BS EN 868-8-2009 灭菌医疗装置的包装.符合EN 285标准的蒸汽灭菌器用再用灭菌容器.要求和测试方法.pdf

ÞÍ ÛÒ èêèóèæîððç ÛËÎÑÐÛßÒ ÍÌßÒÜßÎÜ ÒÑÎÓÛ ÛËÎÑÐWÛÒÒÛ ÛËÎÑÐ×ÍÝØÛ ÒÑÎÓ ÛÒ èêèóè Ó¿§ îððç ×ÝÍ ïïòðèðòíðÍ«°»®-»¼»- ÛÒ èêèóèæïççç Û²¹´·-¸ Ê»®-·±² п½µ¿¹·²¹ º±® ¬»®³·²¿´´§ -¬»®·´·¦»¼ ³»¼·½¿´ ¼»ª·½»- ó ﮬ èæ λó «-¿¾´» -¬»®·´·¦¿¬·±² ½±²¬¿·²»®- º±® -¬»¿³ -¬»®·´·¦»®- ½±²º±®³·²¹ ¬± ÛÒ îèë ó λ¯«·®»³»²¬- ¿²¼ ¬»-¬ ³»¬¸±¼- Ó¿¬7®·¿«¨ ¼ù»³¾¿´´¿¹» °±«® ´»- ¼·-°±-·¬·º- ³7¼·½¿«¨ -¬7®·´·-7- ¿« -¬¿¼» ¬»®³·²¿´ ó ﮬ·» èæ ݱ²¬»²»«®- ®7«¬·´·-¿¾´»- ¼» -¬7®·´·-¿¬·±² °±«® -¬7®·´·-¿¬»«®- ´¿ ª¿°»«® ¼ù»¿« ½±²º±®³»- ´ùÛÒ îèë ó Û¨·¹»²½»- »¬ ³7¬¸±¼»- ¼ù»-¿· Ê»®°¿½µ«²¹»² º$® ·² ¼»® Û²¼ª»®°¿½µ«²¹ ¦« -¬»®·´·-·»®»²¼» Ó»¼·¦·²°®±¼«µ¬» ó Ì»·´ èæ É·»¼»®ª»®©»²¼¾¿®» ͬ»®·´·-·»®¾»¸ 1 mm when tested in accordance with Annex C. If a permanent deformation is measured, performance characteristics of the container (in particular sterile barrier properties) shall be demonstrated to remain unchanged. ÞÍ ÛÒ èêèóèæîððç EN 868-8:2009 (E) 7 4.2.6 Stacking capability 4.2.6.1 The top and base of each container shall be sufficiently strong to allow stacking and shall be fitted with means to ensure that all containers of the same nominal size and of the same provenance shall stack securely. After the test in accordance with Annex D, the container shall show no permanent deformation 1 mm and shall have unchanged performance characteristics. When tested in accordance with Annex E, the tested container shall remain stacked. 4.2.6.2 The containers shall be designed and constructed so that when stacked and loaded into the sterilizer in the manner specified by the manufacturer they will allow free passage of steam and/or air between containers. Compliance shall be tested by the performance tests carried out as described in Annex C to F. 4.2.7 Sterilant Port 4.2.7.1 Each container shall be provided with a sterilant port in one or more of its principle surfaces. 4.2.7.2 The sterilant port shall be designed to meet the following requirements: a) It shall permit the attainment of the specified sterilization conditions. Compliance shall be tested in accordance with Annex F. b) It shall permit adequate drying when processed in a sterilizer conforming to EN 285. Compliance shall be tested in accordance with Annex G. c) It shall permit microbial barrier properties during removal, transport and subsequent storage as specified in EN ISO 11607-1:2006, 5.1.10 b). Compliance shall be tested in accordance with applicable barrier tests (see EN ISO 11607-1:2006). NOTE A condensate drain is considered to be a sterilant port. 4.2.8 Load A full size container, i.e. of one sterilization module size, shall be designed and constructed to allow a total load of up to 10 kg to be sterilized in a sterilizer conforming to EN 285. Fractional sizes shall accommodate proportionally smaller loads. NOTE National or regional legislation on occupational health and work safety may require a limitation or restriction of the acceptable weight to handle. 4.3 Service life The sterilization container and its components shall, when processed in accordance with the provided instructions for use, meet all requirements during its useful life as it is stated by the manufacturer. NOTE 1 The manufacturers instructions include also important information on service, cleaning procedures, the manner of inspection and acceptance criteria, maintenance and replacement of components (see e.g. ISO 11607-1:2006, 5.1.10) ÞÍ ÛÒ èêèóèæîððç EN 868-8:2009 (E) 8 NOTE 2 500 cycles are considered a minimum as a useful life for containers and 100 cycles as a minimum for specific components like gaskets. For demonstration of compliance, using accelerated aging protocols shall be regarded as sufficient challenge until data from real-time aging studies are available. NOTE 3 For guidance on determination of useful life, see Annex H. 4.4 Material requirements 4.4.1 The container and its components shall be able to withstand (both chemical and physical) steam sterilization in a sterilizer conforming to EN 285 without any adverse effects on the container or its components. Compliance with EN ISO 11607-1:2006, 5.3 shall be tested: a) in a container which has been subjected to the stated number of use cycles; and b) on a container which has been subjected to 5 use-cycles, stored under ambient conditions with the lid closed for 6 months and then subjected to 5 further use-cycles. 4.4.2 The container and its reusable components shall be able to withstand proper cleaning procedures as indicated by the manufacturer without adverse effect to the container or its components. Compliance with EN ISO 11607-1 shall be tested: a) in a container which has been subjected to the stated number of cleaning procedures as indicated by the manufacturer; and b) on a container which has been subjected to 5 use-cycles, stored under ambient conditions with the lid closed for 6 months and then subjected to 5 further use-cycles. 