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1、American National Standard ANSI/AAMI/ISO 11135:1994 AAMI Association for the Advancement of Medical Instrumentation Medical devicesValidation and routine control of ethylene oxide sterilization Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AA
2、MI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:22:01 MDTNo reproduction or networking permitted without license from IHS -,-,- Association for the Advancement of Medical Instrumentation 1110 N. Glebe Rd., Suite 220 Arlington, VA 22201-4795 2000 by the Associati
3、on for the Advancement of Medical Instrumentation All Rights Reserved Copyright and Permissions Publication, reproduction, photocopying, storage, or transmission, electronically or otherwise, of all or any part of these documents without the prior written permission of the Association for the Advanc
4、ement of Medical Instrumentation or the copyright holder (if not AAMI) is prohibited by law. It is illegal under federal law (17 U.S.C. 101, et seq.) to make copies of all or any part of these documents (whether internally or externally) without the prior written permission of the copyright holder.
5、Violators risk legal action, including civil and criminal penalties, and damages of $100,000 per offense. For permission regarding the use of all or any part of these documents, contact AAMI, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax: (703) 525-1067. Violato
6、rs of this copyright policy should be reported to AAMIs legal counsel: McKenna inevitably this means that there is always a finite probability that a microorganism may survive regardless of the extent of treatment applied. For a given treatment, the probability of survival is determined by the numbe
7、r and types of microorganisms and the environment in which the organisms exist before and during treatment. It follows that the sterility of any one item in a population of items subjected to sterilization can only be expressed in terms of the probability of the existence of a nonsterile item in tha
8、t population. Requirements for the quality system for the design/development, production, supply, installation and servicing are given in the ISO 9000 series. The ISO 9000 series of Standards designates certain processes used in manufacture as “special“ in that the 2000 Association for the Advanceme
9、nt of Medical Instrumentation Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:22:01 MDTNo reproduction or networking permitted without license from IHS -,-,
10、- results cannot be fully verified by subsequent inspection and testing of the product. Sterilization is an example of a special process because efficacy cannot be verified by inspection and testing of the product. For this reason, sterilization processes need to be validated before use and the perf
11、ormance of the process needs to be monitored routinely. The manufacture of a sterile medical device requires attention to product and package characteristics, and to sterilization methods, facilities and controls. It is important to be aware that exposure to a properly validated and accurately contr
12、olled sterilization process is not the only factor associated with the provision of reliable assurance that the product is sterile and suitable for its intended use. Attention should also be given to a number of factors including the microbiological status (bioburden) of incoming raw materials and t
13、heir subsequent storage, and to the control of the environment in which the product is manufactured, assembled and packaged. This International Standard contains requirements and offers guidance (as given in the annexes) for the validation and routine monitoring of sterilization by gaseous ethylene
14、oxide. The validation of sterilization procedures presupposes that the sterilization equipment complies with appropriate specifications. NOTE 1 The requirements are the obligatory parts of this standard with which compliance has to be achieved. The guidance given in the Informative Annexes is not ob
15、ligatory and it is not provided as a check list for auditors. The guidance included in the annexes provides explanations as well as methods which are accepted as being suitable for achieving compliance with the requirements. This guidance is provided in order to assist in obtaining a uniform underst
16、anding and implementation of this International Standard. Methods other than those given in the guidance may be used. However, these methods need to be demonstrated to be effective in achieving compliance with the requirements of this International Standard. Medical devicesValidation and routine con
17、trol of ethylene oxide sterilization 1 Scope 1.1 This International Standard establishes requirements and guidance for validation and routine control of ethylene oxide sterilization processes for medical devices. Particular attention is drawn to the need for specific testing for safety, quality and
18、efficacy, possibly exceeding the requirements of 4.2, which may be necessary for a specific product. NOTE 2 Although this International Standard has been written for medical device sterilization, it may also apply to other health care products. 1.2 It does not cover the quality assurance system whic
19、h is essential to control all stages of manufacture which include the sterilization process. 1.3 It does not cover operator safety (for further information, see IEC 1010-2). Ethylene oxide is toxic, flammable and explosive. Attention is drawn to the existence in some countries of regulations laying
20、down safety requirements for handling ethylene oxide and for premises in which it is used. Attention is drawn to the existence in some countries of statutory regulations laying down limits for the level of ethylene oxide residues within medical devices and products. 1.4 It does not cover sterilizati
21、on either by the technology of injecting ethylene oxide or its mixtures directly into individual product packages or continuous sterilization processes. 1.5 It does not cover analytical methods for determining levels of residual ethylene oxide and/or its reaction products (see ISO 10993-7). 2000 Ass
22、ociation for the Advancement of Medical Instrumentation Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:22:01 MDTNo reproduction or networking permitted wit
23、hout license from IHS -,-,- 1.6 It does not cover products that are affected adversely by ethylene oxide or by other ethylene oxide residuals produced in the processes described. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provi
24、sions of this International Standard. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the standar
25、ds indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 9001:1987, Quality systems Model for quality assurance in design/development, production, installation and servicing. ISO 9002:1987, Quality systems Model for quality assurance in production
