Glossary / 鏈琛?¶
This glossary provides definitions and Chinese-English translations for common terms in medical device embedded software development.
鏈湳璇〃鎻愪緵鍖荤枟鍣ㄦ宓屽叆寮忚蒋浠跺紑鍙戜腑甯哥敤鏈鐨勫畾涔夊拰涓嫳鏂囧鐓с€?
A¶
ADC (Analog-to-Digital Converter) | 妯℃暟杞崲鍣?¶
An electronic device that converts analog signals to digital signals. Used in medical devices to acquire sensor signals.
灏嗘ā鎷熶俊鍙疯浆鎹负鏁板瓧淇″彿鐨勭數瀛愬櫒浠躲€傚湪鍖荤枟鍣ㄦ涓敤浜庨噰闆嗕紶鎰熷櫒淇″彿銆?
Acceptance Criteria | 楠屾敹鏍囧噯¶
Verifiable conditions that define whether software requirements are met.
瀹氫箟杞欢闇€姹傛槸鍚︽弧瓒崇殑鍙獙璇佹潯浠躲€?
B¶
BSS Segment | BSS娈?¶
Memory region storing uninitialized global and static variables, zeroed at program startup.
瀛樺偍鏈垵濮嬪寲鍏ㄥ眬鍙橀噺鍜岄潤鎬佸彉閲忕殑鍐呭瓨鍖哄煙,绋嬪簭鍚姩鏃舵竻闆躲€?
Buffer Overflow | 缂撳啿鍖烘孩鍑?¶
Writing data beyond a buffer's capacity, potentially causing security vulnerabilities.
鍚戠紦鍐插尯鍐欏叆瓒呰繃鍏跺閲忕殑鏁版嵁锛屽彲鑳藉鑷村畨鍏ㄦ紡娲炪€?
C¶
CERT C | CERT C瀹夊叏缂栫爜鏍囧噯¶
C language secure coding standard developed by Carnegie Mellon University's Software Engineering Institute, focusing on security vulnerability prevention.
鐢卞崱鍐呭熀姊呴殕澶у杞欢宸ョ▼鐮旂┒鎵€寮€鍙戠殑C璇█瀹夊叏缂栫爜鏍囧噯锛屼笓娉ㄤ簬瀹夊叏婕忔礊棰勯槻銆?
Class A/B/C Software | A/B/C绫昏蒋浠?¶
Software safety classification defined by IEC 62304: Class A (low risk), Class B (medium risk), Class C (high risk).
IEC 62304瀹氫箟鐨勮蒋浠跺畨鍏ㄥ垎绫伙細Class A锛堜綆椋庨櫓锛夈€丆lass B锛堜腑椋庨櫓锛夈€丆lass C锛堥珮椋庨櫓锛夈€?
Configuration Management | 閰嶇疆绠＄悊¶
Process of systematically managing changes and versions of software configuration items.
绯荤粺鍦扮鐞嗚蒋浠堕厤缃」鐨勫彉鏇村拰鐗堟湰鐨勮繃绋嬨€?
D¶
DAC (Digital-to-Analog Converter) | 鏁版ā杞崲鍣?¶
An electronic device that converts digital signals to analog signals.
灏嗘暟瀛椾俊鍙疯浆鎹负妯℃嫙淇″彿鐨勭數瀛愬櫒浠躲€?
DMA (Direct Memory Access) | 鐩存帴鍐呭瓨璁块棶¶
Technology allowing peripherals to access memory directly without CPU intervention.
鍏佽澶栬鐩存帴璁块棶鍐呭瓨鑰屼笉闇€瑕丆PU骞查鐨勬妧鏈€?
E¶
EMC (Electromagnetic Compatibility) | 鐢电鍏煎鎬?¶
Ability of equipment to function properly in electromagnetic environment without causing interference to other equipment.
璁惧鍦ㄧ數纾佺幆澧冧腑姝ｅ父宸ヤ綔涓斾笉瀵瑰叾浠栬澶囦骇鐢熷共鎵扮殑鑳藉姏銆?
