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Is there a COSHH, (Control of Substances Hazardous to Health), information data sheet generally available for stainless steels to outline any risks associated with its handling, fabrication and use.
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The European Directives 76/769/EEC and 94/27/ECC, (12th amendment to 76/769/EEC, dated 30th June 1994), are sometimes referred to as the ‘nickel or jewellery’ directives. There are two separate issues, Body Piercing and Skin Contact. The selection and suitability of stainless steels for these uses is outlined.
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The special compositions, non-metallic inclusion, ferrite and grain size requirements of these steel grades, D and E specified for surgical implants are outlined. Commercially produced 316 type steels cannot be used for surgical implants as the available composition and micro-cleanness information is very unlikely to meet the requirements of BS 7252-1 ISO 5832-1.
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Steel grades A, (410, 1.4006), B, (1.4021), C, (1.4028), D, (1.4034), E, (1.4116), F , G, H, I, K, (1.4122), R, L, (1.4105), M, (304, 1.4301), N, (303, 1.4305), O, (301, 1.4310), and P, (316, 1.4401) of BS EN ISO 7153-1:2001, (BS 5194-1:1991) are shown. The surgical and dental applications for these grades are outlined. These include cutting and non-cutting instruments and fitting parts and assemblies. (Body implants are NOT covered here.) Corrosion resistance, corrosion testing and the affects on these surgical steels of sterilisation practices are covered.
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Paper originally delivered at the BSSA Conference ‘Stainless Solutions for a Sustainable Future’ held in Rotherham on 3rd April 2003. This paper discusses applications for stainless steels in beverage dairy and food, drinking water supply, medical devices and pharmaceutical industry applications. Chloride limits in waters for grade selection and metal ion release criteria are outlined. The EU Medical Device Directive sets criteria for medical devices that stainless steels can meet and the range of grades used for various devices is also discussed along with the scope of ISO standards 7153 and 5832, (surgical implants). The application of grades 1.4006, (410), 1.4021, (420), 1.4122, 1.4116 and 1.4125, (440C), martensitic, 1.4016, (430), ferritic, 1.4301, (304), 1.4305, (303), and 1.4401, (316), austenitic and 1.4462, (2205) and 1.4362, (2304), duplex grades in these industries is outlined.
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Article by Tony Newson, AvestaPolarit, (This article first appeared in Business Briefing: Medical Device Manufacturing & Technology 2002, published by World Markets Research Centre, London www.wmrc.com). The application of austenitic, martensitic and precipitation hardening stainless steel types in medical implant and dental and surgical instruments is discussed. The special implant grades to ISO 5832 are compared to more commonly recognisable ISO 7153-1 instrument grades, used where body contact is only transient. A comparison of electropolished and mechanically polished finishes for stainless steel medical devices is made. The reusability and recycling issues are discussed in relation to single use instruments where the spread of infection is a possible risk.
