Learn about the steps required for an ANSI/AAMI/ISO 11137-1: 2006 and –2: 2006 quarterly dose audit. Gamma & E- Beam Sterilization for Medical Devices - ISO 1. Gamma and E- Beam sterilization are both radiation based sterilization techniques. While the former is performed by exposing the product to continuous Gamma rays, E- Beam sterilization utilizes Electron beams. Both methods are equally effective, but E- Beam is more powerful and hence the exposure time of the device is lesser. Reusable devices sterilized by these methods must undergo a . The frequency of these audits will become lesser as the years progress. Neither method results in any radioactivity. In fact sterilization through irradiation is considered a . Furthermore the rays can penetrate dense materials (especially so for Gamma) and closed package products with minimal rise in temperature and effect on the product material (unlike Steam and Et. O/gas). E- Beam radiation displays certain limitations when penetrating dense materials (or) products with varying densities.
ISO 11135 provides guidelines on the validation, process control & routine monitoring of an ethylene oxide sterilization process for medical devices.This International Standard specifies requirements for validation, process control and routine monitoring in the radiation sterilization of health care products. It applies to continuous and batch type gamma irradiators using the radionuclides 6. Co and 1. 37 Cs, and to irradiators using a beam from electron or x- ray generator. The ISO standard also provides information and guidance on equipment, irradiation compatible materials, Dose setting methods and dosimetric aspects for Gamma, E- Beam and X- Ray sterilization. For example the standard explains that all plastics can be classified as materials whose molecules either i) predominantly degrade with irradiation or ii) predominantly crosslink with irradiation. The latter types tend to have higher radiation stability. Some specific guidelines for material selection are: Aromatic materials are more stable than aliphatic materials. High levels of antioxidants help radiation stability. In general, the level of antioxidant should be doubled if the device is going to be radiation sterilized. Most polypropylenes and polytetrafluoroethylene are unstable with irradiation and would need to be stabilized. Phenolic antioxidants contained in most plastics are a cause of discoloration. Use of non- phenolic additives may eliminate the problem. Elastic modulus of plastics is not significantly affected with a sterilizing dose of irradiation. For a given polymer class, the lower the density the greater the radiation stability. ISO 11137: Method 1 study (irradiation validation) A method 1 study is for the verification of a minimum irradiation dose for a particular bioburden loading on a product. Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose 1 Scope This part of ISO 11137 specifies methods for determining. ANSI/AAMI/ISO 1. 11. Sterilization of Health Care Products Package ANSI/AAMI/ISO 1. ANSI/AAMI/ISO 1. 11. ANSI/AAMI/ISO 1. 11. ISO 1. 11. 37- 1: 2. Although the scope of ISO 1. ISO 1. 11. 37- 1: 2. Co or 1. 37. Cs, a beam from an electron generator or a beam from an X- ray generator. ISO 1. 11. 37- 1: 2. Creutzfeldt- Jakob disease; detail specified requirements for designating a medical device as sterile; specify a quality management system for the control of all stages of production of medical devices; specify requirements for occupational safety associated with the design and operation of irradiation facilities; specify requirements for the sterilization of used or reprocessed devices.
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