26、 and installation. ISO 9004:1987, Quality management and quality system elements Guidelines. ISO 10993-7:1), Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals. ISO 11138-1:1), Sterilization of health care products Biological indicators Part 1: General. 3 Definit
27、ions For the purposes of this International Standard, the following definitions apply. 3.1 aeration: Part of the sterilization process during which ethylene oxide and/or its reaction products desorb from the medical device until predetermined levels are reached. NOTE 3 This may be performed within t
28、he sterilizer and/or in a separate chamber or room. 3.2 aeration area: Either a chamber or a room in which aeration occurs. 3.3 biological indicator (BI): Inoculated carrier contained within its primary pack providing a known resistance to the relevant process. 3.4 calibration: Comparison of a measu
29、rement system or device of unknown accuracy to a measurement system or device of known accuracy (traceable to national standards) to detect, correlate, report, or eliminate by adjustment, any variation from the required performance limits of the unverified measurement system or device. 3.5 chamber:
30、Enclosed area which only accommodates sufficient product to fill the sterilizer. 3.6 commissioning; installation qualification: Obtaining and documenting evidence that equipment has been provided and installed in accordance with its specifications and that it functions within predetermined limits wh
31、en operated in accordance with operational instructions. (See also validation.) 3.7 conditioning: Treatment of product within the sterilization cycle, but prior to sterilant admission, to attain a predetermined temperature and relative humidity. This part of the sterilization cycle may be carried ou
32、t either at atmospheric pressure or under vacuum. (See also preconditioning.) 3.8 cycle completion: That point after completion of the sterilization cycle at which the sterilization load is ready to be removed from the chamber. 3.9 exposure time: Time for which the sterilizer chamber is maintained w
33、ithin the specified range for temperature, sterilant concentration, pressure and humidity. 2000 Association for the Advancement of Medical Instrumentation Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, U
34、ser=Wing, Bernie Not for Resale, 03/21/2007 02:22:01 MDTNo reproduction or networking permitted without license from IHS -,-,- 3.10 flushing: Procedure by which the sterilant is removed from the load and chamber by either a) multiple alternate admissions of filtered air or inert gas and evacuations
35、of the chamber; or b) continuous passage of filtered air or inert gas through the load and chamber. 3.11 inoculated carrier: Carrier on which a defined number of test organisms has been deposited. 3.12 medical device: Any instrument, apparatus, appliance, material or other article, whether used alon
36、e or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purposes of: diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for
37、an injury or handicap; investigation, replacement or modification of the anatomy or of a physiological process; control of conception; and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in i
38、ts function by such means. 3.13 parametric release: Declaring product as sterile, based on physical and/or chemical process data rather than on the basis of sample testing or biological indicator results. 3.14 performance qualification: Obtaining and documenting evidence that the equipment as commis
39、sioned will produce acceptable product when operated in accordance with the process specification. (See also validation.) 3.15 preconditioning: Treatment of product prior to the sterilization cycle in a room or chamber to attain specified limits for temperature and relative humidity. (See also condi
40、tioning.) NOTE 4 This part of the sterilization cycle may be carried out either at atmospheric pressure or under vacuum. 3.16 preconditioning area: Either a chamber or a room in which preconditioning occurs. 3.17 process challenge device: Object which simulates the worst case of conditions as they a
41、re given for the sterilizing agent(s) in the items of the goods to be sterilized. NOTES 5 The device is so constituted that a biological indicator can be arranged in the place most difficult for the sterilant to reach. The design of the process challenge device depends on the kind of goods to be ste
42、rilized and the sterilization procedure. The biological indicator should not interfere with the function of the process challenge device. 6 In some process challenge devices an inoculated carrier may be used in place of a biological indicator. 3.18 process development: Documented program of studies
43、which is performed in order to define the sterilization process based upon the product/packaging/loading pattern and/or equipment limitations. 3.19 product compatibility: Ability of the sterilization process to achieve the intended results without detrimental effect on the product. 3.20 reference lo
44、ad: Specified sterilization load made up to represent the most difficult combination of products to be sterilized. 3.21 revalidation: Set of documented procedures to confirm an established validation. 2000 Association for the Advancement of Medical Instrumentation Copyright Association for the Advan
45、cement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:22:01 MDTNo reproduction or networking permitted without license from IHS -,-,- 3.22 room: Enclosed area capable of holding more product than c
46、an be accommodated in the sterilizer(s) at any one time. 3.23 sterilant injection stage: Stage beginning with the first introduction of sterilant into the chamber and ending whenever the set operating pressure has been attained. 3.24 sterilant injection time: Duration of the sterilant injection stag
47、e. 3.25 sterilant removal time: Portion of the sterilization cycle in which sterilant is removed from the chamber and sterilization load, but not necessarily desorbed from individual products. (See also aeration.) 3.26 sterility: State of being free from viable microorganisms. (See sterilization.) N
48、OTE 7 In practice no such absolute statement regarding the absence of microorganisms can be proven. 3.27 sterile: Free from viable microorganisms. (See sterilization and note 7.) 3.28 sterilization: Validated process used to render a product free of all forms of viable microorganisms. NOTE 8 In a st
49、erilization process, the nature of microbial death is described by an exponential function. Therefore, the presence of viable microorganisms on any individual item can be expressed in terms of probability. While this probability may be reduced to a very low number, it can never be reduced to zero. The probability can be expressed as a sterility a