GOST EN 14180-2011 Sterilizers for medical purposes Low temperature steam and formaldehyde sterilizers Requirements and tests《医学用途灭菌器 低温蒸汽和甲醛灭菌器 试验和要求》.pdf

1、 , () INTERSTATE COUNCIL FOR STANDARTIZATION, METROLOGY AND CERTIFICATION (ISC) C (EN 14180:2003, IDT) 2013 EN 14180 2011 N 141802011 II , 1.092 . 1.22009 . , . , , , 1 - () 2 () 3 , ( 40-2011 29 2011 .) : ( 3166) 00497 ( 3166) 00497 BY KZ KG RU TJ UZ 4 13 2011 . 1369- EN 141802011 1 2013 . 5 EN 141

2、80:2003 Sterilizers of the medical purpose Low temperature steam and formaldehyde sterilizes Reguirements and tests ( . . ). C (IDT). EH 141802008 . 6 ( ) . , . . C, 2013 , N 141802011 V , (LTSF/) , . ( -) , . - , . - . . . -. , -, EN IS 14937:2000. - , (scrapie), (Bovine spongiform encephalopathy)

3、-. , N 141802011 VI (. EN IS 14937:2000, 1.6, 2). , , , . F. - , EN IS 14971, . , , EN 61010-1, EN 61010-2-042 . EN 60204-1 . N 141802011 1 _ Sterilizers of the medical purpose. Low temperature steam and formaldehyde sterilizers. Requirements and tests _ 20130101 1 ( -; ), , -. - , , . : N 141802011

4、 2 - - ; - -, . 2 : EN 867-5 Non-biological systems for use in sterilizers Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S ( . 5. ) N 868-5 Packaging materials and systems for medical devices which are t

5、o be sterilized Part 5: Heat and self-sealable pouches and reels of paper and plastic film construction Requirements and test methods ( , . 5. . ) EN 60584-2 Thermocouples Part 2: Tolerances (. 2. ) EN 60751 Industrial platinum resistance thermometer sensors ( ) N 61010-1 Safety requirements for ele

6、ctrical equipment for measurement, control and laboratory use Part 1: General requirements ( N 141802011 3 , . 1. ) EN 61010-2-042 Safety requirements for electrical equipment for measurement, control, and laboratory use Part 2-042: Particular requirements for autoclaves and sterilizers using toxic

7、gas for the treatment of medical materials, and for laboratory processes ( , . . 2-042. , ) N ISO 11138-1 Sterilization of health care products - Biological indicators Part 1: General requirements ( . . 1. ) N ISO 11138-5 Sterilization of health care products - Biological indicators - Part 1: Genera

8、l requirements ( . . 5. ) EN 61326 Electrical equipment for measurement, control and laboratory use EMC requirements ( , . ) EN ISO 3746 Acoustics - Determination of sound power levels of noise sources using sound pressure - Survey method using an enveloping measurement surface over a reflecting pla

9、ne (. . ) IS 228-1 Pipe threads where pressure-tight joints are not made on the threads Part 1: Dimensions, tolerances and designation ( , N 141802011 4 . 1. , ) 3 : 3.1 (access device): , . - , () . 3.2 (aeration): ( ) , , . 3.3 (air removal): , . 3.4 (automatic controller): , . 3.5 (biological ind

10、icator): . EN 866-1:1997, 3.1 3.6 (chamber pre-heating): N 141802011 5 . 3.7 (conditioning): , , . 3.8 (cycle complete): . EN 285:1996, 3.10 3.9 (cycle parameter): . 3.10 (cycle variables): , . - ( ) , , , . 3.11 (desorption): . 3.12 (double-nded sterilizer): , . N 285:1996, 3.13 3.13 (equilibration

11、 time): . N 141802011 6 3.14 (exposure time): . 3.15 (holding time): , , . . 3.16 (inoculated carrier): , -. EN 866-1:1997, 3.8 3.17 ; IQ (installation qualification; IQ): , . EN IS 14937:2000, 3.9 3.18 (loading door): , . EN 285:1996, 3.21 (. 3.43 .) 3.19 (medical device): , , , , , , , , : - , , , ; N 141802011 7- , , , ; - , ; - , , , . EN IS 13485:2000, 3.1 3.20 (microbicidal solution): ,