Hence, ferrous metals are all those metals that contain iron. Ferrous metals may contain small amounts of other elements such as carbon or nickel, in a specific proportion, that are added to achieve the desired properties. All the ferrous metals are generally magnetic and have high tensile strength.

11. Nonferrous metals Nonferrous metals and nonferrous alloys are not based on iron and include metals and alloys of aluminum, brass, bronze, copper, lead, tin, titanium, zinc, nickel, cobalt, tungsten, molybdenum, magnesium, precious metals, refractory metals. They are used in a variety of applications from construction to medical devices. A nonferrous alloy consists of two or more materials, one of which must be a nonferrous metal. Many nonferrous metals can be used in alloys and are chosen for specific characteristics such as strength, magnetic and electrical properties, and corrosion resistance.

13. CLASSIFICATION OF MEDICAL TOOLS All medical tools which apply in medical practice are classified on: • - The prickly; • - The cutting; • - Clips; • - The expanding; • - Wringing out; • - The probing

14. TOOLS FOR PUNCTURES, INJECTIONS, INFUSIONS • Syringes are made up of a round cylindrical barrel, a close-fitting plunger and a tip where the hub of a needle is attached. They come in a number of sizes, ranging from 5 ml to 60 ml. A 1- to 3-ml syringe is normally adequate for injections given into tissues under the skin, also called subcutaneous injections, or injections into muscle, also known as intramuscular injections. Larger syringes are used to add medication to intravenous lines and irrigate wounds.

15. Syringes are generally classified as Luer-Lok or non-Luer-Lok syringes. This classification is based on the type of syringe tip. Luer-Lok syringes have tips that require needles that can be twisted and locked into place. This design prevents the needle from accidentally slipping off the syringe. Non-Luer-Lok syringes have tips that require needles that can be pressed on to the tip of the syringe without being twisted into place.

16. To injection of liquid in significant amounts apply a syringe of type "Record" of continuous action (fig. 2-9), having a spring on a rod of the piston and supplied with tees-nozzles. Syringes for washing of cavities (fig. 2-11) differ from injection syringes in capacity and ring presence on the rod end. Exist S. for washings (fig. 2-12) in which diameter of the piston can be regulated by means of a special washer from silicone rubber. • Let out special S, the liquids intended for introduction in a throat, in a uterus, and also stomatologic, for oral cavity washing (fig. 3-14, 15, 17, 18). They, as a rule, are supplied by demountable tips. For introduction of contraceptives are intended special S.from plastic (fig. 3-13), To special concern also S.for introduction of roentgen substances. At angiography apply S. with a clamp to a needle or an adapter (fig. 4-19), thus needle or an adapter has screw cutting. • For introduction of medical products and antipillboxes at urgent medical aid, itself and mutual aid apply a syringe-tube — the syringe filled with dosed out quantity of a certain medical product.

17. S. RECORD

20. Fig. 2

21. Fig. 3

22. Fig. 4

23. Insulin Syringe • Insulin syringes are small in size, they hold between 0.3 and 1 ml of medication. These needles are not calibrated in milliliters, they are calibrated in units. Most insulin syringes are calibrated up to 100 units. Insulin syringes are designed for self-injection and are used to give subcutaneous injections. • Tuberculin Syringe • Tuberculin syringes are used for tuberculosis testing. The fluid they contain is injected right into the skin. This syringe is small and is calibrated in milliliters. It has a long, thin barrel with a preattached needle. The tuberculin syringe can hold up to 1 ml of fluid. Even though this syringe is small, it cannot be used to give insulin.

24. Device of Bobrov is intended for injections of great volumes isotonic or physical solutions. Consists of the glass graduated banks on 500 or 1000 ml where the solution is poured; a rubber stopper with two apertures through which two tubes bent at an angle (one long, the second short) and the rubber air pump are passed. In the complete set two glass filters, two rubber tubes in length on 4 sm and two needles of Bobrov enter also. To the end of a long glass tube attach the rubber tubule which free end spread on the glass filter, filled with sterile cotton wool. On other end of the glass filter spread the rubber air pump. When air pump up in bank in last the elevated pressure, therefore a solution from banks through a rubber tubule which is attached is created to a short tubule, and a needle arrives in a blood vessel.

26. Needles • Most needles are made of stainless steel. The needle is hollow with a hole in the middle and has three parts: the hub, which fits on to the tip of the syringe; the shaft, which is the long length of the needle; and the bevel, which is the slanted tip of the needle. The bevel creates a narrow slit or hole in a persons skin through which the fluid in the syringe is injected into a person. This slit closes once the needle is removed from the person's skin so there is no leakage of medication or blood. Long-beveled tips are sharper and narrower, which reduces discomfort when it pierces the skin.

27. Types Of Needles • Needles are differentiated based on their length and diameter. The length of needles range from between 1/2-inch to 3 inches. The diameter of a needle is measured in gauges. A 25-gauge needle has a smaller diameter than a 19-gauge needle. As the needle gauge gets bigger, the needle's diameter gets smaller. Two different needles may have the same length and have different gauge sizes. Needle gauges range from between 7 gauge being the largest to 33 gauge the smallest. Gauge selection is made based on the thickness of a medication to be given. If the medication is thick, a needle with a small gauge and big diameter would be the needle of choice. Intramuscular medications are given with long needles, while subcutaneous medications are given with shorter needles.

28. Seam surgical materials. Cannula Sutural surgical material used for applying surgical sutures and bandaging individual anatomical structures (vessels, skin, muscles, bones etc.) as well as to stop the bleeding.

29. As suture material used silk, catgut, paper and nylon thread, parenthesis, metal, metal wire, horsehair, yarn with deer tendon, special nails, screws and metal plates, etc.. In applying these suture materials include properties of fabrics crosslinking terms of their growth, etc.          To suture materials placed several requirements: they must be very strong, stretch, have a smooth surface so as not to injure tissue, have equal diameter throughout length, should form strong networks, to cause minimal local inflammatory or allergic reaction, easy sterylizuvatysya without losing while their physical properties.         There suture material, which resolves in the body, and material that does not resolve.

30. The most common suture material in surgery, which resolves, a suture. Its made of muscular layer and submucosa thin sheep intestines. Gut widely used for stitching organs and tissues, liver surgery, for sewing subcutaneous tissue, peritoneum, etc., where not required combination of high strength fabrics. The term resorption of catgut from 2 to 4 weeks depending on the thickness of threads. Humidity thread about 20% fat content to 2%.       Use also chromed catgut, thread is covered with a film of chromium compounds. This thread has a smooth surface that resolve within a month. Chromium plated catgut used in urology, abdominal and thoracic surgery.     Produce suture in sheepskin bags (dry catgut) non-sterile and sterile vials. The package put 5-10 on gut strings, depending on their size, but in the ampoules - only one thread.

31. The whole production process in the gut do not spend aseptic plant conditions and received sterilized catgut znezhyryuyut and chemical methods because it does not withstand sterilization hot "boiling.       For degreasing suture placed in approx 24 hours in ethanol. Sterilizing its pairs of iodine (method Sytkivskoho), alcoholic solution of iodine (method Gubarev), or aqueous solution of iodine (method Heinz-Klaudiusa).

32. Coils in the gut (sterile) remain at constant temperature (usually at 15 deg.) And normal moisture in dry premises, protected from dust, moth and rodents.        In recent years, were widely used synthetic strings, which dissolve in the body. These include: dekson (USA)  vikryl (England) oktselon and kapromed (Russia) katselon, karbotsel. They are harmless, do not cause tissue inflammation, do not cause allergic reactions resolve within the time required for zazhyvlennya wounds. Terms of resorption of 1 to 2.5 months. Available in sterile packaging.      Dekson - yarn, wreathed with polymer hlikoliyevoyi acids, which are painted green. Made in the numbering from 00000 to number 2 to 75 cm long, with a united atravmatychnymy with needles. Issued as a thread length 120 cm, cm 2h45 and 10h45 cm without needles. Used in all branches of surgery.

33. VikrylDekson

34. Oktselon designed for applying surgical sutures on the skin, subcutaneous tissue, soft Yazy for internal stitches on the organs of the gastrointestinal tract, lung tissue when stitching, liver, gall bladder Ushivanie bed.          Oktselon - a twisted or braided yarn fiber material, which consists of monokarboksylmetalolihandnoho complex, oxidized nitrogen dioxide. Producing numbers from 00 to number 8 in the sealed package in two versions: double plastic bag with tape coiled on the coil of polymeric material, sealed in glass containers in the form of approx.         Before surgical seam material that does not resolve in the body include: surgical silk, nylon yarn, horse hair, metal suture material, metal parenthesis.

35. Silk Surgical -  natural material that does not resolve, has high strength and stability. Made from natural silk, raw silk, well bleached and refined, with minimal addition of impurities of high grades of cotton fibers to increase strength fibers.        Use silk mainly to check "being" vessels aponeurositis stitching, leather, anastomat hollow bodies, etc. He hardly stretched, head of "undertake two nodes. Silk threads in the body over time, gradually encapsulates.        Silk produced in the form of long, thin, twisted treated well (at least woven), yarns, because they are stronger. However, less elastic threads and bad head "yazuyutsya in knots.

36. Sterile surgical silk produced in approx length strings of 45 and 9 m, depending on the number of threads and sterile - in vitro (available in ampoules) long strings of 4, 10 and 15 m also depending on the number.         Preservation solutions in vitro (ampoules) is 70% ethanol, formalin or other antiseptics. Silk in vitro using immediately, ie without pretreatment. Coils in the Silk after degreasing in alcohol and ether mixture sterilized hot "boiling in 0.1% solution sulemy for 10 minutes. And stored in glass coiled coil in a mixture of equal parts alcohol and ether or absolute alcohol in the jar with prytertym peel.

37. In surgical practice, a number of widely used synthetic materials, namely: Kapron, nylon (lavsan) and their analogues (mersylk, mersylen, prolen and others).          Nylon yarn - a synthetic material, which receive fibers from twisting thin plastic (polyamide compounds). Nylon thread is strong, well withstands hot "boiling, well tolerated by body tissues. Produced in Nylon thread twisted length 45 and 9 m, which in appearance is different from silk. Manufactured in the same size as the silk. Methods of sterilization as the same as for silk threads.

38. Metallic suture material used mainly for the "unity of bones and tendons. Industry produced lihaturnyy hromonikelevoyi wire stainless steel sterilized in a drying oven at 160 degrees. We also manufacture metallic suture material of aluminum-bronze, silver, tantalum, titanium steel Coils of wire in the form of various lengths.      Parenthesis metal - a plate of stainless steel or nickel alloy length of 12 and 14 mm and a width of 2.7 mm, which have sharp ends strong cloves (spikes). Use for stitching wounds by fastening the edges of the skin. At put skobok use tweezers that their folds, with sharp spikes skobok pierce the skin and keep skin edges of wounds to their growth, and the staples removed.       Parenthesis produce 2 sizes (12 and 14 mm). Their string of wire holder for 25 pieces of equal size.

39. Currently being developed biologically active suture material with antimicrobial action and biostimulant effect. They can get by drawing on a thread coating that contains biologically active substances (BAS) by impregnation threads in the thread by introducing chemical groups that link the bar by making threads of material that is biologically active properties.

40. In the 60's was first established bactericidal suture letylan - lavsan, which are very susceptible Staphylococcus aureus, Escherichia coli, the proteome. The disadvantage of this material was that after 30 min. implantation, he began to lose its antimicrobial properties, and 5:00 through them completely lost.       Currently received benzotoniyevi biocide threads benzalkoniyevyy silk yarn with antimicrobial sulfohrupamy. Bolharski scientists suggested antimicrobial thread "Polikon" (based on polyamide). Proposed for use in medical practice braided nylon with a coating that contains silver ions, which are sensitive Staphylococcus aureus, esheryhiya circle, pseudomonad, klebsiela pneumonia dyzenteryyna stick.        In practice, general and abdominal surgery tested ftorlonovi twisted threads "nyft's (with hinifurylom), nyft-l (with levomitsetina) kaprohent (with gentamicin).