4.4.3 The container and its components shall be made of materials which are lightstable under the conditions of use. Compliance shall be tested in accordance with ISO 4582. 4.4.4 If the container and/or its components are made from different materials, there shall be no negative interaction (e.g. contact-corrosion) between the materials. Compliance shall be deemed to be met if the performance test according to 4.4.1 and 4.4.2 has been carried out successfully. 4.4.5 When the container is used as intended, the materials used for the container or its components shall not build up any electrostatic charge. 4.4.6 The material, design, construction and surface finish shall facilitate easy internal and external disinfection and cleaning. 4.5 Marking Containers shall be marked with the manufacturer's or supplier's name or trademark. 5 Information to be supplied by the manufacturer The following information should be supplied in addition to EN ISO 11607-1:2006, Clause 7: a) the manufacturer's or supplier's name or trade name, and address; ÞÍ ÛÒ èêèóèæîððç EN 868-8:2009 (E) 9 b) specification of the essential parts; c) manner of inspection and maintenance and/or replacement; d) service-life of the container (use cycles); e) service-life of gasket; f) service and cleaning procedures; g) description on how thermocouples can be inserted into the container (for validation purposes) without being damaged and without altering performance; h) maximum load of the container to be used for the determination of the sterilization performance and load dryness tests. NOTE For requirements on information to be provided by the manufacturer national or regional legislation may apply, see in particular Directive 93/42/EEC, Annex I, Section 13. 6 Test methods NOTE 1 If the specific test procedures do not specify otherwise, tests can be carried out concurrently. NOTE 2 With regard to the verification of the material requirements no test is needed if historical evidence can be documented or if there are bibliographic references for materials which have been previously used satisfactorily. NOTE 3 Determinations of useful life (see Annex H) can be used prior to longevity testing. ÞÍ ÛÒ èêèóèæîððç EN 868-8:2009 (E) 10 Annex A (informative) Details of significant technical changes between this European Standard and the previous edition Changes between this European Standard and EN 868-8:1999 are the following: a) changes in order to align this European Standard with the EN ISO 11607 series, in particular by 1) amending the main element of the title, the scope and the terminology; 2) using EN ISO 11607-1 as normative reference regarding the general requirements for materials, sterile barrier systems and packaging systems; 3) amending the requirements on lid and lid-latching devices, the tamper evident closure system, the gasket, the microbial barrier properties of the sterilant port and materials; b) in addition to a) first dash, the scope has been modified to explain that other requirements might be of relevance for additional materials being used inside a sterile barrier system; c) an explanatory note has been inserted to refer the user of this European Standard to the general requirements on conditions during production and handling with respect to their impact on the product in EN ISO 11607; d) requirements on the design of handles have been amended to be more general; e) requirements on robustness (forming) and stacking capability have been amended in order to improve verifiability; f) requirements on service life have been amended; g) test methods on sterilization performance and load dryness have been amended on the basis of EN 285:2006 (second edition); h) requirements on information to be provided by the manufacturer have been amended; i) text has been revised editorially (e.g. by updating normative and informative references). NOTE This list is not exhaustive. ÞÍ ÛÒ èêèóèæîððç EN 868-8:2009 (E) 11 Annex B (informative) Guidance on dimensions Historical evidence demonstrates the dimensions shown in Figure B.1 allow adequate space for loading and unloading of the sterilizer. Containers with fractional sizes (e.g. 1/2 sterilization unit (STU), 1/4 STU, etc.) should have the same width as given in Figure B.1. Dimensions in millimetres Key 1 Loadable space 1) Maximum outer height hmax = 270 mm. Heights 3 000 mbar absolute t1 2 min t2 3 min Figure H.1 Test cycle ÞÍ ÛÒ èêèóèæîððç EN 868-8:2009 (E) 19 Bibliography 1 EN 1041, Information supplied by the manufacturer of medical devices 2 EN ISO 11607-2, Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006) 3 93/42/EEC, COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices