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
3.220.4 performance qualification; PQ;
process of establishing by objective evidence that the process, under anticipated conditions, consistently produces a product which meets all predetermined requirements
3.220.4 funkční kvalifikace; PQ;
proces potvrzování objektivními důkazy, že proces za předpokládaných podmínek poskytuje trvale výrobek, který splňuje všechny předem stanovené požadavky