Embedded System | 宓屽叆寮忕郴缁?¶
Computer system dedicated to specific functions, typically integrated into larger devices.
涓撶敤浜庣壒瀹氬姛鑳界殑璁＄畻鏈虹郴缁燂紝閫氬父闆嗘垚鍦ㄦ洿澶х殑璁惧涓€?
F¶
FDA (Food and Drug Administration) | 缇庡浗椋熷搧鑽搧鐩戠潱绠＄悊灞€¶
Federal agency responsible for regulating medical devices in the United States.
璐熻矗鐩戠缇庡浗鍖荤枟鍣ㄦ鐨勮仈閭︽満鏋勩€?
FFT (Fast Fourier Transform) | 蹇€熷倕閲屽彾鍙樻崲¶
An efficient algorithm for computing discrete Fourier transform, used in signal processing.
涓€绉嶉珮鏁堣绠楃鏁ｅ倕閲屽彾鍙樻崲鐨勭畻娉曪紝鐢ㄤ簬淇″彿澶勭悊銆?
Firmware | 鍥轰欢¶
Software stored in non-volatile memory that controls basic hardware device functions.
瀛樺偍鍦ㄩ潪鏄撳け鎬у瓨鍌ㄥ櫒涓殑杞欢锛屾帶鍒剁‖浠惰澶囩殑鍩烘湰鍔熻兘銆?
H¶
HAL (Hardware Abstraction Layer) | 纭欢鎶借薄灞?¶
Software layer providing unified interface to access hardware, isolating hardware dependencies.
鎻愪緵缁熶竴鎺ュ彛璁块棶纭欢鐨勮蒋浠跺眰锛岄殧绂荤‖浠朵緷璧栥€?
Heap | 鍫?¶
Memory region for dynamic memory allocation, manually managed by programmers.
鐢ㄤ簬鍔ㄦ€佸唴瀛樺垎閰嶇殑鍐呭瓨鍖哄煙锛岀敱绋嬪簭鍛樻墜鍔ㄧ鐞嗐€?
I¶
I2C (Inter-Integrated Circuit) | 闆嗘垚鐢佃矾鎬荤嚎¶
Serial communication protocol for connecting low-speed peripheral devices. Supports multiple masters and slaves.
涓€绉嶄覆琛岄€氫俊鍗忚锛岀敤浜庤繛鎺ヤ綆閫熷鍥磋澶囥€傛敮鎸佸涓绘満鍜屽浠庢満銆?
IEC (International Electrotechnical Commission) | 鍥介檯鐢靛伐濮斿憳浼?¶
Organization that develops international standards for electrical and electronic technologies.
鍒跺畾鐢垫皵鍜岀數瀛愭妧鏈浗闄呮爣鍑嗙殑缁勭粐銆?
IEC 62304 | IEC 62304鏍囧噯¶
International standard for medical device software lifecycle processes.
鍖荤枟鍣ㄦ杞欢鐢熷懡鍛ㄦ湡杩囩▼鍥介檯鏍囧噯銆?
Interrupt | 涓柇¶
Hardware or software event that suspends current program execution to handle urgent tasks.
纭欢鎴栬蒋浠朵簨浠讹紝鏆傚仠褰撳墠绋嬪簭鎵ц浠ュ鐞嗙揣鎬ヤ换鍔°€?
ISO (International Organization for Standardization) | 鍥介檯鏍囧噯鍖栫粍缁?¶
Independent non-governmental organization that develops international standards.
鍒跺畾鍥介檯鏍囧噯鐨勭嫭绔嬮潪鏀垮簻缁勭粐銆?
ISO 13485 | ISO 13485鏍囧噯¶
International standard for medical device quality management systems.
鍖荤枟鍣ㄦ璐ㄩ噺绠＄悊浣撶郴鍥介檯鏍囧噯銆?
ISO 14971 | ISO 14971鏍囧噯¶
International standard for medical device risk management.
鍖荤枟鍣ㄦ椋庨櫓绠＄悊鍥介檯鏍囧噯銆?
M¶
Memory Fragmentation | 鍐呭瓨纰庣墖¶
Non-contiguous memory space resulting from frequent allocation and deallocation.
