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Medical electrical equipment - Part 1: General requirements for safety - 4. Collateral standard: Programmable electrical medical systems
| 분야 | TC 62 : Medical equipment, software, and systems |
|---|---|
| 적용범위 | Specifies requirements for the process by which a programmable electrical medical system is designed. Serves as the basis of requirements of Particular Standards, including serving as a guide to safety requirements for the purpose of reducing and managing risk.This standard covers requirement specification, architecture, detailed design and implementation software development, modification, verification and validation, marking and accompanying documents. |
| 국제분류(ICS)코드 | 11.040.01 : 일반 의료장비 |
| 페이지수 | 61 |
| Edition | 1.0 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | IEC 60601-1-4:1996+AMD1:1999 CSV | Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems | 2000-04-07 | 폐지 |
| 2 | IEC 60601-1-4:1996/AMD1:1999 | Amendment 1 - Medical electrical equipment - Part 1: General requirements for safety - 4. Collateral standard: Programmable electrical medical systems | 1999-10-29 | 폐지 |
| 3 | IEC 60601-1-4:1996 | Medical electrical equipment - Part 1: General requirements for safety - 4. Collateral standard: Programmable electrical medical systems | 1996-05-31 | 폐지 |
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