41. Were also tested resorbtive suture material with antimicrobial action "kapromed Far East (dioxidin, hinoksydyn), kaproyod (iodine). Study the surgical suture material "nikant", based on polyamide yarn coated with the modified polymer containing antibiotic doxycycline. Studies have shown that this has antibacterial suture material within 10-14 days.        An important problem is the creation of surgical suture material, in particular rezorb- appliance, with biostimulant effect. Thus, when tested resorbtive surgical threads - Rimini, based on a modified cellulose, it was noted that despite the rapid resorption (3-5 days), wound edges are not diverged.

42. Needles SURGICAL • Surgical needles are for sewing tissue in surgical operations. They are classified on surgical needles, which are used for sewing with holkotrymatelya and needles lihaturni.        Surgical needles are of the form of direct or bent rod, sharpened at one end and at the other end for a needle zasylennya threads. Needles are distinguished by form - degree bend from the line-up to strongly curved, the size of the needle length, shape traversing - round (piercing) and trihedral (barbed-cutting) needle form ears - of pruzhynyachymy, open, double, mechanical and ears of ordinary tailor's ears.         Depending on the form of shared needles, curved, straight, straight with a flat-oval part, thick, thin.

43. Needle made of carbon steel wire mark in a 7A or 8A. Almost half of the surgical needle is the needle bent on 4 / 8 range, which are widely used in surgery. However, let the needle bent on 2 / 8, 3 / 8 and 5 / 8 circle. Needle covered with a thin layer of chromium that prevents them from corrosion. Needles are hardening, so they should be sharp and easy to pierce suede thickness 0,4-0,7 mm. Surgical needles are used repeatedly, at least 20 times. Produce non-sterile needles in plastic packaging by 10 pieces that are placed on the 30 pieces in cardboard boxes. Recommend sterilized needles at 180 degrees.

44. Atravmatychni produce needles with thread woven kapron lavsan or cord, which are painted in dark colors. On one thread can hold out a needle or two needles on both ends of the thread.      Atravmatychni produce sterile needle and sterile. After zavertannya in double plastic bag needle sterilized by radiation. Reel of unsterile needles and sterilized hot plate "boiling. This put the needle on the plate for the coiled thread, and not to rozmotuvalasya at sterilization. End of thread is fixed in an aperture plate. Needles stack of parchment in the bags to 20 or 40 pieces, packages placed in cardboard boxes. Lihaturni needles - a tool by which base metal (thread) sum for vessels that need to check "connection, or in areas of tissues, vessels that have to be traversing. To produce this right and left blunt needles 3 rooms with different sizes of the working parts. Working part reminds bent cannula traversing the Oval, but for zasylennya needle thread is near the end of the sharpened needle.

45. Plug lihaturni - a tool designed for lowering the base metal at the site, check "yaztsi vessels in remote areas and deep cavities. Unit while pre-head "around yazuyut krovozupynnoho clamp imposed on the vessel, and then plug it into the lower depth and duration of her wounds on the vessel. Plug produced the piece. To check "being" brain vessels using silver clips. This produces a special set of tools that includes three types of pliers: straight and curved horizontally and vertically, as well as a shop, where previously imposed clips before surgery. For overlap seams, stitching and fabric of the widely used special apparatus of crosslinking. Weld metal by imposing skobok that are made of tantalum or special alloy. Issued apparatus by which crosslinking is carried by one individual parenthesis. But most machines make sewing all right parenthesis. Industry produced about 20 items for sewing machines, including black. blood vessels, nerves, tissues and root lungs, bronchial stump for sewing, bladder, impose gastrointestinal anastomoses.

46. Fork lihaturna

47. Thank you for attation!