棰戠箒鍒嗛厤鍜岄噴鏀惧唴瀛樺鑷寸殑鍐呭瓨绌洪棿涓嶈繛缁幇璞°€?
Memory Leak | 鍐呭瓨娉勬紡¶
Failure to properly release allocated memory, causing gradual reduction in available memory.
绋嬪簭鍒嗛厤鍐呭瓨鍚庢湭鑳芥纭噴鏀撅紝瀵艰嚧鍙敤鍐呭瓨閫愭笎鍑忓皯銆?
Memory Pool | 鍐呭瓨姹?¶
Collection of pre-allocated fixed-size memory blocks providing deterministic memory management.
棰勫厛鍒嗛厤鐨勫浐瀹氬ぇ灏忓唴瀛樺潡闆嗗悎锛屾彁渚涚‘瀹氭€х殑鍐呭瓨绠＄悊銆?
MISRA C | MISRA C缂栫爜鏍囧噯¶
C language coding standard developed by Motor Industry Software Reliability Association, widely used in safety-critical systems.
姹借溅宸ヤ笟杞欢鍙潬鎬у崗浼氬埗瀹氱殑C璇█缂栫爜鏍囧噯锛屽箍娉涘簲鐢ㄤ簬瀹夊叏鍏抽敭绯荤粺銆?
MPU (Memory Protection Unit) | 鍐呭瓨淇濇姢鍗曞厓¶
Hardware component used to protect memory regions from illegal access.
纭欢缁勪欢锛岀敤浜庝繚鎶ゅ唴瀛樺尯鍩熷厤鍙楅潪娉曡闂€?
P¶
PMA (Premarket Approval) | 涓婂競鍓嶆壒鍑?¶
FDA approval process for high-risk medical devices.
FDA瀵归珮椋庨櫓鍖荤枟鍣ㄦ鐨勫鎵规祦绋嬨€?
Pointer | 鎸囬拡¶
Variable storing memory address, used for indirect data access.
瀛樺偍鍐呭瓨鍦板潃鐨勫彉閲忥紝鐢ㄤ簬闂存帴璁块棶鏁版嵁銆?
Property-Based Testing | 鍩轰簬灞炴€х殑娴嬭瘯¶
Testing method that verifies system properties hold across many random inputs.
閫氳繃楠岃瘉绯荤粺灞炴€у湪澶ч噺闅忔満杈撳叆涓嬩繚鎸佷笉鍙樻潵娴嬭瘯杞欢鐨勬柟娉曘€?
R¶
Real-Time System | 瀹炴椂绯荤粺¶
System that must respond to events within specified time, classified as hard real-time or soft real-time.
蹇呴』鍦ㄨ瀹氭椂闂村唴鍝嶅簲浜嬩欢鐨勭郴缁燂紝鍒嗕负纭疄鏃跺拰杞疄鏃躲€?
Requirements Traceability | 闇€姹傝拷婧?¶
Establishing relationships between requirements and design, implementation, and testing.
寤虹珛闇€姹備笌璁捐銆佸疄鐜般€佹祴璇曚箣闂寸殑鍏宠仈鍏崇郴銆?
Risk Management | 椋庨櫓绠＄悊¶
Systematic process of identifying, evaluating, and controlling product risks.
璇嗗埆銆佽瘎浼板拰鎺у埗浜у搧椋庨櫓鐨勭郴缁熻繃绋嬨€?
RTOS (Real-Time Operating System) | 瀹炴椂鎿嶄綔绯荤粺¶
Operating system capable of responding to external events within specified time.
鑳藉鍦ㄨ瀹氭椂闂村唴鍝嶅簲澶栭儴浜嬩欢鐨勬搷浣滅郴缁熴€?
S¶
Safety Classification | 瀹夊叏鍒嗙被¶
Classifying software based on severity of harm that software failure may cause.
鏍规嵁杞欢鏁呴殰鍙兘閫犳垚鐨勫嵄瀹崇▼搴﹀杞欢杩涜鍒嗙被銆?
