ČSN EN ISO 11139 - Sterilizace výrobků pro zdravotní péči - Slovník - Termíny používané v normách pro sterilizaci a v normách pro souvisící zařízení a procesy
| Stáhnout normu: | ČSN EN ISO 11139 (Zobrazit podrobnosti) Zákazníci, kteří mají na svém počítači sjednanou od České agentury pro standardizaci (ČAS) službu ČSN on-line pro elektronický přístup do plných textů norem v pdf (verzi pro firmy nebo pro jednotlivce), mohou zde přímo otevírat citované ČSN. |
| Datum vydání/vložení: | 2019-04-01 |
| Zdroj: | https://www.iso.org/standard/66262.html |
| Třidící znak: | 855256 |
| Obor: | Všeobecné předpisy a směrnice pro výrobky zdravotnické techniky |
| ICS: |
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| Stav: | Platná |
- 3.1 A0
- 3.2 absolute pressure
- 3.3 absorbed dose
- 3.4 access device
- 3.5 action level
- 3.6 active ingredient
- 3.7 aeration
- 3.8 air break
- 3.9 air detector
- 3.10 airlock
- 3.11 alert level
- 3.12 analyte
- 3.13 aseptic presentation
- 3.14 aseptic processing
- 3.15 aseptic processing area; APA;
- 3.16 aseptic technique
- 3.17 assurance of sterility
- 3.18 automatic controller
- 3.19 bacterial challenge test
- 3.20 bacteriostasis/fungistasis test
- 3.21 batch
- 3.22 bedpan washer-disinfector
- 3.23 bioburden
- 3.24 bioburden correction factor
- 3.25 bioburden estimate
- 3.26 bioburden spike
- 3.27 bio-decontamination
- 3.28 biological contaminant
- 3.29 biological indicator
- 3.30 block
- 3.31 calibration
- 3.32 calorifier
- 3.33 carrier
- 3.34 cell-based
- 3.35 cell-processing area; CPA;
- 3.36 chamber
- 3.37 chamber pre-heating
- 3.38 chamber reference temperature
- 3.39 change control
- 3.40 channel separator
- 3.41 chemical compatibility
- 3.42 chemical disinfection
- 3.43 chemical indicator
- 3.43.1 chemical indicator system
- 3.44 chemical indicator endpoint
- 3.45 clean
- 3.46 cleaning
- 3.47 cleaning agent
- 3.48 clean-in-place; CIP;
- 3.49 clinical use
- 3.50 closed system
- 3.51 closure
- 3.52 closure integrity
- 3.53 colony forming unit; CFU;
- 3.54 combination product
- 3.55 combined standard measurement uncertainty
- 3.56 come-down period
- 3.57 come-up period
- 3.58 conditioning
- 3.59 containment
- 3.60 containment area
- 3.61 containment facility
- 3.62 continuous process machine
- 3.63 control
- 3.64 correction
- 3.65 corrective action
- 3.66 coverage factor
- 3.67 critical processing zone
- 3.68 critical surface
- 3.69 culture collection number
- 3.70 culture condition
- 3.71 cycle complete
- 3.72 cycle parameter
- 3.73 cycle time
- 3.74 cycle variable
- 3.75 D value; D10 value;
- 3.76 dead leg
- 3.77 depyrogenation
- 3.78 desorption
- 3.79 development
- 3.80 dew point
- 3.81 direct support zone
- 3.82 disinfectant
- 3.83 disinfecting agent
- 3.84 disinfection
- 3.85 disinfection temperature
- 3.86 disinfection time
- 3.87 dose mapping
- 3.88 dose uniformity ratio
- 3.89 dosimeter
- 3.90 dosimetry
- 3.91 dosimetry system
- 3.92 double-ended
- 3.93 drying stage
- 3.94 endoscope connector
- 3.95 endoscope leak test
- 3.96 endoscope port
- 3.97 endoscope product family
- 3.98 endoscope surrogate device
- 3.99 endoscope type test group
- 3.100 endoscope washer-disinfector
- 3.101 endotoxin
- 3.102 environmental control
- 3.103 environmental isolate
- 3.104 EO-cartridge
- 3.105 equilibration time
- 3.106 equipment maintenance
- 3.107 establish
- 3.108 excipient
- 3.109 expanded measurement uncertainty
- 3.110
- 3.111 exposure phase
- 3.112 extrinsic contamination
- 3.113 F value
- 3.113.2 FBIO value
- 3.113.3 FH value
- 3.114 facultative organism
- 3.115 fail safe
- 3.116 fault
- 3.117 filter
- 3.118 filter integrity test
- 3.119 flexible sterilization bag
- 3.120 fluid
- 3.121 flushing
- 3.122 fraction positive
- 3.123 fractional cycle
- 3.124 free draining
- 3.125 gas concentration
- 3.126 gauge pressure
- 3.127 gowning procedure
- 3.128 growth promotion test
- 3.129 half cycle
- 3.130 hazard
- 3.131 hazardous situation
- 3.132 health care product
- 3.133 holding time
- 3.134 human waste
- 3.135 human waste container
- 3.136 humidity
- 3.136.1 absolute humidity
- 3.136.2 relative humidity
- 3.137 inactivation curve
- 3.138 incremental dose
- 3.139 indicate
- 3.140 indicator exposure period
- 3.141 indirect dose measurement
- 3.142 indirect support zone
- 3.143 influence quantity
- 3.144 inoculated carrier
- 3.145 intrinsic contamination
- 3.146 irradiation container
- 3.147 irradiator operator
- 3.148 irrigation plan
- 3.149 isolator
- 3.150 isolator system
- 3.151 labelling
- 3.152 leachable
- 3.153 lethal rate; L;
- 3.154 liquid transport system
- 3.155 load
- 3.156 load configuration
- 3.157 loading door
- 3.158 lumen device
- 3.159 manual cleaning
- 3.160 master product
- 3.161 maximum acceptable dose
- 3.162 measurement accuracy
- 3.163 measurement precision
- 3.164 measurement uncertainty
- 3.165 measuring chain
- 3.166 medical device
- 3.167 medical device manufacturer
- 3.168 method suitability
- 3.169 microbial barrier
- 3.170 microbial characterization
- 3.171 microbial contamination
- 3.172 microbial inactivation
- 3.173 microbial inactivation factor
- 3.174 microbial reduction factor
- 3.175 microbial resistance
- 3.176 microorganism
- 3.177 minimum effective concentration; MEC;
- 3.178 minimum recommended concentration; MRC;
- 3.179 moist heat
- 3.180 monitoring
- 3.181 negative air pressure area
- 3.182 nominal population
- 3.183 non-condensable gas
- 3.184 non-invasive device
- 3.185 normal operation
- 3.186 obligate anaerobe
- 3.187 obstruction
- 3.188 operating cycle
- 3.189 operating pressure
- 3.190 overkill approach
- 3.191 override
- 3.192 packaging system
- 3.193 parametric release
- 3.194 penetration
- 3.195 plateau period
- 3.196 pore size rating
- 3.197 porous
- 3.198 port closure
- 3.199 powered device
- 3.200 preconditioning
- 3.201 preformed sterile barrier system
- 3.202 pressure vessel
- 3.203 preventive action
- 3.204 primary package
- 3.205 process challenge device; PCD;
- 3.206 process challenge location; PCL;
- 3.207 process chemical
- 3.208 process confirmation study
- 3.209 process control
- 3.210 process development
- 3.211 process parameter
- 3.212 process simulation
- 3.213 process variable
- 3.214 processing
- 3.215 processing category
- 3.216 processor
- 3.217 product
- 3.218 product family
- 3.219 protective packaging
- 3.220 qualification
- 3.220.1 design qualification
- 3.220.2 installation qualification; IQ;
- 3.220.3 operational qualification; OQ;
- 3.220.4 performance qualification; PQ;
- 3.220.5 requalification