SOUP (Software of Unknown Provenance) | 鏉ユ簮涓嶆槑杞欢¶
Third-party software, open-source software, or commercial off-the-shelf software requiring special management.
绗笁鏂硅蒋浠躲€佸紑婧愯蒋浠舵垨鍟嗕笟鐜版垚杞欢锛岄渶瑕佺壒娈婄鐞嗐€?
SPI (Serial Peripheral Interface) | 涓茶澶栬鎺ュ彛¶
High-speed full-duplex synchronous serial communication protocol.
涓€绉嶉珮閫熷叏鍙屽伐鍚屾涓茶閫氫俊鍗忚銆?
Stack | 鏍?¶
Automatically managed memory region for storing local variables and function call information.
鑷姩绠＄悊鐨勫唴瀛樺尯鍩燂紝鐢ㄤ簬瀛樺偍灞€閮ㄥ彉閲忓拰鍑芥暟璋冪敤淇℃伅銆?
Stack Overflow | 鏍堟孩鍑?¶
Stack memory usage exceeding allocated size, potentially causing system crash.
鏍堝唴瀛樹娇鐢ㄨ秴杩囧垎閰嶅ぇ灏忥紝鍙兘瀵艰嚧绯荤粺宕╂簝銆?
Static Analysis | 闈欐€佸垎鏋?¶
Technique of analyzing source code without executing it to find potential defects.
涓嶆墽琛岀▼搴忚€屽垎鏋愭簮浠ｇ爜浠ュ彂鐜版綔鍦ㄧ己闄风殑鎶€鏈€?
Static Memory | 闈欐€佸唴瀛?¶
Memory allocated at compile time with lifetime spanning entire program execution.
鍦ㄧ紪璇戞椂鍒嗛厤銆佺敓鍛藉懆鏈熻疮绌挎暣涓▼搴忕殑鍐呭瓨銆?
T¶
Task Scheduling | 浠诲姟璋冨害¶
Mechanism in RTOS determining which task executes when.
RTOS涓喅瀹氬摢涓换鍔″湪浣曟椂鎵ц鐨勬満鍒躲€?
Traceability Matrix | 杩芥函鐭╅樀¶
Table documenting relationships between requirements and other artifacts (design, tests, etc.).
鏂囨。鍖栭渶姹備笌鍏朵粬宸ヤ欢锛堣璁°€佹祴璇曠瓑锛変箣闂村叧绯荤殑琛ㄦ牸銆?
U¶
UART (Universal Asynchronous Receiver/Transmitter) | 閫氱敤寮傛鏀跺彂鍣?¶
Asynchronous serial communication protocol commonly used for inter-device communication.
涓€绉嶅紓姝ヤ覆琛岄€氫俊鍗忚锛屽父鐢ㄤ簬璁惧闂撮€氫俊銆?
Unit Testing | 鍗曞厓娴嬭瘯¶
Testing method that verifies smallest testable units of software.
瀵硅蒋浠舵渶灏忓彲娴嬭瘯鍗曞厓杩涜楠岃瘉鐨勬祴璇曟柟娉曘€?
V¶
Validation | 纭¶
Process of verifying product meets user needs and intended use.
楠岃瘉浜у搧婊¤冻鐢ㄦ埛闇€姹傚拰棰勬湡鐢ㄩ€旂殑杩囩▼銆?
Verification | 楠岃瘉¶
Process of verifying product meets specified requirements.
楠岃瘉浜у搧婊¤冻瑙勫畾闇€姹傜殑杩囩▼銆?
W¶
Watchdog Timer | 鐪嬮棬鐙楀畾鏃跺櫒¶
Hardware or software timer used to detect and recover from system failures.
纭欢鎴栬蒋浠跺畾鏃跺櫒锛岀敤浜庢娴嬪拰鎭㈠绯荤粺鏁呴殰銆?
This glossary is continuously updated. Suggestions and additions are welcome.
*鏈湳璇〃鎸佺画鏇存柊涓€傚鏈夊缓璁垨琛ュ厖锛屾杩庡弽棣堛€?
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