- 3.221 reagent
- 3.222 recognized culture collection
- 3.223 record; verb;
- 3.224 recorder
- 3.225 recovery efficiency
- 3.226 reference load
- 3.227 reference measurement point
- 3.228 reference microorganism
- 3.229 reference standard
- 3.230 repeatability
- 3.231 reproducibility
- 3.232 residues challenge device
- 3.233 resistometer
- 3.234 response time; τ90;
- 3.236 reusable medical device
- 3.237 rinsing
- 3.238 routine test
- 3.239 safety data sheet; SDS;
- 3.240 sample item portion
- 3.241 saturated steam
- 3.242 scan length
- 3.243 scan width
- 3.244 seal
- 3.245 seal integrity
- 3.246 seal strength
- 3.247 secondary package
- 3.248 self-contained biological indicator
- 3.249 self-disinfection cycle
- 3.250 separative device
- 3.251 service life
- 3.252 services
- 3.253 shift
- 3.254 simulated product
- 3.255 single-use medical device
- 3.256 small steam sterilizer
- 3.257 soil
- 3.258 spatial resolution
- 3.259 specify
- 3.260 spore log reduction; SLR;
- 3.261 stabilization period
- 3.262 stage
- 3.263 standard distribution of resistances; SDR;
- 3.264 standard measurement uncertainty
- 3.265 stated value; SV;
- 3.266 steady state period
- 3.267 steam penetration resistance
- 3.268 sterilant
- 3.269 sterilant/sterilizing agent injection
- 3.270 sterilant/sterilizing agent injection time
- 3.271 sterile
- 3.272 sterile barrier system; SBS;
- 3.273 sterile fluid-path packaging
- 3.274 sterility
- 3.275 sterility assurance level; SAL;
- 3.276 sterilizing filtration
- 3.277 sterilization
- 3.278 sterilization compatibility
- 3.279 sterilization cycle
- 3.280 sterilization dose; SD;
- 3.281 sterilization dose audit
- 3.282 sterilization in place
- 3.283 sterilization module
- 3.284 sterilization process
- 3.285 sterilization system
- 3.286 sterilization temperature
- 3.287 sterilizer
- 3.288 sterilizing agent
- 3.289 storage cabinet
- 3.290 storage solution
- 3.291 surrogate product
- 3.292 survival-kill window
- 3.293 temperature band
- 3.293.1 temperature band
- 3.294 terminal process
- 3.295 terminal sterilization
- 3.296 terminally sterilized
- 3.297 test equilibration time
- 3.298 test for sterility
- 3.299 test of sterility
- 3.300 test soil
- 3.301 thermal disinfection
- 3.302 thermolabile
- 3.303 tissue
- 3.304 transfer port
- 3.305 transit dose
- 3.306 type test
- 3.307 uncertainty budget
- 3.308 unidirectional airflow
- 3.309 unit operation
- 3.310 unloading door
- 3.311 usable chamber space
- 3.312 user-assembled pack
- 3.313 validation
- 3.314 verification
- 3.315 verification dose
- 3.316 viable count
- 3.317 visible change
- 3.318 volume
- 3.318.1 chamber volume
- 3.318.2 dead volume
- 3.318.3 load volume
- 3.319 washer-disinfector; WD;
- 3.320 washer-disinfector accessory
- 3.321 washing
- 3.322 washing temperature
- 3.323 washing time
- 3.324 water charge
- 3.325 works test
- 3.326 z value
- 3.327 (process
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Nahlásit chybu
3.220.1 design qualification
process for verification that the proposed specification for the facility, equipment, or system meets the expectation for the intended use
3.220.1 kvalifikace návrhu
proces pro ověření, že navržená specifikace zařízení, vybavení nebo systému splňuje předpoklady pro určené použití